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Agenda - CAT agenda of the 19-21 January 2021 meeting (PDF/401.65 KB) (new)

Draft
First published: 20/01/2022
EMA/CAT/778538/2021
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Committee for Advanced Therapies (CAT): 19-21 January 2022 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 19/01/2022 to 21/01/2022, Last updated: 20/01/2022
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EU/3/16/1751: Public summary of positive opinion for orphan designation of fenretinide for the treatment of peripheral T-cell lymphoma (PDF/186.65 KB) (updated)

Adopted
First published: 15/11/2016
Last updated: 19/01/2022
EMA/622420/2016
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Management Board meeting: 7 October 2021 (updated)

European Medicines Agency, Amsterdam, the Netherlands, 07/10/2021, Last updated: 18/01/2022
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Minutes of the 113th meeting of the Management Board: 7 October 2021 (PDF/223.54 KB) (new)

Adopted
First published: 18/01/2022
EMA/MB/571618/2021
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Agenda - PDCO agenda of the 18-21 January 2022 meeting (PDF/383.97 KB) (new)

Draft
First published: 18/01/2022
EMA/PDCO/5821/2022
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P/0340/2021: EMA decision of 9 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bumetanide (EMEA-001303-PIP01-12-M04) (PDF/272.8 KB) (new)

Adopted
First published: 18/01/2022
EMA/439409/2021
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P/0160/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides pteronyssinus / dermatophagoides farinae (Acarizax and associated names), (EMEA-001258-PIP01-11- M07) (PDF/213.11 KB) (new)

Adopted
First published: 18/01/2022
EMA/190398/2021
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P/0154/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Orbactiv), (EMEA-001270-PIP01-12-M03) (PDF/242.04 KB) (new)

Adopted
First published: 18/01/2022
EMA/191215/2021
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P/0170/2021: EMA decision of 9 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bumetanide (EMEA-001303-PIP01-12-M03) (PDF/205.06 KB) (new)

Adopted
First published: 18/01/2022
EMA/193109/2021
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P/0134/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed PIP for citric acid / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate / potassium chloride (Clensia) (PDF/234.01 KB) (new)

Adopted
First published: 18/01/2022
EMA/150427/2021
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P/0133/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP02-13-M01) (PDF/200.23 KB) (new)

Adopted
First published: 18/01/2022
EMA/150638/2021
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P/0177/2021: EMA decision of 12 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine (Pifeltro), (EMEA-001676-PIP01-14-M04) (PDF/248.09 KB) (new)

Adopted
First published: 18/01/2022
EMA/193122/2021
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P/0176/2021: EMA decision of 12 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine / lamivudine / tenofovir disoproxil (fumarate) (Delstrigo), (EMEA-001695-PIP01-14-M04) (PDF/222.31 KB) (new)

Adopted
First published: 18/01/2022
EMA/193126/2021
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P/0132/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for defatted powder of peanuts (PALFORZIA), (EMEA-001734-PIP01-14-M05) (PDF/217.43 KB) (new)

Adopted
First published: 18/01/2022
EMA/150640/2021
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P/0167/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M04) (PDF/197.15 KB) (new)

Adopted
First published: 18/01/2022
EMA/192367/2021
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P/0166/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP04-17-M02) (PDF/245.89 KB) (new)

Adopted
First published: 18/01/2022
EMA/192364/2021
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P/0131/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for volanesorsen (Waylivra), (EMEA-001915-PIP01-15-M03) (PDF/221.98 KB) (new)

Adopted
First published: 18/01/2022
EMA/150641/2021
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P/0152/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (EMEA- 001949-PIP01-16-M04) (PDF/210.03 KB) (new)

Adopted
First published: 18/01/2022
EMA/152078/2021
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P/0151/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol, (EMEA- 001949-PIP02-18-M01) (PDF/207.8 KB) (new)

Adopted
First published: 18/01/2022
EMA/152075/2021
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P/0168/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bimekizumab (EMEA-002189-PIP01-17-M02) (PDF/209.72 KB) (new)

Adopted
First published: 18/01/2022
EMA/192377/2021
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P/0169/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dienogest / ethinyl estradiol (EMEA-002229-PIP01-17-M02) (PDF/196.04 KB) (new)

Adopted
First published: 18/01/2022
EMA/192380/2021
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P/0171/2021: EMA decision of 9 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ganaxolone ,(EMEA- 002341-PIP01-18-M01) (PDF/195.21 KB) (new)

Adopted
First published: 18/01/2022
EMA/197408/2021
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P/0148/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for valoctocogene roxaparvovec, (EMEA-002427-PIP01-18-M01) (PDF/194.67 KB) (new)

Adopted
First published: 18/01/2022
EMA/152079/2021
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P/0178/2021: EMA decision of 19 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for spesolimab (EMEA-002475-PIP02-19-M01) (PDF/210.02 KB) (new)

Adopted
First published: 18/01/2022
EMA/212135/2021

7121 results

Agenda - CAT agenda of the 19-21 January 2021 meeting (PDF/401.65 KB) (new)

Committee for Advanced Therapies (CAT): 19-21 January 2022 (updated)

EU/3/16/1751: Public summary of positive opinion for orphan designation of fenretinide for the treatment of peripheral T-cell lymphoma (PDF/186.65 KB) (updated)

Management Board meeting: 7 October 2021 (updated)

Minutes of the 113th meeting of the Management Board: 7 October 2021 (PDF/223.54 KB) (new)

Agenda - PDCO agenda of the 18-21 January 2022 meeting (PDF/383.97 KB) (new)

P/0340/2021: EMA decision of 9 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bumetanide (EMEA-001303-PIP01-12-M04) (PDF/272.8 KB) (new)

P/0160/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides pteronyssinus / dermatophagoides farinae (Acarizax and associated names), (EMEA-001258-PIP01-11- M07) (PDF/213.11 KB) (new)

P/0154/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Orbactiv), (EMEA-001270-PIP01-12-M03) (PDF/242.04 KB) (new)

P/0170/2021: EMA decision of 9 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bumetanide (EMEA-001303-PIP01-12-M03) (PDF/205.06 KB) (new)

P/0134/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed PIP for citric acid / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate / potassium chloride (Clensia) (PDF/234.01 KB) (new)

P/0133/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP02-13-M01) (PDF/200.23 KB) (new)

P/0177/2021: EMA decision of 12 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine (Pifeltro), (EMEA-001676-PIP01-14-M04) (PDF/248.09 KB) (new)

P/0176/2021: EMA decision of 12 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine / lamivudine / tenofovir disoproxil (fumarate) (Delstrigo), (EMEA-001695-PIP01-14-M04) (PDF/222.31 KB) (new)

P/0132/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for defatted powder of peanuts (PALFORZIA), (EMEA-001734-PIP01-14-M05) (PDF/217.43 KB) (new)

P/0167/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M04) (PDF/197.15 KB) (new)

P/0166/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP04-17-M02) (PDF/245.89 KB) (new)

P/0131/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for volanesorsen (Waylivra), (EMEA-001915-PIP01-15-M03) (PDF/221.98 KB) (new)

P/0152/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (EMEA- 001949-PIP01-16-M04) (PDF/210.03 KB) (new)

P/0151/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol, (EMEA- 001949-PIP02-18-M01) (PDF/207.8 KB) (new)

P/0168/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bimekizumab (EMEA-002189-PIP01-17-M02) (PDF/209.72 KB) (new)

P/0169/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dienogest / ethinyl estradiol (EMEA-002229-PIP01-17-M02) (PDF/196.04 KB) (new)

P/0171/2021: EMA decision of 9 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ganaxolone ,(EMEA- 002341-PIP01-18-M01) (PDF/195.21 KB) (new)

P/0148/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for valoctocogene roxaparvovec, (EMEA-002427-PIP01-18-M01) (PDF/194.67 KB) (new)

P/0178/2021: EMA decision of 19 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for spesolimab (EMEA-002475-PIP02-19-M01) (PDF/210.02 KB) (new)