38 results
Keyword Alkindi Remove keyword
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Direct healthcare professional communication (DHPC): Risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations to Alkindi (hydrocortisone granules in capsules for opening)
Active substance: hydrocortisone, DHPC type: Safety signal, Last updated: 04/02/2021hydrocortisone formulations to Alkindi (hydrocortisone granules … hydrocortisone formulations to Alkindi (hydrocortisone granules … hydrocortisone formulations to Alkindi (hydrocortisone granules … -
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Human medicine European public assessment report (EPAR): Alkindi
hydrocortisone, Adrenal Insufficiency
Date of authorisation: 09/02/2018, Revision: 7, Authorised, Last updated: 11/02/2022Alkindi Adrenal Gland Diseases Endocrine … assessment report (EPAR) for Alkindi. It explains how the Agency … practical advice on how to use Alkindi. For practical information … -
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Press release: First paediatric medicine to treat rare hormonal disorder
CHMP, Last updated: 15/12/2017gives positive opinion to Alkindi for paediatric-use marketing … authorisation (PUMA) for Alkindi (hydrocortisone) for the … replace the missing cortisol. Alkindi is a paediatric-specific … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
PRAC, Last updated: 15/01/2021children when switching to Alkindi The PRAC evaluated a safety … hydrocortisone formulations to Alkindi granules, due to potential … formulations, crushed or compounded. Alkindi , available as capsules containing … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2017
CHMP, Last updated: 15/12/2017Alkindi … -
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Human medicine European public assessment report (EPAR): Efmody
hydrocortisone, Adrenal Hyperplasia, Congenital
Date of authorisation: 27/05/2021, Revision: 2, Authorised, Last updated: 24/06/2022 -
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PRAC recommendations on safety signals (updated)
Last updated: 05/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/03/2022 to 10/03/2022, Last updated: 22/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 July 2022
European Medicines Agency, Amsterdam, the Netherlands, from 04/07/2022 to 07/07/2022, Last updated: 04/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 18/01/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 16/05/2022 to 19/05/2022, Last updated: 12/08/2022 -
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EMA 2022 event supporting materials
Last updated: 14/06/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 January 2021
Virtual meeting, from 11/01/2021 to 14/01/2021, Last updated: 27/02/2018 -
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Download medicine data
Last updated: 02/12/2021 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 27/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/03/2021 to 11/03/2021, Last updated: 27/02/2018 -
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Newsletters (updated)
Last updated: 16/01/2023 -
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Paediatric Committee (PDCO): 23-26 January 2018
European Medicines Agency, London, UK, from 23/01/2018 to 26/01/2018, Last updated: 10/04/2018 -
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News: Human medicines: highlights of 2021
Last updated: 15/02/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022
PRAC, Last updated: 08/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 31 August-3 September 2020
Virtual meeting, from 31/08/2020 to 03/09/2020, Last updated: 27/02/2018 -
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Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021
PRAC, Last updated: 12/03/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
PRAC, Last updated: 11/03/2022