Notice: Multiple additions to the Prescription Drug List (PDL)
October 14, 2022
Our file number: 22-110895-558
The purpose of this Notice of Amendment is to notify about the addition of abrocitinib, asciminb, belzutifan, difelikefalin, maribavir and tezepelumab 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|
|Abrocitinib or its salts||N/A||N/A|
|Asciminib or its salts||N/A||N/A|
|Difelikefalin or its salts||N/A||N/A|
|Maribavir or its salts||N/A||N/A|
These additions are effective at the time of posting.
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.
Cibinqo (abrocitinib tablets) is indicated for the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis, including the relief of pruritus, who have had an inadequate response to other systemic drugs (e.g. steroid or biologic), or for whom these treatments are not advisable. Cibinqo can be used with or without medicated topical therapies for atopic dermatitis.
Korsuva (difelikefalin) is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adult patients on hemodialysis (HD).
Livtencity (maribavir) is indicated for the treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are refractory (with or without genotypic resistance) to one or more prior antiviral therapies.
Scemblix (asciminib tablets) is indicated for the treatment of adult patients with: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors.
Tezspire (tezepelumab injection) is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma.
Welireg (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated non-metastatic renal cell carcinoma (RCC), not requiring immediate surgery.
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:
Pharmaceutical Drugs Directorate
Bureau of Policy, Science and International Programs
Office of Science
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