This is a summary of the European public assessment report (EPAR) for Eurartesim. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eurartesim.
- What is Eurartesim?
Eurartesim is a medicine that contains the active substances piperaquine tetraphosphate and dihydroartemisinin. It is available as tablets (160 mg/20 mg; 320 mg/40 mg).
- What is Eurartesim used for?
Eurartesim is used to treat uncomplicated malaria caused by the Plasmodium falciparum parasite. ‘Uncomplicated’ means the disease does not involve severe, life-threatening symptoms. It can be used in adults and children aged 6 months and over and weighing 5 kg or more.
The medicine can only be obtained with a prescription.
- How is Eurartesim used?
Eurartesim is taken once a day for three consecutive days, at the same time each day, at a dose determined by the patient’s body weight. The tablets are swallowed with water and without food, at least three hours from any meal. The tablets may be crushed and mixed with water if needed.
- How does Eurartesim work?
Malaria is an infectious disease caused by a parasite known as Plasmodium and spread through the bite of an infected mosquito. The active substances in Eurartesim, dihydroartemisinin and piperaquine tetraphosphate are antimalarial agents which kill the P. falciparum parasite. Dihydroartemisinin is a derivative of the naturally occurring substance artemisinin. Although the exact way in which it kills the parasite is not fully understood, it is believed to damage the parasite membrane. Piperaquine tetraphosphate is a a so-called bisquinolone. It is chemically related to other widely available agents used to treat malaria. It is thought to work by blocking a step in the parasite’s metabolism needed for its survival.
- How has Eurartesim been studied?
The effects of Eurartesim were first tested in experimental models before being studied in humans.
Eurartesim was investigated in two main studies in patients with uncomplicated P. falciparum malaria. In the first study, Eurartesim was compared with another antimalarial medicine containing artesunate and mefloquine in 1,150 patients. The main measure of effectiveness was the proportion of patients who were cured 63 days after treatment. In the second study, Eurartesim was compared with another antimalarial medicine containing artemether and lumefantrine in 1,553 children. The main measure of effectiveness was the proportion of patients who were cured 28 days after treatment.
- What benefit has Eurartesim shown during the studies?
Eurartesim was shown to be effective in treating uncomplicated P. falciparum malaria. In the first study, 63 days after treatment 97% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine. In the second study, 28 days after treatment 93% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
- What is the risk associated with Eurartesim?
In adults, the most common side effects with Eurartesim (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), headache, QTc prolongation (an alteration of the electrical activity of the heart, which can cause a life-threatening abnormality of heart rhythm), tachycardia (rapid heartbeat), asthenia (weakness) and pyrexia (fever). In children, the most common side effects with Eurartesim (seen in more than 1 patient in 10) were influenza (flu), cough and pyrexia. For the full list of all side effects reported with Eurartesim, see the package leaflet.
Eurartesim must not be used in patients who are hypersensitive (allergic) to the active substances or any of the other ingredients. It must not be used in patients with severe malaria (which may be life threatening). It must not be used in patients who have or are at risk of QTc interval prolongation or cardiac arrhythmias (unstable heartbeat) due to heart conditions or taking medicines that can affect heart rhythm. Due to this risk of QTc prolongation it is important that Eurartesim is taken without food and at least three hours from any meal. Eurartesim should also not be used during pregnancy if an effective alternative medicine is available. For the full list of restrictions, see the package leaflet.
- Why has Eurartesim been approved?
The CHMP considered that Eurartesim had been shown to be effective in treating uncomplicated P. falciparum malaria while the side effects were similar to those seen with comparable treatments. The CHMP noted the potential risk for QTc interval prolongation, and included restrictions in the product information to minimize the risk to patients. The Committee noted that Eurartesim meets World Health Organization recommendations for P. falciparum malaria treatment by offering a new alternative artemisinin combination therapy containing two active substances which work in different ways. Therefore, the Committee concluded that the benefits of Eurartesim outweigh its risks and recommended that it be granted marketing authorisation.
- What measures are being taken to ensure the safe use of Eurartesim?
The company that markets Eurartesim will provide all doctors expected to prescribe or use Eurartesim with an educational pack containing important safety information on the correct use of the medicine, including a checklist of the medicines that Eurartesim must not be given together with, in order to reduce the risk of QTc interval prolongation.
- Other information about Eurartesim
The European Commission granted a marketing authorisation valid throughout the European Union for Eurartesim on 27 October 2011.
For more information about treatment with Eurartesim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 01/04/2016 .
15/02/2016 Eurartesim -EMEA/H/C/001199 -IAIN/0022/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- 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.
Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, children and infants 6 months and over and weighing 5 kg or more.
Consideration should be given to official guidance on the appropriate use of antimalarial agents.
Changes since initial authorisation of medicine
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|Eurartesim : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||29/05/2012||01/04/2016|
Initial marketing-authorisation documents
This medicine is approved for use in the European Union