Skyrizi 150 mg solution for injection in pre-filled pen
*Company:
AbbVie LimitedStatus:
No Recent UpdateLegal 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 29 July 2024
File name
Skyrizi_SmPC_150mg PFP_UC & 180mg OBI_July 24_clean.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 29 July 2024
File name
Skyrizi_PIL_150mgPFP_UC & 180mg OBI_July 24_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 12 January 2024
File name
Skyrizi_SmPC_150mg PFP_Renewal & 90mg PFS_Jan 24.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 January 2024
File name
Skyrizi_PIL_150mg PFP_Renewal & 90mg PFS_Jan 24.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 28 September 2023
File name
Skyrizi_SmPC_75mg_150mg_Type II CCDS v14 LIMMITLESS_Sept 23.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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 02 March 2023
File name
Skyrizi_PIL_75mg_150mg_Type II CCDS V13_Feb 2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Free text change information supplied by the pharmaceutical company
With this CCDS v13 update, the frequencies for urticaria and rash in SmPC section 4.8 will be changed from not known to uncommon and common, respectively.
Updated on 02 March 2023
File name
Skyrizi_SmPC_75mg_150mg_Type II CCDS V13_Feb 2023.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)
Free text change information supplied by the pharmaceutical company
With this CCDS v13 update, the frequencies for urticaria and rash in SmPC section 4.8 will be changed from not known to uncommon and common, respectively.
Updated on 13 January 2023
File name
Skyrizi_PIL_5th PSUR-150mg-Pen-Jan 2023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Changes were made to Section 4 of the PIL to add urticaria and rash as ADRs with frequency “not known”.
Updated on 13 January 2023
File name
Skyrizi_SmPC_5th PSUR-75mg-150mg-Jan 2023.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)
Free text change information supplied by the pharmaceutical company
Changes were made to Section 4.8 (Undesirable effects) of the SPC to add urticaria and rash as ADRs with frequency “not known”
Updated on 23 November 2022
File name
Skyrizi_SmPC_Type II_Chron's_Indication_Nov 2022.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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
Minor grammatical updates have been made to Section 2 and 4.2 of the SPC and in section 4.8 changes were made to incorporate an update on the safety profile to include the percentages of patients with Chron's disease and Psoriasis who had reported upper respiratory infections.
Updated on 17 November 2021
File name
Skyrizi_SmPC_PsA + RT_November 2021_NOT MARKETED.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 26 May 2021
File name
Skyrizi_SmPC_Line Extension_May 2021_NOT MARKETED.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)