Omlyclo 150 mg & 300 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 150 & 300mg PFS_May 2026.pdf
Reasons for updating
- New PIL for new product
Updated on 16 July 2026
File name
Omlyclo 300mg_AI_Leaflet(IE)_ver2(400x805(40x135)).pdf
Reasons for updating
- New PIL for new product
Updated on 16 July 2026
File name
SmPC Omlyclo 150 & 300mg PFS & PFP_en_May 2026.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC updated to include details on new 300 mg strength pre-filled pen and pre-filled syringe.
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.
Updated on 24 September 2025
File name
Omlyclo 150mg Pre-Filled Pen_Patient Leaflet(IE)_ver1.pdf
Reasons for updating
- New PIL for new product
Updated on 24 September 2025
File name
SmPC Omlyclo 150mg PFP & PFS_v5.0_July 2025.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Celltrion Healthcare Ireland Ltd.
Address:
26 Arrow Building, Old Belgard Road, Tallaght, Dublin, D24 ND70Medical Information E-mail:
Medinfoie@celltrionhc.comTelephone:
01 223 4026