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Grepid (clopidogrel besilate) – Labelling - B01AC04

Updated on site: 07-Oct-2017

Medication nameGrepid
ATC CodeB01AC04
Substanceclopidogrel besilate
ManufacturerPharmathen S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for blisters of 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Grepid 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 lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

10 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

50 film-coated tablets

84 film-coated tablets

90 film-coated tablets

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

Store below 25°C (for PVC/PE/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

Pharmathen S.A.,

6 Dervenakion

15351 Pallini Attiki

Greece

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/535/001-16

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Grepid 75 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}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/ 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Grepid 75 mg film-coated tablets clopidogrel

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Pharmathen S.A.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

Calendar days

Mon

Tue

Wed

Thu

Fri

Sat

Sun

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