24 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: 5, Authorised, Last updated: 18/11/2019Alkindi Adrenal Insufficiency … 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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Herbal medicinal product: Pistacia lentiscus, resinum (mastic)
F: Assessment finalised, Last updated: 05/05/2020 -
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PRAC recommendations on safety signals
Last updated: 06/01/2020 -
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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: 29/01/2021 -
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Download medicine data
Last updated: 29/04/2020 -
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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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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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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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PRAC: Agendas, minutes and highlights (updated)
Last updated: 16/02/2021 -
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Public data from Article 57 database (updated)
Last updated: 16/02/2021 -
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CHMP: Agendas, minutes and highlights
Last updated: 29/01/2021 -
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European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting
European Medicines Agency, London, UK, from 17/04/2018 to 18/04/2018, Last updated: 27/06/2018 -
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PDCO: Agendas, minutes and meeting reports
Last updated: 11/11/2020 -
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Committee for Medicinal Products for Human Use (CHMP): 11-14 December 2017
European Medicines Agency, London, UK, from 11/12/2017 to 14/12/2017, Last updated: 06/01/201411 3.1.1. Alkindi - hydrocortisone - PUMA … -
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Leaflets
Last updated: 23/09/2016patients. Endocrinology Endocrinology Alkindi for the treatment of primary …
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Newsletters
Last updated: 03/02/2020 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 January 2018
European Medicines Agency, London, UK, from 22/01/2018 to 25/01/2018, Last updated: 06/01/2014 -
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News: EMA 2017 annual report published
Last updated: 02/05/2018 -
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Annual reports and work programmes
Last updated: 15/06/2020 -
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CHMP: meeting archive 2016-2018
Last updated: 26/02/2020