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Clopidogrel Teva Generics B.V. (clopidogrel hydrochloride) – Labelling - B01AC04

Updated on site: 06-Oct-2017

Medication nameClopidogrel Teva Generics B.V.
ATC CodeB01AC04
Substanceclopidogrel hydrochloride
ManufacturerTeva Pharma B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel Teva Generics B.V. 75 mg film-coated tablets

Clopidogrel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

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

3.

LIST OF EXCIPIENTS

 

 

 

 

It also contains hydrogenated castor oil.

 

authorised

 

 

 

 

See leaflet for further information.

 

 

 

 

 

 

 

 

 

 

4.

 

 

 

 

longer

 

PHARMACEUTICAL FORM AND CONTENTS

 

 

28 film-coated tablets

 

 

 

 

28x1 film-coated tablets

 

 

no

 

 

30 film-coated tablets

 

 

product

 

 

 

 

 

 

84 film-coated tablets

 

 

 

 

30x1 film-coated tablets

 

 

 

 

 

50 film-coated tablets

 

 

 

 

 

 

50x1 film-coated tablets

 

 

 

 

 

56 film-coated tablets

 

 

 

 

 

 

56x1 film-coated tablets

 

 

 

 

 

 

 

 

 

 

 

 

 

Medicinal

 

 

 

 

84x1 film-coated tablets

 

 

 

90 film-coated tablets

90x1 film-coated tablets

100 film-coat d tablets

100x1 film-coat d 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 REACH AND SIGHT OF CHILDREN

Keep 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 package in order to protect from moisture and 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

Teva Generics B.V.

 

 

authorised

Computerweg 10

 

 

3542 DR Utrecht

 

 

 

 

 

The Netherlands

 

 

 

 

longer

 

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

no

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

Lot

 

product

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

Medicinal product subje t to medical prescription.

 

 

 

 

 

15.

INSTRUCTIONS ON USE

 

 

 

Medicinal

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

Clopidogrel Teva Generics B.V. 75 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER (28, 28x1, 30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90, 90x1, 100, 100x1 film-coated tablets)

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel Teva Generics B.V. 75 mg film-coated tablets

Clopidogrel

2. NAME OF THE MARKETING AUTHORISATION HOLDER

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28x1 film-coated tablets-calendar pack)

1. NAME OF THE MEDICINAL PRODUCT

Clopidogrel Teva Generics B.V. 75 mg film-coated tablets Clopidogrel

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva Generics B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Mon

 

Tue

 

Wed

 

Thu

 

Fri

 

Sat

Medicinal

Sun

 

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

Comments

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