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Otulfi 45 mg solution for injection in pre-filled pen

*
Pharmacy Only: Prescription

  • Company:

    Fresenius Kabi Ltd

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Ustekinumab

    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 22 June 2026

File name

IE-SmPC-Otulfi-45mg-PFP- V003.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

  • Update to SPC to remove the indications of Paediatric Plaque Psoriasis and Paediatric Crohn's Disease and the consequential information as per EMA request.


  • Shelf life update from 18 months to 2 years.


Updated on 22 June 2026

File name

PPM-PH-0036333-2026-Jun Otulfi 45 mg PFP-PIL-IE.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

Change to PIL:

  • Update PIL to remove the indications of Paediatric Plaque Psoriasis and Paediatric Crohn's Disease and the consequential information as per EMA request.


  • Shelf life update from 18 months to 2 years.


Updated on 09 April 2026

File name

PPM-PH-0036333-2026-Mar-Otulfi 45 mg PFP-PIL-IE.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 April 2026

File name

IE-SmPC-Otulfi-45mg-PFP- V001.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Fresenius Kabi Ltd

Fresenius Kabi Ltd