Is Dinutuximab approved by the US FDA?

Drugs@FDA lists 1 application product line for Dinutuximab, including UNITUXIN (Prescription).

Is Dinutuximab authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Dinutuximab.

Are there safety signals or safety updates for Dinutuximab?

US FDA: 1 entry (latest 2020-09-29).

Active substance

Dinutuximab

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
UNITUXIN	17.5MG/5ML	injectable · intravenous	UNITED THERAP	Prescription	10 Mar 2015

EMA European Union — centrally authorised medicines

Unituxin United Therapeutics Europe Ltd · Withdrawn · authorised 14 Aug 2015 · ATC L01FX06

Therapeutic indication (EMA)

Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
UNITUXIN	02483076	3.5 MG / ML	SOLUTION · INTRAVENOUS	UNITED THERAPEUTICS CORPORATION

Safety signals and safety-related labeling changes

US FDA 29 Sep 2020 UNITUXIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for dinutuximab →

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.