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

First published: 29/11/2021
Version 1.0
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Committee for Advanced Therapies (CAT): 6-8 October 2021 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 06/10/2021 to 08/10/2021, Last updated: 29/11/2021
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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: 29/11/2021
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Committee for Advanced Therapies (CAT): 11-13 August 2021 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 11/08/2021 to 13/08/2021, Last updated: 29/11/2021
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Committee for Advanced Therapies (CAT): 14-16 July 2021 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 14/07/2021 to 16/07/2021, Last updated: 29/11/2021
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Committee for Advanced Therapies (CAT): 16-18 June 2021 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 16/06/2021 to 18/06/2021, Last updated: 29/11/2021
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CAT monthly report of application procedures, guidelines and related documents on advanced therapies: November 2021 (PDF/160.48 KB) (new)

Adopted
First published: 29/11/2021
EMA/CAT/586930/2021
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CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2021 (PDF/179.45 KB) (new)

Adopted
First published: 29/11/2021
EMA/CAT/586930/2021
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Minutes of the CAT written procedure 11-13 August 2021 (PDF/302.38 KB) (new)

Adopted
First published: 29/11/2021
EMA/CAT/458500/2021
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Minutes of the CAT meeting 14-16 July 2021 (PDF/458.38 KB) (new)

Adopted
First published: 29/11/2021
EMA/CAT/407165/2021
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Minutes of the CAT meeting 16-18 June 2021 (PDF/448.37 KB) (new)

Adopted
First published: 29/11/2021
EMA/CAT/349953/2021
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Agenda - CAT agenda of the 6-8 October 2021 meeting (PDF/333.95 KB) (updated)

Draft
First published: 08/10/2021
Last updated: 29/11/2021
EMA/CAT/526882/2021
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P/0118/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cabotegravir (Vocabria) (EMEA-001418-PIP02-15-M01) (PDF/203.13 KB) (new)

First published: 26/11/2021
EMA/93310/2021
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P/0105/2021 : EMA decision of 17 March 2021 on the refusal of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride) (Reagila) (EMEA-001652-PIP01-14-M03) (PDF/271.96 KB) (new)

First published: 26/11/2021
EMA/94420/2021
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P/0103/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for roxadustat (EMEA-001557-PIP01-13-M05) (PDF/225.32 KB) (new)

First published: 26/11/2021
EMA/94318/2021
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P/0120/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tildrakizumab (Ilumetri) (EMEA-001451-PIP01-13-M01) (PDF/196.24 KB) (new)

First published: 26/11/2021
EMA/93320/2021
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P/0119/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cobimetinib (Cotellic) (EMEA-001425-PIP01-13-M05) (PDF/172.16 KB) (new)

First published: 26/11/2021
EMA/93313/2021
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P/0117/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica) (EMEA-001397-PIP03-14-M05) (PDF/227.68 KB) (new)

First published: 23/11/2021
EMA/93299/2021
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P/0116/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir / abacavir / lamivudine (Triumeq) (EMEA-001219-PIP01-11-M05) (PDF/213.87 KB) (new)

First published: 23/11/2021
EMA/93290/2021
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P/0115/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine (Valdoxan and associated names) (EMEA-001181-PIP01-11-M06) (PDF/352.01 KB) (new)

First published: 23/11/2021
EMA/93279/2021
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P/0125/2021 : EMA decision of 17 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for linear single strand of deoxyribonucleic acid........(EMEA-002827-PIP01-20) (PDF/208.68 KB) (new)

First published: 19/11/2021
EMA/97583/2021
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P/0097/2021 : EMA decision of 19 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for telitacicept (EMEA-002824-PIP01-20) (PDF/248.38 KB) (new)

First published: 19/11/2021
EMA/73059/2021
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P/0098/2021 : EMA decision of 19 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for respiratory Syncytial Virus PreF3 recombinant.......(EMEA-002821-PIP01-20) (PDF/224.56 KB) (new)

First published: 19/11/2021
EMA/73054/2021
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P/0100/2021 : EMA decision of 17 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rozibafusp alfa (EMEA-002815-PIP01-20) (PDF/201.72 KB) (new)

First published: 19/11/2021
EMA/71537/2021
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P/0102/2021 : EMA decision of 17 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (S)-2-(5-((3-ethoxypyridin-2-yl)oxy)pyridin-3-yl)-N....(EMEA-00277-PIP01-20) (PDF/178.71 KB) (new)

First published: 19/11/2021
EMA/71539/2021

6359 results

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

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

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

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

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

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

CAT monthly report of application procedures, guidelines and related documents on advanced therapies: November 2021 (PDF/160.48 KB) (new)

CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2021 (PDF/179.45 KB) (new)

Minutes of the CAT written procedure 11-13 August 2021 (PDF/302.38 KB) (new)

Minutes of the CAT meeting 14-16 July 2021 (PDF/458.38 KB) (new)

Minutes of the CAT meeting 16-18 June 2021 (PDF/448.37 KB) (new)

Agenda - CAT agenda of the 6-8 October 2021 meeting (PDF/333.95 KB) (updated)

P/0118/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cabotegravir (Vocabria) (EMEA-001418-PIP02-15-M01) (PDF/203.13 KB) (new)

P/0105/2021 : EMA decision of 17 March 2021 on the refusal of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride) (Reagila) (EMEA-001652-PIP01-14-M03) (PDF/271.96 KB) (new)

P/0103/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for roxadustat (EMEA-001557-PIP01-13-M05) (PDF/225.32 KB) (new)

P/0120/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tildrakizumab (Ilumetri) (EMEA-001451-PIP01-13-M01) (PDF/196.24 KB) (new)

P/0119/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cobimetinib (Cotellic) (EMEA-001425-PIP01-13-M05) (PDF/172.16 KB) (new)

P/0117/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica) (EMEA-001397-PIP03-14-M05) (PDF/227.68 KB) (new)

P/0116/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir / abacavir / lamivudine (Triumeq) (EMEA-001219-PIP01-11-M05) (PDF/213.87 KB) (new)

P/0115/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine (Valdoxan and associated names) (EMEA-001181-PIP01-11-M06) (PDF/352.01 KB) (new)

P/0125/2021 : EMA decision of 17 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for linear single strand of deoxyribonucleic acid........(EMEA-002827-PIP01-20) (PDF/208.68 KB) (new)

P/0097/2021 : EMA decision of 19 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for telitacicept (EMEA-002824-PIP01-20) (PDF/248.38 KB) (new)

P/0098/2021 : EMA decision of 19 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for respiratory Syncytial Virus PreF3 recombinant.......(EMEA-002821-PIP01-20) (PDF/224.56 KB) (new)

P/0100/2021 : EMA decision of 17 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rozibafusp alfa (EMEA-002815-PIP01-20) (PDF/201.72 KB) (new)

P/0102/2021 : EMA decision of 17 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (S)-2-(5-((3-ethoxypyridin-2-yl)oxy)pyridin-3-yl)-N....(EMEA-00277-PIP01-20) (PDF/178.71 KB) (new)