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Summary of opinion: Opdivo (new)
nivolumab, opinion date: 25/05/2023, Positive, Last updated: 26/05/2023the first‑line treatment of adult patients with unresectable … indicated for the treatment of advanced renal cell carcinoma … the first‑line treatment of adult patients with intermediate/poor‑risk … -
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Summary of opinion: Sohonos (updated)
palovarotene, opinion date: 26/01/2023, Negative, Last updated: 26/05/2023palovarotene Opinion Re-examination confirms refusal … re-examining its initial opinion, the European Medicines Agency … intended for the treatment of fibrodysplasia ossificans … -
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Summary of opinion: Lagevrio
molnupiravir, opinion date: 23/02/2023, Negative, Last updated: 13/03/2023has requested a A review of an opinion by a scientific committee of the Agency, triggered at … triggered at the request of the applicant. re-examination … Official address Domenico Scarlattilaan … -
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Summary of opinion: Omblastys
iodine (131I) omburtamab, opinion date: 15/12/2022, Negative, Last updated: 16/12/2022iodine (131I) omburtamab Opinion The European Medicines Agency … has recommended the refusal of the The approval to market … intended for the treatment of neuroblastoma, a rare cancer … -
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Summary of opinion: Tidhesco
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 26/04/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Use (CHMP) Update as of 26 April 2023: The applicant … -
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Summary of opinion: Lacosamide Adroiq
lacosamide, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Tolvaptan Accord
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Ztalmy (new)
ganaxolone, opinion date: 26/05/2023, Positive, Last updated: 26/05/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Arexvy
recombinant, adjuvanted, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023Official address Domenico Scarlattilaan … 0)88 781 6000 An agency of the European Union © … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Lytgobi
futibatinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Vegzelma
bevacizumab, opinion date: 23/06/2022, Positive, Last updated: 21/06/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Xofluza
baloxavir marboxil, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Lonquex
lipegfilgrastim, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Orkambi
lumacaftor, ivacaftor, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Xydalba
dalbavancin, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Fintepla
fenfluramine, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Adcirca (previously Tadalafil Lilly)
tadalafil, opinion date: 16/12/2022, Positive, Last updated: 16/12/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Kerendia
finerenone, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022Official address Domenico Scarlattilaan … 0)88 781 6000 An agency of the European Union © … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Trecondi
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Zerbaxa
ceftolozane, tazobactam, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary … -
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Summary of opinion: Imfinzi
durvalumab, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … Products for Human Use (CHMP) Summary …