Approval · Notice of Compliance 13588 · 2012
SUBLINOX: Notice of Compliance 13588
Issued August 27, 2012
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
- 13588
- Date
- August 27, 2012
- Company
- Meda AbSolna, --, Sweden
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New strength and patient population: 5 mg tablet )orally disinegrating) for use in the elderly and in patients with hepatic impairment.
- Therapeutic class
- Hypnotic Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SUBLINOX | 02391678 | Marketed |
Medicinal ingredients
- ZOLPIDEM TARTRATE 5 MG per TAB