Slovakia SUKL

ONTOZRY (cenobamate): new requirements for liver function monitoring due to reports of serious liver injury

Original title: ONTOZRY (cenobamát): nové požiadavky na monitorovanie funkcie pečene vzhľadom na hlásenia závažného poškodenia pečene

New liver function monitoring requirements imposed for cenobamate (ONTOZRY) following reports of serious hepatic injury.

Low obligation Product class Pharmaceuticals Slovakia Pharmacovigilance

12.05.2026|Oznamy držiteľov - DHPC|Bezpečnosť liekov|Pre odborníkov a firmy

Dates and deadlines

Regulatory Deadline

December 05, 2026

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