Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Alfasigma S.p.A., Via Ragazzi del '99, n. 5, 40133 Bologna, Italy Tel: +39 051 6489602 Fax: +39 051 388689 Email: antonietta.pazardjiklian@alfasigma.com
Eurartesim 320 mg/40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). White oblong biconvex film-coated tablet (dimension 16x8mm/thickness 5.5mm) with a break-line and marked on one side with two “σ” letters. The tablet can be divided into equal doses. |
Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 40 mg artenimol (artenimol).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Artenimol |
Artenimol is an artemisinin derivative and antimalarial agent used in the treatment of uncomplicated Plasmodium falciparum infections. Artemisinin combination therapy is highly effective against malaria. |
|
| Artenimol and Piperaquine |
Artenimol is able to reach high concentrations within the parasitized erythrocytes. Its endoperoxide bridge is thought to be essential for its antimalarial activity, causing free-radical damage to parasite membrane systems. The exact mechanism of action of piperaquine is unknown, but it likely mirrors that of chloroquine, a close structural analogue. Piperaquine is a bisquinoline, and this class has shown good antimalarial activity against chloroquineresistant Plasmodium strains in vitro. |
|
| Piperaquine |
|
| List of Excipients |
|---|
|
Tablet core: Pre-gelatinised starch Film coating: Hypromellose (E464) |
Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9, 12, 270 or 300 tablets.
Alfasigma S.p.A., Via Ragazzi del '99, n. 5, 40133 Bologna, Italy
Tel: +39 051 6489602
Fax: +39 051 388689
Email: antonietta.pazardjiklian@alfasigma.com
EU/1/11/716/001
EU/1/11/716/002
EU/1/11/716/003
EU/1/11/716/004
EU/1/11/716/006
EU/1/11/716/007
Date of first authorisation: 27 October 2011
Date of latest renewal: 09 September 2016
| Drug | Countries | |
|---|---|---|
| EURARTESIM | Austria, Cyprus, Estonia, Spain, France, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom |
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