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.
Product type:
Contact:
Medicinal Ingredient(s):
Follitropin alfa, lutropin alfa
Control Number:
291390
Brand/Product Name:
Pergoveris
Therapeutic Area:
Sex hormones and modulators of the genital system
Type of Submission:
Supplement to a New Drug Submission
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of this Supplement to a New Drug Submission (SNDS) was to seek Health Canada’s approval for revising the Product Monograph (PM) of Pergoveris (follitropin alfa/lutropin alfa). The proposed revisions involve Indications, Warning and Precautions, and Dosage and Administration sections of the PM.
Why was the decision issued?
Internationally, the understanding of hypogonadotropic hypogonadism (HH) and severe luteinizing hormone (LH) and follicle-stimulating hormone (FSH) deficiency have evolved in the past decades. HH includes not only the congenital forms of HH but also acquired or functional deficiencies. A single assessment of LH/FSH level is not adequate to diagnose severe LH/FSH deficiency. Therefore, the revision of wording in the Indications section of the Product Monograph (PM), deleting the word of “hypogonadotropic hypogonadal” and the LH/FSH levels, is clinically relevant.
A systematic literature review which summarised published studies on participants undergoing ovarian stimulation with assisted reproductive technology who were treated with recombinant human follicle stimulating hormone and recombinant human luteinizing hormone was conducted. This review showed that 1) it was common that LH and FSH deficiency was attributed to an acquired cause due to iatrogenic or functional origin; 2) comorbidities were commonly reported in participants, such as advanced maternal age and poor/diminished ovarian reserve; and 3) no new safety signals were identified.
It is known that gonadotropin treatment could increase risks of ovarian hyperstimulation syndrome (OHSS) and multiple-gestation pregnancy. The risk of OHSS and multiple pregnancy risk have been included in the PM.
Overall, the revision of the PM provides clarification and is in line with the up-to-date medical practice of severe LH and FSH deficiency. In addition, the proposed revisions do not alter the dosage and administration recommendations. The benefit/risk ratio remains unchanged with the proposed revisions of the PM. Therefore, a Notice of Compliance (NOC) was recommended.
Following review, the final labelling and Product Monograph were considered to be acceptable.
For further details about Pergoveris, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2025-08-11
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription Status:
Available by prescription only
Date Filed:
2024-10-16
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| PERGOVERIS | 02470667 | EMD SERONO, A DIVISION OF EMD INC., CANADA | FOLLITROPIN ALFA 900 UNIT / 1.44 ML LUTROPIN ALFA 450 UNIT / 1.44 ML |
| PERGOVERIS | 02470659 | EMD SERONO, A DIVISION OF EMD INC., CANADA | FOLLITROPIN ALFA 450 UNIT / 0.72 ML LUTROPIN ALFA 225 UNIT / 0.72 ML |
| PERGOVERIS | 02445301 | EMD SERONO, A DIVISION OF EMD INC., CANADA | FOLLITROPIN ALFA 150 UNIT / VIAL LUTROPIN ALFA 75 UNIT / VIAL |
| PERGOVERIS | 02470640 | EMD SERONO, A DIVISION OF EMD INC., CANADA | FOLLITROPIN ALFA 300 UNIT / 0.48 ML LUTROPIN ALFA 150 UNIT / 0.48 ML |