Kesimpta 20 mg solution for injection in pre filled pen
*Company:
Novartis Ireland LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 August 2026
File name
Kesimpta REG SPC PF26-094 July 2026_clean IPHA.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.6 ‘Fertility, pregnancy and lactation’ updated to include data from approximately 400 prospective reports of pregnancies with known outcomes following exposure to ofatumumab during the pre-conception period and/or during the first trimester of pregnancy.
Updated on 24 June 2026
File name
Kesimpta REGPIL PF26-0075 clean 06.2026.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 24 June 2026
File name
Kesimpta REGPIL PF26-0073 clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 24 June 2026
File name
Kesimpta REGSPC PSUR-0000317682 PF26-0075 -clean 06.2026.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 June 2026
File name
Kesimpta REGPIL PF26-0073 clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 18 June 2026
File name
Kesimpta-REGSPC VR-0000315655- PF26-0073-clean 05.2026.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2026
File name
Kesimpta REGPIL PF 26-0005 clean 01.2026.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 20 January 2026
File name
Kesimpta REGSPC PF26-0005 Clean 01.2026.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
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 February 2025
File name
Kesimpta_20mg_solution for injection in pre-filled pen PF25-0032 clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 06 February 2025
File name
Kesimpta_REGSPC PF25-0032_Clean_Feb-25.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2025
File name
Kesimpta_20mg_solution for injection in pre-filled pen PF25-0012 clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product contains
Updated on 20 January 2025
File name
Kesimpta REGSPC PF25-0012 clean dec 2024.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
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)
Novartis Ireland Limited
Address:
Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, IrelandMedical Information E-mail:
medinfo.dublin@novartis.comTelephone:
+353 1 2601255Fax:
+353 1 2601263