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Januvia (sitagliptin) – Labelling - A10BH01

Updated on site: 08-Oct-2017

Medication nameJanuvia
ATC CodeA10BH01
Substancesitagliptin
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Januvia 25 mg film-coated tablets

Sitagliptin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

50 x 1 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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/383/001 14 film-coated tablets

EU/1/07/383/002 28 film-coated tablets

EU/1/07/383/019 30 film-coated tablets

EU/1/07/383/003 56 film-coated tablets

EU/1/07/383/004 84 film-coated tablets

EU/1/07/383/020 90 film-coated tablets

EU/1/07/383/005 98 film-coated tablets

EU/1/07/383/006 50 x 1 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

Januvia 25 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Januvia 25 mg tablets

Sitagliptin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Januvia 50 mg film-coated tablets

Sitagliptin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

50 x 1 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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/383/007 14 film-coated tablets

EU/1/07/383/008 28 film-coated tablets

EU/1/07/383/021 30 film-coated tablets

EU/1/07/383/009 56 film-coated tablets

EU/1/07/383/010 84 film-coated tablets

EU/1/07/383/022 90 film-coated tablets

EU/1/07/383/011 98 film-coated tablets

EU/1/07/383/012 50 x 1 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

Januvia 50 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Januvia 50 mg tablets

Sitagliptin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Januvia 100 mg film-coated tablets

Sitagliptin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

84 film-coated tablets

90 film-coated tablets

98 film-coated tablets

50 x 1 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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/383/013 14 film-coated tablets

EU/1/07/383/014 28 film-coated tablets

EU/1/07/383/023 30 film-coated tablets

EU/1/07/383/015 56 film-coated tablets

EU/1/07/383/016 84 film-coated tablets

EU/1/07/383/024 90 film-coated tablets

EU/1/07/383/017 98 film-coated tablets

EU/1/07/383/018 50 x 1 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

Januvia 100 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Januvia 100 mg tablets

Sitagliptin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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