IRINOTECAN ACCORD, IRINOTECAN INTAS (Accord Healthcare Pty Ltd)
Product name
IRINOTECAN ACCORD, IRINOTECAN INTAS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
178 working days (255)
Active ingredients
irinotecan hydrochloride trihydrate
Registration type
New generic medicine
Indication
IRINOTECAN ACCORD, IRINOTECAN INTAS (concentrated solution for injection) 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.