TADALAFIL INTAS, TADALACCORD, TADALAFIL AN, TADALAFIL ASTRON, TADALAFIL AMEDA, TADALAFIL SANDOZ, TADALCA, TADALAFIL AN PHT (Accord Healthcare Pty Ltd)
Product name
TADALAFIL INTAS, TADALACCORD, TADALAFIL AN, TADALAFIL ASTRON, TADALAFIL AMEDA, TADALAFIL SANDOZ, TADALCA, TADALAFIL AN PHT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
123 working days (255)
Active ingredients
tadalafil
Registration type
New generic medicine
Indication
TADALAFIL INTAS, TADALACCORD, TADALAFIL AN, TADALAFIL ASTRON, TADALAFIL AMEDA, TADALAFIL SANDOZ
Tadalafil (tablets) is indicated for the treatment of:
- erectile dysfunction (ED) in adult males;
- moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males.
TADALCA/TADALAFIL AN PHT
Tadalafil (tablets) is indicated for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.