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Dificlir (fidaxomicin) – Labelling - A07AA12

Updated on site: 06-Oct-2017

Medication nameDificlir
ATC CodeA07AA12
Substancefidaxomicin
ManufacturerAstellas Pharma Europe BV

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

DIFICLIR 200 mg film-coated tablets fidaxomicin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of fidaxomicin.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

20 film-coated tablets

60 film-coated tablets

100 x 1 film-coated tablet.

20 x 1 film-coated tablet.

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/733/001 20 film-coated tablets

EU/1/11/733/002 60 film-coated tablets

EU/1/11/733/003 100 x 1 film-coated tablet

EU/1/11/733/004 20 x 1 film-coated tablet

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

dificlir

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

HDPE BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

DIFICLIR 200 mg film-coated tablets fidaxomicin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of fidaxomicin.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

20 film-coated tablets

60 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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/733/001 20 film-coated tablets

EU/1/11/733/002 60 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

DIFICLIR 200 mg film-coated tablets fidaxomicin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Astellas

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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