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Opinion/decision on a Paediatric investigation plan (PIP): half-life extended bispecific T-cell engager (BiTE) antibody construct that binds to prostate-specific membrane antigen and cluster of differentiation 3, with a single chain fragment crystallizable moiety
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002655-PIP02-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 12/08/2020, Last updated: 24/06/2021, Compliance check: XKey facts half-life extended bispecific T-cell … specific waiver for half-life extended bispecific T-cell … specific waiver for half-life extended bispecific T-cell … -
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News: Agnès Saint Raymond appointed to UN Commission on life-saving commodities for women and children
Last updated: 16/04/2012appointed to UN Commission on life-saving commodities for women and … United Nations Commission on Life-Saving Commodities for Women and … which could be prevented with life-saving medicines. Recent experience … -
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News: Public Statement on Viramune (Nevirapine) - Severe and Life-Threatening Cutaneous and Hepatic Reactions
Last updated: 12/04/2000Nevirapine) - Severe and Life-Threatening Cutaneous and Hepatic Reactio … confirmed that severe and life-threatening cutaneous (including cases … appearance of severe and life-threatening skin reactions or serious … -
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Quality: lifecycle management
Last updated: 21/04/2016Quality: lifecycle management … and pharmaceutical product lifecycle management help medicine …
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Product authorisation lifecycle
Last updated: 31/12/2009Product authorisation lifecycle …
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News: How to improve product lifecycle management
Last updated: 26/10/2015How to improve product lifecycle management … hosting a workshop on product lifecycle management from 28 to 29 … the guideline on product lifecycle management that is currently … -
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News: New antiretrovirals improve quality of life of HIV/AIDS patients
Last updated: 28/11/2014antiretrovirals improve quality of life of HIV/AIDS patients … management of HIV infection. These life-long treatments can effectively … well as patient quality of life. Current developments should … -
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News: Optimising safety information for medicines in Europe throughout product lifecycle
Last updated: 06/04/2017Europe throughout product lifecycle … -
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Workshop on health-related quality of life in oncology
European Medicines Agency, London, UK, 02/05/2012, Last updated: 30/04/2012health-related quality of life in oncology … health-related quality of life (HRQoL) in oncology aims … health-related quality of life in oncology PDF icon application/pdf … -
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News: Public Statement on Orlaam (Levacetylmethadol) - Life threatening Ventricular Rhythm Disorders
Last updated: 19/12/2000Orlaam (Levacetylmethadol) - Life threatening Ventricular Rhythm … aware of 10 case reports of life-threatening cardiac disorders including … since 1994. These 10 cases of life-threatening cardiac rhythm disorders … -
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Maximum in-use shelf-life for medicated drinking water
Last updated: 01/12/2002Maximum in-use shelf-life for medicated drinking water … Shelf-life, stability, medicated drinking …
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News: Public Statement on Levacetylmethadol (Orlaam) - Life Threatening Cardiac Rhythm Disorders
Last updated: 15/12/1999Levacetylmethadol (Orlaam) - Life Threatening Cardiac Rhythm … of torsade de pointes (a life-threatening cardiac rhythm disorder … Levacetylmethadol (Orlaam) - Life threatening cardiac rhythm … -
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ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
Last updated: 04/03/2020for pharmaceutical product lifecycle management … manner across the product lifecycle. A globally harmonised approach … regulatory considerations for lifecycle management will benefit patients …
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Predictive biomarker-based assay development in the context of drug development and lifecycle
Last updated: 28/07/2017context of drug development and lifecycle … context of drug development and lifecycle PDF icon application/pdf … CDx, and the development and lifecycle of a medicine …
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News: Concept paper on development and lifecycle of personalised medicines and companion diagnostics
Last updated: 28/07/2017paper on development and lifecycle of personalised medicines … paper on the development and lifecycle of personalised medicines … of drug development and 5 lifecycle 6 7 Agreed by Pharmacogenomics … -
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News: Launch of European project for monitoring benefits and risks of vaccines throughout their lifecycle
Last updated: 26/11/2013vaccines throughout their lifecycle … vaccines throughout their lifecycle, and for communicating these … -
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Press release: Marvel LifeSciences Ltd withdraws its marketing-authorisation applications for Solumarv, Isomarv medium and Combimarv (human insulin)
Last updated: 27/11/2012Marvel LifeSciences Ltd withdraws its marketing-authorisation … formally notified by Marvel LifeSciences Ltd of its decision to withdraw … Press release Marvel LifeSciences Ltd withdraws its marketing … -
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A practical approach to effective lifecycle implementation of systems and processes for pharmaceutical manufacturing
Sheraton, Brussels, Belgium, from 14/11/2011 to 16/11/2011, Last updated: 20/07/2011practical approach to effective lifecycle implementation of systems … practical approach to effective lifecycle implementation of systems … -
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A practical approach to effective lifecycle implementation of systems and processes for pharmaceutical manufacturing
Crystal Gateway Marriott, Arlington, Virginia, United States of America, from 04/10/2011 to 06/10/2011, Last updated: 20/07/2011practical approach to effective lifecycle implementation of systems … system across the product lifecycle according to the ICH Q10 … practical approach to effective lifecycle implementation of systems … -
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Press release: CTI Life Sciences Ltd. withdraws its marketing authorisation application for Opaxio (paclitaxel poliglumex)
Last updated: 23/09/2009CTI Life Sciences Ltd. withdraws its … formally notified by CTI Life Sciences Ltd. of its decision … application at a later stage. CTI Life Sciences Ltd. withdraws its … -
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Press release: European Medicines Agency recommendations on extension of shelf life for Tamiflu
CHMP, Last updated: 08/05/2009recommendations on extension of shelf life for Tamiflu … recommended that the shelf life of Tamiflu capsules should … recommendations on extension of shelf life for Tamiflu PDF icon application/pdf … -
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Extension of the shelf life for the antigen stocks during the type II variation assessment
Last updated: 19/05/2006Extension of the shelf life for the antigen stocks during … Sterility testing, shelf-life, antigen stock, immunological …
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Maximum shelf-life for sterile products for human use after first opening or following reconstitution
Last updated: 28/01/1998Maximum shelf-life for sterile products for … provided on maximum shelf-life for sterile products for … NfG on Maximum shelf-life for sterile products for …
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Maximum shelf-life for sterile medicinal products after first opening or following reconstitution
Last updated: 01/07/2000Maximum shelf-life for sterile medicinal products … Shelf-life, sterile products, stability …
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Regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products
Last updated: 27/07/2005health-related quality of life (HRQL) measures in the evaluation … Health-related quality of life (HRQL …