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News: EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 (new)

CHMP, PDCO, Last updated: 23/06/2022
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Agenda - PDCO agenda of the 21-24 June 2022 meeting (PDF/1.07 MB) (new)

First published: 21/06/2022
EMA/PDCO/557550/2022
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Minutes - PDCO minutes of the 19-22 April 2022 meeting (PDF/428.32 KB) (new)

Adopted
First published: 16/06/2022
EMA/PDCO/247621/2022
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Agenda - CAT agenda of the 15-17 June 2022 meeting (PDF/346.4 KB) (new)

Draft
First published: 15/06/2022
EMA/CAT/376180/2022
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Tabalumab : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/133.95 KB) (new)

First published: 14/06/2022
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Expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision (PDF/98.97 KB) (new)

First published: 14/06/2022
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Insulin peglispro : Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision (PDF/126.33 KB) (new)

First published: 14/06/2022
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Recombinant human heparan-N-sulfatase (rhHNS, SHP610, HGT-1410, Sulfamidase, San-A) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/92.74 KB) (new)

First published: 14/06/2022
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Methyl aminolevulinate hydrochloride : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/117.83 KB) (new)

First published: 14/06/2022
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Minutes of the CAT meeting 11-13 April 2022 (PDF/473.59 KB) (new)

Adopted
First published: 10/06/2022
EMA/CAT/184995/2022
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Minutes of the CAT meeting 16-18 March 2022 (PDF/467.35 KB) (new)

Adopted
First published: 10/06/2022
EMA/CAT/186491/2022
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Minutes of the CAT meeting 16-17 February 2022 (PDF/469.59 KB) (new)

Adopted
First published: 10/06/2022
EMA/CAT/110649/2022
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Minutes of the CAT meeting 19-21 January 2022 (PDF/419.49 KB) (new)

Adopted
First published: 10/06/2022
EMA/CAT/47833/2022
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Arimoclomol citrate : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/68.38 KB) (new)

First published: 10/06/2022
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P/0246/2021 : EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan for odevixibat (EMEA-002054-PIP03-20) (PDF/233.16 KB) (new)

Adopted
First published: 10/06/2022
EMA/360346/2021
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P/0375/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cendakimab (EMEA-002640-PIP01-19) (PDF/210.71 KB) (new)

Adopted
First published: 10/06/2022
EMA/471081/2021
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P/0388/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benralizumab (Fasenra) (EMEA-001214-PIP05-19) (PDF/247.33 KB) (new)

Adopted
First published: 10/06/2022
EMA/418670/2021
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P/0361/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent) (EMEA-001501-PIP04-19-M01) (PDF/220.23 KB) (new)

Adopted
First published: 10/06/2022
EMA/440400/2021
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Deleobuvir : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/178.01 KB) (new)

First published: 09/06/2022
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Selonsertib : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/95.92 KB) (new)

First published: 07/06/2022
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Paediatric Committee (PDCO): 22-25 March 2022 (updated)

Virtual meeting, from 22/03/2022 to 25/03/2022, Last updated: 03/06/2022
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Minutes - PDCO minutes of the 22-25 March 2022 meeting (PDF/486.25 KB) (new)

Adopted
First published: 03/06/2022
EMA/PDCO/202678/2022
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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: 31/05/2022
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Minutes of the CAT meeting 3-5 November 2021 (PDF/406.66 KB) (new)

Adopted
First published: 31/05/2022
EMA/CAT/636354/2021
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Paediatric Committee (PDCO): 17-20 May 2022

Virtual meeting, from 17/05/2022 to 20/05/2022, Last updated: 18/05/2022

6524 results

News: EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 (new)

Agenda - PDCO agenda of the 21-24 June 2022 meeting (PDF/1.07 MB) (new)

Minutes - PDCO minutes of the 19-22 April 2022 meeting (PDF/428.32 KB) (new)

Agenda - CAT agenda of the 15-17 June 2022 meeting (PDF/346.4 KB) (new)

Tabalumab : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/133.95 KB) (new)

Expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision (PDF/98.97 KB) (new)

Insulin peglispro : Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision (PDF/126.33 KB) (new)

Recombinant human heparan-N-sulfatase (rhHNS, SHP610, HGT-1410, Sulfamidase, San-A) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/92.74 KB) (new)

Methyl aminolevulinate hydrochloride : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/117.83 KB) (new)

Minutes of the CAT meeting 11-13 April 2022 (PDF/473.59 KB) (new)

Minutes of the CAT meeting 16-18 March 2022 (PDF/467.35 KB) (new)

Minutes of the CAT meeting 16-17 February 2022 (PDF/469.59 KB) (new)

Minutes of the CAT meeting 19-21 January 2022 (PDF/419.49 KB) (new)

Arimoclomol citrate : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/68.38 KB) (new)

P/0246/2021 : EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan for odevixibat (EMEA-002054-PIP03-20) (PDF/233.16 KB) (new)

P/0375/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cendakimab (EMEA-002640-PIP01-19) (PDF/210.71 KB) (new)

P/0388/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benralizumab (Fasenra) (EMEA-001214-PIP05-19) (PDF/247.33 KB) (new)

P/0361/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent) (EMEA-001501-PIP04-19-M01) (PDF/220.23 KB) (new)

Deleobuvir : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/178.01 KB) (new)

Selonsertib : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/95.92 KB) (new)

Paediatric Committee (PDCO): 22-25 March 2022 (updated)

Minutes - PDCO minutes of the 22-25 March 2022 meeting (PDF/486.25 KB) (new)

Committee for Advanced Therapies (CAT): 3-5 November 2021 (updated)

Minutes of the CAT meeting 3-5 November 2021 (PDF/406.66 KB) (new)

Paediatric Committee (PDCO): 17-20 May 2022