Notice: Multiple Additions to the Prescription Drug List (PDL)
Date: January 24, 2022
Our file number: 22-100898-943
The purpose of this Notice of Amendment is to notify about the additions of Anifrolumab, Avalglucosidase alfa, Dostarlimab, Fostemsavir, Palovarotene and Tecovirimat to the Prescription Drug List (PDL) for human and veterinary use.
The new medicinal ingredients will be added to the PDL as the following:
| Drugs containing any of the following |
Including (but not limited to) |
Qualifier |
|---|---|---|
Anifrolumab |
N/A |
N/A |
Avalglucosidase alfa |
N/A |
N/A |
Dostarlimab |
N/A |
N/A |
Fostemsavir or its salts |
N/A |
N/A |
Palovarotene or its salts |
N/A |
N/A |
Tecovirimat |
N/A |
N/A |
These additions are effective at the time of posting.
Rationale
A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these drugs require prescription status.
JEMPERLI (dostarlimab for injection) is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum containing regimen.
NEXVIAZYME (avalglucosidase alfa for injection) is an enzyme replacement therapy (ERT) indicated for the long-term treatment of patients with late-onset Pompe disease (acid α-glucosidase deficiency).
RUKOBIA (fostemsavir extended release tablets) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen due to resistance, intolerance or safety considerations.
SAPHNELO (anifrolumab for injection) is indicated in addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus (SLE).
SOHONOS (palovarotene capsules) is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with Fibrodysplasia (myositis) Ossificans Progressiva.
TPOXX (tecovirimat capsules) is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 13kg.
Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.
Should you have any questions regarding this notice, please contact:
Health Canada
Therapeutic Products Directorate
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
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