ODOFORIL (Alphapharm Pty Ltd)
Product name
ODOFORIL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
Emtricitabine, Rilpivirine hydrochloride, tenofovir alafenamide fumarate
Registration type
New generic medicine
Indication
ODOFORIL is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents (12 years and older with body weight at least 35 kg) with plasma HIV-1 RNA ≤ 100,000 copies/mL at the start of therapy. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of ODOFORIL.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine