EUG-IRINOTECAN (Eugia Pharma (Australia) Pty Ltd)
Product name
EUG-IRINOTECAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
131 (175 working days)
Active ingredients
irinotecan hydrochloride trihydrate
Registration type
New generic medicine
Indication
Irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.