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Baraclude (entecavir) – Labelling - J05AF10

Updated on site: 05-Oct-2017

Medication nameBaraclude
ATC CodeJ05AF10
Substanceentecavir
ManufacturerBristol-Myers Squibb Pharma EEIG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT

Baraclude 0.5 mg film-coated tablets entecavir

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 0.5 mg of entecavir.

3.LIST OF EXCIPIENTS

Also contains lactose monohydrate.

4.PHARMACEUTICAL FORM AND CONTENTS

 

 

30 x 1 film-coated tablet

Blister pack:

 

 

90 x 1 film-coated tablet

Bottle pack:

 

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

Blister pack:

Do not store above 30°C.

Store in the original carton.

Bottle pack:

Do not store above 25°C.

Keep the bottle tightly closed.

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

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

 

 

EU/1/06/343/003

 

 

 

Blister pack :

30 x 1 film-coated tablet

 

 

EU/1/06/343/006

90 x 1 film-coated tablet

 

Bottle pack:

 

EU/1/06/343/001

30 film-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

Outer carton: Baraclude 0.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Baraclude 0.5 mg tablets entecavir

2.NAME OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT

1. NAME OF THE MEDICINAL PRODUCT

Baraclude 1 mg film-coated tablets entecavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 1 mg of entecavir.

3. LIST OF EXCIPIENTS

Also contains lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

 

 

30 x 1 film-coated tablet

Blister pack:

 

 

90 x 1 film-coated tablet

Bottle pack:

 

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

Blister pack:

Do not store above 30°C.

Store in the original carton.

Bottle pack:

Do not store above 25°C.

Keep the bottle tightly closed.

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

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

 

 

EU/1/06/343/004

 

 

 

Blister pack :

30 x 1 film-coated tablet

 

 

EU/1/06/343/007

90 x 1 film-coated tablet

 

Bottle pack:

 

EU/1/06/343/002

30 film-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

Outer carton: Baraclude 1 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Baraclude 1 mg tablets entecavir

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON AND BOTTLE LABEL TEXT

1. NAME OF THE MEDICINAL PRODUCT

Baraclude 0.05 mg/ml oral solution entecavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml contains 0.05 mg entecavir.

3. LIST OF EXCIPIENTS

Also contains: maltitol, preservatives E216, E218.

4. PHARMACEUTICAL FORM AND CONTENTS

210 ml oral solution with a measuring spoon.

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

Do not store above 30°C.

Keep the bottle in the outer 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

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/343/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Outer carton: Baraclude 0.05 mg/ml

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