Approval · Notice of Compliance 24299 · 2020
EMGALITY: Notice of Compliance 24299
Issued September 17, 2020
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
- 24299
- Date
- September 17, 2020
- Company
- Eli Lilly Canada IncToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional presentation and indication: emgality is indicated for the reduction in the frequency of attacks throughouit a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, of who had contraindications to conventional preventive therapies established y canadian practice guidelines
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EMGALITY | Not yet assigned | — |
| EMGALITY | 02505134 | Marketed |
Medicinal ingredients
- GALCANEZUMAB 120 MG per ML
- GALCANEZUMAB 100 MG per ML
- GALCANEZUMAB 100 MG per PEN