39 results
Keyword Kesimpta Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Kesimpta, Ofatumumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002397-PIP01-18-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/04/2022, Last updated: 19/04/2023, Compliance check: XInvented name Kesimpta Active substance Ofatumumab … investigation plan for ofatumumab (Kesimpta), (EMEA-002397-PIP01-18-M02 … investigation plan for ofatumumab (Kesimpta), (EMEA-002397-PIP01-18-M02 … -
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Human medicine European public assessment report (EPAR): Kesimpta
Ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021,
, Revision: 6, Authorised, Last updated: 31/03/2023
Kesimpta Nervous System Diseases Autoimmune … Kesimpta … EMA/130764/2021 EMEA/H/C/005410 Kesimpta (ofatumumab) An overview of Kesimpta and why it is authorised … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021
CHMP, Last updated: 01/02/2021Kesimpta … -
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Human medicine European public assessment report (EPAR): Tecfidera
dimethyl fumarate, Multiple Sclerosis
Date of authorisation: 30/01/2014, Revision: 27, Authorised, Last updated: 20/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 February 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 06/02/2023 to 09/02/2023, Last updated: 17/05/2023 -
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List of medicines under additional monitoring
Last updated: 26/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/10/2022 to 27/10/2022, Last updated: 31/03/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 14/04/2023, Last updated: 11/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 02/05/2022 to 05/05/2022, Last updated: 06/02/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 26/09/2022 to 29/09/2022, Last updated: 04/07/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2023
European Medicines Agency, Amsterdam, the Netherlands, from 20/02/2023 to 23/02/2023, Last updated: 24/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2021 to 02/12/2021, Last updated: 04/10/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/11/2022 to 10/11/2022, Last updated: 10/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2022 to 10/06/2022, Last updated: 31/03/2022 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 22/05/2023 -
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Download medicine data
Last updated: 02/12/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
PRAC, Last updated: 30/09/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 March 2023
European Medicines Agency, Amsterdam, the Netherlands, from 13/03/2023 to 16/03/2023, Last updated: 18/08/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
PRAC, Last updated: 17/03/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
PRAC, Last updated: 06/05/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 October 2022
PRAC, Last updated: 28/10/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/02/2021 to 25/02/2021, Last updated: 07/12/2021 -
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Newsletters (updated)
Last updated: 16/05/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023
PRAC, Last updated: 10/02/2023