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 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