Regulatory Decision Summary for Pergoveris
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 for Pergoveris for the stimulation of follicular development in anovulatory adult women with gonadotrophin deficiency (hypogonadotropic hypogonadism).
Why was the decision issued?
Pergoveris is a fixed-dose combination drug that consists of two previously-authorized drugs, Gonal-f (follitropin alfa) and Luveris (lutropin alfa). Clinical trials using both component drugs showed improved rates of follicular development in hypogonadotropic hypogonadal women.
Pergoveris is supplied in powder and solvent for solution for injection at the doses of 150 IU follitropin alfa:75 IU lutropin alfa. The recommended starting dose is one vial (150 IU follitropin alfa:75 IU lutropin alfa) per day.
Pergoveris, as other gonadotropins, should not be used in women with primary ovarian failure or other conditions incompatible with pregnancy.
Use of gonadotrophins such as Pergoveris increases the risk of ovarian hyperstimulation syndrome (OHSS). The safety profile of Pergoveris is comparable to its constituent drugs (Gonal-f and Luveris) and to other gonadotrophins authorized in Canada for ovarian stimulation.
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.
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 |
|---|---|---|---|
| PERGOVERIS | 02445301 | EMD SERONO, A DIVISION OF EMD INC., CANADA | FOLLITROPIN ALFA 150 UNIT / VIAL LUTROPIN ALFA 75 UNIT / VIAL |