Ontozry (cenobamate) tablets
*Company:
Angelini Pharma UK-I LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)
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)