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Zomarist (vildagliptin / metformin hydrochloride) – Labelling - A10BD08

Updated on site: 11-Oct-2017

Medication nameZomarist
ATC CodeA10BD08
Substancevildagliptin / metformin hydrochloride
ManufacturerNovartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

FOLDING BOX FOR UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

10 film-coated tablets

30 film-coated tablets

60 film-coated tablets

120 film-coated tablets

180 film-coated tablets

360 film-coated tablets

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 (blister) 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/1/08/483/001

10 film-coated tablets (PA/Alu/PVC/Alu)

 

EU/1/08/483/002

30 film-coated tablets (PA/Alu/PVC/Alu)

 

EU/1/08/483/003

60 film-coated tablets (PA/Alu/PVC/Alu)

 

EU/1/08/483/004

120 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/005

180 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/006

360 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/019

10 film-coated tablets (PCTFE/PVC/Alu)

 

EU/1/08/483/020

30 film-coated tablets (PCTFE/PVC/Alu)

 

EU/1/08/483/021

60 film-coated tablets (PCTFE/PVC/Alu)

 

EU/1/08/483/022

120 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/023

180 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/024

360 film-coated tablets (PCTFE/PVC/Alu)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zomarist 50 mg/850 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

Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride

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 INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

60 film-coated tablets.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 (blister) 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/1/08/483/013

120 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/014

180 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/015

360 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/031

120 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/032

180 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/033

360 film-coated tablets (PCTFE/PVC/Alu)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zomarist 50 mg/850 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

Multipack: 120 (2 packs of 60) film-coated tablets.

Multipack: 180 (3 packs of 60) film-coated tablets.

Multipack: 360 (6 packs of 60) film-coated tablets.

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 (blister) 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/1/08/483/013

120 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/014

180 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/015

360 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/031

120 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/032

180 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/033

360 film-coated tablets (PCTFE/PVC/Alu)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zomarist 50 mg/850 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

FOLDING BOX FOR UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

10 film-coated tablets

30 film-coated tablets

60 film-coated tablets

120 film-coated tablets

180 film-coated tablets

360 film-coated tablets

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 (blister) 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/1/08/483/007

10 film-coated tablets (PA/Alu/PVC/Alu)

 

EU/1/08/483/008

30 film-coated tablets (PA/Alu/PVC/Alu)

 

EU/1/08/483/009

60 film-coated tablets (PA/Alu/PVC/Alu)

 

EU/1/08/483/010

120 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/011

180 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/012

360 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/025

10 film-coated tablets (PCTFE/PVC/Alu)

 

EU/1/08/483/026

30 film-coated tablets (PCTFE/PVC/Alu)

 

EU/1/08/483/027

60 film-coated tablets (PCTFE/PVC/Alu)

 

EU/1/08/483/028

120 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/029

180 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/030

360 film-coated tablets (PCTFE/PVC/Alu)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zomarist 50 mg/1000 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

Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride

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 INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

60 film-coated tablets. 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 (blister) 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/1/08/483/016

120 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/017

180 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/018

360 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/034

120 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/035

180 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/036

360 film-coated tablets (PCTFE/PVC/Alu)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zomarist 50 mg/1000 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

Multipack: 120 (2 packs of 60) film-coated tablets.

Multipack: 180 (3 packs of 60) film-coated tablets.

Multipack: 360 (6 packs of 60) film-coated tablets.

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 (blister) 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/1/08/483/016

120 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/017

180 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/018

360 film-coated tablets (PA/Alu/PVC/Alu)

EU/1/08/483/034

120 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/035

180 film-coated tablets (PCTFE/PVC/Alu)

EU/1/08/483/036

360 film-coated tablets (PCTFE/PVC/Alu)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zomarist 50 mg/1000 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

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