Vabysmo 120 mg/mL solution for injection

*
Pharmacy Only: Prescription DHPC
  • Company:

    Roche Registration GmbH
  • Status:

    Updated
  • 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 23 December 2024

File name

Vabysmo_II-0014_19Dec2024_SmPC.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 23 December 2024

File name

Vabysmo_II-0014_19Dec2024_PIL.pdf

Reasons for updating

  • Change to section 3 - how to take/use

COM Updated on 22 October 2024

File name

03_Vabysmo_DHPC_17Oct2024__HPRA_approved_signed.pdf

Reasons for updating

  • New ADCOM File

Updated on 31 July 2024

File name

PIL_Vabysmo_II-005_26 Jul 204.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to information for healthcare professionals

Updated on 31 July 2024

File name

SmPC_Vabysmo_II-005_26 Jul 204.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 March 2024

File name

Vabysmo_II09_PIL_08Feb2024.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 March 2024

File name

Vabysmo_II09_SmPC_08Feb2024.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 03 August 2023

File name

Vabysmo EU Annexes_0002_22Jun2023_SmPC.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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 7 - Marketing authorisation holder
  • 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 03 August 2023

File name

Vabysmo EU Annexes_0002_22Jun2023_PL.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to date of revision

EDM Updated on 28 February 2023

File name

Vabysmo Patient Brochure IE Version 1.3.2 Final PDF.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 28 February 2023

File name

63e4c602a05ed.mp3

Reasons for updating

  • Add New Link

EDM Updated on 09 February 2023

File name

Vabysmo Ireland.mp3

Reasons for updating

  • Add New Audio

Updated on 22 September 2022

File name

Vabysmo EU Annexes_MAA_15Sept2022_SmPC_1.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 September 2022

File name

Vabysmo EU Annexes_MAA_15Sept2022_PL_1_updated.pdf

Reasons for updating

  • New PIL for new product