Approval · Notice of Compliance 12333 · 2011
AXERT: Notice of Compliance 12333
Issued May 3, 2011
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
- 12333
- Date
- May 3, 2011
- Company
- McNeil Consumer Healthcare, division of Johnson & Johnson Inc.Markham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Acute treatment of migraine headache pain in patients 12-17 years of age who have a history of migraine attacks with or without aura usually lasting 4 hours or longer (when untreated)
- Therapeutic class
- 5-HT1 receptor agonist migraine therapy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AXERT | Not yet assigned | — |
Medicinal ingredients
- ALMOTRIPTAN MALATE 6.25 MG per TAB
- ALMOTRIPTAN MALATE 12.5 MG per TAB