Aspaveli 1080 mg solution for infusion

*
Pharmacy Only: Prescription
  • Company:

    Swedish Orphan Biovitrum Ltd
  • Status:

    Updated
  • Legal 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 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 

EDM Updated on 06 March 2024

File name

Aspaveli (pegcetacoplan) Patient Carer Guide_ROI_final.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 06 March 2024

File name

Aspaveli (pegcetacoplan) Patient Card_ROI_final.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 06 March 2024

File name

Aspaveli (pegcetacoplan) Guide for Healthcare Professionals_ROI_final.pdf

Reasons for updating

  • Replace File

EDM 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