Skyrizi 600 mg concentrate for solution for infusion
*Company:
AbbVie LimitedStatus:
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 17 January 2025
File name
PIL_ Skyrizi 600mg conc-solu-infus_13Jan2025.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 17 January 2025
File name
SmPC_ Skyrizi 600mg conc-solu-infus_13Jan2025.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)
Free text change information supplied by the pharmaceutical company
Section 4.4
Existing warning on hypersensitivity has been updated regarding anaphylactic reactions. The updated text reads:
Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of risankizumab (see section 4.8). If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
Section 4.8
Anaphylactic reactions with a frequency rare has been added to Table 1
Section 10.
Date of revision of the text has been updated to 01/2025
Updated on 29 July 2024
File name
Skyrizi_SmPC_600mg_UC & 180mg OBI_July 24_clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 29 July 2024
File name
Skyrizi_PIL_600mg_UC & 180mg OBI_July 24_clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 22 January 2024
File name
Skyrizi_SmPC_600mg_Renewal & 90mg PFS_Jan 24.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 January 2024
File name
Skyrizi_PIL_600mg_Renewal & 90mg PFS_Jan 24.pdf
Reasons for updating
- New PIL for new product