Regulatory Decision Summary for PLEGRIDY
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this NDS is to seek market authorization of PLEGRIDY for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS).
Why was the decision issued?
The efficacy and safety of PLEGRIDY was evaluated in a 2-year Phase III clinical trial. The results obtained from this clinical trial showed, that the treatment with PLEGRIDY reduces the relapse rate and the progression of disability in patients with RRMS.
PLEGRIDY is supplied in a single-use, pre-filled syringe/pen. The recommended dosage of PLEGRIDY is 125 micrograms to be injected subcutaneously every 2 weeks.
PLEGRIDY should not be used in pregnant women and in patients with severe depression and/or suicidal ideation.
The safety profile of PLEGRIDY is comparable to other beta-1 interferons authorized in Canada for the treatment of RRMS. In order to ensure that this benefit continues to outweigh any risk after authorization, Health Canada has required several post-approval activities to be carried out and a Risk Management Plan.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| PLEGRIDY | 02444402 | BIOGEN CANADA INC | PEGINTERFERON BETA-1A 63 MCG / 0.5 ML PEGINTERFERON BETA-1A 94 MCG / 0.5 ML |
| PLEGRIDY | 02444372 | BIOGEN CANADA INC | PEGINTERFERON BETA-1A 63 MCG / 0.5 ML |
| PLEGRIDY | 02444380 | BIOGEN CANADA INC | PEGINTERFERON BETA-1A 94 MCG / 0.5 ML |
| PLEGRIDY | 02444399 | BIOGEN CANADA INC | PEGINTERFERON BETA-1A 125 MCG / 0.5 ML |