Approval · Notice of Compliance 27072 · 2021
LUCENTIS: Notice of Compliance 27072
Issued November 19, 2021
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
- 27072
- Date
- November 19, 2021
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication in preterm infants for : the treatment of retinopathy of prematurity (ROP) with zone I[stage 1 with plus disease (1+), stage 2 with plus disease (2+), or stage 3 with or without plus disease (3 or 3+)], or zone II [stage 3 with plus disease (3+)] or aggressive posterior ROP (AP-ROP) disease.
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LUCENTIS | Not yet assigned | — |
Medicinal ingredients
- RANIBIZUMAB 10 MG per ML
- RANIBIZUMAB 10 MG per VIAL