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Farydak (panobinostat lactate anhydrous) – Labelling - L01XX42

Updated on site: 06-Oct-2017

Medication nameFarydak
ATC CodeL01XX42
Substancepanobinostat lactate anhydrous
ManufacturerNovartis Europharm Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Farydak 10 mg hard capsules panobinostat

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains panobinostat lactate anhydrous equivalent to 10 mg panobinostat.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

6 capsules

12 capsules

24 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/1/15/1023/001

6 capsules

 

EU/1/15/1023/002

 

12 capsules

EU/1/15/1023/003

 

24 capsules

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Farydak 10 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Farydak 10 mg capsules panobinostat

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Farydak 15 mg hard capsules panobinostat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains panobinostat lactate anhydrous equivalent to 15 mg panobinostat.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

6 capsules

12 capsules

24 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/1/15/1023/004

6 capsules

 

EU/1/15/1023/005

 

12 capsules

EU/1/15/1023/006

 

24 capsules

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Farydak 15 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Farydak 15 mg capsules panobinostat

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Week 1

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Week 3

Day 1

Day 2

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Farydak 20 mg hard capsules panobinostat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains panobinostat lactate anhydrous equivalent to 20 mg panobinostat.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

6 capsules

12 capsules

24 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/1/15/1023/007

6 capsules

 

EU/1/15/1023/008

 

12 capsules

EU/1/15/1023/009

 

24 capsules

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Farydak 20 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Farydak 20 mg capsules panobinostat

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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