Mycapssa

RSS

octreotide

Authorised
This medicine is authorised for use in the European Union.

Overview

Mycapssa is a medicine used for the maintenance (long-term) treatment of acromegaly (a condition where the body produces too much growth hormone, leading to excessive growth of body tissue and bones, particularly of the hands, feet and face). Mycapssa can be used in adults who have previously responded to and tolerated treatment with other somatostatin analogues (synthetic versions of the hormone somatostatin).

Mycapssa is a ‘hybrid medicine’, meaning that it is similar to a ‘reference medicine’ containing the same active substance, but there are certain differences between the two. The reference medicine for Mycapssa is Sandostatin IR, which is a solution given as an injection or infusion (drip), whereas Mycapssa is a capsule given by mouth.

Acromegaly is rare, and Mycapssa was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 5 August 2013.

Mycapssa contains the active substance octreotide. 

This EPAR was last updated on 22/12/2022

Authorisation details

Product details
Name
Mycapssa
Agency product number
EMEA/H/C/005826
Active substance
Octreotide acetate
International non-proprietary name (INN) or common name
octreotide
Therapeutic area (MeSH)
Acromegaly
Anatomical therapeutic chemical (ATC) code
H01CB02
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Amryt Pharmaceuticals DAC
Date of issue of marketing authorisation valid throughout the European Union
02/12/2022
Contact address

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

Product information

02/12/2022 Mycapssa - EMEA/H/C/005826 -

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

Related content

How useful was this page?

Add your rating