| TOPICAL NEWS AND PUBLICATIONS |
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News from the EMA / Activities of the COMP / December meeting |
Dec. 20, 2012 |
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The COMP met from 5-6 December 2012 and adopted the following 13 positive opinions on orphan medicinal product designation ...
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News from the EMA / Activities of the PDCO / December meeting |
Dec. 20, 2012 |
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During its meeting from 5-7 December 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the CHMP / December meeting |
Dec. 17, 2012 |
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During its meeting from 10-13 December 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / November meeting |
Nov. 21, 2012 |
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During its meeting from 7-9 November 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the CHMP / November meeting |
Nov. 19, 2012 |
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During its meeting from 12-15 November 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted ...
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News from the EMA / Activities of the COMP / November meeting |
Nov. 13, 2012 |
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The COMP met from 6-7 November 2012 and adopted the following 13 positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the PDCO / October meeting |
Oct. 15, 2012 |
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During its meeting from 3-5 October 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the COMP / October meeting |
Oct. 12, 2012 |
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The COMP met from 3-5 October 2012 and adopted the following 16 positive opinions on orphan medicinal product designation ...
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News from the EMA / Activities of the PDCO / September meeting |
Sep. 17, 2012 |
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During its meeting from 5-7 September 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the COMP / September meeting |
Sep. 17, 2012 |
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The COMP met on 4-5 September 2012 and elected for a 3-year mandate the new Chair, Prof. Bruno Sepodes and the new Vice-Chair, Ms Lesley Greene ... |
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News from the EMA / Activities of the PDCO / August meeting |
Aug. 28, 2012 |
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During its meeting from 15-17 August 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the CHMP / July meeting |
Jul. 23, 2012 |
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During its meeting from 16-19 July 2012 the Committee for Human Medicinal Products (CHMP) adopted: |
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News from the EMA / Activities of the COMP / July meeting |
Jul. 18, 2012 |
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The COMP met on 10-11 July 2012 and adopted the following 14 positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the PDCO / July meeting |
Jul. 16, 2012 |
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During its meeting from 4-6 July 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the PDCO / June meeting |
Jul. 02, 2012 |
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During its meeting from 6-8 June 2012 the Paediatric Committee (PDCO) adopted the following opinions ...
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News from the EMA / Activities of the CHMP / June meeting |
Jul. 02, 2012 |
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During its meeting from 18-21 June 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / June meeting |
Jun. 19, 2012 |
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The COMP met on 12-13 June 2012 and adopted the following nine positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the CHMP / May meeting |
May. 29, 2012 |
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During its meeting from 21-24 May 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / May meeting |
May. 29, 2012 |
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During its meeting from 14-16 May 2012 the Paediatric Committee (PDCO) adopted the following opinions ...
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News from the EMA / Activities of the COMP / May meeting |
May. 23, 2012 |
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The COMP met on 10-11 May 2012 and adopted the following 16 positive opinions on orphan medicinal product designation ...
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News from the EMA / Activities of the COMP / April meeting |
Apr. 25, 2012 |
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The COMP met on 11-12 April 2012 and adopted the following eight positive opinions ... |
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News from the EMA / Activities of the CHMP / April meeting |
Apr. 23, 2012 |
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During its meeting from 16-19 April 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / April meeting |
Apr. 23, 2012 |
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During its meeting from 11-13 April 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the COMP / March meeting |
Mar. 27, 2012 |
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The COMP met on 7-8 March 2012 and adopted the following 13 positive opinions on orphan medicinal product designation ...
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News from the EMA / Activities of the CHMP / March meeting |
Mar. 19, 2012 |
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During its meeting from 12-15 March 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / March meeting |
Mar. 19, 2012 |
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During its meeting from 7-9 March 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the COMP / February meeting |
Feb. 22, 2012 |
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The COMP met on 7-9 February 2012 and adopted the following seven positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the CHMP / February meeting |
Feb. 20, 2012 |
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During its meeting from 13-16 February 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / February meeting |
Feb. 20, 2012 |
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During its meeting from 8-10 February 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the PDCO / January meeting |
Jan. 25, 2012 |
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During its meeting from 11-13 January 2012 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the CHMP / January meeting |
Jan. 24, 2012 |
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During its meeting from 16-19 January 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / January meeting |
Jan. 17, 2012 |
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The COMP met on 11-12 January 2012 and adopted the following 16 positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the PDCO / December meeting |
Dec. 21, 2011 |
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During its meeting from 7-9 December 2011 the Paediatric Committee (PDCO) adopted the following opinions ...
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News from the EMA / Activities of the CHMP / December meeting |
Dec. 19, 2011 |
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During its meeting from 12-15 December 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / December meeting |
Dec. 12, 2011 |
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The COMP met on 6-7 December 2011 and adopted the following nine positive opinions on orphan medicinal product designation ...
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News from the EMA / Activities of the CHMP / November meeting |
Nov. 21, 2011 |
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During its meeting from 14-17 November 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / November meeting |
Nov. 18, 2011 |
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During its meeting from 9-11 November 2011 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the COMP / November meeting |
Nov. 17, 2011 |
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The COMP met on 8-9 November 2011 and adopted the following eleven positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the CHMP / October meeting |
Oct. 24, 2011 |
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During its meeting from 17–20 October 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / October meeting |
Oct. 24, 2011 |
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During its meeting from 12-14 October 2011 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the COMP / October meeting |
Oct. 14, 2011 |
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The COMP met on 5-7 October 2011 and adopted the following twelve positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the CHMP / September meeting |
Sep. 26, 2011 |
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During its meeting from 20-22 September 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / September meeting |
Sep. 22, 2011 |
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The COMP met on 6-8 September 2011 and adopted the following 13 positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the PDCO / September meeting |
Sep. 19, 2011 |
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During its meeting from 7-9 September 2011 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the PDCO / August meeting |
Aug. 22, 2011 |
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During its meeting from 10-12 August 2011 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the PDCO / July meeting |
Aug. 15, 2011 |
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During its meeting from 13-15 July 2011 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the COMP / July meeting |
Aug. 15, 2011 |
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The COMP met on 6-8 July 2011 and adopted the following 16 positive opinions on orphan medicinal product designation ...
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News from the EMA / Activities of the CHMP / July meeting |
Aug. 12, 2011 |
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During its meeting from 18–21 July 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / June meeting |
Jul. 18, 2011 |
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During its meeting from 15-17 June 2011 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the COMP / June meeting |
Jun. 27, 2011 |
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The COMP met on 8-10 June 2011 and adopted the following seven positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the CHMP / June meeting |
Jun. 27, 2011 |
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During its meeting from 20-23 June 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the PDCO / May meeting |
May. 30, 2011 |
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During its meeting from 18-20 May 2011 the Paediatric Committee (PDCO) adopted the following opinions ... |
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News from the EMA / Activities of the CHMP / May meeting |
May. 23, 2011 |
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During its meeting from 16-19 May 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / May meeting |
May. 09, 2011 |
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The COMP met on 4-5 May 2011 and adopted the following ten positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the PDCO / April meeting |
May. 04, 2011 |
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During its meeting from 18-20 April 2011 the Paediatric Committee (PDCO) thanked Alexandra Soldatou, former alternate from Greece, for her work as she has resigned from the Committee. The PDCO adopted the following opinions ... |
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News from the EMA / Activities of the CHMP / April meeting |
Apr. 18, 2011 |
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During its meeting from 11-14 April 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / April meeting |
Apr. 12, 2011 |
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The COMP met on 6-7 April 2011 and adopted the following four positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the PDCO / March meeting |
Mar. 28, 2011 |
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During its meeting from 16-18 March 2011 the Paediatric Committee (PDCO) welcomed ... |
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News from the EMA / Activities of the CHMP / March meeting |
Mar. 21, 2011 |
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During its meeting from 14-17 March 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / March meeting |
Mar. 16, 2011 |
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The COMP met on 8-9 March 2011 and adopted the following six positive opinions ... |
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News from the EMA / Activities of the PDCO / February meeting |
Mar. 03, 2011 |
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During its meeting from 16-18 February 2011 the Paediatric Committee (PDCO) welcomed the new member from Belgium, Prof. Koenraad Norga Dana Gabriela Marin ... |
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News from the EMA / Activities of the CHMP / February meeting |
Feb. 21, 2011 |
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During its meeting from 14-17 February 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / February meeting |
Feb. 15, 2011 |
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The COMP met on 8-9 February 2011 and adopted the following 13 positive opinions on orphan medicinal product designation ... |
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News from the EMA / Activities of the PDCO / January meeting |
Jan. 26, 2011 |
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During its meeting from 12-14 January 2011 the Paediatric Committee (PDCO) welcomed the new alternate from Romania, Dr Dana Gabriela Marin, who has been nominated by the Committee for Medicinal Products for Human Use, and the new alternate from France, Dr Sylvie Benchetrit, appointed by the French regulatory agency AFSSAPS and adopted the following opinions:
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News from the EMA / Activities of the CHMP / January meeting |
Jan. 25, 2011 |
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During its meeting from 17–20 January 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted ... |
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News from the EMA / Activities of the COMP / January meeting |
Jan. 18, 2011 |
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The COMP met on 11-12 January 2011 and adopted the following ten positive opinions on orphan medicinal product designation: |
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News from the EMA / Activities of the PDCO / December meeting |
Dec. 20, 2010 |
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During its meeting from 8-10 December 2010 the Paediatric Committee (PDCO)
elected two of its members, Dirk Mentzer and Paolo Rossi, to represent the Committee in the European paediatric research network at the EMA (EnprEMA) and welcomed the appointment of Dr Nela Vilceanu by the CHMP as the new member from Romania. The following opinions were adopted: |
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News from the EMA / Activities of the CHMP / December meeting |
Dec. 20, 2010 |
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During its meeting from 13–16 December 2010 the Committee for Human Medicinal Products (CHMP) adopted: |
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News from the EMA / Activities of the COMP / December meeting |
Dec. 16, 2010 |
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The COMP met on 7-8 December 2010 and adopted the following six positive opinions on orphan medicinal product designation... |
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Agency internal and external IT systems offline from 26 November 1800 UK time to 29 November 0900 UK time |
Nov. 23, 2010 |
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All the Agencys internal and external IT systems including the corporate website will be offline from Friday 26 November 2010 1800 UK time until Monday 29 November 2010 0900 UK time...
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News from the EMA / Activities of the PDCO / November meeting |
Nov. 22, 2010 |
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During its meeting from 10-12 November 2010 the Paediatric Committee (PDCO) thanked Robert Ancuceanu for his exceptional work as he has resigned from the Committee and adopted the following opinions... |
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News from the EMA / Activities of the CHMP / November meeting |
Nov. 22, 2010 |
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During its meeting from 15-18 November 2010 the Committee for Human Medicinal Products (CHMP) adopted... |
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European Medicines Agency confirms that presence of unexpected viral DNA in live attenuated vaccines does not raise public health concerns |
Nov. 19, 2010 |
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The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has finalised a review on the impact of the detection, using a new testing method, of DNA fragments from viral agents in some live attenuated vaccines...
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Committee for Advanced Therapies adopts five-year work programme to foster development of advanced therapies |
Nov. 19, 2010 |
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The European Medicines Agencys Committee for Advanced Therapies (CAT) has unveiled a Work Programme to 2015, intended to help increase the number of advanced-therapy medicinal products (ATMPs) that make it from the early research stage to the market...
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News from the EMA / Activities of the COMP / November meeting |
Nov. 15, 2010 |
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The COMP met on 9-10 November 2010 and adopted the following 12 positive opinions on orphan medicinal product designation... |
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European Medicines Agency and Massachusetts Institute of Technology launch joint project on regulatory science |
Nov. 11, 2010 |
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The European Medicines Agency (EMA) and the Massachusetts Institute of Technologys (MITs) Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals...
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Report on origins of clinical trial participants updated |
Nov. 11, 2010 |
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The European Medicines Agency has published an updated report on the geographical origins of patients included in clinical trials submitted to the Agency in applications for marketing authorisations...
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Schering-Plough Europe withdraws its marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate) |
Nov. 10, 2010 |
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The European Medicines Agency has been formally notified by Schering-Plough Europe of its decision to withdraw its application for a centralised marketing authorisation for the medicine Zenhale (mometasone furoate/formoterol fumarate) 50/5, 100/5 or 200/5 mg, pressurised inhalation...
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ENCePP releases for public consultation draft Guide on Methodological Standards in Pharmacoepidemiology |
Nov. 09, 2010 |
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The European Medicines Agency (EMA) and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have released for public consultation a draft Guide on Methodological Standards in Pharmacoepidemiology...
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Recruitment procedure for new Executive Director of the European Medicines Agency started |
Nov. 04, 2010 |
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A vacancy notice announcing the recruitment of a new Executive Director for the European Medicines Agency has been published...
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CHMP working parties reorganised |
Oct. 26, 2010 |
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The European Medicines Agencys website has been updated to reflect the changes in the organisation of the working parties of the Committee for Medicinal Products for Human Use (CHMP)...
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Pilots of multi-stakeholder consultations in early-stage drug development |
Oct. 26, 2010 |
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Healthcare institutions from Europe have launched a new pilot process testing multi-stakeholder consultations in early-stage drug development...
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News from the EMA / Activities of the CHMP / October meeting |
Oct. 25, 2010 |
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During its meeting from 18-21 October 2010 the Committee for Human Medicinal Products (CHMP) adopted... |
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European Medicines Agency reviews treatment recommendations for Fabrazyme |
Oct. 25, 2010 |
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The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has reviewed its previous recommendations on the use of Fabrazyme (agalsidase beta) during the ongoing supply shortage. This was triggered by an increase in reported adverse events in patients treated with the lower dose of Fabrazyme that has been introduced during the shortage...
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European Medicines Agency recommends use of fibrates as second-line treatment |
Oct. 25, 2010 |
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Benefit-risk profile of lipid-lowering medicines continues to be positive, but first-line treatment is not recommended...
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European Medicines Agency concludes that benefit-risk balance of Invirase remains positive |
Oct. 22, 2010 |
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Agency recommends reduced starting dose of Invirase in treatment-naïve patients...
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European Medicines Agency strengthens rules on conflicts of interests of its scientific experts |
Oct. 18, 2010 |
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New rules aim for a more robust, efficient and transparent process...
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News from the EMA / Activities of the COMP / October meeting |
Oct. 15, 2010 |
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The COMP met on 6-7 October 2010 and adopted the following 15 positive opinions on orphan medicinal product designation... |
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New fees for marketing authorisation applications in force |
Oct. 14, 2010 |
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The European Medicines Agency reminds applicants that revised implementing rules on fees payable to the Agency apply as of 7 October 2010...
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European Medicines Agency publishes second work package of benefit-risk methodology project |
Oct. 14, 2010 |
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The European Medicines Agency has published the report on the second work package of its benefit-risk methodology project...
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European Medicines Agency Management Board adopt new policies on handling of conflicts of interests and on access to documents |
Oct. 11, 2010 |
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The European Medicines Agencys (EMA) Management Board adopted a number of important policies at its 68th meeting...
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European Medicines Agency receives 1,000th application for a Paediatric Investigation Plan or Waiver |
Oct. 11, 2010 |
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The European Medicines Agency has received and validated the 1,000th application for a Paediatric Investigation Plan (PIP) or Waiver since its Paediatric Committee was established in July 2007...
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European Medicines Agency awards first "ENCePP study" seal for post-marketing study |
Oct. 04, 2010 |
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New seal awarded to transparent, independent observational study in patients with chronic obstructive pulmonary disease...
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Warner Chilcott UK Ltd withdraws its application for an extension of indication for Intrinsa |
Sep. 30, 2010 |
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The European Medicines Agency (EMA) has been formally notified by Warner Chilcott UK Ltd of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Intrinsa (testosterone) transdermal patch...
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News from the EMA / Activities of the CHMP / September meeting |
Sep. 28, 2010 |
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During its meeting from 20-23 September 2010 the Committee for Human Medicinal Products (CHMP) adopted... |
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European Medicines Agency recommends suspension of Octagam in all EU Member States |
Sep. 28, 2010 |
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CHMP recommendation based on risk of thrombo-embolic reactions...
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European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim |
Sep. 24, 2010 |
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The European Medicines Agency today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months...
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European Medicines Agency confirms positive benefit-risk balance of RotaTeq |
Sep. 24, 2010 |
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Very low levels of porcine circovirus type 2 DNA fragments in the oral vaccine pose no risk to public health...
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European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy |
Sep. 24, 2010 |
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Available evidence does not confirm a link; more research needed...
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News from the EMA / Activities of the PDCO / September meeting |
Sep. 23, 2010 |
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During its meeting from 8–9 September 2010 the Paediatric Committee (PDCO) elected Dr Daniel Brasseur as its Chair for a second term of three years, and Dr Dirk Mentzer as Vice-Chair and adopted the following opinions... |
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European Medicines Agency welcomes adoption of new pharmacovigilance legislation by European Parliament |
Sep. 23, 2010 |
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The European Medicines Agency welcomes the adoption of the new pharmacovigilance legislation by the European Parliament today. This is a major step towards the legislation coming into force, currently expected for mid-2012...
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News from the EMA / Activities of the COMP / September meeting |
Sep. 21, 2010 |
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The COMP met on 7-9 September 2010 and adopted the following 14 positive opinions on orphan medicinal product designation... |
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Agency publishes first review of orphan designation |
Sep. 20, 2010 |
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The Agency has published the first of its ‘review of orphan designation’ documents. These documents summarise the review of the orphan designation carried out by the Committee for Orphan Medicinal Products (COMP) whenever an orphan medicine reaches marketing authorisation...
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Novartis Europharm Ltd withdraws its marketing authorisation application for Rasival (aliskiren/valsartan) |
Sep. 20, 2010 |
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The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Rasival (aliskiren/valsartan), 150/160 mg and 300/320 mg film-coated tablets...
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European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements indefinitely |
Sep. 16, 2010 |
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The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003. This cooperation will now continue indefinitely without the need for further renewal...
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European Medicines Agency holds international workshop on clinical trials in the context of global medicines development |
Sep. 10, 2010 |
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Participants from around the world emphasise the need for cooperation to ensure a robust global framework for clinical trials...
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CHMP meets to discuss Avandia and Pandemrix |
Sep. 09, 2010 |
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The Committee for Medicinal Products for Human Use (CHMP) met on Wednesday 8 September to discuss the ongoing benefit-risk review of the rosiglitazone-containing medicines Avandia, Avandamet and Avaglim...
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Patients and Consumers Working Party elects new co-chair |
Sep. 09, 2010 |
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The Human Scientific Committees Working Party with Patients and Consumers Organisations (PCWP) has elected Lise Murphy as its new co-chair at todays meeting...
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European Medicines Agency holds first scientific workshop on nanomedicines |
Sep. 07, 2010 |
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European and international experts prepare for the evaluation of future nanomedicines...
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European Medicines Agency starts review of Pandemrix |
Aug. 31, 2010 |
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Agency is investigating whether there is a link between vaccine and cases of narcolepsy
The European Medicines Agency has launched a review of Pandemrix on the request of the European Commission to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. A limited number of cases was reported, all collected through spontaneous reporting systems, mainly in Sweden and Finland. Pandemrix, an influenza vaccine, has been used since September 2009 for vaccination against H1N1 influenza...
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Agency website down for maintenance from 18:00 UK time 27 August until 09:00 UK time 30 August |
Aug. 27, 2010 |
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The European Medicines Agency website at http://www.ema.europa.eu will be down for essential maintenance from 1800 UK time on Friday 27 August until Monday 30 August 0900 UK time. In addition, the following websites and applications will be down during...
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News from the EMA / Activities of the PDCO / August meeting |
Aug. 18, 2010 |
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During its meeting from 4–6 August 2010 the Paediatric Committee (PDCO) adopted the following opinions... |
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EMA and US FDA seek potential candidate companies for joint GMP inspection programme |
Aug. 13, 2010 |
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The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Companies that have submitted in parallel two equivalent marketing authorisation applications for the same...
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News from the EMEA / Activities of the PDCO / July meeting |
Aug. 09, 2010 |
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During its meeting from 14–16 July 2010 the Paediatric Committee (PDCO) adopted the following opinions... |
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News from the EMA / Activities of the CHMP / July meeting |
Aug. 09, 2010 |
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During its meeting from 19 - 22 July 2010 the Committee for Human Medicinal Products (CHMP) adopted... |
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