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Vipidia (alogliptin) – Labelling - A10BH04

Updated on site: 10-Oct-2017

Medication nameVipidia
ATC CodeA10BH04
Substancealogliptin
ManufacturerTakeda Pharma A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Vipidia 6.25 mg film-coated tablets

alogliptin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 6.25 mg alogliptin (as benzoate)

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

10 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

100 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

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

Takeda Pharma A/S

Dybendal Alle 10

2630 Taastrup

Denmark

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/844/001 10 film-coated tablets

EU/1/13/844/002 14 film-coated tablets

EU/1/13/844/003 28 film-coated tablets

EU/1/13/844/004 30 film-coated tablets

EU/1/13/844/005 56 film-coated tablets

EU/1/13/844/006 60 film-coated tablets

EU/1/13/844/007 90 film-coated tablets

EU/1/13/844/008 98 film-coated tablets

EU/1/13/844/009 100 film-coated tablets

EU/1/13/844/028 84 film-coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Vipidia 6.25 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Vipidia 6.25 mg tablets

alogliptin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Takeda

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Vipidia 12.5 mg film-coated tablets

alogliptin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 12.5 mg alogliptin (as benzoate)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

10 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

100 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

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

Takeda Pharma A/S

Dybendal Alle 10

2630 Taastrup

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/844/010 10 film-coated tablets

EU/1/13/844/011 14 film-coated tablets

EU/1/13/844/012 28 film-coated tablets

EU/1/13/844/013 30 film-coated tablets

EU/1/13/844/014 56 film-coated tablets

EU/1/13/844/015 60 film-coated tablets

EU/1/13/844/016 90 film-coated tablets

EU/1/13/844/017 98 film-coated tablets

EU/1/13/844/018 100 film-coated tablets

EU/1/13/844/029 84 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vipidia 12.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Vipidia 12.5 mg tablets

alogliptin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Takeda

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Vipidia 25 mg film-coated tablets

alogliptin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 25 mg alogliptin (as benzoate)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

10 film-coated tablets

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

60 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

100 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

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

Takeda Pharma A/S

Dybendal Alle 10

2630 Taastrup

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/844/019 10 film-coated tablets

EU/1/13/844/020 14 film-coated tablets

EU/1/13/844/021 28 film-coated tablets

EU/1/13/844/022 30 film-coated tablets

EU/1/13/844/023 56 film-coated tablets

EU/1/13/844/024 60 film-coated tablets

EU/1/13/844/025 90 film-coated tablets

EU/1/13/844/026 98 film-coated tablets

EU/1/13/844/027 100 film-coated tablets

EU/1/13/844/030 84 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vipidia 25 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Vipidia 25 mg tablets

alogliptin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Takeda

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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