Lunsumio 1 mg and 30 mg concentrate for solution for infusion
*Company:
Roche Registration GmbHStatus:
No Recent UpdateLegal 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 24 October 2023
File name
Lunsumio IB-0007G EU Annex_clean_SmPC_1.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 October 2023
File name
Lunsumio IB-0007G EU Annex_clean_PL_1.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to date of revision
Updated on 25 April 2023
File name
Lunsumio_Renewal_19Apr2023_SmPC.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 March 2023
File name
Lunsumio Patient Alert Card IE Version 1.2.1 (4) (1).pdf
Reasons for updating
- Add New Doc
Updated on 10 June 2022
File name
Lunsumio_MAA_03Jun2022_SmPC.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
EMEA/H/C/0005680/0000. Initial MAA submission.
Updated on 10 June 2022
File name
Lunsumio_MAA_03Jun2022_PIL.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
EMEA/H/C/0005680/0000. Initial MAA submission.