Evrysdi 5 mg film‑coated tablets
*Company:
Roche Registration GmbHStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 January 2026
File name
Renewal_tabs_EVRYSDI_SmPC_08Jan2026.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 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 January 2026
File name
Renewal_tabs_EVRYSDI_PIL_08Jan2026.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 30 June 2025
File name
Evrysdi_art613_FCT_PIL_26Jun2025.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 09 June 2025
File name
Evrysdi_LE24_FCT_SmPC_02Jun2025.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 June 2025
File name
Evrysdi_LE24_FCT_PIL_02Jun2025..pdf
Reasons for updating
- New PIL for new product
Roche Registration GmbH
Address:
3004 Lake Drive, Citywest, Naas Road, Dublin 24Medical Information E-mail:
ireland.druginfo@roche.comTelephone:
+353 1 469 0700Fax:
+353 1 469 0791