EURARTESIM Film-coated tablet Ref.[10713] Active ingredients: Artenimol Artenimol and Piperaquine Piperaquine

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

Product name and form

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.

Qualitative and quantitative composition

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
Dextrin
Hypromellose (E464)
Croscarmellose sodium
Magnesium stearate (E572)

Film coating:

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 400

Pack sizes and marketing

Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9, 12, 270 or 300 tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

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

Drugs

Drug Countries
EURARTESIM Austria, Cyprus, Estonia, Spain, France, Ireland, Lithuania, Netherlands, Poland, United Kingdom

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