Koselugo
selumetinib
Table of contents
Overview
Koselugo is a medicine used to treat plexiform neurofibromas, benign (non-cancerous) tumours along the nerves, when they cause symptoms and cannot be removed by surgery in children from 3 years of age with neurofibromatosis type 1 (NF1).
NF1 is rare, and Koselugo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 31 July 2018. Further information on the orphan designation is available.
Koselugo contains the active substance selumetinib.
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Koselugo : EPAR - Medicine overview (PDF/120.96 KB)
First published: 13/10/2021
EMA/244286/2021 -
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Koselugo : EPAR - Risk-management-plan summary (PDF/444.39 KB)
First published: 13/10/2021
Authorisation details
Product details | |
---|---|
Name |
Koselugo
|
Agency product number |
EMEA/H/C/005244
|
Active substance |
Selumetinib sulfate
|
International non-proprietary name (INN) or common name |
selumetinib
|
Therapeutic area (MeSH) |
Neurofibromatosis 1
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Orphan |
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 | |
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Marketing-authorisation holder |
AstraZeneca AB
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
17/06/2021
|
Contact address |
151 85 Sodertalje |
Product information
31/05/2023 Koselugo - EMEA/H/C/005244 - R/0010
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).
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
Antineoplastic agents
Therapeutic indication
Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above