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Hetronifly concentrate for solution for infusion

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Active Ingredients

Product Documentation

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.

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Hetronifly 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

  • 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 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

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

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