Pyramax: Opinion on medicine for use outside EU
artesunate / pyronaridine
Table of contents
Pyramax is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate. It is available as tablets (180 mg/60 mg) and as granules (60 mg/20 mg in each sachet).
Pyramax is used to treat uncomplicated malaria, caused by two types of malaria parasites, Plasmodium falciparum and Plasmodium vivax. ‘Uncomplicated’ means the disease does not involve severe, life-threatening symptoms. Pyramax tablets are used for adults and children weighing 20 kg or more and the granules are used for babies and children weighing between 5 and 20 kg.
The medicine can only be obtained with a prescription.
|Name of medicinal product||
|Agency opinion number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Shin Poong Pharmaceutical Co., Ltd.
|Date of opinion||
15/06/2022 Pyramax IB/0029/G
- 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.
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.
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CHMP summary of opinion for Pyramax (PDF/52.02 KB)Adopted
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