Omlyclo 75 mg solution for injection in pre-filled pen and syringe
*Company:
Celltrion Healthcare Ireland Ltd.Status:
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 16 July 2026
File name
PL_Omlyclo 75mg PFS_May 2026.pdf
Reasons for updating
- Change to storage instructions
- Change to section 7 - Instructions for use
Updated on 16 July 2026
File name
SmPC Omlyco 75mg PFS & PFP_en_May 2026.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition to section 6.4: If necessary, the carton may be removed from and placed back in the refrigerator. The total combined time out of the refrigerator must not exceed 7 days at temperatures below 25°C.
Addition to section 6.6: The single-use pre-filled syringe is for individual use. It should be taken out of the refrigerator 30 to 45 minutes before injecting to allow it to reach room temperature.
Updated on 24 September 2025
File name
SmPC Omlyclo 75mg PFP & PFS_v5.0_July2025.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
New SPC for new product
Updated on 24 September 2025
File name
Omlyclo 75mg Pre-Filled Pen_Patient Leaflet(IE)_ver1.pdf
Reasons for updating
- New PIL for new product
Updated on 24 September 2025
File name
Omlyclo 75mg_PF Syringe_Patient Leaflet(IE)_final_07Aug24.pdf
Reasons for updating
- New PIL for new product
Celltrion Healthcare Ireland Ltd.
Address:
26 Arrow Building, Old Belgard Road, Tallaght, Dublin, D24 ND70Medical Information E-mail:
Medinfoie@celltrionhc.comTelephone:
01 223 4026