Approval · Notice of Compliance 11785 · 2010
MEMANTINE: Notice of Compliance 11785
Issued October 5, 2010
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 11785
- Date
- October 5, 2010
- Company
- Meliapharm IncMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Product name and company name change
- Therapeutic class
- N-methyl-D-aspartate (NMDA) receptor antagonist
- With conditions
- Yes (NOC/c)
- Canadian reference product
- EBIXA (Lundbeck Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MEMANTINE | 02349116 | Cancelled Post Market |
Medicinal ingredients
- MEMANTINE HYDROCHLORIDE 10 MG per TAB