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CAT quarterly highlights and approved ATMPs - May 2023 (PDF/188.91 KB) (new)

First published: 31/05/2023
EMA/CAT/247792/2023
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HMPC meeting report on European Union herbal monographs, guidelines and other activities - 10-12 May 2023 (PDF/104.07 KB) (new)

First published: 25/05/2023
EMA/HMPC/220353/2023
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Minutes of the HMPC 13-15 March 2023 meeting (PDF/364.02 KB) (new)

Adopted
First published: 23/05/2023
EMA/HMPC/135921/2023
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Agenda of the PDCO meeting 23-26 May 2023 (PDF/382.25 KB) (new)

Draft
First published: 23/05/2023
EMA/PDCO/227981/2023
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Derivative of 4Hpyrazolo[3,4-d]pyrimidin-4-one (BI409306) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/80.15 KB) (new)

First published: 22/05/2023
EMEA-001742-PIP01-14
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P/0185/2022 : EMA decision on 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for avibactam / aztreonam (EMEA-002283-PIP01-17-M03) (PDF/274.43 KB) (new)

Adopted
First published: 17/05/2023
EMA/640003/2008
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P/0187/2022 : EMA decision on 25 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP03-15-M05) (PDF/257.47 KB) (new)

Adopted
First published: 17/05/2023
EMA/274001/2022
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P/0180/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brincidofovir (EMEA- 001904-PIP03-18-M02) (PDF/209.5 KB) (new)

Adopted
First published: 17/05/2023
EMA/205675/2022
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P/0179/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cemiplimab (Libtayo), (EMEA-002007-PIP02-17-M02) (PDF/269.91 KB) (new)

Adopted
First published: 17/05/2023
EMA/205775/2022
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P/0177/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M01) (PDF/210.29 KB) (new)

Adopted
First published: 17/05/2023
EMA/205591/2022
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P/0175/2022 : EMA decision of 13 May 2022 on the refusal of a modification of an agreed paediatric investigation plan for betibeglogene autotemcel (Zynteglo), (EMEA-001665-PIP01-14-M06) (PDF/236.14 KB) (new)

Adopted
First published: 16/05/2023
EMA/206734/2022
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P/0174/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA- 002360-PIP01-18-M02) (PDF/229.81 KB) (new)

Adopted
First published: 16/05/2023
EMA/207913/2022
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P/0168/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for human, recombinant, non-fucosylated IgG1k monoclonal antibody...(EMEA-002886-PIP01-20-M01) (PDF/199.5 KB) (new)

Adopted
First published: 16/05/2023
EMA/204358/2022
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P/0170/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for remibrutinib (EMEA-002582-PIP01-19-M01) (PDF/173.16 KB) (new)

Adopted
First published: 16/05/2023
EMA/204227/2022
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P/0164/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bis-choline tetrathiomolybdate (EMEA-002232-PIP02-19-M02) (PDF/222.26 KB) (new)

Adopted
First published: 16/05/2023
EMA/207916/2022
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P/0163/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M02) (PDF/224.67 KB) (new)

Adopted
First published: 16/05/2023
EMA/207939/2022
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Committee for Advanced Therapies (CAT): 15-17 May 2023 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 15/05/2023 to 17/05/2023, Last updated: 15/05/2023
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Agenda of the CAT meeting 15-17 May 2023 (PDF/330.67 KB) (new)

Draft
First published: 15/05/2023
EMA/CAT/198093/2023
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P/0166/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for regdanvimab (Regkirona), (EMEA-002961-PIP01-21-M01) (PDF/214.83 KB) (new)

Adopted
First published: 12/05/2023
EMA/204850/2022
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P/0159/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for magnesium sulphate heptahydrate / potassium sulphate / sodium sulphate anhydrous... (EMEA-000816-PIP02-10-M03) (PDF/188.54 KB) (new)

Adopted
First published: 12/05/2023
EMA/169200/2022
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P/0160/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine acetate (Zebinix), (EMEA-000696-PIP02-10-M08) (PDF/208.18 KB) (new)

Adopted
First published: 12/05/2023
EMA/169198/2022
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P/0161/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP02-14-M03) (PDF/233.42 KB) (new)

Adopted
First published: 12/05/2023
EMA/169194/2022
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P/0154/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (Lenvima, Kisplyx), (EMEA-001119-PIP03-19-M02) (PDF/274.17 KB) (new)

Adopted
First published: 12/05/2023
EMA/206618/2022
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P/0155/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for luspatercept (Reblozyl), (EMEA-001521-PIP01-13-M06) (PDF/272.66 KB) (new)

Adopted
First published: 12/05/2023
EMA/206730/2022
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P/0157/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M09) (PDF/221.39 KB) (new)

Adopted
First published: 12/05/2023
EMA/206659/2022

9856 results

CAT quarterly highlights and approved ATMPs - May 2023 (PDF/188.91 KB) (new)

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 10-12 May 2023 (PDF/104.07 KB) (new)

Minutes of the HMPC 13-15 March 2023 meeting (PDF/364.02 KB) (new)

Agenda of the PDCO meeting 23-26 May 2023 (PDF/382.25 KB) (new)

Derivative of 4Hpyrazolo[3,4-d]pyrimidin-4-one (BI409306) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/80.15 KB) (new)

P/0185/2022 : EMA decision on 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for avibactam / aztreonam (EMEA-002283-PIP01-17-M03) (PDF/274.43 KB) (new)

P/0187/2022 : EMA decision on 25 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP03-15-M05) (PDF/257.47 KB) (new)

P/0180/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brincidofovir (EMEA- 001904-PIP03-18-M02) (PDF/209.5 KB) (new)

P/0179/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cemiplimab (Libtayo), (EMEA-002007-PIP02-17-M02) (PDF/269.91 KB) (new)

P/0177/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M01) (PDF/210.29 KB) (new)

P/0175/2022 : EMA decision of 13 May 2022 on the refusal of a modification of an agreed paediatric investigation plan for betibeglogene autotemcel (Zynteglo), (EMEA-001665-PIP01-14-M06) (PDF/236.14 KB) (new)

P/0174/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA- 002360-PIP01-18-M02) (PDF/229.81 KB) (new)

P/0168/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for human, recombinant, non-fucosylated IgG1k monoclonal antibody...(EMEA-002886-PIP01-20-M01) (PDF/199.5 KB) (new)

P/0170/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for remibrutinib (EMEA-002582-PIP01-19-M01) (PDF/173.16 KB) (new)

P/0164/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bis-choline tetrathiomolybdate (EMEA-002232-PIP02-19-M02) (PDF/222.26 KB) (new)

P/0163/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M02) (PDF/224.67 KB) (new)

Committee for Advanced Therapies (CAT): 15-17 May 2023 (updated)

Agenda of the CAT meeting 15-17 May 2023 (PDF/330.67 KB) (new)

P/0166/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for regdanvimab (Regkirona), (EMEA-002961-PIP01-21-M01) (PDF/214.83 KB) (new)

P/0159/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for magnesium sulphate heptahydrate / potassium sulphate / sodium sulphate anhydrous... (EMEA-000816-PIP02-10-M03) (PDF/188.54 KB) (new)

P/0160/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine acetate (Zebinix), (EMEA-000696-PIP02-10-M08) (PDF/208.18 KB) (new)

P/0161/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP02-14-M03) (PDF/233.42 KB) (new)

P/0154/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (Lenvima, Kisplyx), (EMEA-001119-PIP03-19-M02) (PDF/274.17 KB) (new)

P/0155/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for luspatercept (Reblozyl), (EMEA-001521-PIP01-13-M06) (PDF/272.66 KB) (new)

P/0157/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M09) (PDF/221.39 KB) (new)