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Tyverb (lapatinib) – Labelling - L01XE07

Updated on site: 10-Oct-2017

Medication nameTyverb
ATC CodeL01XE07
Substancelapatinib
ManufacturerNovartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (14 DAY, SINGLE PACK)

1.NAME OF THE MEDICINAL PRODUCT

Tyverb 250 mg film-coated tablets lapatinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

70 film-coated tablets

84 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

Do not store above 30ºC.

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/1/07/440/001 70 tablets

EU/1/07/440/003 84 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

tyverb 250 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (28-DAY, MULTIPACK)

1. NAME OF THE MEDICINAL PRODUCT

Tyverb 250 mg film-coated tablets lapatinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

140 film-coated tablets

Multipack: 140 (2 packs of 70) 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

Do not store above 30ºC.

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/1/07/440/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tyverb 250 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (14 DAY PACK, PART OF 28 DAY MULTIPACK without blue box)

1. NAME OF THE MEDICINAL PRODUCT

Tyverb 250 mg film-coated tablets lapatinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

70 film-coated tablets

Component of a multipack, cannot to be sold separately.

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

Do not store above 30ºC.

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/1/07/440/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tyverb 250 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Tyverb 250 mg tablets lapatinib

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 AND THE IMMEDIATE PACKAGING

OUTER CARTON AND BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Tyverb 250 mg film-coated tablets lapatinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

70 film-coated tablets

84 film-coated tablets

105 film-coated tablets

140 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

Do not store above 30ºC.

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/1/07/440/004 70 tablets

EU/1/07/440/005 140 tablets

EU/1/07/440/006 84 tablets

EU/1/07/440/007 105 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tyverb 250 mg

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