Ontozry (cenobamate) tablets
*Company:
Angelini Pharma UK-I LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)
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