Approval · Notice of Compliance 7472 · 2005
GEMZAR: Notice of Compliance 7472
Issued September 30, 2005
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 7472
- Date
- September 30, 2005
- Company
- Eli Lilly Canada IncToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: in combination with paclitaxel for patients with unresectable, locally recurrent or metastatic breast cancer, who have good performance status and have relapsed following adjuvant anthracycline-based chemotherapy.
- Therapeutic class
- Antineoplastic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GEMZAR | Not yet assigned | — |
Medicinal ingredients
- GEMCITABINE HYDROCHLORIDE 200 MG per VIAL
- GEMCITABINE HYDROCHLORIDE 1 G per VIAL