Approval · Notice of Compliance 9661 · 2008
FORTEO: Notice of Compliance 9661
Issued July 7, 2008
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
- 9661
- Date
- July 7, 2008
- Company
- Eli Lilly Canada IncToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men an women who are at increased risk for fracture
- Therapeutic class
- Bone formation agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FORTEO | Not yet assigned | — |
Medicinal ingredients
- TERIPARATIDE 250 MCG per ML