Vabysmo 120 mg/mL solution for injection
*Company:
Roche Registration GmbHStatus:
No Recent UpdateLegal 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
- SPC
- Patient Leaflets
- Ed Material - HCP
- Ed Material - Patient
- Additional Comms
- Licence Info
- Doc History
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
File name
Vabysmo Patient Brochure IE Version 1.3.2 Final PDF.pdf
Reasons for updating
- Add New Doc
File name
63e4c602a05ed.mp3
Reasons for updating
- Add New Link
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