Koselugo
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Selumetinib
- Made by
- AstraZeneca AB
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is 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.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (KOSELUGO). It describes the substance, not this exact product.
Selumetinib is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2).
MEK1/2 proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway.
Selumetinib is primarily metabolized by CYP3A4 and to a lesser extent by CYP2C19, CYP1A2, CYP2C9, CYP2E1, and CYP3A5.
Effect of Food No clinically significant differences in selumetinib pharmacokinetics were observed following administration of low fat (400-500 calories) or high-fat (800-1000 calories) meal.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-26
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | AstraZeneca AB |
|---|---|
| Active substance | Selumetinib |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01EE04 · Cancer treatments and immune-system medicines |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2021-06-17 |
| Last updated by the regulator | 2026-07-01 |
| EMA product number | EMEA/H/C/005244 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).