Bimzelx 160 mg solution for injection in pre-filled syringe

*
Pharmacy Only: Prescription
  • Company:

    UCB (Pharma) Ireland Limited
  • 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 23 April 2024

File name

IE PIL - Syringe.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects

Updated on 23 April 2024

File name

IE SPC.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 13 November 2023

File name

ie-bimzelx-smpc.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.8. Undesirable effects: to correct the numbers in section 4.8 (elderly patients (> 65 years)) and to correct and align the formatting throughout the SmPC.


Updated on 13 November 2023

File name

ie-bimzelx-smpc.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.8. Undesirable effects: to correct the numbers in section 4.8 (elderly patients (> 65 years)) and to correct and align the formatting throughout the SmPC.


Updated on 09 June 2023

File name

IE- SmPC- Syringe.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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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 09 June 2023

File name

IE- PIL- Syringe.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 6 - date of revision

Updated on 31 May 2023

File name

ie-smpc-pfs.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 31 May 2023

File name

ie-pil-pfs.pdf

Reasons for updating

  • New PIL for new product