Is Apalutamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Apalutamide, including Alumid (60 mg, Film-coated tablet, SAR 4105.95); ERLEADA 60 mg Film-coated Tablet (60 mg, Film-coated tablet, SAR 10522.15); Erleada (240 mg, Film-coated tablet, SAR 10522.15).

Is Apalutamide approved by the US FDA?

Drugs@FDA lists 2 application product lines for Apalutamide, including ERLEADA (Prescription); APALUTAMIDE (Prescription).

Is Apalutamide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Apalutamide: Erleada.

Are there safety signals or safety updates for Apalutamide?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-06-29).

Active substance

Apalutamide

SFDA 3
US FDA 2
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
Alumid	60 mg	Film-coated tablet · Oral use	60 Blister	SAR 4105.95	Generic · Prescription	Saudi Amarox	Valid
ERLEADA 60 mg Film-coated Tablet	60 mg	Film-coated tablet · Oral use	120 Bottle	SAR 10522.15	NCE · Prescription	JANSSEN BIOTECH INC.	Valid
Erleada	240 mg	Film-coated tablet · Oral use	30 Bottle	SAR 10522.15	NCE · Prescription	Janssen-Cilag International NV	Valid

Indications — CHI Daman Drug Formulary

PROSTATE CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
ERLEADA	60MG; 240MG	tablet · oral	JANSSEN BIOTECH	Prescription	14 Feb 2018
APALUTAMIDE	60MG	tablet · oral	ZYDUS LIFESCIENCES	Prescription	17 Mar 2025

EMA European Union — centrally authorised medicines

Erleada Janssen-Cilag International NV · Authorised · authorised 14 Jan 2019 · ATC L02BB05

Therapeutic indication (EMA)

Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ERLEADA	02478374	60 MG	TABLET · ORAL	JANSSEN INC
ERLEADA	02540185	240 MG	TABLET · ORAL	JANSSEN INC

Safety signals and safety-related labeling changes

US FDA 29 Jun 2026 ERLEADA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Apr 2024 PRAC signal: Lichenoid keratosis
Action for MAH: update of the product information: No
EMA PRAC 14 Apr 2023 PRAC signal: Interstitial lung disease (ILD)
Action for MAH: update of the product information: No

All safety entries for apalutamide →

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.