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Lamivudine Teva (lamivudine) – Labelling - J05AF05

Updated on site: 08-Oct-2017

Medication nameLamivudine Teva
ATC CodeJ05AF05
Substancelamivudine
ManufacturerTeva B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

carton

1.NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva 100 mg film-coated tablets

Lamivudine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg of lamivudine

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Blisters:

28 film-coated tablets

30 film-coated tablets

84 film-coated tablets

100 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/1/09/566/001– 28 Tablets

EU/1/09/566/002 – 30 Tablets

EU/1/09/566/003 – 84 Tablets

EU/1/09/566/004 – 100 Tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Lamivudine Teva 100 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Immediate packaging (blister foil)

1. NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva 100 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

1. NAME OF THE MEDICINAL PRODUCT

Lamivudine Teva 100 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg of lamivudine

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet container:

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/1/09/566/005 – 60 Tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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