Kesimpta 20 mg solution for injection in pre filled pen
*Company:
Novartis Ireland LimitedStatus:
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
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)