Evrenzo Film-Coated Tablets
*Company:
Astellas Pharma Co. LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 01 April 2026
File name
IE_EVRENZO_en_03-2026_SmPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Removal of the black triangle and the associated text.
Updated on 01 April 2026
File name
IE_EVRENZO_en_03-2026_PL.pdf
Reasons for updating
- Change to further information section
- Change to dosage and administration
Free text change information supplied by the pharmaceutical company
Removal of the black triangle and the associated text.
Updated on 18 September 2025
File name
IE_EVRENZO_en_SEP2025_PL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 18 September 2025
File name
IE_EVRENZO_en_09-2025_SmPC.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 April 2025
File name
IE_EVRENZO_en_03-2025_SmPC.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 April 2025
File name
IE_EVRENZO_en_03-2025_PL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 24 September 2024
File name
IE Evrenzo PIL 09-2024.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 September 2024
File name
IE Evrenzo SmPC 19Sept2024.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 not be renewed (A)
Updated on 04 April 2024
File name
NI-IE-pil-clean-Apr2024.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 06 June 2023
File name
NI-IE Evrenzo SmPC 02-06-2023.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 June 2023
File name
NI-IE Evrenzo PIL 02-06-2023.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 06 October 2022
File name
NI-IE Evrenzo SmPC 30-09-2022.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 September 2022
File name
NI-IE Evrenzo PIL 27-09-2022.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 28 September 2022
File name
NI-IE Evrenzo SmPC 27-09-2022.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 not be renewed (A)
Updated on 21 July 2022
File name
IE-NI Evrenzo SmPC 18-07-2022_cl.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 21 July 2022
File name
IE-NI Evrenzo PIL 07-2022_cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 May 2022
File name
Evrenzo film-coated tablets IE 08-2021.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2022
File name
Evrenzo-tablets-PIL-IE Aug-2021.pdf
Reasons for updating
- New PIL for new product
Astellas Pharma Co. Ltd
Address:
Damastown Road, Damastown Industrial Park, Mulhuddart, Dublin 15Telephone:
+353 1 467 1555Fax:
+353 1 467 1550