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Tasigna (nilotinib) – Labelling - L01XE08

Updated on site: 10-Oct-2017

Medication nameTasigna
ATC CodeL01XE08
Substancenilotinib
ManufacturerNovartis Europharm Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Tasigna 150 mg hard capsules

Nilotinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).

3.LIST OF EXCIPIENTS

Contains lactose – see the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Hard capsules

28 hard capsules

40 hard capsules

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

Do not store above 30°C.

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

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/422/005

28 hard capsules

EU/1/07/422/009

 

40 hard capsules

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Tasigna 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Tasigna 150 mg hard capsules

Nilotinib

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF MULTIPACK (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tasigna 150 mg hard capsules

Nilotinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).

3. LIST OF EXCIPIENTS

Contains lactose – see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules

Multipack: 112 (4 packs of 28) hard capsules.

Multipack: 120 (3 packs of 40) hard capsules.

Multipack: 392 (14 packs of 28) hard capsules.

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

Do not store above 30°C.

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

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/422/006

112 hard capsules

 

 

EU/1/07/422/010

 

120 hard capsules

 

 

EU/1/07/422/013

 

392 hard capsules

 

 

 

 

13. BATCH NUMBER

 

 

Lot

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tasigna 150 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tasigna 150 mg hard capsules

Nilotinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).

3. LIST OF EXCIPIENTS

Contains lactose – see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules

28 hard capsules. Component of a multipack. Not to be sold separately. 40 hard capsules. Component of a multipack. Not to be sold separately.

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

Do not store above 30°C.

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

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/422/006

112 hard capsules

 

 

EU/1/07/422/010

 

120 hard capsules

 

 

EU/1/07/422/013

 

392 hard capsules

 

 

 

 

13. BATCH NUMBER

 

 

Lot

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tasigna 150 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK (WALLET)

CARTON OF UNIT PACK (CARTON)

1. NAME OF THE MEDICINAL PRODUCT

Tasigna 200 mg hard capsules

Nilotinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).

3. LIST OF EXCIPIENTS

Contains lactose – see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules

28 hard capsules

40 hard capsules

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

Do not store above 30°C.

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

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/422/001

PVC/PVDC/Alu [in wallet] 28 hard capsules

 

 

 

EU/1/07/422/002

 

PA/Alu/PVC/Alu [in wallet] 28 hard capsules

 

 

EU/1/07/422/007

 

PVC/PVDC/Alu [in carton] 28 hard capsules

 

 

 

EU/1/07/422/011

 

PVC/PVDC/Alu [in carton] 40 hard capsules

 

 

 

 

 

 

13. BATCH NUMBER

 

 

 

 

 

 

 

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tasigna 200 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Tasigna 200 mg hard capsules

Nilotinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF MULTIPACK (WALLET) (INCLUDING BLUE BOX)

CARTON OF MULTIPACK (CARTON) (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tasigna 200 mg hard capsules

Nilotinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).

3. LIST OF EXCIPIENTS

Contains lactose – see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules

Multipack: 112 (4 wallets of 28) hard capsules.

Multipack: 112 (4 packs of 28) hard capsules.

Multipack: 120 (3 packs of 40) hard capsules.

Multipack: 392 (14 packs of 28) hard capsules.

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

Do not store above 30°C.

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

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/422/003

PVC/PVDC/Alu [in wallet] 112 hard capsules

 

 

 

EU/1/07/422/004

 

PA/Alu/PVC/Alu [in wallet] 112 hard capsules

 

 

EU/1/07/422/008

 

PVC/PVDC/Alu [in carton] 112 hard capsules

 

 

 

EU/1/07/422/012

 

PVC/PVDC/Alu [in carton] 120 hard capsules

 

 

 

EU/1/07/422/014

 

PVC/PVDC/Alu [in carton] 392 hard capsules

 

 

 

 

 

 

13. BATCH NUMBER

 

 

 

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tasigna 200 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE WALLET OF MULTIPACK (WITHOUT BLUE BOX) INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Tasigna 200 mg hard capsules

Nilotinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).

3. LIST OF EXCIPIENTS

Contains lactose – see the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsules

28 hard capsules. Component of a multipack comprising 4 wallets. Not to be sold separately. 28 hard capsules. Component of a multipack comprising 4 cartons. Not to be sold separately. 40 hard capsules. Component of a multipack comprising 3 cartons. Not to be sold separately.

28 hard capsules. Component of a multipack comprising 14 cartons. Not to be sold separately.

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

Do not store above 30°C.

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

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/422/003

PVC/PVDC/Alu [in wallet] 112 hard capsules

 

 

 

EU/1/07/422/004

 

PA/Alu/PVC/Alu [in wallet] 112 hard capsules

 

 

EU/1/07/422/008

 

PVC/PVDC/Alu [in carton] 112 hard capsules

 

 

 

EU/1/07/422/012

 

PVC/PVDC/Alu [in carton] 120 hard capsules

 

 

 

EU/1/07/422/014

 

PVC/PVDC/Alu [in carton] 392 hard capsules

 

 

 

 

 

 

13. BATCH NUMBER

 

 

 

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tasigna 200 mg

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