96 results
Keyword Esbriet Remove keyword
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Withdrawn application: Esbriet
pirfenidone, date of withdrawal: 19/05/2021, Post-authorisation, Last updated: 25/06/2021Esbriet: Withdrawn application … marketing authorisation for Esbriet (pirfenidone) Roche Registration … application for the use of Esbriet in the treatment of patients … -
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Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020Esbriet (pirfenidone): Important … Esbriet (pirfenidone): Important … Esbriet Esbriet pirfenidone Pirfenidone Pi … -
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Human medicine European public assessment report (EPAR): Esbriet (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 27/02/2011, Revision: 33, Authorised, Last updated: 17/05/2023Esbriet Pulmonary Fibrosis Idiopathic … horised pirfenidone Overview Esbriet is a medicine used to treat … of the disease is unknown. Esbriet contains the The substance … -
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Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET)
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 20/06/2022,
, Revision: 2, Authorised, Last updated: 12/10/2022
authorised in the EU called Esbriet. For more information on generic … with the reference medicine, Esbriet, and do not need to be repeated … and to be bioequivalent to Esbriet. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,, Authorised, Last updated: 17/01/2023
authorised in the EU called Esbriet. For more information on A … with the reference medicine, Esbriet, and do not need to be repeated … to the reference medicine, Esbriet, its benefits and risks are … -
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Orphan designation: Pirfenidone for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 16/11/2004, Expired, Last updated: 22/03/2021been authorised in the EU as Esbriet since 28 February 2011. The … designation. Update: Pirfenidone (Esbriet) was authorised in the EU … the EU on 28 February 2011. Esbriet is indicated in adults for … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 - 23 February 2023
CHMP, Last updated: 24/02/2023the European Union (EU): Esbriet, Libtayo, Rinvoq and TachoSil … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021
CHMP, Last updated: 25/06/2021Esbriet … -
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Orphan designation: Humanised anti-alpha ν beta 6 monoclonal antibody for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 29/07/2014, Positive, Last updated: 03/04/2023the time of designation, Esbriet (pirfenidone) was the only … the time of designation, Esbriet (pirfenidone) was the only … -
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Orphan designation: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 14/07/2016, Positive, Last updated: 08/12/2022the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2010
CHMP, Last updated: 17/12/2010Esbriet … following new medicines: • Esbriet (pirfenidone), an orphan … fibrosis. The review for Esbriet began on 24 March 2010 with … -
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Orphan designation: 3-pentylbenzeneacetic acid sodium salt for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 09/10/2015, Withdrawn, Last updated: 28/02/2022the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … -
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Orphan designation: 2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)-piperazin-1-yl)-8-methylimidazo[1,2-alpha]pyridin-3-yl)-(methyl)amino)-4-(4-fluorophenyl)-thiazole-5-carbonitrile (ziritaxestat) for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 29/08/2016, Withdrawn, Last updated: 09/04/2021the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … -
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Orphan designation: Sodium cromoglicate for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 26/06/2020, Withdrawn, Last updated: 08/12/2020the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … -
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Orphan designation: Recombinant human pentraxin-2 for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 17/07/2012, Positive, Last updated: 24/04/2020the time of designation, Esbriet (pirfenidone) was the only … the time of designation, Esbriet (pirfenidone) was the only … -
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Orphan designation: 4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol (tanzisertib) for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 09/12/2011, Withdrawn, Last updated: 22/02/2018pulmonary fibrosis. Pirfenidone (Esbriet) was authorised in the EU … pulmonary fibrosis. Pirfenidone (Esbriet) was authorised in the EU … -
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Orphan designation: Tralokinumab for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 08/11/2012, Withdrawn,the time of designation, Esbriet (pirfenidone) was the only … the time of designation, Esbriet (pirfenidone) was the only … -
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Orphan designation: 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid (lanifibranor) for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 19/11/2014, Positive, Last updated: 15/01/2015the time of designation, Esbriet (pirfenidone) was the only … the time of designation, Esbriet (pirfenidone) was the only … -
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Orphan designation: tilorone for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 24/08/2018, Positive, Last updated: 19/12/2018the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … -
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Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 24/08/2018, Positive, Last updated: 19/12/2018the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … -
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Orphan designation: Bis-(3-deoxy-3-(4-(3-fluorophenyl)-1H-1,2,3-triazol-1-yl)-beta-D-galactopyranosyl) sulfane for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 21/08/2020, Positive, Last updated: 25/11/2020the time of designation, Esbriet (pirfenidone) and Ofev (nintedanib … -
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Orphan designation: nintedanib for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 26/04/2013, Withdrawn, Last updated: 09/06/2020the time of designation, Esbriet (pirfenidone) was the only … -
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,
, Revision: 22, Authorised, Last updated: 26/04/2022
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 16/12/2022 -
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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: 24/04/2023