Koselugo
Koselugo ingredients
| Active ingredient | Strength |
|---|---|
| Selumetinib | 7.5 mg/1, 10 mg/1, 25 mg/1, 5 mg/1 |
What Koselugo is used for
The FDA lists the approved uses on the official label (below). In the EU, selumetinib is approved as Koselugo 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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Koselugo
- Generic name
- Selumetinib
- Made by
- AstraZeneca Pharmaceuticals LP
- Forms
- Capsule, Granule
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA219943
- On the US market since
- 2020
Official information
- Koselugo prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Selumetinib)
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?
Koselugo (Selumetinib) is a cancer medicine made by AstraZeneca Pharmaceuticals LP, approved by the US FDA.
What are the ingredients of Koselugo?
Koselugo contains Selumetinib (7.5 mg/1, 10 mg/1, 25 mg/1, 5 mg/1).
Is Koselugo approved in Europe?
The same active substance is approved in the EU as Koselugo.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA