Lunsumio 1 mg and 30 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 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)

EDM 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.