Approval · Notice of Compliance 11657 · 2010
SATIVEX: Notice of Compliance 11657
Issued August 11, 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.
- Notice number
- 11657
- Date
- August 11, 2010
- Company
- Gw Pharma Limited
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Sativex is useful as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS) who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy
- Therapeutic class
- Cannabinoid analgesic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SATIVEX | Not yet assigned | — |
Medicinal ingredients
- CANNABIDIOL 25 MG per ML
- DELTA-9-TETRAHYDROCANNABINOL 27 MG per ML