Hetronifly 10 mg/ml concentrate for solution for infusion: Change history

To extend the therapeutic indication to include 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 greater than or equal to 5. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 of SmPC and PIL have been updated. The updated RMP version (3.1) has also been included.

Variation approval date: 26/06/2026

SmPC sections updated: 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 10

To update sections 4.2, 4.4 and 4.8 of SmPC to include myasthenia gravis and myasthenic syndrome to the list of adverse drug reactions (ADRs) with frequency "rare", based on a signal assessment report. Additional warning and recommendations for treatment modifications are also included. Consequently the PIL has been updated.

Variation approval date: 04/03/2026.