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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) EMA/568014/2018 Rev.1Adopted … 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) Other languages: bg cs da … 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)
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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-PIP02-10-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
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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-PIP01-07-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
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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-PIP01-07-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
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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-PIP01-07-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
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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) 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

Press release: New treatment option recommended for patients with advanced melanoma

CHMP, Last updated: 22/05/2015

other comparing Keytruda with ipilimumab, another melanoma treatment … had not previously received ipilimumab and in patients who had previously … had previously received ipilimumab. The Committee also looked …
List item

Press release: European Medicines Agency recommends approval of Tafinlar for the treatment of metastatic melanoma

CHMP, Last updated: 28/06/2013

them, the monoclonal antibody ipilimumab, targets a molecule found … them, the monoclonal antibody ipilimumab, targets a molecule found …
List item

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

CHMP, Last updated: 27/07/2018

ipilimumab) in combination to treat …
List item

Press release: European Medicines Agency recommends approval of Mekinist for the treatment of melanoma

CHMP, Last updated: 25/04/2014

a monoclonal antibody (ipilimumab) that targets a molecule … including a monoclonal antibody (ipilimumab) that targets a molecule …
List item

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018

CHMP, Last updated: 16/11/2018

ipilimumab) in combination to treat …
List item

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018

CHMP, Last updated: 21/09/2018

ipilimumab) have requested re-examination …
List item

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2018

CHMP, Last updated: 27/04/2018

Name of medicine Yervoy INN ipilimumab Marketing-authorisation holder …
List item

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2017

CHMP, Last updated: 15/12/2017

Name of medicine Yervoy INN ipilimumab Marketing-authorisation holder …
List item

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013

CHMP, Last updated: 20/09/2013

Yervoy INN ipilimumab Marketing-authorisation holder …
List item

Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2011

CHMP, Last updated: 20/05/2011

210 days. • Yervoy (ipilimumab), from Bristol-Myers Squibb … ipilimumab), from Bristol-Myers Squibb …

192 results

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)

Press release: New treatment option recommended for patients with advanced melanoma

Press release: European Medicines Agency recommends approval of Tafinlar for the treatment of metastatic melanoma

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

Press release: European Medicines Agency recommends approval of Mekinist for the treatment of melanoma

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2018

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2017

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013

Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2011