Lunsumio 1 mg and 30 mg concentrate for solution for infusion
*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 07 May 2024
File name
SmPC_Lunsumio_IB009-IB0011_17Apr2024 with page numbers.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 May 2024
File name
PIL_Lunsumio_IB009-IB0011_17Apr2024_CORRECTED.pdf
Reasons for updating
- Change to other sources of information section
- Correction of spelling/typing errors
Updated on 24 April 2024
File name
SmPC_Lunsumio_IB009-IB0011_17Apr2024.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 April 2024
File name
PIL_Lunsumio_IB009-IB0011_17Apr2024.pdf
Reasons for updating
- Change to other sources of information section
- Correction of spelling/typing errors
Updated on 28 March 2024
File name
SmPC_Lunsumio_PBRER 2nd_21Mar2024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 March 2024
File name
PIL_Lunsumio_PBRER 2nd_21Mar2024.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
PSUSA/00010999/202306. PRAC Rapporteur Assessment Report - request to update SmPC sections 4.4 and 4.8 and PIL sections 2 and 4 for HLH. For tracked changes refer to the
corresponding EU record.
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)
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.