Approval · Notice of Compliance 8954 · 2007
SATIVEX: Notice of Compliance 8954
Issued August 1, 2007
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
- 8954
- Date
- August 1, 2007
- Company
- Gw Pharma Limited
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: may be useful as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain, and other revisions to the product monograph
- Therapeutic class
- Cannabinoid analgesic
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SATIVEX | Not yet assigned | — |
Medicinal ingredients
- DELTA-9-TETRAHYDROCANNABINOL 27 MG per ML
- CANNABIDIOL 25 MG per ML