43 results
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 25, Authorised, Last updated: 15/12/2022Methylthioninium chloride Proveblue Hemic and Lymphatic Diseases Hematologic … Methylthioninium chloride Proveblue. It explains how the Agency … Methylthioninium chloride Proveblue For practical information … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 February 2011
CHMP, Last updated: 18/02/2011Methylthioninium chloride Proveblue … Methylthioninium chloride Proveblue (methylthioninium chloride … Methylthioninium chloride Proveblue began on 30 December 2009 … -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of Alagille syndrome
Date of designation: 18/12/2013, Positive, Last updated: 14/12/2022 -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of primary sclerosing cholangitis
Date of designation: 16/01/2014, Withdrawn, Last updated: 14/06/2022 -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of primary biliary cirrhosis
Date of designation: 16/01/2014, Withdrawn, Last updated: 14/06/2022 -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 16/01/2014, Positive, Last updated: 03/12/2021 -
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Orphan designation: Octreotide chloride for: Treatment of acromegaly
Date of designation: 12/06/2009, Positive, Last updated: 30/05/2018 -
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Orphan designation: [5,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III) chloride for: Treatment of Cockayne syndrome
Date of designation: 12/01/2017, Positive, Last updated: 13/07/2017 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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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: 20/02/2023 -
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Guidance documents
Last updated: 19/07/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 23/11/2022 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 27/03/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2022
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2022 to 22/04/2022, Last updated: 12/08/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017
European Medicines Agency, London, UK, from 27/11/2017 to 30/11/2017, Last updated: 27/11/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 30 November-3 December 2015
European Medicines Agency, London, UK, from 30/11/2015 to 03/12/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 December 2013
European Medicines Agency, London, UK, from 02/12/2013 to 05/12/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 May 2013
European Medicines Agency, London, UK, from 13/05/2013 to 16/05/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 1-4 December 2014
European Medicines Agency, London, UK, from 01/12/2014 to 04/12/2014, Last updated: 13/08/2013 -
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Committee for Medicinal Products for Human Use (CHMP): 8-11 November 2021
Online, from 08/11/2021 to 11/11/2021, Last updated: 20/01/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 14-17 February 2011
European Medicines Agency, London, UK, from 14/02/2011 to 17/02/2011, Last updated: 11/06/2010Methylthioninium chloride Proveblue (methylthioninium chloride … Methylthioninium chloride Proveblue began on 30 December 2009 … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 June 2016
European Medicines Agency, London, UK, from 06/06/2016 to 09/06/2016, Last updated: 13/03/2014 -
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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