Mycapssa
Withdrawn
This medicine's authorisation has been withdrawn
octreotide
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
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The European public assessment report (EPAR) for Mycapssa is updated to indicate that the marketing authorisation is no longer valid.
Product information
02/12/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 analoguesTherapeutic indication
Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
News on Mycapssa
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