Galvus (vildagliptin)
- Region
- 🇪🇺 EU
- Active substance
- vildagliptin
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 19 Jul 2007
- EU approval
- Tue 25 Sep 2007
- Application
- EMEA/H/C/000771
- ATC
- A10BH02
- Official record
- www.ema.europa.eu
Indication
Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Jalra Authorised · Novartis Europharm Limited
- 🇪🇺 Xiliarx Authorised · Novartis Europharm Limited
- 🇪🇺 Icandra (previously Vildagliptin / metformin hydrochloride Novartis) Authorised · Novartis Europharm Limited
- 🇪🇺 Zomarist Authorised · Novartis Europharm Limited
- 🇪🇺 Eucreas Authorised · Novartis Europharm Limited
- 🇪🇺 Vildagliptin / Metformin hydrochloride Accord Authorised · Accord Healthcare S.L.U.
Follow Galvus
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.