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Ocaliva (obeticholic acid) – Labelling - A05AA04

Updated on site: 08-Oct-2017

Medication nameOcaliva
ATC CodeA05AA04
Substanceobeticholic acid
ManufacturerIntercept Pharma Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON 5 mg

1.NAME OF THE MEDICINAL PRODUCT

OCALIVA 5 mg film-coated tablets obeticholic acid

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 5 mg of obeticholic acid.

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

Intercept Pharma Ltd.

2 Pancras Square

London, N1C 4AG

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1139/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

OCALIVA 5 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON 10 mg

1. NAME OF THE MEDICINAL PRODUCT

OCALIVA 10 mg film-coated tablets obeticholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 10 mg of obeticholic acid.

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

Intercept Pharma Ltd.

2 Pancras Square

London, N1C 4AG

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1139/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

OCALIVA 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}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON 5 mg

1. NAME OF THE MEDICINAL PRODUCT

OCALIVA 5 mg film-coated tablets obeticholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 5 mg of obeticholic acid.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

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

Intercept Pharma Ltd.

2 Pancras Square

London, N1C 4AG

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1139/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

OCALIVA 5 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON 10 mg

1. NAME OF THE MEDICINAL PRODUCT

OCALIVA 10 mg film-coated tablets obeticholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 10 mg of obeticholic acid.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

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

Intercept Pharma Ltd.

2 Pancras Square

London, N1C 4AG

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1139/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

OCALIVA 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}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE 5 mg

1. NAME OF THE MEDICINAL PRODUCT

OCALIVA 5 mg film-coated tablets obeticholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 5 mg of obeticholic acid.

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

Intercept Pharma Ltd.

2 Pancras Square

London, N1C 4AG

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1139/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE 10 mg

1. NAME OF THE MEDICINAL PRODUCT

OCALIVA 10 mg film-coated tablets obeticholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains10 mg of obeticholic acid.

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

Intercept Pharma Ltd.

2 Pancras Square

London, N1C 4AG

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1139/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE 5 mg

1. NAME OF THE MEDICINAL PRODUCT

OCALIVA 5 mg film-coated tablets obeticholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 5 mg of obeticholic acid.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

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

Intercept Pharma Ltd.

2 Pancras Square

London, N1C 4AG

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1139/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE 10 mg

1. NAME OF THE MEDICINAL PRODUCT

OCALIVA 10 mg film-coated tablets obeticholic acid

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains10 mg of obeticholic acid.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

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

Intercept Pharma Ltd.

2 Pancras Square

London, N1C 4AG

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1139/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

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