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Epivir (lamivudine) – Labelling - J05AF05

Updated on site: 06-Oct-2017

Medication nameEpivir
ATC CodeJ05AF05
Substancelamivudine
ManufacturerViiV Healthcare UK Limited  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

BOTTLE CARTON X 60 FILM-COATED TABLETS (150 mg)

1.NAME OF THE MEDICINAL PRODUCT

Epivir 150 mg film-coated tablets

Lamivudine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains lamivudine 150 mg

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

60 film-coated tablets Scored tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/96/015/001

13.BATCH NUMBER

LOT

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

epivir 150 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

BOTTLE LABEL X 60 FILM-COATED TABLETS (150 mg)

1. NAME OF THE MEDICINAL PRODUCT

Epivir 150 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains lamivudine 150 mg

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 film-coated tablets Scored tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/015/001

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER CARTON X 60 FILM-COATED TABLETS (150 mg)

1. NAME OF THE MEDICINAL PRODUCT

Epivir 150 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains lamivudine 150 mg

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/015/004

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

epivir 150 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Epivir 150 mg tablets

lamivudine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

ViiV Healthcare UK Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

LOT

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

BOTTLE CARTON FOR ORAL SOLUTION

1. NAME OF THE MEDICINAL PRODUCT

Epivir 10 mg/ml oral solution

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of oral solution contains 10 mg lamivudine

3. LIST OF EXCIPIENTS

This product also contains sugar, preservatives: methyl parahydroxybenzoate and propyl parahydroxybenzoate

4. PHARMACEUTICAL FORM AND CONTENTS

Bottle contents: 240 ml oral solution

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C

Discard one month after first opening

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/015/002

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

epivir 10 mg/ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

BOTTLE LABEL FOR ORAL SOLUTION

1. NAME OF THE MEDICINAL PRODUCT

Epivir 10 mg/ml oral solution

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of oral solution contains 10 mg lamivudine

3. LIST OF EXCIPIENTS

This product also contains sugar, preservatives: methyl parahydroxybenzoate and propyl parahydroxybenzoate

4. PHARMACEUTICAL FORM AND CONTENTS

Bottle contents: 240 ml oral solution

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C

Discard one month after first opening

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/015/002

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

BOTTLE CARTON X 30 FILM-COATED TABLETS (300 mg )

1. NAME OF THE MEDICINAL PRODUCT

Epivir 300 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains

Lamivudine 300 mg

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/015/003

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

epivir 300 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

BOTTLE LABEL X 30 FILM-COATED TABLETS (300 mg )

1. NAME OF THE MEDICINAL PRODUCT

Epivir 300 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains

Lamivudine 300 mg

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/015/003

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER CARTON X 30 FILM-COATED TABLETS (300 mg )

1. NAME OF THE MEDICINAL PRODUCT

Epivir 300 mg film-coated tablets

Lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains lamivudine 300 mg

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/015/005

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

epivir 300 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Epivir 300 mg tablet

lamivudine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

ViiV Healthcare UK Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

LOT

5. OTHER

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