Koselugo
What Koselugo is used for
Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older. Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Koselugo
- Active substance
- selumetinib
- Disease area
- Neurofibromatosis 1
- Medicine group
- Antineoplastic agents
- ATC code
- L01EE04
- Marketing authorisation holder
- AstraZeneca AB
- Authorised in the EU since
- 2021
Official information
In the USA
Same active substance: Koselugo
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Koselugo used for?
Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older. Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.
What is the active substance in Koselugo?
Koselugo contains selumetinib.
Who makes Koselugo?
The EU marketing authorisation holder is AstraZeneca AB.
Is Koselugo an orphan medicine?
Yes. Koselugo is designated an orphan medicine in the EU, for a rare disease (Neurofibromatosis 1).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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