Notice: Multiple additions to the Prescription Drug List (PDL)
- December 22, 2022
- Our file number: 22-113424-10
The purpose of this Notice of Amendment is to notify about the addition of finerenone, lenacapavir, mavacamten, selumetinib, ubrogepant 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 |
|---|---|---|
| Finerenone or its salts | N/A | N/A |
| Lenacapavir or its salts | N/A | N/A |
| Mavacamten or its salts | N/A | N/A |
| Selumetinib or its salts | N/A | N/A |
| Ubrogepant or its salts or derivatives | 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.
Camzyos (mavacamten capsules) is indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) Class II-III in adult patients.
Kerendia (finerenone) is indicated as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of:
- End-stage kidney disease and a sustained decrease in estimated glomerular filtration rate,
- Cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure.
Koselugo (selumetinib) is indicated for the treatment of pediatric patients aged 2 years and above, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Sunlenca (lenacapavir) in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations.
Ubrelvy (ubrogepant tablet) is indicated for the acute treatment of migraine, with or without aura, in adults.
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
- Pharmaceutical Drugs Directorate
- Bureau of Policy, Science and International Programs
- Office of Science
- Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
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