VIRATERO, HETEVIR, TENOFOVIR HETERO, HETENOFOVIR, TEROVIR (Hetero Australia Pty Ltd)
Product name
VIRATERO, HETEVIR, TENOFOVIR HETERO, HETENOFOVIR, TEROVIR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
160 working days (255)
Active ingredients
Tenofovir disoproxil fumarate
Registration type
New generic medicine
Indication
VIRATERO, HETEVIR, TENOFOVIR HETERO, HETENOFOVIR, TEROVIR (tablets) in combination with other antiretroviral agents, are indicated for the treatment of HIV-infected adults and paediatric patients 12 years of age and older.
VIRATERO, HETEVIR, TENOFOVIR HETERO, HETENOFOVIR, TEROVIR are also indicated for the treatment of chronic hepatitis B in adults and in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels or evidence of active inflammation.