Basic Information
Koselugo
Regulatory Information
EMEA/H/C/005244
June 17, 2021
April 22, 2021
6
March 14, 2025
Company Information
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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
Overview Summary
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](/en/medicines/human/orphan-designations/eu-3-18-2050) is available. Koselugo contains the active substance selumetinib.