ATOVACUE (Freyr Australia Pty Ltd)
Product name
ATOVACUE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
Atovaquone
Registration type
New generic medicine
Indication
ATOVACUE oral liquid suspension is indicated for:
Acute treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) (difference of alveolar and arterial oxygen tensions [(A-a) DO2] ≤45 mmHg (6 kPa) and oxygen tension in arterial blood (Pa02) ≥60 mmHg (8 kPa) breathing room air) in adult patients with AIDS who are intolerant of trimethoprim/sulfamethoxazole therapy.