🇪🇺 octreotide capsules in European Union

EMA authorised octreotide capsules on 2 December 2022

Marketing authorisation

EMA — authorised 2 December 2022

  • Application: EMEA/H/C/005826
  • Marketing authorisation holder: Amryt Pharmaceuticals DAC
  • Local brand name: Mycapssa
  • Indication: Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
  • Status: withdrawn

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octreotide capsules in other countries

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

Other Endocrinology approved in European Union

Frequently asked questions

Is octreotide capsules approved in European Union?

Yes. EMA authorised it on 2 December 2022.

Who is the marketing authorisation holder for octreotide capsules in European Union?

Amryt Pharmaceuticals DAC holds the EU marketing authorisation.