Mosquirix H-W-2300
Name of the medicinal product | Mosquirix |
Opinion holder | GlaxoSmithKline Biologicals S.A. Rue de l'institut 89 1330 Rixensart Belgium |
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 or common name | Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted) |
Pharmaco-therapeutic group | Vaccines |
ATC code | |
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. |
Orphan medicinal product designation date | Not applicable |
Revision | 4 |
-
List item
Mosquirix: Summary for the public (PDF/77.71 KB)
First published: 01/10/2015
Last updated: 01/10/2015
EMA/518713/2015 -
List item
Mosquirix : Procedural steps taken and scientific information after authorisation (PDF/171.25 KB)
First published: 12/02/2018
Last updated: 31/07/2020 -
List item
Mosquirix: Risk-management-plan summary (PDF/208.46 KB)
First published: 01/10/2015
Last updated: 31/07/2020 -
List item
Mosquirix: All authorised presentations (PDF/30.27 KB)
First published: 01/10/2015
Last updated: 01/10/2015 -
List item
Mosquirix: Public Assessment Report (PDF/4.76 MB)
Adopted
First published: 01/10/2015
Last updated: 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
Last updated: 24/07/2015
EMA/CHMP/464758/2015
*This document includes:
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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.