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Minutes - PCDO minutes of the 21-24 June 2022 meeting (PDF/514.37 KB) (new)

First published: 02/08/2022
EMA/PDCO/625532/2022
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Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 August 2022 (PDF/418.12 KB) (new)

First published: 01/08/2022
Legal effective date: 01/08/2022
EMA/MB/95162/2022
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CAT quarterly highlights and approved ATMPs - July 2022 (PDF/450.51 KB) (new)

First published: 29/07/2022
EMA/CAT/654429/2022
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News: EMA Paediatric Committee elects Brian Aylward as its new Chair (new)

PDCO, Last updated: 25/07/2022
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P/0282/2021: EMA decision of 19 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cabozantinib (Cometriq, Cabometyx), (EMEA-001143-PIP01-11-M03) (PDF/256.28 KB) (new)

First published: 25/07/2022
EMA/394138/2021
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P/0254/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat (Rezolsta), (EMEA-001280-PIP01-12-M04) (PDF/245.37 KB) (new)

First published: 25/07/2022
EMA/357657/2021
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P/0250/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP03-18-M01) (PDF/215.45 KB) (new)

First published: 22/07/2022
EMA/640003/2008
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P/0269/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir alafenamide (Vemlidy), (EMEA-001584-PIP01-13-M06) (PDF/236.26 KB) (new)

First published: 22/07/2022
EMA/358271/2021
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P/0253/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for nemolizumab (EMEA- 001624-PIP01-14-M03) (PDF/228.97 KB) (new)

First published: 22/07/2022
EMA/358444/2021
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P/0244/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ralinepag (EMEA-002432-PIP02-20) (PDF/209.62 KB) (new)

First published: 22/07/2022
EMA/318092/2021
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P/0280/2021: EMA decision of 16 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bardoxolone (methyl) (EMEA-002488-PIP01-18) (PDF/258.34 KB) (new)

First published: 22/07/2022
EMA/384669/2021
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P/0243/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for finerenone (EMEA-001623-PIP03-20) (PDF/215.51 KB) (new)

First published: 22/07/2022
EMA/357803/2021
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P/0255/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M03) (PDF/251.68 KB) (new)

Adopted
First published: 22/07/2022
EMA/359907/2021
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P/0267/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir (Tivicay),(EMEA-000409-PIP01-08-M06) (PDF/228.21 KB) (new)

Adopted
First published: 22/07/2022
EMA/359351/2021
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P/0268/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana), (EMEA-001030-PIP01-10-M09) (PDF/220.73 KB) (new)

Adopted
First published: 22/07/2022
EMA/359518/2021
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Committee for Advanced Therapies (CAT): 15-17 June 2022 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 15/06/2022 to 17/06/2022, Last updated: 22/07/2022
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Minutes of the CAT meeting 15-17 June 2022 (PDF/461.52 KB) (new)

First published: 22/07/2022
EMA/CAT/600000/2022
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P/0245/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP04-20) (PDF/194.54 KB) (new)

First published: 22/07/2022
EMA/358055/2021
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P/0265/2021: EMA decision of 7 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous selected renal cells (EMEA-002844-PIP01-20) (PDF/271.76 KB) (new)

First published: 22/07/2022
EMA/315803/2021
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P/0251/2021: EMA decision of 9 July 2021 on the granting of a product specific waiver for human papilloma virus type 16 E6 071-095 / human papilloma virus type 16 E6 109-140 / human papilloma virus type 16 E7 001-035 / ... (EMEA-001055-PIP02-21) (PDF/190.51 KB) (new)

First published: 22/07/2022
EMA/357082/2021
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P/0278/2021: EMA decision of 8 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for adeno-associated viral vector serotype 8...(EMEA-002734-PIP01-19) (PDF/216.36 KB) (new)

First published: 22/07/2022
EMA/359172/2021
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P/0277/2021: EMA decision of 8 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant monoclonal antibody...(EMEA-002856-PIP01-20) (PDF/171.44 KB) (new)

First published: 22/07/2022
EMA/359062/2021
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P/0271/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pralsetinib (EMEA-002575-PIP02-20) (PDF/250.57 KB) (new)

First published: 22/07/2022
EMA/357806/2021
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CAT quarterly highlights and approved ATMPs - April 2022 (PDF/403.59 KB) (new)

First published: 21/07/2022
EMA/CAT/253709/2022
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Paediatric Committee (PDCO): 17-20 May 2022 (updated)

Virtual meeting, from 17/05/2022 to 20/05/2022, Last updated: 21/07/2022

7293 results

Minutes - PCDO minutes of the 21-24 June 2022 meeting (PDF/514.37 KB) (new)

Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 August 2022 (PDF/418.12 KB) (new)

CAT quarterly highlights and approved ATMPs - July 2022 (PDF/450.51 KB) (new)

News: EMA Paediatric Committee elects Brian Aylward as its new Chair (new)

P/0282/2021: EMA decision of 19 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cabozantinib (Cometriq, Cabometyx), (EMEA-001143-PIP01-11-M03) (PDF/256.28 KB) (new)

P/0254/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat (Rezolsta), (EMEA-001280-PIP01-12-M04) (PDF/245.37 KB) (new)

P/0250/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP03-18-M01) (PDF/215.45 KB) (new)

P/0269/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir alafenamide (Vemlidy), (EMEA-001584-PIP01-13-M06) (PDF/236.26 KB) (new)

P/0253/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for nemolizumab (EMEA- 001624-PIP01-14-M03) (PDF/228.97 KB) (new)

P/0244/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ralinepag (EMEA-002432-PIP02-20) (PDF/209.62 KB) (new)

P/0280/2021: EMA decision of 16 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bardoxolone (methyl) (EMEA-002488-PIP01-18) (PDF/258.34 KB) (new)

P/0243/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for finerenone (EMEA-001623-PIP03-20) (PDF/215.51 KB) (new)

P/0255/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M03) (PDF/251.68 KB) (new)

P/0267/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir (Tivicay),(EMEA-000409-PIP01-08-M06) (PDF/228.21 KB) (new)

P/0268/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana), (EMEA-001030-PIP01-10-M09) (PDF/220.73 KB) (new)

Committee for Advanced Therapies (CAT): 15-17 June 2022 (updated)

Minutes of the CAT meeting 15-17 June 2022 (PDF/461.52 KB) (new)

P/0245/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP04-20) (PDF/194.54 KB) (new)

P/0265/2021: EMA decision of 7 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous selected renal cells (EMEA-002844-PIP01-20) (PDF/271.76 KB) (new)

P/0251/2021: EMA decision of 9 July 2021 on the granting of a product specific waiver for human papilloma virus type 16 E6 071-095 / human papilloma virus type 16 E6 109-140 / human papilloma virus type 16 E7 001-035 / ... (EMEA-001055-PIP02-21) (PDF/190.51 KB) (new)

P/0278/2021: EMA decision of 8 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for adeno-associated viral vector serotype 8...(EMEA-002734-PIP01-19) (PDF/216.36 KB) (new)

P/0277/2021: EMA decision of 8 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant monoclonal antibody...(EMEA-002856-PIP01-20) (PDF/171.44 KB) (new)

P/0271/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pralsetinib (EMEA-002575-PIP02-20) (PDF/250.57 KB) (new)

CAT quarterly highlights and approved ATMPs - April 2022 (PDF/403.59 KB) (new)

Paediatric Committee (PDCO): 17-20 May 2022 (updated)