Aspaveli 1080 mg solution for infusion
*Company:
Swedish Orphan Biovitrum 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 18 April 2024
File name
Aspaveli SPC IE NI (Apr 2024).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
ATC code change (SmPC section 5.1):
Shelf-life extension (SmPC Section 6.3):
From 24 to 30 months
Updated on 06 March 2024
File name
Aspaveli (pegcetacoplan) Patient Carer Guide_ROI_final.pdf
Reasons for updating
- Add New Doc
Updated on 06 March 2024
File name
Aspaveli (pegcetacoplan) Patient Card_ROI_final.pdf
Reasons for updating
- Add New Doc
Updated on 06 March 2024
File name
Aspaveli (pegcetacoplan) Guide for Healthcare Professionals_ROI_final.pdf
Reasons for updating
- Replace File
Updated on 06 March 2024
File name
Aspaveli (pegcetacoplan) Guide for Healthcare Professionals_ROI_final.pdf
Reasons for updating
- Add New Doc
Updated on 17 June 2022
File name
Aspaveli PL NI and IE (May2022).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 17 June 2022
File name
Aspaveli SPC NI and IE (May2022).pdf.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 25 February 2022
File name
Aspaveli SPC NI and IE (Feb2022).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 February 2022
File name
Aspaveli PL NI and IE (Feb2022).pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 05 January 2022
File name
Aspaveli SPC NI and IE (Dec2021).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2022
File name
Aspaveli PL NI and IE (Dec2021).pdf
Reasons for updating
- New PIL for new product