Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Jalra 50 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet. One side is debossed with “NVR”, and the other side with “FB”. |
Each tablet contains 50 mg of vildagliptin.
Excipient with known effect: Each tablet contains 47.82 mg lactose (anhydrous).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vildagliptin |
Vildagliptin enhances the sensitivity of beta cells to glucose, resulting in improved glucose-dependent insulin secretion by increasing the endogenous levels of these incretin hormones. The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide). |
| List of Excipients |
|---|
|
Lactose, anhydrous |
Aluminium/Aluminium (PA/Al/PVC//Al) blister.
Available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3 packs of 112) tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/08/485/001-011
ate of first authorisation: 19 November 2008
Date of latest renewal: 28 November 2013
| Drug | Countries | |
|---|---|---|
| JALRA | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, South Africa |
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