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Repatha (evolocumab) – Labelling - C10

Updated on site: 09-Oct-2017

Medication nameRepatha
ATC CodeC10
Substanceevolocumab
ManufacturerAmgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON PRE-FILLED SYRINGE

1.NAME OF THE MEDICINAL PRODUCT

Repatha 140 mg solution for injection in pre-filled syringe evolocumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution.

3.LIST OF EXCIPIENTS

Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. 1 pre-filled syringe.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use.

Read the package leaflet before 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

Contains latex, read the package leaflet before use.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original carton in order to protect from light.

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/1/15/1016/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Repatha 140 syringe

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PRE-FILLED SYRINGE BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Repatha 140 mg solution for injection evolocumab

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL PRE-FILLED SYRINGE

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

Repatha 140 mg injection evolocumab

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

CARTON PRE-FILLED PEN

1. NAME OF THE MEDICINAL PRODUCT

Repatha 140 mg solution for injection in pre-filled pen evolocumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.

3. LIST OF EXCIPIENTS

Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

1SureClick pre-filled pen.

2SureClick pre-filled pens.

3SureClick pre-filled pens.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use.

Read the package leaflet before 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

Contains latex, read the package leaflet before use.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original carton in order to protect from light.

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/1/15/1016/002

EU/1/15/1016/003

EU/1/15/1016/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Repatha 140 pen

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON PRE-FILLED PEN (without blue box)

1. NAME OF THE MEDICINAL PRODUCT

Repatha 140 mg solution for injection in pre-filled pen evolocumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.

3. LIST OF EXCIPIENTS

Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

2 SureClick pre-filled pens. Component of a multi-pack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use.

Read the package leaflet before 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

Contains latex, read the package leaflet before use.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original carton in order to protect from light.

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/1/15/1016/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Repatha 140 pen

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACK LABEL PRE-FILLED PEN (with blue box)

1. NAME OF THE MEDICINAL PRODUCT

Repatha 140 mg solution for injection in pre-filled pen evolocumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.

3. LIST OF EXCIPIENTS

Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

Multipack: 6 (3 packs of 2) single use SureClick pre-filled pens.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

Contains latex, read the package leaflet before use.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original carton in order to protect from light.

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/1/15/1016/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Repatha 140 pen

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL PRE-FILLED PEN

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

Repatha 140 mg injection evolocumab

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

CARTON AUTOMATED MINI DOSER

1. NAME OF THE MEDICINAL PRODUCT

Repatha 420 mg solution for injection in cartridge evolocumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).

3. LIST OF EXCIPIENTS

Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

1 cartridge and automated mini doser.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use.

Read the package leaflet before 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.

Store in the original carton in order to protect from light and moisture.

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/1/15/1016/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Repatha 420 cartridge

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON AUTOMATED MINI DOSER (without blue box)

1. NAME OF THE MEDICINAL PRODUCT

Repatha 420 mg solution for injection in cartridge evolocumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).

3. LIST OF EXCIPIENTS

Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

1 cartridge and automated mini doser. Component of a multi-pack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use.

Read the package leaflet before 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.

Store in the original carton in order to protect from light and moisture.

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/1/15/1016/007

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Repatha 420 cartridge

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIPACK LABEL AUTOMATED MINI DOSER (with blue box)

1. NAME OF THE MEDICINAL PRODUCT

Repatha 420 mg solution for injection in cartridge evolocumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).

3. LIST OF EXCIPIENTS

Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

Multipack: 3 (3 packs of 1) cartridges and automated mini dosers.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use.

Read the package leaflet before 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.

Store in the original carton in order to protect from light and moisture.

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/1/15/1016/007

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Repatha 420 cartridge

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL CARTRIDGE

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

Repatha 420 mg injection evolocumab

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3.5 ml

6. OTHER

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