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TOPOTECAN ACCORD, TOPOTECAN INTAS (Accord Healthcare Pty Ltd)
Product name
TOPOTECAN ACCORD, TOPOTECAN INTAS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
207 working days (255)
Active ingredients
topotecan hydrochloride
Registration type
New generic medicine
Indication
TOPOTECAN ACCORD, TOPOTECAN INTAS (concentrated solution for injection) are indicated as single agent therapy for the treatment of patients with:
- Small cell lung carcinoma after failure of first line chemotherapy.
- Metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
TOPOTECAN ACCORD, TOPOTECAN INTAS are indicated in combination with cisplatin for the treatment of patients with:
- Histologically confirmed Stage IV-B, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.