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

PIL sections updated: Index, 1, 2, 3, 4, 5 and 6

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.