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Xeloda (capecitabine) – Labelling - L01BC06

Updated on site: 11-Oct-2017

Medication nameXeloda
ATC CodeL01BC06
Substancecapecitabine
ManufacturerRoche Registration Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Xeloda 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.

4.PHARMACEUTICAL FORM AND CONTENTS

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

Do not store above 30°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

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/00/163/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

xeloda 150 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

1. NAME OF THE MEDICINAL PRODUCT

Xeloda 150 mg film-coated tablets

Capecitabine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Roche Registration Ltd.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Xeloda 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.

4. PHARMACEUTICAL FORM AND CONTENTS

120 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

Do not store above 30°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

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/163/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

xeloda 500 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

1. NAME OF THE MEDICINAL PRODUCT

Xeloda 500 mg film-coated tablets

Capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Roche Registration Ltd.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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