Mosquirix H-W-2300

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Name of the medicinal productMosquirix
Opinion holderGlaxoSmithKline Biologicals S.A.
Rue de l'institut 89
1330 Rixensart
Belgium
Active substanceRTS,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 groupVaccines
ATC code 
Therapeutic indicationActive 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 dateNot applicable

 

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Document(s) Language Status First published Last updated Effective Date
Mosquirix: Summary for the public (English only)   2015-10-01    
Mosquirix: EPAR - Risk-management-plan summary (English only)   2015-10-01    
Mosquirix: All authorised presentations (English only)   2015-10-01    
Mosquirix: Public Assessment Report (English only) adopted 2015-10-01    
CHMP summary of positive opinion for Mosquirix (English only) adopted 2015-07-24    

Product Information* 23/07/2015 Mosquirix-H-W-2300

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Document(s) Language Status First published Last updated Effective Date
Mosquirix: Product information (English only)   2015-10-01    

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*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.