Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Tesavel 25 mg film-coated tablets.
Tesavel 50 mg film-coated tablets.
Tesavel 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Tesavel 25 mg film-coated tablets: Round, pink film-coated tablet with “221” on one side. Tesavel 50 mg film-coated tablets: Round, light beige film-coated tablet with “112” on one side. Tesavel 100 mg film-coated tablets: Round, beige film-coated tablet with “277” on one side. |
Tesavel 25 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Tesavel 50 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Tesavel 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
Tesavel 25 mg film-coated tablets:
EU/1/07/435/001
EU/1/07/435/002
EU/1/07/435/003
EU/1/07/435/004
EU/1/07/435/005
EU/1/07/435/006
EU/1/07/435/019
EU/1/07/435/020
Tesavel 50 mg film-coated tablets:
EU/1/07/435/007
EU/1/07/435/008
EU/1/07/435/009
EU/1/07/435/010
EU/1/07/435/011
EU/1/07/435/012
EU/1/07/435/021
EU/1/07/435/022
Tesavel 100 mg film-coated tablets:
EU/1/07/435/013
EU/1/07/435/014
EU/1/07/435/015
EU/1/07/435/016
EU/1/07/435/017
EU/1/07/435/018
EU/1/07/435/023
EU/1/07/435/024
Date of first authorisation: 10 January 2008
Date of latest renewal: 20 September 2012
| Drug | Countries | |
|---|---|---|
| TESAVEL | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland |
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