Koselugo

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selumetinib

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

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.

This EPAR was last updated on 10/11/2021

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 monitoringAdditional 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 approvalConditional 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.

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
AstraZeneca AB
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
17/06/2021
Contact address

151 85 Sodertalje
Sweden

Product information

19/10/2021 Koselugo - EMEA/H/C/005244 - IB/0002

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

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

Assessment history

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