Regulatory PathRegulatory requirements compared

Active substance

Toripalimab

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
LOQTORZI240MG/6ML(40MG/ML)injectable · injectionCOHERUS BIOSCIENCES INCPrescription27 Oct 2023

EMA European Union — centrally authorised medicines

Loqtorzi Topalliance Biosciences Europe Limited · Authorised · authorised 19 Sep 2024 · ATC L01FF13

Therapeutic indication (EMA)

Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
LOQTORZI0256221940 MG / MLSOLUTION · INTRAVENOUSAPOTEX INC

Safety signals and safety-related labeling changes

All safety entries for toripalimab →

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.