Approval · Notice of Compliance 9730 · 2008
SEROQUEL: Notice of Compliance 9730
Issued August 22, 2008
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
- 9730
- Date
- August 22, 2008
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: the acute management of depressive episodes associated with bipolar i and bipolar ii disorder.
- Therapeutic class
- Antipsychotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SEROQUEL | Not yet assigned | — |
Medicinal ingredients
- QUETIAPINE FUMARATE 25 MG per TAB
- QUETIAPINE FUMARATE 100 MG per TAB
- QUETIAPINE FUMARATE 200 MG per TAB
- QUETIAPINE FUMARATE 300 MG per TAB