Approval · Notice of Compliance 5721 · 2004
ZYPREXA: Notice of Compliance 5721
Issued October 20, 2004
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
- 5721
- Date
- October 20, 2004
- 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: monotherapy maintenance treatment in bipolar patients with manic or mixed episodes
- Therapeutic class
- Antipsychotic, antimanic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZYPREXA | Not yet assigned | — |
| ZYPREXA ZYDIS | Not yet assigned | — |
| ZYPREXA INTRAMUSCULAR | Not yet assigned | — |
Medicinal ingredients
- OLANZAPINE 2.5 MG per TAB
- OLANZAPINE 5 MG per TAB
- OLANZAPINE 7.5 MG per TAB
- OLANZAPINE 10 MG per TAB
- OLANZAPINE 15 MG per TAB
- OLANZAPINE 20 MG per TAB
- OLANZAPINE TARTRATE 10 MG per VIAL