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Iscover (clopidogrel) – Labelling - B01AC04

Updated on site: 08-Oct-2017

Medication nameIscover
ATC CodeB01AC04
Substanceclopidogrel
ManufacturerSanofi-aventis groupe

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Iscover 75 mg film-coated tablets clopidogrel

2.STATEMENT OF ACTIVE SUBSTANCE(S)

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

3.LIST OF EXCIPIENTS

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

50x1 film-coated tablets

84 film-coated tablets

90 film-coated tablets

100 film-coated tablets

14 film-coated tablets

7 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

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

sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/98/070/001a 28 tablets

EU/1/98/070/001b 28 tablets

EU/1/98/070/002a 50x1 tablets

EU/1/98/070/002b 50x1 tablets

EU/1/98/070/003a 84 tablets

EU/1/98/070/003b 84 tablets

EU/1/98/070/004a 100 tablets

EU/1/98/070/004b 100 tablets

EU/1/98/070/005a 30 tablets

EU/1/98/070/005b 30 tablets

EU/1/98/070/006a 90 tablets

EU/1/98/070/006b 90 tablets

EU/1/98/070/007a 14 tablets

EU/1/98/070/007b 14 tablets

EU/1/98/070/011a 7 tablets

EU/1/98/070/011b 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

Iscover 75 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PARTICULARS TO APPEAR ON BLISTERS (BLISTER / 7, 14, 28 or 84 tablets)

1.NAME OF THE MEDICINAL PRODUCT

Iscover 75 mg film-coated tablets clopidogrel

2.NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3.EXPIRY DATE

4.BATCH NUMBER

Batch:

5.OTHER

Calendar days

Mon

Tue

Wed

Thu

Fri

Sat

Sun

Week 1

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)

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

1.NAME OF THE MEDICINAL PRODUCT

Iscover 75 mg film-coated tablets clopidogrel

2.NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3.EXPIRY DATE

4.BATCH NUMBER

Batch:

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Iscover 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.

4.PHARMACEUTICAL FORM AND CONTENTS

4x1 film-coated tablets

30x1 film-coated tablets

100x1 film-coated tablets

10x1 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

sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/98/070/008

 

4x1 film-coated tablets

EU/1/98/070/009

30x1 film-coated tablets

EU/1/98/070/010 100x1 film-coated tablets

EU/1/98/070/012 10x1 film-coated tablets

13.BATCH NUMBER

Batch:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Iscover 300 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 4x1, 10x1, 30x1 or 100x1 tablets

1.NAME OF THE MEDICINAL PRODUCT

Iscover 300 mg film-coated tablets clopidogrel

2.NAME OF THE MARKETING AUTHORISATION HOLDER

sanofi-aventis groupe

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch:

5.OTHER

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