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Summary of opinion: Comirnaty
tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 19/10/2022, Positive, Last updated: 19/10/2022Official 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: Esbriet (new)
pirfenidone, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023pirfenidone Opinion On 23 February 2023, the … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Dapagliflozin Viatris
dapagliflozin, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023adults for the treatment of chronic kidney disease. Detailed … recommendations for the use of this product will be described … describing the properties and the officially approved conditions … -
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Summary of opinion: Tidhesco (new)
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023ivosidenib Opinion On 23 February 2023, the … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Bekemv (new)
eculizumab, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023eculizumab Opinion On 23 February 2023, the … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Elfabrio (new)
pegunigalsidase alfa, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … CHMP ) adopted a positive opinion, recommending the granting … -
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Summary of opinion: Pombiliti
cipaglucosidase alfa, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022cipaglucosidase alfa Opinion On 15 December 2022, the … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Sotyktu
deucravacitinib, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023deucravacitinib Opinion On 26 January 2023, the The … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Akeega (new)
niraparib, abiraterone acetate, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023substance or combination of substances that is intended … containing fixed-dose combinations of 50 mg niraparib / 500 mg … responsible for the activity of a medicine. active substances … -
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Summary of opinion: Tremelimumab AstraZeneca
tremelimumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022tremelimumab Opinion On 15 December 2022, the … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Opzelura (new)
ruxolitinib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023ruxolitinib Opinion On 23 February 2023, the … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Wakix
pitolisant, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023for the treatment of narcolepsy with or without … recommendations for the use of this product will be described … describing the properties and the officially approved conditions … -
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Summary of opinion: Trecondi
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023recommendations for the use of this product will be described … describing the properties and the officially approved conditions of use of a medicine … Official address Domenico Scarlattilaan … -
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Summary of opinion: Tibsovo (new)
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023ivosidenib Opinion On 23 February 2023, the … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023ptin metformin hydrochloride Opinion On 26 January 2023, the The … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Hyftor (new)
sirolimus, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023sirolimus Opinion On 23 February 2023, the … for preparing the Agency's opinions on questions concerning human … for preparing the Agency's opinions on questions concerning human … -
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Summary of opinion: Lagevrio (updated)
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: Sohonos
palovarotene, opinion date: 26/01/2023, Negative, Last updated: 13/02/2023has 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: 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: 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: Vafseo (new)
vadadustat, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023Official 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: 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 …