Is Pemigatinib 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 Pemigatinib, including Pemazyre (13.5 mg, Tablet, SAR 32542.40); Pemazyre (9 mg, Tablet, SAR 32542.40); Pemazyre (4.5 mg, Tablet, SAR 32542.40).

Is Pemigatinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Pemigatinib, including PEMAZYRE (Prescription).

Is Pemigatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pemigatinib: Pemazyre.

Are there safety signals or safety updates for Pemigatinib?

US FDA: 1 entry (latest 2022-08-25).

Active substance

Pemigatinib

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Pemazyre	13.5 mg	Tablet · Oral use	14 Blister	SAR 32542.40	NCE · Prescription	Incyte Biosciences International Sarl	Valid
Pemazyre	9 mg	Tablet · Oral use	14 Blister	SAR 32542.40	NCE · Prescription	Incyte Biosciences International Sarl	Valid
Pemazyre	4.5 mg	Tablet · Oral use	14 Blister	SAR 32542.40	NCE · Prescription	Incyte Biosciences International Sarl	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
PEMAZYRE	4.5MG; 9MG; 13.5MG	tablet · oral	INCYTE CORP	Prescription	17 Apr 2020

EMA European Union — centrally authorised medicines

Pemazyre Incyte Biosciences Distribution B.V. · Authorised · authorised 26 Mar 2021 · ATC L01EN02

Therapeutic indication (EMA)

Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PEMAZYRE	02519933	4.5 MG	TABLET · ORAL	INCYTE CORPORATION
PEMAZYRE	02519941	9 MG	TABLET · ORAL	INCYTE CORPORATION
PEMAZYRE	02519968	13.5 MG	TABLET · ORAL	INCYTE CORPORATION

Safety signals and safety-related labeling changes

US FDA 25 Aug 2022 PEMAZYRE — 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

All safety entries for pemigatinib →

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.