50 results
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Human medicine European public assessment report (EPAR): Aerius
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 46, Authorised, Last updated: 12/01/2022Aerius Rhinitis, Allergic Respiratory … assessment report (EPAR) for Aerius. It explains how the The committee … the conditions of use for Aerius. What is Aerius? Aerius is a medicine containing … -
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,
, Revision: 10, Authorised, Last updated: 20/01/2022
authorised in the EU called Aerius. For more information on generic … with the reference medicine, Aerius, and do not need to be repeated … and to be bioequivalent to Aerius. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Dasselta
desloratadine, Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Urticaria
Date of authorisation: 28/11/2011,, Revision: 12, Authorised, Last updated: 08/07/2021
European Union (EU) called Aerius. What is Dasselta used for … to the reference medicine, Aerius. Two medicines are bioequivalent … and to be bioequivalent to Aerius. Therefore, the CHMP’s view … -
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Human medicine European public assessment report (EPAR): Desloratadine Actavis
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 14, Authorised, Last updated: 01/03/2022
European Union (EU) called Aerius. What is Desloratadine Actavis … to the reference medicine, Aerius. Two medicines are bioequivalent … and to be bioequivalent to Aerius. Therefore, the Committee … -
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Human medicine European public assessment report (EPAR): Desloratadine Teva
desloratadine, Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Date of authorisation: 24/11/2011,, Revision: 17, Authorised, Last updated: 14/09/2021
European Union (EU) called Aerius. What is Desloratadine Teva … to the reference medicine, Aerius. Two medicines are bioequivalent … and to be bioequivalent to Aerius. Therefore, the Committee … -
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Human medicine European public assessment report (EPAR): Allex
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Withdrawn, Last updated: 31/12/2009use Therapeutic indication Aerius is indicated for the relief … containing desloratadine i.e. Aerius, Azomyr and Neoclarityn … -
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Press release: Krka, d.d., Novo mesto withdraws its marketing authorisation application for Desloratadine Krka (desloratadine)
Last updated: 19/10/2011Desloratadine Krka is a generic of Aerius which has been authorised … Desloratadine Krka is a generic of Aerius which has been authoris 15 … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,18-21 February 2008
CHMP, Last updated: 21/02/2008Aerius and Neoclarityn (desloratadine … urticaria to urticaria. Azomyr, Aerius and Neoclarityn are currently … -
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Human medicine European public assessment report (EPAR): Azomyr
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 47, Authorised, Last updated: 20/01/2022 -
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Human medicine European public assessment report (EPAR): Neoclarityn
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 42, Authorised, Last updated: 12/01/2022 -
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Human medicine European public assessment report (EPAR): Opulis
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Withdrawn, Last updated: 19/05/2004containing desloratadine i.e. Aerius, Azomyr and Neoclarityn … -
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Withdrawn application: Desloratadine Krka
desloratadine, date of withdrawal: 14/10/2011, Initial authorisation, Last updated: 17/11/2011system. Desloratadine Krka is a generic of Aerius which has been authorised … with the reference product Aerius. A question and answer document … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2021 to 22/04/2021, Last updated: 07/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 21/06/2021 to 24/06/2021, Last updated: 07/12/2021 -
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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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Download medicine data
Last updated: 02/12/2021 -
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CHMP: Agendas, minutes and highlights
Last updated: 08/02/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2021 to 10/06/2021, Last updated: 07/06/2021 -
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Sampling and testing
Last updated: 28/03/2019 -
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Committee for Medicinal Products for Human Use (CHMP): 12-15 October 2020
Virtual meeting, from 12/10/2020 to 15/10/2020, Last updated: 16/10/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017
European Medicines Agency, London, UK, from 06/03/2017 to 09/03/2017, Last updated: 06/03/2017 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 02/05/2022