APO-VARDENAFIL, VARDENAFIL APOTEX (Apotex Pty Ltd)
Product name
APO-VARDENAFIL, VARDENAFIL APOTEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
162 working days (255)
Active ingredients
vardenafil (as hydrochloride trihydrate)
Registration type
New generic medicine
Indication
APO-VARDENAFIL, VARDENAFIL APOTEX (tablets) is indicated for the treatment of erectile dysfunction in adult male (inability to achieve or maintain penile erection sufficient for sexual performance). Vardenafil is not indicated for use by women.