286 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
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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News: EMA recommends approval of Spikevax for children aged 6 to 11
CHMP, PDCO, Last updated: 24/02/2022children were carried out in accordance with Spikevax’s A development … -
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News: EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
CHMP, PDCO, Last updated: 23/06/2022years is being carried out in accordance with the A development plan … -
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Paediatric Committee (PDCO): 17-20 January 2023 (updated)
Virtual meeting, from 17/01/2023 to 20/01/2023, Last updated: 17/01/2023adopted or considered public according to the principles stated … -
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Paediatric Committee (PDCO): 8-11 November 2022
Virtual meeting, from 08/11/2022 to 11/11/2022, Last updated: 05/01/2023adopted or considered public according to the principles stated … -
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Committee for Advanced Therapies (CAT): 3-4 November 2022
European Medicines Agency, Amsterdam, the Netherlands, from 03/11/2022 to 04/11/2022, Last updated: 21/12/2022and 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): 7-9 December 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/12/2022 to 09/12/2022, Last updated: 07/12/2022and 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): 13-16 December 2022
Virtual meeting, from 13/12/2022 to 16/12/2022, Last updated: 13/12/2022and 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): 6-9 September 2022
Virtual meeting, from 06/09/2022 to 09/09/2022, Last updated: 26/10/2022and 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): 11-14 October 2022
Virtual meeting, from 11/10/2022 to 14/10/2022, Last updated: 12/10/2022and 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): 5-7 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 05/10/2022 to 07/10/2022, Last updated: 05/10/2022and 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): 13-15 July 2022
European Medicines Agency, Amsterdam, the Netherlands, from 13/07/2022 to 15/07/2022, Last updated: 22/09/2022and 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): 10-12 August 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/08/2022 to 12/08/2022, Last updated: 22/09/2022adopted or considered public according to the principles stated … therapeutic indication procedure according to Commission Regulation … -
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Committee for Advanced Therapies (CAT): 7-9 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/09/2022 to 09/09/2022, Last updated: 07/09/2022and 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): 15-17 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 15/06/2022 to 17/06/2022, Last updated: 22/07/2022and 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): 17-20 May 2022
Virtual meeting, from 17/05/2022 to 20/05/2022, Last updated: 21/07/2022adopted or considered public according to the principles stated … -
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Committee for Advanced Therapies (CAT): 11-13 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 11/05/2022 to 13/05/2022, Last updated: 01/07/2022and 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): 21-24 June 2022
Virtual meeting, from 21/06/2022 to 24/06/2022, Last updated: 21/06/2022and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated …