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Cometriq (cabozantinib) – Labelling - L01XE

Updated on site: 06-Oct-2017

Medication nameCometriq
ATC CodeL01XE
Substancecabozantinib
ManufacturerIpsen Pharma

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER CARD, 60 mg dose

1.NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

Cabozantinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

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

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Hard capsules 20 mg

60 mg Dose

Pack for the 60 mg daily dose

21 x 20 mg capsules (60 mg/day dose for a 7-day supply) Each 60 mg daily dose contains three grey 20 mg capsules.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before use.

Package leaflet inside pouch.

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

Dispensing instructions

Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules). Record date of first dose.

1. Push in tab

2. Peel paper backing

3.Push capsule through foil

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

COMETRIQ 20 mg 60 mg/day dose

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF 28 DAY PACK, 60 mg dose (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

Cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

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

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 mg Dose

28 day pack: 84 capsules (4 blister cards of 21 x 20 mg capsules) for the 60 mg daily dose for a 28 day supply.

Each 60 mg daily dose contains a combination of three grey 20 mg capsules.

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

Refer to individual blister cards for dispensing instructions.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/004

84 capsules (4 blisters cards of 21 x 20 mg) (60 mg/day dose for 28 day supply)

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

COMETRIQ 20 mg 60 mg/day dose

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 60 mg dose (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

Cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

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

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules 20 mg

60 mg Dose

21 x 20 mg capsules (60 mg/day dose for a 7-day supply). Component of a 28 day pack, can’t be sold separately.

Pack for the 60 mg daily dose

Each 60 mg daily dose contains three grey 20 mg capsules.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before use.

Package leaflet inside pouch.

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

Dispensing instructions

Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules). Record date of first dose.

1.Push in tab

2.Peel paper backing

3.Push capsule through foil

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/004

84 capsules (4 blisters cards of 21 x 20 mg) (60 mg/day dose for 28 day supply)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER CARD, 100 mg dose

1. NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

COMETRIQ 80 mg hard capsules

Cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg of cabozantinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules 20 mg and 80 mg 100 mg Dose

Pack for the 100 mg daily dose

7 x 20 mg capsules and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply).

Each 100 mg daily dose contains a combination of one grey 20 mg capsule and one orange 80 mg capsule.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before use.

Package leaflet inside pouch.

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

Dispensing instructions

Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules). Record date of first dose.

1. Push in tab

2.Peel paper backing

3.Push capsule through foil

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

COMETRIQ 20 mg COMETRIQ 80 mg 100 mg/day dose

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF 28 DAY PACK, 100 mg dose (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

COMETRIQ 80 mg hard capsules

Cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg of cabozantinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

100 mg Dose

28 day pack: 56 capsules (4 blister cards of 7 x 20 mg capsules and 7 x 80 mg capsules) for the 100 mg daily dose for a 28 day supply.

Each 100 mg daily dose contains a combination of one grey 20 mg capsule and one orange 80 mg capsule.

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

Refer to individual blister cards for dispensing instructions.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/005

56 capsules (4 blisters cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day

supply)

 

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

COMETRIQ 20 mg COMETRIQ 80 mg 100 mg/day dose

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 100 mg dose (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

COMETRIQ 80 mg hard capsules

Cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg of cabozantinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules 20 mg and 80 mg 100 mg Dose

7 x 20 mg capsules and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply). Component of a 28 day pack, can’t be sold separately.

Pack for the 100 mg daily dose

Each 100 mg daily dose contains a combination of one grey 20 mg capsule and one orange 80 mg capsule.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before use.

Package leaflet inside pouch.

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

Dispensing instructions

Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules). Record date of first dose.

1.Push in tab

2.Peel paper backing

3.Push capsule through foil

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/005 56 capsules (4 blisters cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER CARD 140 mg dose

1. NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

COMETRIQ 80 mg hard capsules

Cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg of cabozantinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules 20 mg and 80 mg 140 mg Dose

Pack for the 140 mg daily dose

21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)

Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before use.

Package leaflet inside pouch.

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

Dispensing instructions

Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules). Record date of first dose.

1. Push in tab

2.Peel paper backing

3.Push capsule through foil

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

COMETRIQ 20 mg COMETRIQ 80 mg 140 mg/day dose

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF 28 DAY PACK, 140 mg dose (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

COMETRIQ 80 mg hard capsules

Cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg of cabozantinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

140 mg Dose

28 day pack: 112 capsules (4 blister cards of 21 x 20 mg capsules and 7 x 80 mg capsules) for the 140 mg daily dose for a 28 day supply.

Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.

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

Refer to individual blister cards for dispensing instructions.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/006

112 capsules (4 blisters cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose for 28

day supply)

 

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

COMETRIQ 20 mg COMETRIQ 80 mg 140 mg/day dose

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 140 mg dose (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

COMETRIQ 20 mg hard capsules

COMETRIQ 80 mg hard capsules

Cabozantinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg of cabozantinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules 20 mg and 80 mg 140 mg Dose

21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply). Component of a 28 day pack, can’t be sold separately.

Pack for the 140 mg daily dose

Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before use.

Package leaflet inside pouch.

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

Dispensing instructions

Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules). Record date of first dose.

1.Push in tab

2.Peel paper backing

3.Push capsule through foil

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture.

Do not store above 25°C.

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/1/13/890/006 112 capsules (4 blisters cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose for 28 day supply)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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