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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: 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: 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: Regulatory information - Paediatric guidance revised to reflect changes to European Commission guideline
PDCO, Last updated: 21/01/2015PDCO) Legal Basis In accordance with Article 25 of Regulation … the EMA will be made public according to the rules of transparency … -
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News: European Medicines Agency publishes first public summaries of Paediatric Committee evaluations of paediatric investigation plans
PDCO, Last updated: 31/07/2014the studies conducted in accordance with the agreed Paediatric … -
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News: European Medicines Agency seeks views on involvement of children and young people in Paediatric Committee
PDCO, Last updated: 17/09/2012EMA/PDCO/388684/2012 Page 2/6 According to Art. 25(2) of the Universal … matters which concern them in accordance with their age and maturity” … being given due weight in accordance with the age and maturity … -
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News: European Medicines Agency publishes policy on changing scope of paediatric investigation plans
PDCO, Last updated: 27/07/2012new pharmaceutical form[s] according to article 7 and 8 respectively … the documents submitted in accordance with article 7 “shall cover … the granting of the reward (according to articles 28 and 36-38 … -
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News: European Medicines Agency launches database of clinical studies in children completed before 2007
PDCO, Last updated: 11/10/2011‘Paediatric Regulation’) In accordance with Article 41(2) of the … Trials Register (EU CTR). According to European Commission’s … format of a synopsis in accordance with the ICH Topic E 3 guidance … -
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News: Public consultation opens on standard paediatric investigation plans for two types of cancer in children
PDCO, Last updated: 22/02/2013 -
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News: European Medicines Agency starts consultation on inventory of needs for children's medicines
PDCO, Last updated: 30/08/2012may change over time and according to region. This may … -
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Press release: Meeting highlights from the Paediatric Committee: 16 - 18 September 2009
PDCO, Last updated: 24/09/2009 -
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Press release: Meeting highlights from the Paediatric Committee: 27-29 May 2009
PDCO, Last updated: 11/02/2010 -
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Press release: Meeting highlights from the Paediatric Committee: 11 - 13 November 2009
PDCO, Last updated: 24/11/2009decision have been conducted in accordance with the decision, including … -
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Press release: Meeting highlights from the Paediatric Committee :14 -16 October 2009
PDCO, Last updated: 22/10/2009decision have been conducted in accordance with the decision, including … -
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Press release: Meeting highlights from the Paediatric Committee held by written procedure: 19 - 21 August 2009
PDCO, Last updated: 25/08/2009decision have been conducted in accordance with the decision, including … in children conducted in accordance with an approved PIP, or … Applications submitted in accordance with the referenced article … -
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Press release: Meeting highlights from the Paediatric Committee: 22 - 24 July 2009
PDCO, Last updated: 31/07/2009decision have been conducted in accordance with the decision, including … -
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Press release: Meeting highlights from the Paediatric Committee: 24 - 26 June 2009
PDCO, Last updated: 01/07/2009paediatric therapeutics’. According to the terms of these principles … in children conducted in accordance with an approved PIP, or … -
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Press release: Meeting highlights from the Paediatric Committee:27 - 29 May 2009
PDCO, Last updated: 03/06/2009 -
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Press release: Meeting highlights from the Paediatric Committee: 1 - 3 April 2009
PDCO, Last updated: 24/04/2009decision have been conducted in accordance with the decision, including … -
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News: Meeting highlights from the Paediatric Committee: 09 -11 December 2009
PDCO, Last updated: 17/12/2009 -
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Press release: Meeting highlights from the Paediatric Committee: 29 - 31 July 2008
PDCO, Last updated: 04/09/2008in children conducted in accordance with an approved PIP or an … have been carried out in accordance with the EMEA decision on … Pediatric Therapeutics. According to the terms of these principles … -
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Press release: Meeting highlights from the Paediatric Committee: 4 - 6 February 2009
PDCO, Last updated: 13/02/2009decision have been conducted in accordance with the decision including …