Kesimpta 20 mg solution for injection in pre filled pen

*
Pharmacy Only: Prescription
  • Company:

    Novartis 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 11 July 2024

File name

Kesimpta 20 mg solution for injection in pre filled pen_PIL_20.06.2024_Clean_Barcelona (002).pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 26 June 2024

File name

Kesimpta 20 mg solution for injection in pre filled pen_PIL_20.06.2024_Clean_Barcelona.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Updated on 26 June 2024

File name

Kesimpta_REGSPC PF24-0136_June 24 Clean.pdf

Reasons for updating

  • 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

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

Updated on 23 February 2024

File name

Kesimpta Pen_REG PIL_PF24-0020_18.01.2024_clean_Barcelona.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Updated on 23 February 2024

File name

Kesimpta_REG SPC_PF 24-0020_18.01.2024_clean.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

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

Updated on 06 March 2023

File name

Kesimpta REGSPC PF 23-0048_Clean Feb 2023.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 11 November 2022

File name

Kesimpta-II 07 REGSPC PF22-0211 Clean Oct 2022.pdf

Reasons for updating

  • 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 29 March 2022

File name

Kesimpta Pen_REG PIL_PF22-0068_22.03.2022_clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 29 March 2022

File name

Kesimpta_REG SPC_PF22-0068_22.03.2022_clean.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

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

Updated on 31 January 2022

File name

Kesimpta_20mg_PIL_26-Mar-21_English_Clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 January 2022

File name

Kesimpta_REG SPC_PF21-0117_12.05.2021_clean.pdf

Reasons for updating

  • New SPC for new product

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