Is Mogamulizumab 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 Mogamulizumab, including POTELIGEO (4 mg/ml, Concentrate for solution for infusion, SAR 5905.30).

Is Mogamulizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Mogamulizumab, including POTELIGEO (Prescription).

Is Mogamulizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mogamulizumab: Poteligeo.

Are there safety signals or safety updates for Mogamulizumab?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-02-19).

Active substance

Mogamulizumab

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
POTELIGEO	4 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 5905.30	Biological · Prescription	Kyowa Kirin Holdings B.V.	Valid

Indications — CHI Daman Drug Formulary

T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
POTELIGEO	20MG/5ML	injectable · injection	KYOWA KIRIN	Prescription	8 Aug 2018

EMA European Union — centrally authorised medicines

Poteligeo Kyowa Kirin Holdings B.V. · Authorised · authorised 22 Nov 2018 · ATC L01XC25

Therapeutic indication (EMA)

Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
POTELIGEO	02527715	4 MG / ML	SOLUTION · INTRAVENOUS	KYOWA KIRIN, INC.

Safety signals and safety-related labeling changes

US FDA 19 Feb 2026 POTELIGEO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 13 Feb 2025 PRAC signal: Colitis
Action for MAH: update of the product information: Yes
EMA PRAC 3 Oct 2024 PRAC signal: Colitis
Action for MAH: update of the product information: No

All safety entries for mogamulizumab →

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.