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Capecitabine Medac (capecitabine) – Labelling - L01BC06

Updated on site: 05-Oct-2017

Medication nameCapecitabine Medac
ATC CodeL01BC06
Substancecapecitabine
Manufacturermedac Gesellschaft für klinische Spezialpräparate mbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Capecitabine medac 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 the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

84 film-coated tablets

112 film-coated tablets

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

For PVC/PVdC/Aluminium blisters:

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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/802/001-014

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Capecitabine medac 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

Capecitabine medac 150 mg tablets capecitabine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

medac GmbH

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine medac 300 mg film-coated tablets capecitabine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 300 mg capecitabine.

3. LIST OF EXCIPIENTS

Also contains anhydrous lactose, see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

84 film-coated tablets

112 film-coated tablets

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

For PVC/PVdC/Aluminium blisters:

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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/802/015-028

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Capecitabine medac 300 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

Capecitabine medac 300 mg tablets capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

medac GmbH

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine medac 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 the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

84 film-coated tablets

112 film-coated tablets

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

For PVC/PVdC/Aluminium blisters:

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

medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/802/029-042

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Capecitabine medac 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

Capecitabine medac 500 mg tablets capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

medac GmbH

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

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