Is Selumetinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Selumetinib, including Koselugo (10 mg, Capsule, hard, SAR 19792.55); Koselugo (25 mg, Capsule, hard, SAR 49481.45).

Is Selumetinib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Selumetinib, including KOSELUGO (Prescription); KOSELUGO (Prescription); KOSELUGO (Prescription).

Is Selumetinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Selumetinib: Koselugo.

Are there safety signals or safety updates for Selumetinib?

EMA PRAC: 1 entry; US FDA: 2 entries (latest 2026-05-26).

Active substance

Selumetinib

SFDA 2
US FDA 3
EMA 1
Health Canada 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Koselugo	10 mg	Capsule, hard · Oral use	60 Bottle	SAR 19792.55	NCE · Prescription	AstraZeneca AB	Valid
Koselugo	25 mg	Capsule, hard · Oral use	60 Bottle	SAR 49481.45	NCE · Prescription	AstraZeneca AB	Valid

Indications — CHI Daman Drug Formulary

BRAIN CANCERS; Neurofibromatosis Type 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
KOSELUGO	EQ 10MG BASE; EQ 25MG BASE	capsule · oral	ASTRAZENECA	Prescription	10 Apr 2020
KOSELUGO	EQ 5MG BASE; EQ 7.5MG BASE	granule · oral	ASTRAZENECA	Prescription	10 Sep 2025
KOSELUGO	10MG; 25MG	capsule · oral	ASTRAZENECA	Prescription	10 Sep 2025

EMA European Union — centrally authorised medicines

Koselugo AstraZeneca AB · Authorised · authorised 17 Jun 2021 · ATC L01EE04

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KOSELUGO	02530139	10 MG	CAPSULE · ORAL	ALEXION PHARMA GMBH
KOSELUGO	02530147	25 MG	CAPSULE · ORAL	ALEXION PHARMA GMBH

Safety signals and safety-related labeling changes

US FDA 26 May 2026 KOSELUGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 May 2026 KOSELUGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 30 Oct 2025 PRAC signal: Photosensitivity reaction
Action for MAH: update of the product information: No

All safety entries for selumetinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.