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Jalra (vildagliptin) – Labelling - A10BH02

Updated on site: 08-Oct-2017

Medication nameJalra
ATC CodeA10BH02
Substancevildagliptin
ManufacturerNovartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Jalra 50 mg tablets vildagliptin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin.

3.LIST OF EXCIPIENTS

Contains lactose (see leaflet for further information).

4.PHARMACEUTICAL FORM AND CONTENTS

Tablet

7 tablets

14 tablets

28 tablets

30 tablets

56 tablets

60 tablets

90 tablets

112 tablets

180 tablets

336 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

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/1/08/485/001

7 tablets

 

 

EU/1/08/485/002

14 tablets

 

 

EU/1/08/485/003

28 tablets

 

EU/1/08/485/004

30 tablets

 

EU/1/08/485/005

56 tablets

 

EU/1/08/485/006

60 tablets

 

EU/1/08/485/007

90 tablets

 

EU/1/08/485/008

112 tablets

 

EU/1/08/485/009

180 tablets

EU/1/08/485/010

336 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Jalra 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

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Jalra 50 mg tablets vildagliptin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin.

3. LIST OF EXCIPIENTS

Contains lactose (see leaflet for further information).

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

Multipack: 336 (3 packs of 112) 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

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/1/08/485/011

336 tablets (3 packs of 112)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Jalra 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 INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Jalra 50 mg tablets vildagliptin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg vildagliptin.

3. LIST OF EXCIPIENTS

Contains lactose (see leaflet for further information).

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

112 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

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/1/08/485/011

336 tablets (3 packs of 112)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Jalra 50 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Jalra 50 mg tablets vildagliptin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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