Is Erdafitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Erdafitinib, including BALVERSA (3 mg, Film-coated tablet, SAR 37903.30); BALVERSA (4 mg, Film-coated tablet, SAR 50537.75); BALVERSA (5 mg, Film-coated tablet, SAR 31586.10); Ryhava (3 mg, Film-coated tablet, SAR 26532.30); Ryhava (4 mg, Film-coated tablet, SAR 35376.40).

Is Erdafitinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Erdafitinib, including BALVERSA (Prescription).

Is Erdafitinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Erdafitinib: Balversa.

Are there safety signals or safety updates for Erdafitinib?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-01-15).

Active substance

Erdafitinib

SFDA 7
US FDA 1
EMA 1
Health Canada 3
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
BALVERSA	3 mg	Film-coated tablet · Oral use	56 Bottle	SAR 37903.30	NCE · Prescription	JANSSEN BIOTECH INC.	Valid
BALVERSA	4 mg	Film-coated tablet · Oral use	56 Bottle	SAR 50537.75	NCE · Prescription	JANSSEN BIOTECH INC.	Valid
BALVERSA	5 mg	Film-coated tablet · Oral use	28 Bottle	SAR 31586.10	NCE · Prescription	JANSSEN BIOTECH INC.	Valid
BALVERSA	3 mg	Film-coated tablet · Oral use	84 Bottle	SAR 56854.95	NCE · Prescription	JANSSEN BIOTECH INC.	Valid
Ryhava	3 mg	Film-coated tablet · Oral use	56 Bottle	SAR 26532.30	Generic · Prescription	Boston Oncology Arabia	Valid
Ryhava	4 mg	Film-coated tablet · Oral use	56 Bottle	SAR 35376.40	Generic · Prescription	Boston Oncology Arabia	Valid
Ryhava	5 mg	Film-coated tablet · Oral use	28 Bottle	SAR 22110.25	Generic · Prescription	Boston Oncology Arabia	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
BALVERSA	3MG; 4MG; 5MG	tablet · oral	JANSSEN BIOTECH	Prescription	12 Apr 2019

EMA European Union — centrally authorised medicines

Balversa · Authorised · authorised 22 Aug 2024 · ATC L01EN01

Therapeutic indication (EMA)

Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BALVERSA	02493217	3 MG	TABLET · ORAL	JANSSEN INC
BALVERSA	02493225	4 MG	TABLET · ORAL	JANSSEN INC
BALVERSA	02493233	5 MG	TABLET · ORAL	JANSSEN INC

Safety signals and safety-related labeling changes

EMA PRAC 15 Jan 2026 PRAC signal: Growth accelerated
Action for MAH: update of the product information: Yes
US FDA 17 Oct 2025 BALVERSA — 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 4 Sep 2025 PRAC signal: Growth accelerated
Action for MAH: update of the product information: No

All safety entries for erdafitinib →

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.