🇪🇺 Opsumit in European Union

EMA authorised Opsumit on 20 December 2013

Marketing authorisation

EMA — authorised 20 December 2013

  • Status: approved

Opsumit 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 Opsumit approved in European Union?

Yes. EMA authorised it on 20 December 2013.

Who is the marketing authorisation holder for Opsumit in European Union?

AstraZeneca is the originator. The local marketing authorisation holder may differ — check the official source linked above.