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P/0143/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zilucoplan (EMEA-002747-PIP01-20) (PDF/245.58 KB) (new)

Adopted
First published: 14/01/2022
EMA/175350/2021
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P/0142/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for surufatinib (EMEA-002750-PIP01-19) (PDF/279.87 KB) (new)

Adopted
First published: 14/01/2022
EMA/151840/2021
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Minutes of the CAT meeting 6-8 October 2021 (PDF/362.76 KB) (new)

Adopted
First published: 14/01/2022
EMA/CAT/574435/2021
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Minutes of the CAT meeting 8-10 September 2021 (PDF/372.45 KB) (new)

Adopted
First published: 14/01/2022
EMA/CAT/515396/2021
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P/0146/2021: EMA decision of 14 April 2021 on the granting of a product specific waiver for sutimlimab (EMEA-002542-PIP03-20) (PDF/214.7 KB) (new)

Adopted
First published: 13/01/2022
EMA/188461/2021
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P/0145/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ruxolitinib (phosphate) (EMEA-002618-PIP02-20) (PDF/246.81 KB) (new)

Adopted
First published: 13/01/2022
EMA/190698/2021
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P/0159/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for chikungunya Virus Virus-Like Particle Vaccine / aluminum hydroxide, (EMEA-002656-PIP01-19) (PDF/204.34 KB) (new)

Adopted
First published: 13/01/2022
EMA/152116/2021
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P/0129/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for sepofarsen (EMEA-002717-PIP02-20) (PDF/227.86 KB) (new)

Adopted
First published: 13/01/2022
EMA/151843/2021
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P/0153/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dupilumab (Dupixent), (EMEA-001501-PIP07-20) (PDF/315.03 KB) (new)

Adopted
First published: 12/01/2022
EMA/191363/2021
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P/0130/2021: EMA decision of 14 April 2021 on the granting of a product specific waiver for talazoparib (Talzenna), (EMEA-002066-PIP02-20) (PDF/152.5 KB) (new)

Adopted
First published: 12/01/2022
EMA/151819/2021
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P/0150/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a waiver for metformin (hydrochloride) / pioglitazone (hydrochloride) / spironolactone, (EMEA-002187-PIP01-17) (PDF/205.83 KB) (new)

Adopted
First published: 12/01/2022
EMA/152108/2021
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P/0149/2021: EMA decision of 16 April 2021 on the granting of a product specific waiver for nadofaragene firadenovec, (EMEA-002376-PIP02-20) (PDF/178.41 KB) (new)

Adopted
First published: 12/01/2022
EMA/152090/2021
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P/0147/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ritlecitinib (EMEA-002451-PIP01-18) (PDF/329.98 KB) (new)

Adopted
First published: 12/01/2022
EMA/175282/2021
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P/0230/2018: EMA decision of 3 August 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for risankizumab (EMEA-001776-PIP03-17) (PDF/148.72 KB) (updated)

Adopted
First published: 28/01/2019
Last updated: 06/01/2022
EMA/480849/2018 Corr.
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Paediatric Committee (PDCO): 20-23 July 2021

Virtual meeting, from 20/07/2021 to 23/07/2021, Last updated: 15/12/2021
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PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 July 2021 (PDF/217.26 KB)

Adopted
First published: 15/12/2021
EMA/PDCO/433151/2021
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Agenda - PDCO agenda of the 14-17 December 2021 meeting (PDF/410.48 KB)

Draft
First published: 14/12/2021
EMA/PDCO/695889/2021
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Agenda - CAT agenda of the 8-10 December 2021 meeting (PDF/352.19 KB)

Draft
First published: 08/12/2021
EMA/CAT/685109/2021
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Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with Article 17 of Regulation (EC) No 1394/2007 (PDF/325.53 KB)

Adopted
First published: 23/02/2010
Last updated: 30/11/2021
EMA/CAT/99623/2009 Rev. 2
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Guide on advanced therapy medicinal products - Quality flowchart (PDF/144.33 KB)

First published: 29/11/2021
Version 1.0
List item

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

European Medicines Agency, Amsterdam, the Netherlands, from 03/11/2021 to 05/11/2021, Last updated: 29/11/2021
List item

Committee for Advanced Therapies (CAT): 11-13 August 2021

European Medicines Agency, Amsterdam, the Netherlands, from 11/08/2021 to 13/08/2021, Last updated: 29/11/2021
List item

Committee for Advanced Therapies (CAT): 6-8 October 2021

European Medicines Agency, Amsterdam, the Netherlands, from 06/10/2021 to 08/10/2021, Last updated: 29/11/2021
List item

Committee for Advanced Therapies (CAT): 14-16 July 2021

European Medicines Agency, Amsterdam, the Netherlands, from 14/07/2021 to 16/07/2021, Last updated: 29/11/2021
List item

Committee for Advanced Therapies (CAT): 16-18 June 2021

European Medicines Agency, Amsterdam, the Netherlands, from 16/06/2021 to 18/06/2021, Last updated: 29/11/2021

6367 results

P/0143/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zilucoplan (EMEA-002747-PIP01-20) (PDF/245.58 KB) (new)

P/0142/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for surufatinib (EMEA-002750-PIP01-19) (PDF/279.87 KB) (new)

Minutes of the CAT meeting 6-8 October 2021 (PDF/362.76 KB) (new)

Minutes of the CAT meeting 8-10 September 2021 (PDF/372.45 KB) (new)

P/0146/2021: EMA decision of 14 April 2021 on the granting of a product specific waiver for sutimlimab (EMEA-002542-PIP03-20) (PDF/214.7 KB) (new)

P/0145/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ruxolitinib (phosphate) (EMEA-002618-PIP02-20) (PDF/246.81 KB) (new)

P/0159/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for chikungunya Virus Virus-Like Particle Vaccine / aluminum hydroxide, (EMEA-002656-PIP01-19) (PDF/204.34 KB) (new)

P/0129/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for sepofarsen (EMEA-002717-PIP02-20) (PDF/227.86 KB) (new)

P/0153/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dupilumab (Dupixent), (EMEA-001501-PIP07-20) (PDF/315.03 KB) (new)

P/0130/2021: EMA decision of 14 April 2021 on the granting of a product specific waiver for talazoparib (Talzenna), (EMEA-002066-PIP02-20) (PDF/152.5 KB) (new)

P/0150/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a waiver for metformin (hydrochloride) / pioglitazone (hydrochloride) / spironolactone, (EMEA-002187-PIP01-17) (PDF/205.83 KB) (new)

P/0149/2021: EMA decision of 16 April 2021 on the granting of a product specific waiver for nadofaragene firadenovec, (EMEA-002376-PIP02-20) (PDF/178.41 KB) (new)

P/0147/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ritlecitinib (EMEA-002451-PIP01-18) (PDF/329.98 KB) (new)

P/0230/2018: EMA decision of 3 August 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for risankizumab (EMEA-001776-PIP03-17) (PDF/148.72 KB) (updated)

Paediatric Committee (PDCO): 20-23 July 2021

PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 July 2021 (PDF/217.26 KB)

Agenda - PDCO agenda of the 14-17 December 2021 meeting (PDF/410.48 KB)

Agenda - CAT agenda of the 8-10 December 2021 meeting (PDF/352.19 KB)

Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with Article 17 of Regulation (EC) No 1394/2007 (PDF/325.53 KB)

Guide on advanced therapy medicinal products - Quality flowchart (PDF/144.33 KB)

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

Committee for Advanced Therapies (CAT): 11-13 August 2021

Committee for Advanced Therapies (CAT): 6-8 October 2021

Committee for Advanced Therapies (CAT): 14-16 July 2021

Committee for Advanced Therapies (CAT): 16-18 June 2021