Columvi 2.5 mg and 10 mg concentrate for solution for infusion

*
Pharmacy Only: Prescription
  • Company:

    Roche Registration GmbH
  • Status:

    No Recent Update
  • Legal 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 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

EDM Updated on 13 September 2023

File name

Columvi Patient Card IE Version 1.2.1.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 13 September 2023

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