590 results
Keyword Extraneal Remove keyword
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Referral: Extraneal
icodextrin, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 22/10/2009, EC decision date: 20/01/2010, Last updated: 27/10/2009Extraneal … arbitration procedure for Extraneal 7.5% solution for peritoneal … marketing authorisation for Extraneal to include a peptidoglycan … -
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Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs) - Scientific guideline
Last updated: 26/06/2020answers on management of extraneous agents in immunological veterinary … answers on management of extraneous agents in immunological veterinary …
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Methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products - Scientific guideline
Last updated: 17/09/2021demonstrating freedom from extraneous agents of the seeds used … demonstrating freedom from extraneous agents of the seeds used … demonstrating freedom from extraneous agents of the seeds used …
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Stem cell-based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) - Scientific guideline
Last updated: 28/06/2019use: Specific questions on extraneous agents to be addressed by … use: Specific questions on extraneous agents to be addressed by … use: Specific questions on extraneous agents 13 July 2017 …
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Stem cell -based products for veterinary use: Specific questions on extraneous agents to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
Last updated: 27/06/2016use: Specific questions on extraneous agents to be addressed by … development of a guidance on extraneous agents intended for veterinary … Stem cells -based products extraneous agents - problem statement …
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Referral: Bovilis BVD
Article 33
Status: European Commission final decision, opinion/position date: 17/04/2007, EC decision date: 29/06/2007, Last updated: 07/12/2011demonstrate freedom from extraneous agents was insufficient to … in general, the absence of extraneous agents in vaccines can be … of the production system Extraneous agents testing of raw materials … -
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Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo for: Treatment of extranodal NK/T-cell lymphoma, nasal type
Date of designation: 14/07/2016, Withdrawn, Last updated: 25/05/2020designation for the treatment of extranodal NK/T-cell lymphoma, nasal … -
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Orphan designation: Pralatrexate for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 13/04/2007, Positive, Last updated: 07/04/2011T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T- cell lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Orphan designation: Zanolimumab for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 20/03/2007, Positive, Last updated: 10/03/2011T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Orphan designation: Idelalisib for: Treatment of extranodal marginal-zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)
Date of designation: 05/08/2013, Withdrawn, Last updated: 18/11/2013designation for the treatment of extranodal marginal-zone lymphoma of … Idelalisib for the treatment of extranodal marginal zone lymphoma of … Idelalisib for the treatment of extranodal marginal zone lymphoma of … -
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Human medicine European public assessment report (EPAR): Istodax
romidepsin, Lymphoma, Non-Hodgkin
Date of refusal: 12/02/2013,
, Refused, Last updated: 14/03/2013
T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Orphan designation: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 28/10/2005, Positive, Last updated: 12/10/2018T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Orphan designation: Alisertib for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 06/12/2012, Withdrawn, Last updated: 07/02/2017T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Orphan designation: Belinostat for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 10/10/2012, Positive, Last updated: 08/02/2016T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Orphan designation: Darinaparsin for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 15/04/2011, Positive, Last updated: 14/07/2022T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Orphan designation: Recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 09/08/2012, Positive, Last updated: 04/02/2022T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Orphan designation: Mogamulizumab for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 11/01/2012, Positive, Last updated: 18/10/2018T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated … -
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Press release: European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions
CHMP, Last updated: 17/12/2010dialysis solutions Dianeal, Extraneal and Nutrineal. These are … side effects with Dianeal, Extraneal and Nutrineal that are likely … which the batches of Dianeal, Extraneal and Nutrineal that potentially … -
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National registers of authorised medicines
Last updated: 23/03/2023Portugese flag Portugal extranet.infarmed.pt Romanian flag Romania www.anm.ro …
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Orphan designation: Tipifarnib for: Treatment of peripheral T-cell lymphoma
Date of designation: 19/10/2020, Positive, Last updated: 24/05/2022the lymph nodes (primary extranodal). Symptoms of the disease vary … the lymph nodes (primary extranodal). Symptoms of the disease … -
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Orphan designation: Fenretinide for: Treatment of peripheral T-cell lymphoma
Date of designation: 14/10/2016, Withdrawn, Last updated: 19/01/2022the lymph nodes (primary extranodal). The symptoms of the disease … the lymph nodes (primary extranodal). The symptoms of the disease … -
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Orphan designation: N-(2-aminophenyl)-4-(1-[(1,3-dimethyl-1H-pyrazol-4-yl)methyl]piperidin)benzamide for: Treatment of peripheral T-cell lymphoma
Date of designation: 12/10/2017, Positive, Last updated: 15/01/2018the lymph nodes (primary extranodal). The symptoms of the disease … -
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Orphan designation: Sintilimab for: Treatment of peripheral T-cell lymphoma
Date of designation: 28/02/2020, Positive, Last updated: 06/05/2020the lymph nodes (primary extranodal). The symptoms of the disease … -
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Referral: Baxter dialysis solutions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013plant. These include: Dianeal, Extraneal and Nutrineal solutions for … endotoxins in batches of Dianeal, Extraneal and Nutrineal made in the … plant. These include: Dianeal, Extraneal and Nutrineal solutions for … -
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Requirements for the production and control of immunological veterinary medicinal products - Scientific guideline
Last updated: 24/06/2022demonstrate freedom from extraneous agents (PDF/165.71 KB … 4 2.1. Absence of extraneous agents … demonstrate freedom from extraneous agents as part of the production …