🇪🇺 Omnitrope in European Union

EMA authorised Omnitrope on 12 April 2006

Marketing authorisations

EMA — authorised 12 April 2006

  • Marketing authorisation holder: SANDOZ GMBH
  • Local brand name: Omnitrope
  • Status: approved

EMA

  • Application: EMEA/H/C/000607
  • Local brand name: Omnitrope
  • Status: approved

Omnitrope 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 Omnitrope approved in European Union?

Yes. EMA authorised it on 12 April 2006; EMA has authorised it.

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

SANDOZ GMBH holds the EU marketing authorisation.