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 24 October 2024
File name
Aspaveli PIL IE NI (Oct 2024).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 September 2024
File name
Aspaveli SPC IE NI (Sept 2024).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 09 September 2024
File name
Aspaveli PIL IE NI (Sep 2024).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 23 July 2024
File name
Aspaveli SPC IE NI (July 2024).pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 May 2024
File name
Aspaveli SPC IE NI (May 2024).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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Extension of indication to allow for first line treatment with Aspaveli based on Study APL2-PNH-308 (PRINCE).
Updated on 20 May 2024
File name
Aspaveli PIL IE NI (May 2024).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Extension of indication to allow for first line treatment with Aspaveli based on Study APL2-PNH-308 (PRINCE).
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
File name
Aspaveli (pegcetacoplan) Patient Carer Guide_ROI_final.pdf
Reasons for updating
- Add New Doc
File name
Aspaveli (pegcetacoplan) Patient Card_ROI_final.pdf
Reasons for updating
- Add New Doc
File name
Aspaveli (pegcetacoplan) Guide for Healthcare Professionals_ROI_final.pdf
Reasons for updating
- Replace File
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