ENZALINE/ LUTACIP/ ENZACIP/ CIP ENZALUTAMIDE (Cipla Australia Pty Ltd)
Product name
ENZALINE/ LUTACIP/ ENZACIP/ CIP ENZALUTAMIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
123 (255 working days)
Active ingredients
enzalutamide
Registration type
New generic medicine
Indication
The approved indications for these therapeutic goods are:
ENZALINE/ LUTACIP/ ENZACIP/ CIP ENZALUTAMIDE is indicated for:
- the treatment of patients with metastatic hormone-sensitive prostate cancer.
- the treatment of patients with non-metastatic castration-resistant prostate cancer (see PROSPER, section 5.1 - Pharmacodynamic properties - Clinical trials).
- the treatment of patients with metastatic castration resistant prostate cancer following failure of androgen deprivation therapy in whom chemotherapy is not yet indicated.
- the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine