Columvi 2.5 mg and 10 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 19 September 2024
File name
Columvi_IA_PIL_16Sep2024.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 September 2024
File name
Columvi_IA_SmPC_16Sep2024.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 02 April 2024
File name
Columvi_IB-0001_03Jan2024_SmPC V2.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2024
File name
Columvi_IB-0001_03Jan2024_SmPC.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2024
File name
Columvi_IB-0001_03Jan2024.pdf
Reasons for updating
- Change to information for healthcare professionals
File name
Columvi Patient Card IE Version 1.2.1.pdf
Reasons for updating
- Add New Doc
File name
Columvi HCP Guide IE Version 1.2.1.pdf
Reasons for updating
- Add New Doc
Updated on 14 July 2023
File name
Columvi_MAA_07Jul2023_clean_SmPC_1.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
New SmPC for new product
Updated on 14 July 2023
File name
Columvi_MAA_07Jul2023_clean_PL_1.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product