Idacio 40 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):
*Additional information is available within the SPC or upon request to the company
Updated on 31 March 2026
File name
IE SmPC Idacio 40mg Solution - Prefilled syringe & Prefilled Pen-V007.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- 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
- Change in pack size of the finished product - Deletion of a pack size(s)
- Change to in-process tests or limits applied during the manufacture of the AS - Addition of a new in-process test and limits
- Changes in the composition (excipients) of the finished product - Other excipients - Change that relates to a biological/immunological product
- Changes in the manufacturing process of the AS - The change refers to a [-] substance in the manufacture of a biological/immunological substance which may have a significant impact on the medicinal product and is not related to a protocol
- Updated artwork as per new branding
- Change in the SPC following assessment of the same change for the reference product
- The request came from EMA, and it was based on an update of the originator (Humira) label, more precisely in Summary of Product Characteristics.
As you will see in the attached tracked version, the changes are very limited, i.e. addition of the word “spontaneously” in the section 4.8 Undesirable effects.
Updated on 11 February 2026
File name
Idacio-PFS-PIL-IE.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL
Updated on 11 February 2026
File name
IE SmPC Idacio 40mg Solution - Prefilled syringe & Prefilled Pen-V006.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC added
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