🇪🇺 Xermelo in European Union

EMA authorised Xermelo on 17 September 2017

Marketing authorisation

EMA — authorised 17 September 2017

  • Application: EMEA/H/C/003937
  • Marketing authorisation holder: SERB SAS
  • Local brand name: Xermelo
  • Indication: Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
  • Pathway: orphan
  • Status: approved

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Xermelo in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Xermelo approved in European Union?

Yes. EMA authorised it on 17 September 2017.

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

SERB SAS holds the EU marketing authorisation.