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Clopidogrel BMS (clopidogrel hydrogen sulphate) – Conditions or restrictions regarding supply and use - B01AC04

Updated on site: 06-Oct-2017

Medication nameClopidogrel BMS
ATC CodeB01AC04
Substanceclopidogrel hydrogen sulphate
ManufacturerBristol-Myers Squibb Pharma EEIG

A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

-Clopidogrel BMS 75 mg film-coated tablets

Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave

F-33565 Carbon Blanc cedex France

Sanofi Winthrop Industrie 6, Boulevard de l’Europe F-21800 Quétigny France

B. CONDITIONS OF THE MARKETING AUTHORISATION

Sanofi Synthelabo Limited

 

 

authorised

Edgefield Avenue

 

 

 

Fawdon

 

 

 

Newcastle upon Tyne NE3 3TT – UK

 

 

 

 

 

United Kingdom

 

 

 

 

The printed package leaflet of the medicinal product must state the name and address of the

manufacturer responsible for the release of the concerned batch.

 

-

Clopidogrel BMS 300 mg film-coated tablets

longer

 

Sanofi Winthrop Industrie

no

 

 

 

1, rue de la Vierge

 

 

 

Ambarès & Lagrave

 

 

 

 

 

 

 

F-33565 Carbon Blanc cedex

 

 

 

France

product

 

 

 

 

 

 

 

 

• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER

Medicinal product subject to medical prescription

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

MedicinalNot applicable.

OTHER CONDITIONS

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 dated

25 September 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.

 

 

 

longer

 

A. LABELLING

 

product

no

 

Medicinal

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Clopidogrel BMS 75 mg film-coated tablets clopidogrel

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

 

 

Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).

authorised

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

 

 

 

50x1 film-coated tablets

 

longer

 

 

 

 

It also contains: hydrogenated castor oil and lactose. See leaflet for further information.

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

28 film-coated tablets

 

 

 

 

 

 

 

30 film-coated tablets

 

 

 

no

 

 

 

 

 

84 film-coated tablets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

90 film-coated tablets

 

 

product

 

 

 

 

 

 

100 film-coated tablets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14 film-coated tablets

 

 

 

 

 

 

 

 

 

7 film-coated tablets

 

 

 

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

 

Oral use

 

 

 

 

 

Medicinal

 

 

 

 

 

 

 

Read the package leaflet before use.

 

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

 

 

 

Keep out of the reach and sight of children.

 

 

 

 

 

 

 

 

 

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

 

 

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

Store below 30°C (for PVC/PVDC/aluminium blisters)

Or No special storage conditions (for all aluminium blisters)

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

 

authorised

 

 

 

Uxbridge Business Park

 

 

 

 

Sanderson Road

 

 

 

 

 

 

 

 

Uxbridge UB8 1DH

 

 

 

 

 

 

 

United Kingdom

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12. MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/08/464/001

 

 

 

longer

 

 

 

14 tablets

 

 

 

 

EU/1/08/464/002

14 tablets

 

 

 

 

 

EU/1/08/464/003

28 tablets

 

 

 

 

 

EU/1/08/464/004

28 tablets

 

 

 

 

 

EU/1/08/464/005

30 tablets

 

 

 

 

 

EU/1/08/464/006

30 tablets

 

 

 

 

 

 

no

 

 

 

 

EU/1/08/464/007

50x1 tablets

 

 

 

 

EU/1/08/464/008

 

product

 

 

 

 

 

50x1 tablets

 

 

 

 

 

EU/1/08/464/009

84 tablets

 

 

 

 

 

 

EU/1/08/464/010

84 tablets

 

 

 

 

 

 

EU/1/08/464/011

90 tablets

 

 

 

 

 

 

EU/1/08/464/012

90 tablets

 

 

 

 

 

 

EU/1/08/464/013 100 tablets

 

 

 

 

 

 

EU/1/08/464/014 100 tablets

 

 

 

 

 

 

EU/1/08/464/018 7 tablets

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

 

 

EU/1/08/464/019 7 tablets

 

 

 

 

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Clopidogrel BMS 75 mg

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel BMS 75 mg film-coated tablets clopidogrel

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol Myers Squibb Pharma EEIG

3. EXPIRY DATE

 

 

4.

BATCH NUMBER

 

longer

 

 

 

 

 

 

 

 

 

 

Batch:

 

 

 

 

 

 

5.

OTHER

 

 

no

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Calendar days

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Mon

 

 

 

product

 

 

 

 

 

Tue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Wed

 

 

 

 

 

 

 

 

 

 

Thu

 

 

 

 

 

 

 

 

 

 

Fri

 

 

 

 

 

 

 

 

 

 

Sat

 

 

 

 

 

 

 

 

 

 

Sun

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Week 1

 

 

 

 

 

Medicinal

 

 

 

 

 

 

 

Week 2 (for boxes of 14, 28 and 84 tablets)

 

 

 

Week 3 (for boxes of 28 and 84 tablets)

Week 4 (for boxes of 28 and 84 tablets)

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/Boxes of 30, 50x1, 90 or 100 tablets

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel BMS 75 mg film-coated tablets clopidogrel

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol Myers Squibb Pharma EEIG

3. EXPIRY DATE

 

 

 

longer

 

OTHER

 

 

 

5.

 

 

 

4.

BATCH NUMBER

 

 

 

Batch:

 

 

 

 

 

 

product

no

 

 

 

 

 

Medicinal

 

 

 

 

 

 

authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel BMS 300 mg film-coated tablets clopidogrel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg of clopidogrel (as hydrogen sulphate).

3. LIST OF EXCIPIENTS

It also contains: hydrogenated castor oil and lactose. See leaflet for further information.authorised

4.PHARMACEUTICAL FORM AND CONTENTSlonger4x1 film-coated tablets30x1 film-coated tablets100x1 film-coated tablets

 

 

 

 

 

5.

 

no

 

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Keep out of the reach andproductsight of children.

 

 

Oral use

 

 

Read the package leaflet before use.

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

 

OF THE REACH AND SIGHT OF CHILDREN

 

Medicinal

 

 

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

Bristol Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/464/015

 

4x1 film-coated tablets

EU/1/08/464/016

30x1 film-coated tablets

EU/1/08/464/017 100x1 film-coated tablets

13. BATCH NUMBER

 

Batch:

 

 

 

longer

 

 

 

 

 

 

14.

 

 

no

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subject to medical prescription.

 

 

15.

 

product

 

 

 

INSTRUCTIONS ON USE

 

 

 

INFORMATION IN BRAILLE

 

 

 

16.

 

 

 

CLOPIDOGREL BMS 300 mg

 

 

Medicinal

 

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / Box of 4x1, 30x1 or 100x1 tablets

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel BMS 300 mg film-coated tablets clopidogrel

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Bristol Myers Squibb Pharma EEIG

3. EXPIRY DATE

 

EXP

 

 

 

longer

 

OTHER

 

 

 

5.

 

 

 

4.

BATCH NUMBER

 

 

 

Batch:

 

 

 

 

 

 

product

no

 

 

 

 

 

Medicinal

 

 

 

 

 

 

authorised

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