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Capecitabine SUN (capecitabine) – Labelling - L01BC06

Updated on site: 05-Oct-2017

Medication nameCapecitabine SUN
ATC CodeL01BC06
Substancecapecitabine
ManufacturerSun Pharmaceutical Industries Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine SUN 150 mg film-coated tablets capecitabine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg capecitabine.

3. LIST OF EXCIPIENTS

Also contains anhydrous lactose. See package leaflet for further information.authorised

4. PHARMACEUTICAL FORM AND CONTENTS

60 film-coated tablets

 

 

longer

 

 

 

 

 

 

 

 

 

no

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

product

 

 

 

 

 

Read the package leaflet before use.

6.SPECIAL WARNINGMedicinalTHAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/831/001

13. BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLYlongerMedicinal product subject to medical prescription.

15.

 

product

no

 

 

INSTRUCTIONS ON USE

 

16.

Medicinal

 

 

INFORMATION IN BRAILLE

 

Capecitabine SUN 150 mg film-coated tablets

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine SUN 150 mg film-coated tablets capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Sun Pharmaceutical Industries Europe B.V.

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine SUN 500 mg film-coated tablets capecitabine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 500 mg capecitabine.

3. LIST OF EXCIPIENTS

Also contains anhydrous lactose. See package leaflet for further information.authorised

4. PHARMACEUTICAL FORM AND CONTENTS

120 film-coated tablets

 

 

longer

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

product

no

 

 

 

 

 

Read the package leaflet before use.

 

 

 

 

 

 

 

 

Medicinal

 

 

 

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

Do not store above 25°C.

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

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/831/002

13. BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLYlongerMedicinal product subject to medical prescription.

15.

 

product

no

 

 

INSTRUCTIONS ON USE

 

16.

Medicinal

 

 

INFORMATION IN BRAILLE

 

Capecitabine SUN 500 mg film-coated tablets

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine SUN 500 mg film-coated tablets capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Sun Pharmaceutical Industries Europe B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

Medicinal

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

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