74 results
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Opinion/decision on a Paediatric investigation plan (PIP): Brilique, ticagrelor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000480-PIP01-08-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension, Tablet, Orodispersible tablet, Age-appropriate oral dosage form
Decision date: 19/07/2018, Last updated: 27/11/2018, Compliance check: XInvented name Brilique Active substance ticagrelor … Brilique Brilique ticagrelor ticagrelor tica … -
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Human medicine European public assessment report (EPAR): Brilique
ticagrelor, Peripheral Vascular Diseases, Acute Coronary Syndrome
Date of authorisation: 03/12/2010, Revision: 15, Authorised, Last updated: 24/02/2020Brilique Peripheral Vascular Diseases Acute … Brilique … Brilique, INN-ticagrelor EMA/214091/2016 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 December 2015
CHMP, Last updated: 18/12/2015Brilique … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 20-23 September 2010
CHMP, Last updated: 24/09/2010Brilique … prepandemic guideline. • Brilique and Possia (ticagrelor … syndromes. The review for Brilique began on 18 November 2009 … -
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Human Medicines Highlights: Issue 24 - January 2011
Last updated: 01/02/2011Possia , Brilique ( ticagrelor ) Prevention …
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Human Medicines Highlights: Issue 20 - September 2010
Last updated: 01/10/2010Possia and Brilique (ticagrelor) Treatment of …
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Herbal medicinal product: Mate folium
Ilex paraguariensis St. Hilaire, Maté Leaf, F: Assessment finalised, Last updated: 01/03/2018 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of first decision: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of first decision: 22/05/2006, Positive, Last updated: 01/07/2016 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of first decision: 27/07/2005, Positive, Last updated: 23/03/2015 -
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Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021 (updated)
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 9-12 November 2020
Virtual meeting, from 09/11/2020 to 12/11/2020, Last updated: 07/01/2021 -
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CHMP: Agendas, minutes and highlights
Last updated: 29/01/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 16/02/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 14/09/2020 -
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Paediatric Committee (PDCO): 11-13 February 2015
European Medicines Agency, London, UK, from 11/02/2015 to 13/02/2015, Last updated: 19/02/2013 -
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Paediatric Committee (PDCO): 18-20 March 2015
European Medicines Agency, London, UK, from 18/03/2015 to 20/03/2015, Last updated: 19/02/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 July 2013
European Medicines Agency, London, UK, from 08/07/2013 to 11/07/2013, Last updated: 02/07/2012 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 November 2015
European Medicines Agency, London, UK, from 16/11/2015 to 19/11/2015, Last updated: 16/11/2015 -
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PRAC recommendations on safety signals: monthly overviews: Archive
Last updated: 30/05/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2015
European Medicines Agency, London, UK, from 06/07/2015 to 09/07/2015, Last updated: 13/03/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 12-15 September 2016
European Medicines Agency, London, UK, from 12/09/2016 to 15/09/2016, Last updated: 06/01/2014 -
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Paediatric Committee (PDCO): 7-9 August 2013
European Medicines Agency, London, UK, from 07/08/2013 to 09/08/2013, Last updated: 21/12/2010 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 February 2013
European Medicines Agency, London, UK, from 04/02/2013 to 07/02/2013, Last updated: 02/06/201211 4.2.1. Ticagrelor – BRILIQUE (CAP), POSSIA (CAP … -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2015
European Medicines Agency, London, UK, from 20/07/2015 to 23/07/2015, Last updated: 03/01/2014