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Ecansya (Capecitabine Krka) (capecitabine) – Labelling - L01BC06

Updated on site: 06-Oct-2017

Medication nameEcansya (Capecitabine Krka)
ATC CodeL01BC06
Substancecapecitabine
ManufacturerKrka, d.d., Novo mesto

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Ecansya 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 leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

30 film-coated tablets

60 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBER (S)

Aluminium/aluminium blisters

EU/1/12/763/001 30 film-coated tablets

EU/1/12/763/002 60 film-coated tablets

EU/1/12/763/003 120 Film-coated tablets

PVC/PVdC/aluminium blisters

EU/1/12/763/004 30 film-coated tablets

EU/1/12/763/005 60 film-coated tablets

EU/1/12/763/006 120 film-coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Ecansya 150 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Ecansya 150 mg film-coated tablets

multilingual blister:

Ecansya 150 mg tablets

Capecitabine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Ecansya 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 leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

30 film-coated tablets

60 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER (S)

Aluminium/aluminium blisters

EU/1/12/763/007 30 film-coated tablets

EU/1/12/763/008 60 film-coated tablets

EU/1/12/763/009 120 film-coated tablets

PVC/PVdC/aluminium blisters

EU/1/12/763/010 30 film-coated tablets

EU/1/12/763/011 60 film-coated tablets

EU/1/12/763/012 120 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ecansya 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

Ecansya 300 mg film-coated tablets

multilingual blister:

Ecansya 300 mg tablets

Capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Ecansya 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 leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

30 film-coated tablets

60 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER (S)

Aluminium/aluminium blisters

EU/1/12/763/013 30 film-coated tablets

EU/1/12/763/014 60 film-coated tablets

EU/1/12/763/015 120 film-coated tablets

PVC/PVdC/aluminium blisters

EU/1/12/763/016 30 film-coated tablets

EU/1/12/763/017 60 film-coated tablets

EU/1/12/763/018 120 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ecansya 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

Ecansya 500 mg film-coated tablets

multilingual blister:

Ecansya 500 mg tablets

Capecitabine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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