Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Januvia 25 mg film-coated tablets.
Januvia 50 mg film-coated tablets.
Januvia 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Januvia 25 mg film-coated tablets: Round, pink film-coated tablet with “221” on one side. Januvia 50 mg film-coated tablets: Round, light beige film-coated tablet with “112” on one side. Januvia 100 mg film-coated tablets: Round, beige film-coated tablet with “277” on one side. |
Januvia 25 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Januvia 50 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Januvia 100 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sitagliptin |
Sitagliptin is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors. The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film coating: Poly(vinyl alcohol) |
Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets and 50 × 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Januvia 25 mg film-coated tablets:
EU/1/07/383/001
EU/1/07/383/002
EU/1/07/383/003
EU/1/07/383/004
EU/1/07/383/005
EU/1/07/383/006
EU/1/07/383/019
EU/1/07/383/020
Januvia 50 mg film-coated tablets:
EU/1/07/383/007
EU/1/07/383/008
EU/1/07/383/009
EU/1/07/383/010
EU/1/07/383/011
EU/1/07/383/012
EU/1/07/383/021
EU/1/07/383/022
Januvia 100 mg film-coated tablets:
EU/1/07/383/013
EU/1/07/383/014
EU/1/07/383/015
EU/1/07/383/016
EU/1/07/383/017
EU/1/07/383/018
EU/1/07/383/023
EU/1/07/383/024
Date of first authorisation: 21 March 2007
Date of latest renewal: 23 February 2012
| Drug | Countries | |
|---|---|---|
| JANUVIA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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