255 results
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News: Committee for paediatric medicinal products - towards more and better information on the use of medicines for children
PDCO, Last updated: 18/02/2013medicine for children in accordance with the requirements of … formulated and investigated according to their specific needs … EMA/PDCO/388684/2012 Page 2/6 According to Art. 25(2) of the Universal … -
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News: Paper calls for continued support for development of advanced therapies
CAT, Last updated: 13/03/2012advanced-therapy medicines, according to a paper published in the … transitional period, by which, according to the provisions of Article … workload and resources accordingly - Strengthen dialogue with … -
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News: General Court upholds European Medicines Agency decision to refuse paediatric waiver for perflubutane
PDCO, Last updated: 15/12/2011perflubutane EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … -
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Press release: New Paediatric Committee holds its first meeting
PDCO, Last updated: 06/07/2007data have been generated in accordance with an agreed paediatric … data have been generated in accordance with an agreed paediatric … -
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News: EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 04/10/2021studied for use in children, in accordance with the accelerated timelines … -
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News: EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19 (new)
CHMP, PDCO, PRAC, Last updated: 18/11/2021studied for use in children, in accordance with the accelerated timelines … -
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News: Committee for advanced therapies – election of new chair, overview of 2013 and looking ahead
CAT, Last updated: 14/02/2014The CAT was established in accordance with Regulation (EC) No 1394/2007 … -
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News: EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
CHMP, PDCO, PRAC, Last updated: 11/10/2021studied for use in children, in accordance with the accelerated timelines … -
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Committee for Advanced Therapies (CAT): 6-8 October 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 06/10/2021 to 08/10/2021, Last updated: 29/11/2021and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Committee for Advanced Therapies (CAT): 14-16 July 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 14/07/2021 to 16/07/2021, Last updated: 29/11/2021adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Committee for Advanced Therapies (CAT): 16-18 June 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 16/06/2021 to 18/06/2021, Last updated: 29/11/2021adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Committee for Advanced Therapies (CAT): 3-5 November 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 03/11/2021 to 05/11/2021, Last updated: 29/11/2021and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Committee for Advanced Therapies (CAT): 11-13 August 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 11/08/2021 to 13/08/2021, Last updated: 29/11/2021adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Committee for Advanced Therapies (CAT): 8-10 September 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/09/2021 to 10/09/2021, Last updated: 23/09/2021and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Paediatric Committee (PDCO): 7-10 September 2021
Online, from 07/09/2021 to 10/09/2021, Last updated: 09/09/2021adopted or considered public according to the principles stated … -
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Paediatric Committee (PDCO): 20-23 July 2021
Virtual meeting, from 20/07/2021 to 23/07/2021, Last updated: 27/07/2021and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated … -
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Committee for Advanced Therapies (CAT): 10-12 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 10/05/2021 to 12/05/2021, Last updated: 09/07/2021adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Paediatric Committee (PDCO): 20-23 April 2021
Virtual meeting, from 20/04/2021 to 23/04/2021, Last updated: 30/06/2021and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated … -
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Paediatric Committee (PDCO): 23-26 March 2021
Virtual meeting, from 23/03/2021 to 26/03/2021, Last updated: 12/05/2021and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated … -
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Committee for Advanced Therapies (CAT): 14-16 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 14/04/2021 to 16/04/2021, Last updated: 14/04/2021adopted or considered public according to the principles stated … -
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Committee for Advanced Therapies (CAT): 17-18 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 17/03/2021 to 18/03/2021, Last updated: 17/03/2021adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Paediatric Committee (PDCO): 26-29 January 2021
Virtual meeting, from 26/01/2021 to 29/01/2021, Last updated: 11/03/2021adopted or considered public according to the principles stated … -
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Paediatric Committee (PDCO): 8-11 December 2020
Virtual meeting, from 08/12/2020 to 11/12/2020, Last updated: 01/03/2021and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated … -
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Paediatric Committee (PDCO): 23-26 February 2021
Virtual meeting, from 23/02/2021 to 26/02/2021, Last updated: 23/02/2021adopted or considered public according to the principles stated … -
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Committee for Advanced Therapies (CAT): 17-19 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 17/02/2021 to 19/02/2021, Last updated: 16/02/2021adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation …