TESAVEL Film-coated tablet Ref.[49829] Active ingredients: Sitagliptin

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

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.

Qualitative and quantitative composition

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)
Calcium hydrogen phosphate, anhydrous (E341)
Croscarmellose sodium (E468)
Magnesium stearate (E470b)
Sodium stearyl fumarate

Film coating:

Poly(vinyl alcohol)
Macrogol 3350
Talc (E553b)
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

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

Drugs

Drug Countries
TESAVEL Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland

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