Mosquirix: Opinion on medicine for use outside EU

Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

Opinion on medicine for use outside the European Union
Positive opinion

Overview

Mosquirix is a vaccine that is given to children aged 6 weeks to 17 months to help protect against malaria caused by the parasite Plasmodium falciparum.

The vaccine should only be used in areas of the world where malaria caused by Plasmodium falciparum is prevalent, and according to official recommendations in those areas. Mosquirix also helps protect against infection of the liver with the hepatitis B virus but should not be used only for this purpose.

Opinion details

Product details
Name of medicinal product
Mosquirix
Agency opinion number
H-W-2300
Opinion status
Positive opinion
Active substance
RTS,S [Portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS), and combined with hepatitis B surface antigen (S)]
International non-proprietary name (INN) or common name
Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)
Anatomical therapeutic chemical (ATC) code
J07
Publication details
Opinion holder

GlaxoSmithKline Biologicals S.A.
Rue de l'institut 89
1330 Rixensart
Belgium

Date of opinion
23/07/2015

Product information

16/01/2020 Mosquirix H-W-2300-II-0043

Contents

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Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunisation of children aged 6 weeks up to 17 months against malaria caused by Plasmodium falciparum and against hepatitis B.

The use of Mosquirix should be based on official recommendations considering Plasmodium falciparum malaria epidemiology in different geographical areas.

Assessment history

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