Pyramax H-W-2319

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Name of the medicinal productPyramax
Opinion holderShin Poong Pharmaceutical Co., Ltd.
748-31 Yoksam-Dong
Gangnam-Gu
Seoul 135-925
Korea
Active substancepyronaridine / artesunate
International non-proprietary name or common namepyronaridine / artesunate
Pharmaco-therapeutic groupAntimalarial
ATC codeP01BF06
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 dateNot applicable

 

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Document(s) Language Status First published Last updated Effective Date
CHMP post-authorisation summary of positive opinion for Pyramax (English only) adopted 2015-11-20    
Pyramax: Summary for the public (English only)   2012-06-29 2016-02-05  
Pyramax: All authorised presentations (English only)   2012-06-29 2016-02-05  
Pyramax: Public Assessment Report (English only) adopted 2012-06-29    
Pyramax: Procedural steps taken and scientific information after the authorisation (English only)   2014-06-18 2017-11-07  
Pyramax-H-W-2319-II-0002 : Assessment report (English only) adopted 2016-02-05    
Pyramax-H-W-2319-X-0008-G : Assessment report - Extension (English only) adopted 2016-02-05    
CHMP summary of positive opinion for Pyramax (English only) adopted 2012-02-17    

Product Information* 13/07/2017 Pyramax-H-W-2319 - II/0015

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Document(s) Language Status First published Last updated Effective Date
Pyramax: Product information (English only)   2012-06-29 2017-11-07  

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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.
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