Approval · Notice of Compliance 21831 · 2019
TECFIDERA: Notice of Compliance 21831
Issued February 5, 2019
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
- 21831
- Date
- February 5, 2019
- Company
- Biogen Canada IncToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- The purpose of the submission was to include information based on the results of study 109MS202 (study 202) designed to determine the pharmacokinetics (PK) efficacy and safety of Tecfidera in pediatric patients with relapsing-remitting multiple sclerosis (RRMS) to obtain the pediatric data extension of the drug data protection under C.08.004.1
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TECFIDERA | Not yet assigned | — |
Medicinal ingredients
- DIMETHYL FUMARATE 120 MG per CAP
- DIMETHYL FUMARATE 240 MG per CAP