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Efient (prasugrel) – Labelling - B01AC22

Updated on site: 06-Oct-2017

Medication nameEfient
ATC CodeB01AC22
Substanceprasugrel
ManufacturerDaiichi Sankyo Europe GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 5mg FILM-COATED TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Efient 5 mg film-coated tablets prasugrel

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg prasugrel (as hydrochloride)

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30x1 film-coated tablet

56 film-coated tablets

84 film-coated tablets

90x1 film-coated tablet

98 film-coated tablets

30 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 in the original package in order to protect from air and 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

Daiichi Sankyo Europe GmbH

81366 Munich

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/503/001 14 film-coated tablets

EU/1/08/503/002 28 film-coated tablets

EU/1/08/503/003 30x1 film-coated tablet

EU/1/08/503/004 56 film-coated tablets

EU/1/08/503/005 84 film-coated tablets

EU/1/08/503/006 90x1 film-coated tablet

EU/1/08/503/007 98 film-coated tablets

EU/1/08/503/015 30 film-coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Efient 5 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 5 mg FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Efient 5 mg film-coated tablets prasugrel

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Daiichi-Sankyo (Logo)

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

<MON, TUE, WED, THU, FRI, SAT, SUN>

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 10 mg FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Efient 10 mg film-coated tablets prasugrel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg prasugrel (as hydrochloride)

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30x1 film-coated tablet

56 film-coated tablets

84 film-coated tablets

90x1 film-coated tablet

98 film-coated tablets

30 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 in the original package in order to protect from air and 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

Daiichi Sankyo Europe GmbH

81366 Munich

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/503/008 14 film-coated tablets

EU/1/08/503/009 28 film-coated tablets

EU/1/08/503/010 30x1 film-coated tablet

EU/1/08/503/011 56 film-coated tablets

EU/1/08/503/012 84 film-coated tablets

EU/1/08/503/013 90x1 film-coated tablet

EU/1/08/503/014 98 film-coated tablets

EU/1/08/503/016 30 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Efient 10 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 mg FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Efient 10 mg film-coated tablets prasugrel

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Daiichi-Sankyo (Logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot:

5. OTHER

<MON, TUE, WED, THU, FRI, SAT, SUN>

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