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Cabometyx (cabozantinib s-malate) – Labelling - L01XE26

Updated on site: 05-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

CABOMETYX 20 mg film-coated tablets cabozantinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

28 film-coated tablets

30 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

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused product or waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1136/001

EU/1/16/1136/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

CABOMETYX 20 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

CABOMETYX 20 mg film-coated tablets cabozantinib

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma

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

CABOMETYX 40 mg film-coated tablets cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

28 film-coated tablets

30 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

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1136/003

EU/1/16/1136/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

CABOMETYX 40 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

CABOMETYX 40 mg film-coated tablets cabozantinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma

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

CABOMETYX 60 mg film-coated tablets cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains cabozantinib (S)-malate equivalent to 60 mg of cabozantinib.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

28 film-coated tablets

30 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

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1136/005

EU/1/16/1136/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

CABOMETYX 60 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

CABOMETYX 60 mg film-coated tablets cabozantinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

CABOMETYX 20 mg film-coated tablets cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 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

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

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1136/002

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

CABOMETYX 40 mg film-coated tablets cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 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

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

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1136/004

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

CABOMETYX 60 mg film-coated tablets cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 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

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

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1136/006

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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