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Minutes - PDCO minutes of the 8-11 December 2020 meeting (PDF/568.6 KB) (new)

Adopted
First published: 01/03/2021
EMA/PDCO/622400/2020
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Agenda - PDCO agenda of the 23-26 February 2021 meeting (PDF/360.47 KB) (new)

Adopted
First published: 23/02/2021
EMA/PDCO/67461/2021
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P/0365/2020: EMA decision of 9 September 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mitapivat (EMEA-002684-PIP01-19) (PDF/298.77 KB) (new)

Adopted
First published: 16/02/2021
EMA/415913/2020
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P/0059/2021: EMA decision of 5 February 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 vaccine (Ad26.COV2-S (recombinant)) (EMEA-002880-PIP01-20) (PDF/210.39 KB) (new)

Draft
First published: 16/02/2021
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P/0060/2021: EMA decision of 5 February 2021 on the acceptance of a modification of an agreed paediatric investigation plan for remdesivir (Veklury), (EMEA-002826-PIP01-20-M01) (PDF/167.33 KB) (new)

Adopted
First published: 16/02/2021
EMA/71518/2021
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P/0062/2021: EMA decision of 5 February 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for baricitinib (Olumiant), (EMEA-001220-PIP07-20) (PDF/199.65 KB) (new)

Adopted
First published: 16/02/2021
EMA/501874/2008
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Paediatric Committee (PDCO): 23-26 March 2021

Virtual meeting, from 23/03/2021 to 26/03/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 20-23 April 2021

Virtual meeting, from 20/04/2021 to 23/04/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 18-21 May 2021

Virtual meeting, from 18/05/2021 to 21/05/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 22-25 June 2021

Virtual meeting, from 22/06/2021 to 25/06/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 20-23 July 2021

Virtual meeting, from 20/07/2021 to 23/07/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 7-10 September 2021

Virtual meeting, from 07/09/2021 to 10/09/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 12-15 October 2021

Virtual meeting, from 12/10/2021 to 15/10/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 9-12 November 2021

Virtual meeting, from 09/11/2021 to 12/11/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 14-17 December 2021

Virtual meeting, from 14/12/2021 to 17/12/2021, Last updated: 27/01/2021
List item

Paediatric Committee (PDCO): 26-29 January 2021

Virtual meeting, from 26/01/2021 to 29/01/2021, Last updated: 27/01/2021
List item

Agenda - PDCO agenda of the 26-29 January 2021 meeting (PDF/319.92 KB)

Draft
First published: 27/01/2021
EMA/PDCO/1681/2021
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Paediatric Committee (PDCO): 23-26 February 2021 (updated)

Virtual meeting, from 23/02/2021 to 26/02/2021, Last updated: 23/02/2021
List item

Minutes - PDCO minutes of the 10-13 November 2020 meeting (PDF/519.46 KB)

Adopted
First published: 25/01/2021
EMA/PDCO/615662/2020
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PDCO monthly report of opinions on paediatric investigation plans and other activities 8-11 December 2020 (PDF/191.47 KB)

Adopted
First published: 22/01/2021
EMEA/PDCO/1735/2021
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P/0003/2021: EMA decision of 5 January 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (EMEA-002862-PIP01-20) (PDF/185.1 KB)

Adopted
First published: 05/01/2021
EMA/1708/2021
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Minutes - PDCO minutes of the 1-4 September 2020 meeting (PDF/604.06 KB)

Adopted
First published: 04/01/2021
EMA/PDCO/466199/2020
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P/0480/2020: EMA decision of 27 November 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2) (EMEA-002861.. (PDF/193.57 KB)

Adopted
First published: 18/12/2020
EMA/640530/2020
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P/0481/2020: EMA decision of 30 November 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for mRNA that encodes for the pre-fusion stabilized spike glycoprotein of SARS-CoV-2 (mRNA-1273) (EMEA-002893- PIP01-20) (PDF/212.29 KB)

Adopted
First published: 18/12/2020
EMA/639193/2020
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Minutes - PDCO minutes of the 13-16 October 2020 meeting (PDF/521.23 KB)

Adopted
First published: 14/12/2020
EMA/PDCO/555707/2020

4913 results

Minutes - PDCO minutes of the 8-11 December 2020 meeting (PDF/568.6 KB) (new)

Agenda - PDCO agenda of the 23-26 February 2021 meeting (PDF/360.47 KB) (new)

P/0365/2020: EMA decision of 9 September 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mitapivat (EMEA-002684-PIP01-19) (PDF/298.77 KB) (new)

P/0059/2021: EMA decision of 5 February 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 vaccine (Ad26.COV2-S (recombinant)) (EMEA-002880-PIP01-20) (PDF/210.39 KB) (new)

P/0060/2021: EMA decision of 5 February 2021 on the acceptance of a modification of an agreed paediatric investigation plan for remdesivir (Veklury), (EMEA-002826-PIP01-20-M01) (PDF/167.33 KB) (new)

P/0062/2021: EMA decision of 5 February 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for baricitinib (Olumiant), (EMEA-001220-PIP07-20) (PDF/199.65 KB) (new)

Paediatric Committee (PDCO): 23-26 March 2021

Paediatric Committee (PDCO): 20-23 April 2021

Paediatric Committee (PDCO): 18-21 May 2021

Paediatric Committee (PDCO): 22-25 June 2021

Paediatric Committee (PDCO): 20-23 July 2021

Paediatric Committee (PDCO): 7-10 September 2021

Paediatric Committee (PDCO): 12-15 October 2021

Paediatric Committee (PDCO): 9-12 November 2021

Paediatric Committee (PDCO): 14-17 December 2021

Paediatric Committee (PDCO): 26-29 January 2021

Agenda - PDCO agenda of the 26-29 January 2021 meeting (PDF/319.92 KB)

Paediatric Committee (PDCO): 23-26 February 2021 (updated)

Minutes - PDCO minutes of the 10-13 November 2020 meeting (PDF/519.46 KB)

PDCO monthly report of opinions on paediatric investigation plans and other activities 8-11 December 2020 (PDF/191.47 KB)

P/0003/2021: EMA decision of 5 January 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (EMEA-002862-PIP01-20) (PDF/185.1 KB)

Minutes - PDCO minutes of the 1-4 September 2020 meeting (PDF/604.06 KB)

P/0480/2020: EMA decision of 27 November 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2) (EMEA-002861.. (PDF/193.57 KB)

P/0481/2020: EMA decision of 30 November 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for mRNA that encodes for the pre-fusion stabilized spike glycoprotein of SARS-CoV-2 (mRNA-1273) (EMEA-002893- PIP01-20) (PDF/212.29 KB)

Minutes - PDCO minutes of the 13-16 October 2020 meeting (PDF/521.23 KB)