A Phase III, Randomised, Open Labelled, Active Controlled, Multi Centre, Superiority Trial of ArTiMist Versus Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications.
Phase of Trial: Phase III
Latest Information Update: 03 Apr 2017
Price : $35 *
At a glance
- Drugs Artemether (Primary) ; Quinine
- Indications Falciparum malaria
- Focus Registrational; Therapeutic Use
- Sponsors ProtoPharma
- 03 Apr 2017 According to a SUDA media release, in late 2016, SUDA made a pre-submission to the TGA and based on that filing the TGA has advised that the filing is complete and deemed the MAA submission to be effective and has accepted the dossier for evaluation. The TGA now has 255 days to complete its review and provide an opinion, including potential approval of the ArTiMist Marketing Authorisation.
- 30 Apr 2014 New trial record