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Withdrawal of application to change the marketing authorisation for Opdivo (nivolumab) and Yervoy (ipilimumab) (PDF/140.66 KB)

Opdivo (nivolumab) and Yervoy (ipilimumab … Opdivo (nivolumab) and Yervoy (ipilimumab …

Adopted
First published: 28/02/2020
EMA/92336/2020
Bulgarian
(PDF/158.13 KB)

Croatian
(PDF/155.48 KB)

Czech
(PDF/154.32 KB)

Danish
(PDF/132.29 KB)

Dutch
(PDF/132.36 KB)

Estonian
(PDF/129.46 KB)

Finnish
(PDF/130.62 KB)

French
(PDF/133.89 KB)

German
(PDF/134.43 KB)

Greek
(PDF/159.53 KB)

Hungarian
(PDF/155.11 KB)

Italian
(PDF/130.72 KB)

Latvian
(PDF/176.75 KB)

Lithuanian
(PDF/156.58 KB)

Maltese
(PDF/167.55 KB)

Polish
(PDF/154.61 KB)

Portuguese
(PDF/132.66 KB)

Romanian
(PDF/154.53 KB)

Slovak
(PDF/156.57 KB)

Slovenian
(PDF/152.55 KB)

Spanish
(PDF/132.24 KB)

Swedish
(PDF/131.96 KB)
List item

Questions and answers on the refusal of a change to the marketing authorisations for Opdivo (nivolumab) and Yervoy (ipilimumab) (PDF/78.19 KB)

Opdivo (nivolumab) and Yervoy (ipilimumab … Opdivo (nivolumab) and Yervoy (ipilimumab …

Adopted
First published: 27/07/2018
EMA/568014/2018 Rev.1
List item

Questions and answers on positive opinion on the change to the marketing authorisation for Opdivo (nivolumab) and Yervoy (ipilimumab) (PDF/77.43 KB)

Opdivo (nivolumab) and Yervoy (ipilimumab … Opdivo (nivolumab) and Yervoy (ipilimumab …

First published: 16/11/2018
EMA/799169/2018
Bulgarian
(PDF/122.99 KB)

Croatian
(PDF/113.1 KB)

Czech
(PDF/117.8 KB)

Danish
(PDF/99.6 KB)

Dutch
(PDF/100.08 KB)

Estonian
(PDF/98.15 KB)

Finnish
(PDF/99.59 KB)

French
(PDF/100.32 KB)

German
(PDF/100.29 KB)

Greek
(PDF/123.53 KB)

Hungarian
(PDF/114.09 KB)

Italian
(PDF/99.94 KB)

Latvian
(PDF/120.23 KB)

Lithuanian
(PDF/119.11 KB)

Maltese
(PDF/119.38 KB)

Polish
(PDF/118.44 KB)

Portuguese
(PDF/99.73 KB)

Romanian
(PDF/115.87 KB)

Slovak
(PDF/115.97 KB)

Slovenian
(PDF/111.7 KB)

Spanish
(PDF/99.71 KB)

Swedish
(PDF/99.02 KB)
List item

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

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

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

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

Adopted
First published: 06/08/2012
Last updated: 06/08/2012
EMA/405297/2012
List item

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

Adopted
First published: 06/08/2012
Last updated: 06/08/2012
EMA/405302/2012
List item

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) in … granting of a deferral for ipilimumab (EMEA-000117-PIP02-10) in … paediatric investigation plan for ipilimumab, concentrate for solution …

Adopted
First published: 13/07/2011
Last updated: 13/07/2011
EMA/426558/2011
List item

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, solution for infusion, intravenous …

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

Adopted
First published: 20/03/2017
Last updated: 20/03/2017
EMA/7963/2017
List item

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-PIP02-10-M06 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M06 … 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-PIP01-07-M07 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M07 … paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M07 …

First published: 15/06/2015
Last updated: 15/06/2015
EMA/215073/2015
List item

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

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

Adopted
First published: 30/11/2011
Last updated: 30/11/2011
EMA/848187/2011
List item

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, solution for infusion, intravenous …

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

Yervoy-H-C-2213-II-0055 : EPAR - Assessment Report - Variation (PDF/8.63 MB)

Yervoy, INN-ipilimumab 30 Churchill Place … International non-proprietary name: ipilimumab Procedure No. EMEA/H/C/002213/II/0055 …

Adopted
First published: 05/06/2018
Last updated: 05/06/2018
EMA/291536/2018
List item

Tafinlar -H-C-WS-1274: EPAR - Assessment Report - Variation (PDF/4.23 MB)

Adopted
First published: 11/09/2018
Last updated: 11/09/2018
EMA/550929/2019
List item

Mekinist-H-C-2643-WS-1274 : EPAR - Assessment Report - Variation (PDF/4.24 MB)

Adopted
First published: 07/09/2018
Last updated: 07/09/2018
EMA/550929/2019
List item

Yervoy-H-C-002213-II-0044 : EPAR - Assessment Report - Variation (PDF/5.05 MB)

Yervoy, INN-ipilimumab 30 Churchill Place … International non-proprietary name: ipilimumab Procedure No. EMEA/H/C/002213/II/0044 …

Adopted
First published: 29/01/2018
Last updated: 29/01/2018
EMA/6592/2018
List item

Agenda - CHMP agenda of the 20-23 August 2018 written procedure (PDF/441.42 KB)

Draft
First published: 04/09/2018
Last updated: 04/09/2018
EMA/CHMP/565731/2018 Rev. 1
List item

Yervoy-H-C-2213-P46-034.1 : EPAR - Assessment Report (PDF/3.08 MB)

Yervoy, INN-ipilimumab 30 Churchill Place … 1901/2006 Yervoy ipilimumab Procedure no: EMEA/H/C/002213/P46/034.1 … CA184178 (“A phase 2 study of ipilimumab in children and adolescents …

First published: 28/09/2017
Last updated: 28/09/2017
EMA/CHMP/513045/2017
List item

Yervoy-H-C-PSUSA-00009200-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/70.06 KB)

Yervoy, INN-ipilimumab 30 Churchill Place … Active substance(s): ipilimumab Procedure No. EMEA/H/C/PSUSA/00009200/201703 … Assessment Report on the PSUR for ipilimumab, the scientific conclusions …

First published: 12/01/2018
Last updated: 12/01/2018
EMA/23883/2018
List item

Withdrawal assessment report for: Balimek (binimetinib) (PDF/2.85 MB)

First published: 27/03/2018
Last updated: 27/03/2018
EMA/CHMP/86716/2018
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

275 results

Withdrawal of application to change the marketing authorisation for Opdivo (nivolumab) and Yervoy (ipilimumab) (PDF/140.66 KB)

Questions and answers on the refusal of a change to the marketing authorisations for Opdivo (nivolumab) and Yervoy (ipilimumab) (PDF/78.19 KB)

Questions and answers on positive opinion on the change to the marketing authorisation for Opdivo (nivolumab) and Yervoy (ipilimumab) (PDF/77.43 KB)

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)

Yervoy-H-C-2213-II-0055 : EPAR - Assessment Report - Variation (PDF/8.63 MB)

Tafinlar -H-C-WS-1274: EPAR - Assessment Report - Variation (PDF/4.23 MB)

Mekinist-H-C-2643-WS-1274 : EPAR - Assessment Report - Variation (PDF/4.24 MB)

Yervoy-H-C-002213-II-0044 : EPAR - Assessment Report - Variation (PDF/5.05 MB)

Agenda - CHMP agenda of the 20-23 August 2018 written procedure (PDF/441.42 KB)

Yervoy-H-C-2213-P46-034.1 : EPAR - Assessment Report (PDF/3.08 MB)

Yervoy-H-C-PSUSA-00009200-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/70.06 KB)

Withdrawal assessment report for: Balimek (binimetinib) (PDF/2.85 MB)

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