Approval · Notice of Compliance 13356 · 2012
REBIF: Notice of Compliance 13356
Issued June 7, 2012
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
- 13356
- Date
- June 7, 2012
- Company
- Emd Serono A Division Of Emd Inc CanadaMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of indication: The treatment of patients who have experienced a single demyelizing event, accompanied by an active inflammatory process and an abnorman MRI scan with lesions typical of MS, who are determined to be at high risk of developing clinically definite multiple sclerosis
- Therapeutic class
- Immunomodulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REBIF | Not yet assigned | — |
Medicinal ingredients
- INTERFERON BETA-1A 8.8 MCG per 0.2ML
- INTERFERON BETA-1A 22 MCG per 0.5ML
- INTERFERON BETA-1A 44 MCG per 0.5ML
- INTERFERON BETA-1A 66 MCG per 1.5ML
- INTERFERON BETA-1A 132 MCG per 1.5ML