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Zyprexa (olanzapine) – Labelling - N05AH03

Updated on site: 11-Oct-2017

Medication nameZyprexa
ATC CodeN05AH03
Substanceolanzapine
ManufacturerEli Lilly Nederland B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF COATED TABLETS IN BLISTERS

1.NAME OF THE MEDICINAL PRODUCT

ZYPREXA 2.5 mg coated tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 2.5 mg olanzapine

3.LIST OF EXCIPIENTS

Contains lactose monohydrate see package leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

28 coated tablets

35 coated tablets

56 coated tablets

70 coated tablets

98 coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral 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 the original package 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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/96/022/002 28 coated tablets

EU/1/96/022/023 35 coated tablets

EU/1/96/022/019 56 coated tablets

EU/1/96/022/029 70 coated tablets

EU/1/96/022/035 98 coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

ZYPREXA 2.5 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 2.5 mg COATED TABLETS: BLISTER FOIL LABEL

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 2.5 mg coated tablets

Olanzapine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF COATED TABLETS IN BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 5 mg coated tablets olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 5 mg olanzapine

3. LIST OF EXCIPIENTS

Contains lactose monohydrate see package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

28 coated tablets

35 coated tablets

56 coated tablets

70 coated tablets

98 coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral 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 the original package 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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/022/004 28 coated tablets

EU/1/96/022/024 35 coated tablets

EU/1/96/022/020 56 coated tablets

EU/1/96/022/030 70 coated tablets

EU/1/96/022/036 98 coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ZYPREXA 5 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 5 mg COATED TABLETS: BLISTER FOIL LABEL

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 5 mg coated tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF COATED TABLETS IN BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 7.5 mg coated tablets olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 7.5 mg olanzapine

3. LIST OF EXCIPIENTS

Contains lactose monohydrate see package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

28 coated tablets

35 coated tablets

56 coated tablets

70 coated tablets

98 coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral 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 the original package 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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/022/01128 coated tablets

EU/1/96/022/025 35 coated tablets

EU/1/96/022/006 56 coated tablets

EU/1/96/022/031 70 coated tablets

EU/1/96/022/037 98 coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ZYPREXA 7.5 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 7.5 mg COATED TABLETS: BLISTER FOIL LABEL

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 7.5 mg coated tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF COATED TABLETS IN BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 10 mg coated tablets olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 10 mg olanzapine

3. LIST OF EXCIPIENTS

Contains lactose monohydrate see package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

28 coated tablets

35 coated tablets

56 coated tablets

70 coated tablets

98 coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral 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 the original package 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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/022/009 28 coated tablets

EU/1/96/022/026 35 coated tablets

EU/1/96/022/010 56 coated tablets

EU/1/96/022/032 70 coated tablets

EU/1/96/022/038 98 coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ZYPREXA 10 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 10 mg COATED TABLETS: BLISTER FOIL LABEL

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 10 mg coated tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF COATED TABLETS IN BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 15 mg coated tablets olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 15 mg olanzapine

3. LIST OF EXCIPIENTS

Contains lactose monohydrate see package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

28 coated tablets

35 coated tablets

56 coated tablets

70 coated tablets

98 coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral 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 the original package 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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/022/012 28 coated tablets

EU/1/96/022/027 35 coated tablets

EU/1/96/022/021 56 coated tablets

EU/1/96/022/033 70 coated tablets

EU/1/96/022/039 98 coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ZYPREXA 15 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 15 mg COATED TABLETS: BLISTER FOIL LABEL

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 15 mg coated tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF COATED TABLETS IN BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 20 mg coated tablets olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 20 mg olanzapine

3. LIST OF EXCIPIENTS

Contains lactose monohydrate see package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

28 coated tablets

35 coated tablets

56 coated tablets

70 coated tablets

98 coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral 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 the original package 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

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/022/014 28 coated tablets

EU/1/96/022/028 35 coated tablets

EU/1/96/022/022 56 coated tablets

EU/1/96/022/034 70 coated tablets

EU/1/96/022/040 98 coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ZYPREXA 20 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 20 mg COATED TABLETS: BLISTER FOIL LABEL

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 20 mg coated tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF VIAL OF POWDER

1. NAME OF THE MEDICINAL PRODUCT

ZYPREXA 10 mg powder for solution for injection olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 10 mg olanzapine. After reconstitution each ml of the solution contains 5 mg olanzapine

3. LIST OF EXCIPIENTS

Lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for injection. 1 vial

Powder for solution for injection. 10 vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use. Single use vial. 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

Use solution within 1 hour

9. SPECIAL STORAGE CONDITIONS

Do not store above 25º C. Store in original package 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

Discard syringe and unused solution appropriately

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

12.MARKETING AUTHORISATION NUMBER (S)

EU/1/96/022/016 Powder for solution for injection. 1 vial

EU/1/96/022/017 Powder for solution for injection. 10 vials

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL ON VIAL OF 10 mg POWDER

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

ZYPREXA 10 mg olanzapine powder for solution for injection

IM use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use

3. EXPIRY DATE

EXP

Use solution within 1 hour

4. BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 mg olanzapine per vial

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