Approval · Notice of Compliance 18487 · 2016
SOMAVERT: Notice of Compliance 18487
Issued September 16, 2016
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
- 18487
- Date
- September 16, 2016
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: somavert (pegvisomant for injection) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery, and/or radiation therapy or for whom these therapies are not appropriate. the goal of treatment is to normalize serum insulin-like growth factor-I (igf-I) levels and to improve clinical signs and symptoms
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SOMAVERT | Not yet assigned | — |
Medicinal ingredients
- PEGVISOMANT 10 MG per VIAL
- PEGVISOMANT 15 MG per VIAL
- PEGVISOMANT 20 MG per VIAL
- PEGVISOMANT 25 MG per VIAL
- PEGVISOMANT 30 MG per VIAL