Type II – C.I.4 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, preclinical, clinical or pharmacovigilance data (updating of section 4.2 and 5.2 of SmPC and 3 of Package Leaflet to introduce the crushed tablets method of administration and updating of 4.5 DDI section of SmPC + postal code ACRAF Ancona update on Package Leaflet) related to Ontozry – Cenobamate – tablets and film-coated tablets – all strength (12.5, 25, 50, 100, 150 and 200 mg).

Type II – C.I.4 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, preclinical, clinical or pharmacovigilance data (updating of section 4.2 and 5.2 of SmPC and 3 of Package Leaflet to introduce the crushed tablets method of administration and updating of 4.5 DDI section of SmPC + postal code ACRAF Ancona update on Package Leaflet) related to Ontozry – Cenobamate – tablets and film-coated tablets – all strength (12.5, 25, 50, 100, 150 and 200 mg).

MHRA Official Approval for Type IA Variation (Deletion of manufacturing site SwissCaps) related to Ontozry – Cenobamate – tablets and film-coated tablets – all strength (12.5, 25, 50, 100, 150 and 200 mg) in UK