EMA — authorised 26 September 2007
- Status: approved
🇪🇺 Jalra in European Union
EMA authorised Jalra on 26 September 2007
Marketing authorisations
EMA — authorised 19 November 2008
- Application: EMEA/H/C/001048
- Marketing authorisation holder: Novartis Europharm Limited
- Local brand name: Jalra
- 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 (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
- Status: approved
Jalra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Jalra approved in European Union?
Yes. EMA authorised it on 26 September 2007; EMA authorised it on 19 November 2008.
Who is the marketing authorisation holder for Jalra in European Union?
Marketing authorisation holder not available in our data.