Mycapssa

Withdrawn

This medicine's authorisation has been withdrawn

octreotide

Overview

On 26 February 2025, the European Commission withdrew the marketing authorisation for Mycapssa (octreotide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amryt Pharmaceuticals DAC, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Mycapssa was granted marketing authorisation in the EU on 2 December 2022 for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. The marketing authorisation was initially valid for a 5-year period.

The marketing authorisation holder has committed to ensure that patients who are receiving treatment with Mycapssa for acromegaly on a named-patient basis will continue to have access to the medicine.

The European public assessment report (EPAR) for Mycapssa is updated to indicate that the marketing authorisation is no longer valid.

Mycapssa: EPAR - Medicine overview

Reference Number: EMA/781118/2022

Mycapssa: EPAR - Risk-management-plan

Product information

Mycapssa: EPAR - Product information

Mycapssa: EPAR - All authorised presentations

Product details

• Name of medicine:
  Mycapssa
• Active substance:
  Octreotide acetate
• International non-proprietary name (INN) or common name:
  octreotide
• Therapeutic area (MeSH):
  Acromegaly
• Anatomical therapeutic chemical (ATC) code:
  H01CB02

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Authorisation details

• EMA product number:
  EMEA/H/C/005826
• Marketing authorisation holder:
  Amryt Pharmaceuticals DAC

  45 Mespil Road; Ballsbridge Dublin 4 Co.; Dublin D04 W2F1; Ireland

• Opinion adopted:
  15/09/2022
• Marketing authorisation issued:
  02/12/2022
• Withdrawal of marketing authorisation:
  26/02/2025

Assessment history

Initial marketing authorisation documents

Mycapssa: EPAR - Orphan maintenance assessment report (initial authorisation)

Adopted Reference Number: EMA/OD/0000086000

Mycapssa: EPAR - Public assessment report

Adopted Reference Number: EMA/796198/2022

CHMP summary of positive opinion for Mycapssa

Adopted Reference Number: EMA/721412/2022