Hetronifly 10 mg/ml concentrate for solution for infusion: Change history
View Summary of Product Characteristics (Hetronifly 10 mg/ml concentrate for solution for infusion)
Last updated on this site: 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.
Last updated on this site: 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: 21 Nov 2025)
New product launch.