Approval · Notice of Compliance 18369 · 2016
COPAXONE: Notice of Compliance 18369
Issued August 16, 2016
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
- 18369
- Date
- August 16, 2016
- Company
- Teva Canada LimitedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New clinical studies to support a new dose and a new dosage regimen
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| COPAXONE | 02456915 | Marketed |
Medicinal ingredients
- GLATIRAMER ACETATE 40 MG per ML