Is Mirvetuximab soravtansine 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 Mirvetuximab soravtansine, including ELAHERE (5 mg/ml, Concentrate for solution for infusion, SAR 30015.55).

Is Mirvetuximab soravtansine approved by the US FDA?

Drugs@FDA lists 1 application product line for Mirvetuximab soravtansine, including ELAHERE (Prescription).

Is Mirvetuximab soravtansine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mirvetuximab soravtansine: Elahere.

Are there safety signals or safety updates for Mirvetuximab soravtansine?

US FDA: 1 entry (latest 2024-03-22).

Active substance

Mirvetuximab soravtansine

SFDA 1
US FDA 1
EMA 1
Health Canada 1
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
ELAHERE	5 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 30015.55	Biological · Prescription	ABBVIE Deutschland GmbH	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ELAHERE	100mg/20mL single-dose vial	injectable · injection	IMMUNOGEN INC	Prescription	14 Nov 2022

EMA European Union — centrally authorised medicines

Elahere AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 14 Nov 2024 · ATC L01FX26

Therapeutic indication (EMA)

Elahere as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ELAHERE	02560771	100 MG / 20 ML	SOLUTION · INTRAVENOUS	ABBVIE CORPORATION

Safety signals and safety-related labeling changes

US FDA 22 Mar 2024 ELAHERE — 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 mirvetuximab soravtansine →

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.