Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Ristaben 25 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Round, pink film-coated tablet with “221” on one side. |
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 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
EU/1/10/621/001
EU/1/10/621/002
EU/1/10/621/003
EU/1/10/621/004
EU/1/10/621/005
EU/1/10/621/006
EU/1/10/621/019
EU/1/10/621/020
Date of first authorisation: 15 March 2010
Date of latest renewal: 16 December 2014
| Drug | Countries | |
|---|---|---|
| RISTABEN | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom, South Africa |
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