Mosquirix: Opinion on medicine for use outside EU
Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)
Table of contents
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)
|
Therapeutic area (MeSH) |
Malaria
|
Anatomical therapeutic chemical (ATC) code |
J07XA01
|
Publication details | |
---|---|
Opinion holder |
Rue de l'institut 89 |
Date of opinion |
23/07/2015
|
Product information
29/07/2021 Mosquirix IB/0058
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Malaria 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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List item
Mosquirix: Procedural steps taken and scientific information after authorisation (PDF/1.73 MB)
First published: 12/02/2018
Last updated: 10/07/2023 -
List item
Mosquirix: All presentations (PDF/30.27 KB)
First published: 01/10/2015 -
List item
Mosquirix: Public assessment report (PDF/4.76 MB)
Adopted
First published: 01/10/2015
EMA/CHMP/439337/2015 -
List item
CHMP summary of positive opinion for Mosquirix (PDF/70.24 KB)
Adopted
First published: 24/07/2015
EMA/CHMP/464758/2015