English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Tafinlar (dabrafenib mesylate) – Labelling - L01XE23

Updated on site: 10-Oct-2017

Medication nameTafinlar
ATC CodeL01XE23
Substancedabrafenib mesylate
ManufacturerNovartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Tafinlar 50 mg hard capsules dabrafenib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains dabrafenib mesilate equivalent to 50 mg dabrafenib.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Capsule, hard

28 capsules

120 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

Contains desiccant, do not remove or eat.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

 

EU/1/13/865/001

28 capsules

 

 

 

EU/1/13/865/002

120 capsules

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

 

 

Lot

 

 

 

 

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

tafinlar 50 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 AND THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Tafinlar 50 mg capsules dabrafenib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains dabrafenib mesilate equivalent to 50 mg dabrafenib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Capsule, hard

28 capsules

120 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

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

Novartis Europharm Limited

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

EU/1/13/865/001

28 capsules

 

 

 

EU/1/13/865/002

120 capsules

 

 

 

13.

BATCH NUMBER

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Tafinlar 75 mg hard capsules dabrafenib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains dabrafenib mesilate equivalent to 75 mg dabrafenib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Capsule, hard

28 capsules

120 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

Contains desiccant, do not remove or eat.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

EU/1/13/865/003

28 capsules

 

 

 

EU/1/13/865/004

120 capsules

 

 

 

13.

BATCH NUMBER

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tafinlar 75 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 AND THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Tafinlar 75 mg capsules dabrafenib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains dabrafenib mesilate equivalent to 75 mg dabrafenib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Capsule, hard

28 capsules

120 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

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

Novartis Europharm Limited

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

EU/1/13/865/003

28 capsules

 

 

 

EU/1/13/865/004

120 capsules

 

 

 

13.

BATCH NUMBER

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed