Login

Beyfortus 100 mg solution for injection in pre-filled syringe

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    nirsevimab

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 12 September 2024

File name

1.3.1 Beyfortus PIL - IE - Serious Hypersensitivity Reactions.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 12 September 2024

File name

1.3.1 Beyfortus SPC - IE - Serious Hypersensitivity Reactions.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company 

 Updated on 19 August 2024 
File name
1.3.1 Beyfortus PIL - IE - 01Aug2024.pdf
Reasons for updating
  •  Change to Section 1 - what the product is   
  •  Change to section 1 - what the product is used for  
  •  Change to section 2 - what you need to know - contraindications 
  •  Change to section 2 - what you need to know - warnings and precautions  
  •  Change to section 2 - use in children and adolescents   
  •  Change to section 2 - interactions with other medicines, food or drink  
  •  Change to section 2 - pregnancy, breast feeding and fertility   
  •  Change to section 3 - dose and frequency 
  •  Change to section 3 - use in children/adolescents   
  •  Change to section 3 - how to take/use   
  •  Change to section 3 - duration of treatment 
  •  Change to section 3 - overdose,  missed or forgotten doses  
 Updated on 19 August 2024 
File name
1.3.1 Beyfortus SPC - IE - 01Aug2024.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 4.5 - Interaction with other medicinal products and other forms of interaction 
  •  Change to section 4.8 - Undesirable effects 
  •  Change to Section 4.8 – Undesirable effects - how to report a side effect   
  •  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 19 August 2024 
File name
526_gb_spc_beyfortus-100mg_DP SLE to 3 years_06.08.2024.pdf
Reasons for updating
  •  Change to section 6.3 - Shelf life  
Legal category:Product subject to medical prescription which may not be renewed (A)
 Updated on 06 August 2024 
File name
1.3.1 Beyfortus SPC - IE (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 06 August 2024 
File name
1.3.1 Beyfortus PIL - IE.pdf
Reasons for updating
  •  New PIL for new product