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ATOVAQUOPRO LUPIN (Generic Health Pty Ltd)
Product name
ATOVAQUOPRO LUPIN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
106 (255 working days)
Active ingredients
Proguanil hydrochloride, Atovaquone
Registration type
New generic medicine
Indication
ATOVAQUOPRO LUPIN is indicated for:
- Prophylaxis of Plasmodium falciparum malaria in adults and children ≥11 kg
- Treatment of Plasmodium falciparum malaria in adults and children aged 3 years or older
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine