Medicines showing this symbol are subject to additional monitoring. This will allow quick identification of new safety information. Please click here for more information.
- Active Ingredients
Product Documentation
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View RMM (Hetronifly 10 mg/ml concentrate for solution for infusion)
Last updated on this site: 15 Jul 2026
Serplulimab Patient Card has been updated to v2.0.
MHRA approval date: 09/07/2026
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintHetronifly 10 mg/ml concentrate for solution for infusion
Medicines showing this symbol are subject to additional monitoring. This will allow quick identification of new safety information. Please click here for more information.
- PL Number:
- 20075/1559
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Active
Product Documentation
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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
View Summary of Product Characteristics (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
SmPC sections updated: Heading, 4.1, 4.2, 4.8, 5.1, 5.2, 8 and 10
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaint
For any further assistance, please get in touch.