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Aranesp (darbepoetin alfa) – Labelling - B03XA02

Updated on site: 05-Oct-2017

Medication nameAranesp
ATC CodeB03XA02
Substancedarbepoetin alfa
ManufacturerAmgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1.NAME OF THE MEDICINAL PRODUCT

Aranesp 10 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled syringe contains 10 micrograms darbepoetin alfa (25 micrograms/ml).

3.LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/001 1 pack

EU/1/01/185/002 4 pack

EU/1/01/185/074 1 pack with needle guard

EU/1/01/185/075 4 pack with needle guard

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Aranesp 10 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 10 µg injection

Darbepoetin alfa

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

IV/SC 0.4 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 10 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.4 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 10 µg

Darbepoetin alfa

IV/SC

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6.OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 10 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled syringe contains 10 micrograms darbepoetin alfa (25 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/033

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 10 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 10 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 15 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.375 ml pre-filled syringe contains 15 micrograms darbepoetin alfa (40 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/003 1 pack

EU/1/01/185/004 4 pack

EU/1/01/185/076 1 pack with needle guard

EU/1/01/185/077 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 15 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 15 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.375 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 15 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.375 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 15 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.375 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 15 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.375 ml pre-filled syringe contains 15 micrograms darbepoetin alfa (40 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/034

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 15 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 15 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.375 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 20 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled syringe contains 20 micrograms darbepoetin alfa (40 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/005 1 pack

EU/1/01/185/006 4 pack

EU/1/01/185/078 1 pack with needle guard

EU/1/01/185/079 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 20 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 20 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.5 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 20 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.5 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 20 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 20 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled syringe contains 20 micrograms darbepoetin alfa (40 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/035

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 20 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 20 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 30 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled syringe contains 30 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/007 1 pack

EU/1/01/185/008 4 pack

EU/1/01/185/080 1 pack with needle guard

EU/1/01/185/081 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 30 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 30 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.3 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 30 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.3 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 30 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 30 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled syringe contains 30 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/036

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 30 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 30 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 40 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled syringe contains 40 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/009 1 pack

EU/1/01/185/010 4 pack

EU/1/01/185/082 1 pack with needle guard

EU/1/01/185/083 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 40 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 40 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.4 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 40 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.4 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 40 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 40 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled syringe contains 40 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/037

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 40 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 40 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 50 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled syringe contains 50 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/011 1 pack

EU/1/01/185/012 4 pack

EU/1/01/185/084 1 pack with needle guard

EU/1/01/185/085 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 50 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 50 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.5 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 50 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.5 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 50 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 50 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled syringe contains 50 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/038

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 50 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 50 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 60 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled syringe contains 60 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/013 1 pack

EU/1/01/185/014 4 pack

EU/1/01/185/086 1 pack with needle guard

EU/1/01/185/087 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 60 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 60 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.3 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 60 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.3 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 60 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 60 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled syringe contains 60 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/039

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 60 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 60 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 80 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled syringe contains 80 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/015 1 pack

EU/1/01/185/016 4 pack

EU/1/01/185/088 1 pack with needle guard

EU/1/01/185/089 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 80 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 80 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.4 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 80 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.4 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 80 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 80 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled syringe contains 80 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/040

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 80 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 80 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 100 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled syringe contains 100 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/017 1 pack

EU/1/01/185/018 4 pack

EU/1/01/185/090 1 pack with needle guard

EU/1/01/185/091 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 100 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 100 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.5 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 100 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.5 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 100 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 100 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled syringe contains 100 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/041

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 100 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 100 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 130 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.65 ml pre-filled syringe contains 130 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/069 1 pack

EU/1/01/185/070 4 pack

EU/1/01/185/092 1 pack with needle guard

EU/1/01/185/093 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 130 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 130 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.65 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 130 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.65 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 130 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.65 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 130 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.65 ml pre-filled syringe contains 130 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/071

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 130 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 130 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.65 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 150 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled syringe contains 150 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/019 1 pack

EU/1/01/185/020 4 pack

EU/1/01/185/094 1 pack with needle guard

EU/1/01/185/095 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 150 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 150 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.3 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 150 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.3 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 150 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 150 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled syringe contains 150 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/042

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 150 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 150 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 300 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.6 ml pre-filled syringe contains 300 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/021 1 pack

EU/1/01/185/022 4 pack

EU/1/01/185/096 1 pack with needle guard

EU/1/01/185/097 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 300 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 300 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.6 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 300 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 0.6 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 300 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.6 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 300 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.6 ml pre-filled syringe contains 300 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/043

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 300 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 300 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.6 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 500 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml pre-filled syringe contains 500 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1single use pre-filled syringe. 4 single use pre-filled syringes.

1single use pre-filled syringe with automatic needle guard. 4 single use pre-filled syringes with automatic needle guards.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Important: read the package leaflet before handling pre-filled syringe.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/031 1 pack

EU/1/01/185/032 4 pack

EU/1/01/185/098 1 pack with needle guard

EU/1/01/185/099 4 pack with needle guard

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 500 syringe

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

TRAY FOR PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 500 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 1 ml

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 500 µg injection

Darbepoetin alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

IV/SC 1 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 500 µg

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED SYRINGE CARTON WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 500 micrograms solution for injection in pre-filled syringe

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml pre-filled syringe contains 500 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use pre-filled syringe.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/044

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 500 syringe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 500 µg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 10 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled pen contains 10 micrograms darbepoetin alfa (25 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/045 1 pack

EU/1/01/185/057 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 10 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 10 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 15 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.375 ml pre-filled pen contains 15 micrograms darbepoetin alfa (40 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/046 1 pack

EU/1/01/185/058 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 15 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 15 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.375 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 20 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled pen contains 20 micrograms darbepoetin alfa (40 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/047 1 pack

EU/1/01/185/059 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 20 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 20 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 30 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled pen contains 30 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/048 1 pack

EU/1/01/185/060 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 30 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 30 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 40 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled pen contains 40 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/049 1 pack

EU/1/01/185/061 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 40 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 40 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 50 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled pen contains 50 micrograms darbepoetin alfa (100 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/050 1 pack

EU/1/01/185/062 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 50 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 50 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 60 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled pen contains 60 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/051 1 pack

EU/1/01/185/063 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 60 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 60 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 80 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.4 ml pre-filled pen contains 80 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/052 1 pack

EU/1/01/185/064 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 80 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 80 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.4 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 100 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.5 ml pre-filled pen contains 100 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/053 1 pack

EU/1/01/185/065 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 100 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 100 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 130 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.65 ml pre-filled pen contains 130 micrograms darbepoetin alfa (200 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/072 1 pack

EU/1/01/185/073 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 130 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 130 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.65 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 150 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.3 ml pre-filled pen contains 150 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/054 1 pack

EU/1/01/185/066 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 150 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 150 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.3 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 300 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 0.6 ml pre-filled pen contains 300 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/055 1 pack

EU/1/01/185/067 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 300 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 300 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.6 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PRE-FILLED PEN CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 500 micrograms solution for injection in pre-filled pen

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml pre-filled pen contains 500 micrograms darbepoetin alfa (500 micrograms/ml).

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

SureClick x1

1 single use pre-filled pen

This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4

4 single use pre-filled pens

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/056 1 pack

EU/1/01/185/068 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aranesp 500 pen

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 500 µg injection

Darbepoetin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

Amgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

VIAL CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 25 micrograms solution for injection in vial

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml vial contains 25 micrograms darbepoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use vial

4 single use vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/100 1 pack

EU/1/01/185/101 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 25 mcg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

VIAL CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 40 micrograms solution for injection in vial

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml vial contains 40 micrograms darbepoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use vial

4 single use vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/102 1 pack

EU/1/01/185/103 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 40 mcg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

VIAL CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 60 micrograms solution for injection in vial

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml vial contains 60 micrograms darbepoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use vial

4 single use vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/104 1 pack

EU/1/01/185/105 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 60 mcg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

VIAL CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 100 micrograms solution for injection in vial

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml vial contains 100 micrograms darbepoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use vial

4 single use vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/106 1 pack

EU/1/01/185/107 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 100 mcg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

VIAL CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 200 micrograms solution for injection in vial

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml vial contains 200 micrograms darbepoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use vial

4 single use vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/108 1 pack

EU/1/01/185/109 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 200 mcg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

VIAL CARTON

1. NAME OF THE MEDICINAL PRODUCT

Aranesp 300 micrograms solution for injection in vial

Darbepoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 1 ml vial contains 300 micrograms darbepoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 single use vial

4 single use vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous or subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/185/110 1 pack

EU/1/01/185/111 4 pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Aranesp 300 mcg injection

Darbepoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

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