Pyramax H-W-2319
| Name of the medicinal product | Pyramax |
| Opinion holder | Shin Poong Pharmaceutical Co., Ltd. 748-31 Yoksam-Dong Gangnam-Gu Seoul 135-925 Korea |
| Active substance | pyronaridine / artesunate |
| International non-proprietary name or common name | pyronaridine / artesunate |
| Pharmaco-therapeutic group | Antimalarial |
| ATC code | P01BF06 |
| Therapeutic indication | For tablets and granules combined: Pyramax tablets are indicated in the treatment of acute, uncomplicated malaria infection caused by Plasmodium falciparum or by Plasmodium vivax in adults and children weighing 20 kg or more. Pyramax Granules for oral suspension are indicated in the treatment of acute, uncomplicated malaria infection caused by Plasmodium falciparum or by Plasmodium vivax in children and infants weighing 5 kg to under 20 kg. Consideration should be given to official guidance on the appropriate use of antimalarial agents (see section 4.4). |
| Orphan medicinal product designation date | Not applicable |
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CHMP post-authorisation summary of positive opinion for Pyramax (PDF/70.65 KB)
Adopted
First published: 20/11/2015
Last updated: 20/11/2015
EMA/CHMP/719685/2015 -
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Pyramax: Summary for the public (PDF/110.02 KB)
First published: 29/06/2012
Last updated: 05/02/2016
EMA/436440/2012 -
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Pyramax: All authorised presentations (PDF/18.34 KB)
First published: 29/06/2012
Last updated: 05/02/2016 -
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Pyramax: Public Assessment Report (PDF/998.65 KB)
Adopted
First published: 29/06/2012
Last updated: 29/06/2012
EMA/CHMP/61768/2012 -
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Pyramax: Procedural steps taken and scientific information after the authorisation (PDF/117.07 KB)
First published: 18/06/2014
Last updated: 07/11/2017 -
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Pyramax-H-W-2319-II-0002 : Assessment report (PDF/1.79 MB)
Adopted
First published: 05/02/2016
Last updated: 05/02/2016
EMA/15394/2016 -
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Pyramax-H-W-2319-X-0008-G : Assessment report - Extension (PDF/2 MB)
Adopted
First published: 05/02/2016
Last updated: 05/02/2016
EMA/813257/2015 -
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CHMP summary of positive opinion for Pyramax (PDF/52.02 KB)
Adopted
First published: 17/02/2012
Last updated: 17/02/2012
EMA/CHMP/95965/2012
*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.
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