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Clopidogrel Acino Pharma (clopidogrel) – Labelling - B01AC04

Updated on site: 06-Oct-2017

Medication nameClopidogrel Acino Pharma
ATC CodeB01AC04
Substanceclopidogrel
ManufacturerAcino Pharma GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel Acino Pharma 75 mg film-coated tablets

Clopidogrel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 75 mg of clopidogrel (as besilate).

3. LIST OF EXCIPIENTS

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

 

4. PHARMACEUTICAL FORM AND CONTENTS

 

 

14 film-coated tablets

 

longer

authorised

 

 

 

 

28 film-coated tablets

 

 

 

 

 

 

30 film-coated tablets

 

 

 

 

 

 

50 film-coated tablets

 

 

 

 

 

 

84 film-coated tablets

 

 

 

 

 

 

90 film-coated tablets

 

 

no

 

 

 

100 film-coated tablets

 

 

 

 

 

5. METHOD AND ROUTE(S)

productOF ADMINISTRATION

6.SPECIALMedicinalWARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original blister in order to protect from moisture.

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

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/549/001

EU/1/09/549/002

EU/1/09/549/003

EU/1/09/549/004

EU/1/09/549/005

EU/1/09/549/006

EU/1/09/549/007

13. BATCH NUMBER

14.GENERAL CLASSIFICATION FOR SUPPLYlongerBatchMedicinal product subject to medical prescription.

15.

INSTRUCTIONS ON USE

no

16.

 

product

 

INFORMATION IN BRAILLE

 

Clopidogrel Acino Pharma 75 mg

 

 

Medicinal

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel Acino Pharma 75 mg film-coated tablets

Clopidogrel

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Acino Pharma GmbH

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

Medicinal

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

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