Ontozry (cenobamate) tablets
*Company:
Angelini Pharma UK-I LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)
Updated on 30 July 2026
File name
EMA SMPC July 2026.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
June 2026
Updated on 30 July 2026
File name
EMA PIL July 2026.pdf
Reasons for updating
- XPIL Updated
Free text change information supplied by the pharmaceutical company
June 2026
Updated on 24 April 2025
File name
Cenobamate ema combined PIL - April 2025.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
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).
Updated on 24 April 2025
File name
Cenobamate ema combined SmPC - April 2025.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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).
Updated on 25 March 2025
File name
EMA Ontozry Combined PIL - Dec 2024.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
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
Updated on 23 April 2024
File name
EMA Ontozry PIL - Clean April 2024.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 23 April 2024
File name
Ontozry SmPC actual.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 November 2023
File name
EMA Ontozry SmPC - Clean June 2023.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 November 2023
File name
EMA Ontozry PIL - Clean June 2023.pdf
Reasons for updating
- New PIL for new product
Updated on 17 November 2023
File name
EMA Ontozry PIL - Clean June 2023.pdf
Reasons for updating
- New PIL for new product
Updated on 17 November 2023
File name
EMA Ontozry SmPC - Clean June 2023.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Angelini Pharma UK-I Limited
Address:
Napier House, 24 High Holborn, London, United Kingdom, WC1V 6AZMedical Information E-mail:
UKIReporting@angelinipharma.comTelephone:
+44 (020) 8124 7407 ext 9014Medical Information Direct Line:
0203 488 9643