Stoboclo 60 mg solution for injection in pre-filled 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 28 January 2026
File name
Stoboclo EU SmPC ver6.0 - January 2026.pdf
Reasons for updating
- Error on previous SPC conversion
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Re-uploaded SmPC due to prior issue with HTML format conversion.
Updated on 16 January 2026
File name
Stoboclo EU SmPC ver6.0 - January 2026.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to Section 4.4 of the SmPC in view of available data on a reduction in bone mineral density following denosumab discontinuation. The change follows approval of the same change for the reference product.
File name
HCP Cover Letter_Nov 2025_intro of PRC, denosumab 60mg.pdf
Reasons for updating
- Add New Doc
File name
Denosumab 60 mg Patient Reminder Card_Sept 2025.pdf
Reasons for updating
- Add New Doc
Updated on 09 December 2025
File name
Stoboclo EU SmPC ver5.0 - Nov 2025.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 December 2025
File name
CT-P41 60mg_PFS-S_Leaflet(IE)_ver2(400x805(40x135))(CLT-P).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