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 |
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Mosquirix: Summary for the public (PDF/77.71 KB)
First published: 01/10/2015
Last updated: 01/10/2015
EMA/518713/2015 -
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Mosquirix : Procedural steps taken and scientific information after authorisation (PDF/171.25 KB)
First published: 12/02/2018
Last updated: 31/07/2020 -
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Mosquirix: Risk-management-plan summary (PDF/208.46 KB)
First published: 01/10/2015
Last updated: 31/07/2020 -
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Mosquirix: All authorised presentations (PDF/30.27 KB)
First published: 01/10/2015
Last updated: 01/10/2015 -
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Mosquirix: Public Assessment Report (PDF/4.76 MB)
Adopted
First published: 01/10/2015
Last updated: 01/10/2015
EMA/CHMP/439337/2015 -
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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
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