Lunsumio 5 mg and 45 mg solution for injection
*Company:
Roche Registration GmbHStatus:
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 20 August 2026
File name
Lunsumio SC_EMAVR0000343033-PML_09Jul2026_SmPC_2.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)
Updated on 20 August 2026
File name
Lunsumio SC_EMAVR0000343033-PML_09Jul2026_PL_2.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
File name
Lunsumio Patient Alert Card IE Version 2.0.2.pdf
Reasons for updating
- New EDM File
File name
Lunsumio Patient Alert Card IE Version 2.0.1.pdf
Reasons for updating
- Add New Doc
Updated on 24 November 2025
File name
LUNSUMIO_LEX15_SC_SmPC_17Nov2025.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 November 2025
File name
LUNSUMIO_LEX15_SC_PIL_17Nov2025.pdf
Reasons for updating
- New PIL for new product
Roche Registration GmbH
Address:
3030 Lake Drive, Citywest Business Campus, Dublin 24, D24 KX6Y, IrelandMedical Information E-mail:
ireland.druginfo@roche.comTelephone:
+353 1 469 0700