Selumetinib
Mitogen-Activated Protein Kinase (Mek) Inhibitors
Sold as KOSELUGO
- Drug class
- Mitogen-Activated Protein Kinase (Mek) Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 5
Overview
Selumetinib is an active pharmaceutical ingredient in the Mitogen-Activated Protein Kinase (Mek) Inhibitors group (L01EE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 2 | April 7, 2026 |
| GB United Kingdom | MHRA | 2 | February 20, 2026 |
| EU European Union | EMA | 1 | January 28, 2026 |
CACanada· Health Canada
2 products
Uses
4 Administration 03/2024 7 WARNINGS AND PRECAUTIONS 02/2026 7 WARNINGS AND PRECAUTIONS 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
GBUnited Kingdom· MHRA
2 products
Uses
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.
How to take
EUEuropean Union· EMA
1 product
Uses
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 .
How to take
Drug interactions
Known interactions involving Selumetinib. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02530139 · revised April 7, 2026
- [2]MHRA (UK) · PLGB179010357 · revised February 20, 2026
- [3]European Medicines Agency · EMEA/H/C/005244 · revised January 28, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.