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Capecitabine Accord (capecitabine) – Labelling - L01BC06

Updated on site: 05-Oct-2017

Medication nameCapecitabine Accord
ATC CodeL01BC06
Substancecapecitabine
ManufacturerAccord Healthcare Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine Accord 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 lactose, see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

60 film-coated tablets

120 film-coated tablets

30 x 1 film-coated tablets

60 x 1 film-coated tablets

120 x 1 film-coated tablets

5. METHOD AND ROUTE (S) OF ADMINISTRATION

Oral use.

Read the package leaflet before 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

Accord Healthcare Limited

Sage house, 319, Pinner road

North Harrow

Middlesex HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER (S)

EU/1/12/762/001

EU/1/12/762/002

EU/1/12/762/003

EU/1/12/762/004

EU/1/12/762/005

EU/1/12/762/006

EU/1/12/762/019

EU/1/12/762/020

EU/1/12/762/021

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Capecitabine Accord 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 Accord 150 mg film-coated tablets capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Accord

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine Accord 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 lactose, see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

60 film-coated tablets

120 film-coated tablets

30 x 1 film-coated tablets

60 x 1 film-coated tablets

120 x 1 film-coated tablets

5. METHOD AND ROUTE (S) OF ADMINISTRATION

Oral use.

Read the package leaflet before 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

Accord Healthcare Limited

Sage house, 319, Pinner road

North Harrow

Middlesex HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER (S)

EU/1/12/762/007

EU/1/12/762/008

EU/1/12/762/009

EU/1/12/762/010

EU/1/12/762/011

EU/1/12/762/012

EU/1/12/762/022

EU/1/12/762/023

EU/1/12/762/024

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Capecitabine Accord 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 Accord 300 mg film-coated tablets capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Accord

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Capecitabine Accord 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 lactose, see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

60 film-coated tablets

120 film-coated tablets

30 x 1 film-coated tablets

60 x 1 film-coated tablets

120 x 1 film-coated tablets

5. METHOD AND ROUTE (S) OF ADMINISTRATION

Oral use.

Read the package leaflet before 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

Accord Healthcare Limited

Sage house, 319, Pinner road

North Harrow

Middlesex HA1 4HF

United Kingdom

12. MARKETING AUTHORISATION NUMBER (S)

EU/1/12/762/013

EU/1/12/762/014

EU/1/12/762/015

EU/1/12/762/016

EU/1/12/762/017

EU/1/12/762/018

EU/1/12/762/025

EU/1/12/762/026

EU/1/12/762/027

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Capecitabine Accord 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 Accord 500 mg film-coated tablets capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Accord

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

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