Otulfi 130 mg concentrate for solution for infusion
*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-130 mg Vial-V003.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 6.1 - List of excipients
- 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
Update to SmPC
Updated on 15 July 2025
File name
ema-combined-h-6544-ie vial 130mg.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 6 - what the product looks like and pack contents
- Change to information about pregnancy or lactation
Free text change information supplied by the pharmaceutical company
Update to PIL
Updated on 05 June 2025
File name
IE-SmPC-Otulfi-130 mg Vial-V002.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 March 2025
File name
IE-SmPC-Otulfi-130 mg Vial-V002.pdf
Reasons for updating
- 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
Shelf life updated to three years.
Updated on 11 February 2025
File name
PPM-PH-0030786-2024-Nov-Otulfi-130mg-PIL-IE-cropped IE.pdf
Reasons for updating
- New PIL for new product
Updated on 10 February 2025
File name
IE-SmPC-Otulfi-130 mg Vial-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