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Lamivudine Teva Pharma B.V. (lamivudine) – Labelling - J05AF05

Updated on site: 08-Oct-2017

Medication nameLamivudine Teva Pharma B.V.
ATC CodeJ05AF05
Substancelamivudine
ManufacturerTeva B.V.  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON – LAMIVUDINE TEVA PHARMA B.V. 150 MG FILM-COATED TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva Pharma B.V. 150 mg film-coated tablets

Lamivudine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg of lamivudine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

20 film-coated tablets

30 film-coated tablets

60 film-coated tablets

80 film-coated tablets

90 film-coated tablets

100 film-coated tablets

500 film-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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/596/001

EU/1/09/596/002

EU/1/09/596/003

EU/1/09/596/004

EU/1/09/596/005

EU/1/09/596/006

EU/1/09/596/015

13.BATCH NUMBER

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Lamivudine Teva Pharma B.V. 150 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Immediate packaging (blister foil)

1. NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Lamivudine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

TEVA B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Tablet container – Lamivudine Teva Pharma B.V. 150 mg film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva Pharma B.V. 150 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg of lamivudine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 film-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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/596/007

13. BATCH NUMBER

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON - LAMIVUDINE TEVA PHARMA B.V. 300 MG FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva Pharma B.V. 300 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg of lamivudine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

20 film-coated tablets

30 film-coated tablets

60 film-coated tablets

80 film-coated tablets

90 film-coated tablets

100 film-coated tablets

500 film-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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/596/008

EU/1/09/596/009

EU/1/09/596/010

EU/1/09/596/011

EU/1/09/596/012

EU/1/09/596/013

EU/1/09/596/016

13. BATCH NUMBER

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Lamivudine Teva Pharma B.V. 300 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Immediate packaging (blister foil)

1. NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva Pharma B.V. 300 mg film-coated tablets Lamivudine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

TEVA B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

LOT

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Tablet container – Lamivudine Teva Pharma B.V. 300mg film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva Pharma B.V. 300 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg of lamivudine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/596/014

13. BATCH NUMBER

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

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