Is Gemtuzumab ozogamicin 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 Gemtuzumab ozogamicin, including Mylotarg (4.5 mg, Powder for concentrate for solution for infusion, SAR 35392.50).

Is Gemtuzumab ozogamicin approved by the US FDA?

Drugs@FDA lists 1 application product line for Gemtuzumab ozogamicin, including MYLOTARG (Prescription).

Is Gemtuzumab ozogamicin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Gemtuzumab ozogamicin: Mylotarg.

Are there safety signals or safety updates for Gemtuzumab ozogamicin?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2022-09-29).

Active substance

Gemtuzumab ozogamicin

SFDA 1
US FDA 1
EMA 2
Health Canada 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Mylotarg	4.5 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 35392.50	Biological · Prescription	PFIZER INC	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
MYLOTARG	4.5MG	vial · single-dose	WYETH PHARMS INC	Prescription	1 Sep 2017

EMA European Union — centrally authorised medicines

Mylotarg Pfizer Europe MA EEIG · Authorised · authorised 19 Apr 2018

Therapeutic indication (EMA)

Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).

Mylotarg Wyeth Europa Ltd · Refused · ATC L01XC05

Therapeutic indication (EMA)

re-induction treatment of CD33-positive AML adult patients in first relapse who are not candidates for other intensive re-induction chemotherapy regimens (e.g. high-dose Ara-C) and meet at least one of the following criteria: duration of first remission <12 months, or age >60 years.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MYLOTARG	02494388	4.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

EMA PRAC 29 Sep 2022 PRAC signal: Atypical haemolytic reactions
Action for MAH: update of the product information: No
EMA PRAC 10 Jun 2022 PRAC signal: Atypical haemolytic reactions
Action for MAH: update of the product information: No
EMA PRAC 7 Apr 2022 PRAC signal: Atypical haemolytic reactions
Action for MAH: update of the product information: No
US FDA 16 Jun 2020 MYLOTARG — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for gemtuzumab ozogamicin →

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.