Is Sacituzumab govitecan 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 Sacituzumab govitecan, including Trodelvy (180 mg, Powder for concentrate for solution for infusion, SAR 4836.95).

Is Sacituzumab govitecan approved by the US FDA?

Drugs@FDA lists 1 application product line for Sacituzumab govitecan, including TRODELVY (Prescription).

Is Sacituzumab govitecan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sacituzumab govitecan: Trodelvy.

Are there safety signals or safety updates for Sacituzumab govitecan?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-07-09).

Active substance

Sacituzumab govitecan

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Trodelvy	180 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 4836.95	Biological · Prescription	GILEAD SCIENCES LIMITED (CORK)	Valid

Indications — CHI Daman Drug Formulary

BLADDER CANCER; BREAST CANCER TARGET THERAPY

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

Product	Strength	Form · route	Applicant	Status	First approved
TRODELVY	180MG	injectable · injection	IMMUNOMEDICS INC	Prescription	22 Apr 2020

EMA European Union — centrally authorised medicines

Trodelvy Gilead Sciences Ireland UC · Authorised · authorised 22 Nov 2021 · ATC L01FX06

Therapeutic indication (EMA)

Triple-Negative Breast Cancer Trodelvy is indicated: as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1) HR-Positive, HER2-Negative Breast Cancer Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRODELVY	02520788	180 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	GILEAD SCIENCES CANADA INC

Safety signals and safety-related labeling changes

EMA PRAC 9 Jul 2026 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No
US FDA 24 Jun 2026 TRODELVY — 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 sacituzumab govitecan →

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.