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P/0093/2014: EMA decision of 7 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-10-M03) (PDF/97.2 KB)

paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-1 … paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-1 … paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-10-M03 …

Adopted
First published: 14/05/2014
Last updated: 14/05/2014
EMA/186565/2014
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P/0092/2014: EMA decision of 7 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M06) (PDF/91.85 KB)

paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M06 …

Adopted
First published: 14/05/2014
Last updated: 14/05/2014
EMA/186334/2014
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P/0195/2013: EMA decision of 2 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-07-M05) (PDF/152.09 KB)

paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-0 … paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-0 … paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-07-M05 …

Adopted
First published: 08/10/2013
Last updated: 08/10/2013
EMA/456074/2013
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P/0116/2012: EMA decisionof 2 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M02) (PDF/147.33 KB)

paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M02 …

Adopted
First published: 06/08/2012
Last updated: 06/08/2012
EMA/405297/2012
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P/0115/2012: EMA decision of 2 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M04) (PDF/145.87 KB)

paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M04) 7 …

Adopted
First published: 06/08/2012
Last updated: 06/08/2012
EMA/405302/2012
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P/128/2011: EMA descision of 8 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for ipilimumab (EMEA-000117-PIP02-10) (PDF/143.77 KB)

granting of a deferral for ipilimumab (EMEA-000117-PIP02-10 … granting of a deferral for ipilimumab (EMEA-000117-PIP02-10 … granting of a deferral for ipilimumab (EMEA-000117-PIP02-10) in …

Adopted
First published: 13/07/2011
Last updated: 13/07/2011
EMA/426558/2011
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P/151/2011: EMA decision of 10 June 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M02) (PDF/141.85 KB)

paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M02 … paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M02 … paediatric investigation plan for ipilimumab (EMEA- 000117-PIP01-07-M02 …

Adopted
First published: 13/07/2011
Last updated: 13/07/2011
EMA/440862/2011
List item

P/0003/2017: EMA decision of 12 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M07) (PDF/83.8 KB)

paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M07 …

Adopted
First published: 20/03/2017
Last updated: 20/03/2017
EMA/7963/2017
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P/0162/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M06) (PDF/100.97 KB)

paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M06 …

Adopted
First published: 24/08/2015
Last updated: 24/08/2015
EMA/446651/2015
List item

P/0085/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M07) (PDF/93.21 KB)

paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M07 …

First published: 15/06/2015
Last updated: 15/06/2015
EMA/215073/2015
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P/265/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-10-M01) (PDF/147.27 KB)

paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02 … paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-1 … paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-10-M01 …

Adopted
First published: 30/11/2011
Last updated: 30/11/2011
EMA/849026/2011
List item

P/264/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-07-M03) (PDF/144.83 KB)

paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01 … paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-0 … paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-07-M03 …

Adopted
First published: 30/11/2011
Last updated: 30/11/2011
EMA/848187/2011
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P/92/2010: European medicines agency decision of 2 June 2010 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M01) in accordance with Regulation (EC) No... (PDF/109.34 KB)

paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M01 … paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M01 … paediatric investigation plan for ipilimumab (EMEA- 000117-PIP01-07-M01 …

Adopted
First published: 07/01/2009
Last updated: 28/07/2010
EMA/337445/2010
List item

News: European Medicines Agency increases transparency of ongoing applications for human medicines

PRAC, Last updated: 07/11/2012
List item

Press release: Meeting highlights from the Paediatric Committee: 17 - 19 September 2008

PDCO, Last updated: 28/09/2008

area of haematology; Ipilimumab, from Bristol-Myers Squibb …
List item

List of signals discussed at PRAC since September 2012 (XLSX/175.02 KB) (updated)

Adopted
First published: 08/07/2019
Last updated: 06/01/2021
EMA/PRAC/530804/2013
List item

PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC meeting (PDF/290.5 KB) (updated)

Adopted
First published: 23/11/2020
Last updated: 05/01/2021
EMA/PRAC/570588/2020 Corr.
List item

Agenda - Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients (PDF/734.71 KB)

Nivolumab 12.10 – 12.30: Ipilimumab 12.30: Lunch Session … brentuximab bendamutisne, ipilimumab • Avelumab and standard … Inhibitors CTLA-4 • Ipilimumab and nivolumab • Tremelimumab …

Draft
First published: 19/04/2018
Last updated: 30/08/2018
EMA/242738/2018
List item

Agenda - PRAC draft agenda of meeting 11-14 June 2018 (PDF/633.11 KB)

Draft
First published: 11/06/2018
Last updated: 11/06/2018
EMA/PRAC/395628/2018
List item

Agenda - PRAC draft agenda of meeting 9-12 April 2018 (PDF/629.15 KB)

Draft
First published: 09/04/2018
Last updated: 09/04/2018
EMA/223357/2018
List item

Agenda - PRAC draft agenda of meeting 29 August-1 September 2017 (PDF/790.2 KB)

Draft
First published: 29/08/2017
Last updated: 29/08/2017
EMA/PRAC/568796/2017
List item

P/0049/2018: EMA decision of 22 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo), (EMEA-001407-PIP01-12-M01) (PDF/147.96 KB)

nivolumab in combination with ipilimumab in paediatric patients from …

Adopted
First published: 18/04/2018
Last updated: 18/04/2018
EMA/101776/2018
List item

Minutes of the PRAC meeting 11-14 June 2018 (PDF/624.07 KB)

Adopted
First published: 10/08/2018
Last updated: 10/08/2018
EMA/PRAC/400242/2018
List item

Agenda - PRAC draft agenda of meeting 9-12 July 2018 (PDF/729.91 KB)

Draft
First published: 09/07/2018
Last updated: 09/07/2018
EMA/PRAC/470871/2018
List item

Minutes of the PRAC meeting 14-17 May 2018 (PDF/884.63 KB)

Adopted
First published: 09/07/2018
Last updated: 09/07/2018
EMA/PRAC/394603/2018

129 results

P/0093/2014: EMA decision of 7 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-10-M03) (PDF/97.2 KB)

P/0092/2014: EMA decision of 7 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M06) (PDF/91.85 KB)

P/0195/2013: EMA decision of 2 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-07-M05) (PDF/152.09 KB)

P/0116/2012: EMA decisionof 2 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M02) (PDF/147.33 KB)

P/0115/2012: EMA decision of 2 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M04) (PDF/145.87 KB)

P/128/2011: EMA descision of 8 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for ipilimumab (EMEA-000117-PIP02-10) (PDF/143.77 KB)

P/151/2011: EMA decision of 10 June 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M02) (PDF/141.85 KB)

P/0003/2017: EMA decision of 12 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M07) (PDF/83.8 KB)

P/0162/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M06) (PDF/100.97 KB)

P/0085/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M07) (PDF/93.21 KB)

P/265/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-10-M01) (PDF/147.27 KB)

P/264/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-07-M03) (PDF/144.83 KB)

P/92/2010: European medicines agency decision of 2 June 2010 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M01) in accordance with Regulation (EC) No... (PDF/109.34 KB)

News: European Medicines Agency increases transparency of ongoing applications for human medicines

Press release: Meeting highlights from the Paediatric Committee: 17 - 19 September 2008

List of signals discussed at PRAC since September 2012 (XLSX/175.02 KB) (updated)

PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC meeting (PDF/290.5 KB) (updated)

Agenda - Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients (PDF/734.71 KB)

Agenda - PRAC draft agenda of meeting 11-14 June 2018 (PDF/633.11 KB)

Agenda - PRAC draft agenda of meeting 9-12 April 2018 (PDF/629.15 KB)

Agenda - PRAC draft agenda of meeting 29 August-1 September 2017 (PDF/790.2 KB)

P/0049/2018: EMA decision of 22 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo), (EMEA-001407-PIP01-12-M01) (PDF/147.96 KB)

Minutes of the PRAC meeting 11-14 June 2018 (PDF/624.07 KB)

Agenda - PRAC draft agenda of meeting 9-12 July 2018 (PDF/729.91 KB)

Minutes of the PRAC meeting 14-17 May 2018 (PDF/884.63 KB)