Takeda Receives Positive Chmp Opinion Recommending Approval Of Dengue Vaccine Candidate In Eu And Dengue-Endemic Countries
Tak-003 Recommended For The Prevention Of Dengue Disease Caused By Any Dengue Virus Serotype In Individuals Four Years Of Age And Older In The Eu And In Dengue-Endemic Countries Participating In The Eu-M4All ProcedurePositive Opinion For Tak-003 Based On 4.5 Years Of Safety And Efficacy Data From Pivotal Phase 3 Trial Of Over 20,000 Children And Adolescents Across Eight Dengue-Endemic CountriesMarketing Authorization Expected In Coming Months In Europe Followed By Regulatory Decisions In Latin America And Asia Takeda Today Announced That The Committee For Medicinal Products For Human Use (Chmp) Of The European Medicines Agency (Ema) Recommended The Approval Of Takeda
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