16618 results
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Orphan designation: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} for: Treatment of Netherton syndrome
Date of designation: 17/10/2019, Positive, Last updated: 21/01/20201-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} … 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide} … -
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Press release: Mylan S.A.S. withdraws its marketing authorisation application for Docetaxel Mylan (docetaxel)
Last updated: 15/03/2010authorisation application for Docetaxel Mylan docetaxel … for the medicinal product Docetaxel Mylan docetaxel), 10mg/ml powder and solvent … reference medicinal product for Docetaxel Mylan is Taxotere, which … -
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Press release: Sanofi-Aventis Pharma S.A. withdraws its application for an extension of indication for Taxotere and Docetaxel Winthrop (docetaxel)
Last updated: 17/11/2008indication for Taxotere and Docetaxel Winthrop docetaxel … authorised medicines Taxotere (docetaxel) 20 mg/0.5 ml and 80 mg/2 … solution for infusion and Docetaxel Winthrop docetaxel) 20 mg/0.5 ml and 80 mg/2 … -
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Guidance documents
Last updated: 19/07/2022Guidance documents … Guidance documents … message (XEVPRM) user guidance document. Information on any amendments …
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Key documents
Last updated: 21/12/2020Key documents … Agency (EMA) makes available documents on key areas of the EMA's … https://www.ema.europa.eu/documents/other/revised-framework-interaction-between-european-medicines-agency-healthcare-professionals-their_en.pdf …
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Key documents
Last updated: 21/12/2020Key documents … Key documents …
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Guidance documents
Last updated: 20/04/2020Guidance documents … Guidance documents … of a question and answer document, is intended to clarify how …
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COMP Documents
Last updated: 31/12/2009COMP Documents … COMP Documents …
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CAT Documents
Last updated: 31/12/2009CAT Documents … following list is the latest documents for the CAT committee Topics: …
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HMPC Documents
Last updated: 31/12/2009HMPC Documents … following list is the latest documents for the HMPC committee …
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CVMP Documents
Last updated: 31/12/2009CVMP Documents … following list is the latest documents for the CVMP committee …
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PDCO Documents
Last updated: 31/12/2009PDCO Documents … following list is the latest documents for the PDCO committee Topics: …
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Non-clinical Working Party documents
Last updated: 05/04/2023Non-clinical Working Party documents … Working Party (NcWP) publishes documents related to its work on this … its work on this page. Some document titles mention the retired Safety …
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Biologics Working Party documents
Last updated: 30/03/2021Biologics Working Party documents … Biologics Working Party documents … virus 1 This amended document includes a recommendation …
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Access to documents
Last updated: 23/11/2018Access to documents … widest possible access to its documents following requests from the … on access to unpublished documents Access to Documents Service First publication …
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Marketing authorisation guidance documents
Last updated: 01/06/2016eting authorisation guidance documents … eting authorisation guidance documents …
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Testing document icon links
Last updated: 01/01/2015Testing document icon links … This is a pdf document . This is a word document . This is a powerpoint document . This is an excel …
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Superseded pharmacovigilance guidance documents
Last updated: 12/04/2013pharmacovigilance guidance documents … pharmacovigilance guidance documents … and/or distribution of this document is authorised for non commercial …
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Document and information management
Last updated: 31/12/2009Document and information management … Generic Work instructions on documentation of external requests for … translation workflow of EMA documents PDF icon application/pdf …
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Haematology Working Party documents
Last updated: 31/12/2009Haematology Working Party documents … Haematology Working Party documents … London, 24 January 2008 Doc. Ref. EMEA/CHMP/BPWP/361857/2006 …
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Core management documents
Last updated: 26/05/2010Core management documents …
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Vaccines Working Party documents
Last updated: 23/11/2009Vaccines Working Party documents … and/or distribution of this document is authorised for non commercial … London, 16 January 2007 Doc. Ref: EMEA/CHMP/VWP/14684/2007 …
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Efficacy Working Party documents
Last updated: 23/11/2009Efficacy Working Party documents … and/or distribution of this document is authorised for non commercial … London, 13 December 2007 Doc. Ref. EMEA/CHMP/EWP/490784/2007 …
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Press release: EMA reviewing cancer medicine docetaxel
PRAC, Last updated: 10/03/2017EMA reviewing cancer medicine docetaxel … investigating the cancer medicine docetaxel following cases of neutropenic … known and rare side effect of docetaxel (which may affect up to one … -
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All herbal documents under consultation
Last updated: 01/01/2015All herbal documents under consultation … The herbal documents listed on this page are currently …