Is Darolutamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Darolutamide, including NUBEQA (300 mg, Film-coated tablet, SAR 10502.00).

Is Darolutamide approved by the US FDA?

Drugs@FDA lists 1 application product line for Darolutamide, including NUBEQA (Prescription).

Is Darolutamide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Darolutamide: Nubeqa.

Are there safety signals or safety updates for Darolutamide?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-09-22).

Active substance

Darolutamide

SFDA 1
US FDA 1
EMA 1
Health Canada 1
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
NUBEQA	300 mg	Film-coated tablet · Oral use	112 Blister	SAR 10502.00	NCE · Prescription	BAYER AG	Valid

Indications — CHI Daman Drug Formulary

PROSTATE CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
NUBEQA	300MG	tablet · oral	BAYER HEALTHCARE	Prescription	30 Jul 2019

EMA European Union — centrally authorised medicines

Nubeqa Bayer AG · Authorised · authorised 27 Mar 2020 · ATC L02BB

Therapeutic indication (EMA)

NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NUBEQA	02496348	300 MG	TABLET · ORAL	BAYER INC

Safety signals and safety-related labeling changes

US FDA 22 Sep 2026 NUBEQA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jun 2026 PRAC signal: Angioedema
Action for MAH: update of the product information: Yes
EMA PRAC 15 Jan 2026 PRAC signal: Angioedema
Action for MAH: update of the product information: No

All safety entries for darolutamide →

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.