Is Danicopan 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 Danicopan, including Voydeya (100 mg, Film-coated tablet, SAR 26593.45); Voydeya (50 + 100 mg, Film-coated tablet, SAR 19945.05).

Is Danicopan approved by the US FDA?

Drugs@FDA lists 1 application product line for Danicopan, including VOYDEYA (Prescription).

Is Danicopan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Danicopan: Voydeya.

Active substance

Danicopan

SFDA 2
US FDA 1
EMA 1
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Voydeya	100 mg	Film-coated tablet · Oral use	2 Bottle	SAR 26593.45	NCE · Prescription	Alexion Europe SAS	Valid
Voydeya	50 + 100 mg	Film-coated tablet · Oral use	180 Bottle	SAR 19945.05	NCE · Prescription	Alexion Europe SAS	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
VOYDEYA	50MG; 100MG	tablet · oral	ALEXION PHARMS INC	Prescription	29 Mar 2024

EMA European Union — centrally authorised medicines

Voydeya Alexion Europe SAS · Authorised · authorised 19 Apr 2024 · ATC L04AJ09

Therapeutic indication (EMA)

Voydeya is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VOYDEYA	02550040	150 MG / DOSE	TABLET · ORAL	ALEXION PHARMA GMBH
VOYDEYA	02550059	200 MG / DOSE	TABLET · ORAL	ALEXION PHARMA GMBH

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.