ALTUVOCT powder and solvent for solution for injection

*
Pharmacy Only: Prescription
  • Company:

    Swedish Orphan Biovitrum Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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Updated on 15 January 2026

File name

Altuvoct SmPC IE (Jan 2026).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

PRAC request to Sobi to update the Product Information with information on hypersensitivity 

Updated on 15 January 2026

File name

Altuvoct PIL IE (Jan 2026).pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

PRAC request to Sobi to update the Product Information with information on hypersensitivity 

Updated on 09 January 2025

File name

Altuvoct SPC IE (Jan 2025).pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 January 2025

File name

Altuvoct PIL IE (Jan 2025).pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 25 June 2024

File name

Altuvoct SPC IE NI (June 2024).pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 June 2024

File name

Altuvoct PIL IE NI (June 2024).pdf

Reasons for updating

  • New PIL for new product

Swedish Orphan Biovitrum Ltd

Swedish Orphan Biovitrum Ltd