Hetronifly 10 mg/ml concentrate for solution for infusion: Change history
View Patient Information Leaflet (Hetronifly 10 mg/ml concentrate for solution for infusion)
Last updated on this site: 05 Oct 2026
Description of update: To extend the indication to include HETRONIFLY in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma based on final results from study HLX10-004-NSCLC303; this is a randomized, double-blind, multi-center, phase III pivotal study, to compare the clinical efficacy and safety of serplulimab combined with chemotherapy (carboplatin and nab-paclitaxel) versus placebo combined with chemotherapy (carboplatin and nab-paclitaxel). Consequently, sections 4.1, 4.2, 4.8, 5.1, 5.2 of the SmPC and Leaflet have been updated. The RMP Version 3.2 is provided.
Date of approval: 30/09/2026
PIL sections updated: 1, 2, 3, 4, 6 and HCP section
Last updated on this site: 05 Oct 2026
Description of update: To extend the indication to include HETRONIFLY in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma based on final results from study HLX10-004-NSCLC303; this is a randomized, double-blind, multi-center, phase III pivotal study, to compare the clinical efficacy and safety of serplulimab combined with chemotherapy (carboplatin and nab-paclitaxel) versus placebo combined with chemotherapy (carboplatin and nab-paclitaxel). Consequently, sections 4.1, 4.2, 4.8, 5.1, 5.2 of the SmPC and Leaflet have been updated. The RMP Version 3.2 is provided.
Date of approval: 30/09/2026
PIL sections updated: 1, 2, 3, 4, 6 and HCP section
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Changes: (Updated: 05 Oct 2026)
Description of update: To extend the indication to include HETRONIFLY in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma based on final results from study HLX10-004-NSCLC303; this is a randomized, double-blind, multi-center, phase III pivotal study, to compare the clinical efficacy and safety of serplulimab combined with chemotherapy (carboplatin and nab-paclitaxel) versus placebo combined with chemotherapy (carboplatin and nab-paclitaxel). Consequently, sections 4.1, 4.2, 4.8, 5.1, 5.2 of the SmPC and Leaflet have been updated. The RMP Version 3.2 is provided.
Date of approval: 30/09/2026
PIL sections updated: 1, 2, 3, 4, 6 and HCP section
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Changes: (Updated: 30 Jun 2026)
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
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Changes: (Updated: 09 Mar 2026)
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.
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Changes: (Updated: 09 Mar 2026)
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.
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Changes: (Updated: 24 Nov 2025)
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