Is Serplulimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Serplulimab: Hetronifly.

Are there safety signals or safety updates for Serplulimab?

EMA PRAC: 1 entry (latest 2026-06-11).

Active substance

Serplulimab

EMA 1
Safety 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Hetronifly Accord Healthcare S.L.U. · Authorised · authorised 3 Feb 2025 · ATC L01FF12

Therapeutic indication (EMA)

Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC). Non-small cell lung carcinoma (NSCLC) Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC. Oesophageal squamous cell carcinoma (OSCC) Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.

Safety signals and safety-related labeling changes

EMA PRAC 11 Jun 2026 PRAC signal: Acquired haemophilia
Action for MAH: update of the product information: No

All safety entries for serplulimab →

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.