🇪🇺 Derma-Smoothe/Fs in European Union

Derma-Smoothe/Fs (FLUOCINOLONE ACETONIDE) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/000787
  • Local brand name: Retisert
  • Status: application withdrawn

Derma-Smoothe/Fs in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Derma-Smoothe/Fs approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Derma-Smoothe/Fs in European Union?

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