login
login
Image header Agence Europe
Europe Daily Bulletin No. 13044
Contents Publication in full By article 30 / 33
NEWS BRIEFS / Health

EMA recommends authorisation of a tetravalent dengue vaccine in EU and worldwide

17/10/2022 (Agence Europe)On 13 October, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the authorisation of the live inactivated tetravalent vaccine developed by the Japanese pharmaceutical company Takeda Pharmaceutical to prevent the disease caused by serotypes 1, 2, 3 and 4 of the dengue virus. The vaccine can be given from the age of 4 years. The EMA states that, for the first time, the CHMP is examining a medicinal product simultaneously for the European market, through the centralised procedure, and for marketing in third countries viaEuropean Medicines for All’, a procedure developed with the World Health Organization and based on Article 58 of EC Regulation No. 726/2004, which allows for the accelerated authorisation of high-priority human medicinal products intended for third-country markets. (EV)

Contents

SECTORAL POLICIES
Russian invasion of Ukraine
EXTERNAL ACTION
INSTITUTIONAL
SOCIAL AFFAIRS
ECONOMY - FINANCE - BUSINESS
EU RESPONSE TO COVID-19
FUNDAMENTAL RIGHTS - SOCIETAL ISSUES
NEWS BRIEFS
Kiosk