Malacef® 60, artesunate 60 mg

  • Product

    Malacef 60, artesunate 60 mg, powder and solvent for solution for injection (i.v.)

  • Authorisation

    Orphan Drug Designation EU/3/07/430 (2007)

  • Active ingredient

    Artesunate 60 mg

  • Indication

    Severe or complicated malaria (hospital treatment), caused by P. falciparum

  • Storage condition

    Below 25 ⁰C

Artesunate is a bicarbonate soluble artemisinin derivative for the emergency treatment of severe and/or complicated malaria caused by Plasmodium falciparum (malaria tropica).

Publications* about the treatment outcome of intravenous artesunate prove the efficacy of artesunate over quinine in treatment of severe malaria tropica.

Legal status

Malacef is an unlicensed medicine in the Netherlands. The Dutch Health Care Inspectorate (IGJ) has given permission for the supply.

Malacef is supplied solely to pharmacies (on named patient basis). An order signed by the pharmacist and a physician’s statement from the prescribing physician are required with every order.

Availability for Pharmacies

In France, Malacef has an ATU Nominative. Distribution to pharmacies in France is carried out by Laboratoire Intsel Chimos.

In the United Kingdom, pharmacies that require Malacef can contact Mawdsleys.

Pharmacists that would like to know more about the availability of this product outside these countries are welcome to contact us via our contact form.

If you have ordered Malacef with us before, please use the order form to place a new order. Click on ‘Products’ in the menu to find our current order form.

Distribution activities

Since August 2018 the distribution activities of ARTECEF BV have been transferred to sister company Ace Pharmaceuticals BV.


Ace Pharmaceuticals has cooperated in the creation of publications about artesunate. An overview with links to these publications can be found at the Publications page.

* South East Asian Quinine Artesunate Malaria Trial (SEQUAMAT): Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. The Lancet 2005, 366:717-725
* Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. The Lancet 2010, 376:1647-1657