Otulfi 45 mg solution for injection in pre-filled syringe
*Company:
Fresenius Kabi 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 02 December 2025
File name
IE-SmPC-Otulfi-45mg-PFS- V003.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Safety updates to align with the originator product. Extension of the paediatric Crohn's disease indication. Inclusion of the PS80 needle gauge size as 29G.
Updated on 15 July 2025
File name
IE-SmPC-Otulfi-45mg-PFS- V002.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC Update
Updated on 15 July 2025
File name
ema-combined-h-6544-ie- PFS 45mg.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 3 - use in children/adolescents
Free text change information supplied by the pharmaceutical company
Update to PIL
Updated on 10 February 2025
File name
PPM-PH-0030799-2024-Nov-Otulfi 45mg-PIL-IE-cropped IE.pdf
Reasons for updating
- New PIL for new product
Updated on 10 February 2025
File name
IE-SmPC-Otulfi-45mg-PFS- 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
Address:
Unit 3B Fingal Bay Business Park, Balbriggan, Co. Dublin, Ireland, K32YK12Medical Information E-mail:
Medical.Information-uk@fresenius-kabi.com , jeremy.morais@fresenius-kabi.comTelephone:
+353 01 8413030 0Website:
www.fresenius-kabi.com/ieMedical Information Facsimile:
+ 353 1 849 6949Medical Information Direct Line:
+ 353 1 841 3030 , +44 1928 533575Stock Availability:
FK-enquiries.Ireland@fresenius-kabi.com