Notice: Multiple additions to the Prescription Drug List (PDL) [2024-08-13]
August 13, 2024
Our file number: 24-107297-36
The purpose of this Notice of Amendment is to notify about the addition of capromorelin (veterinary), eplontersen, lebrikizumab, talquetamab, and zilucoplan to the Prescription Drug List (PDL) for human and/or veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Eplontersen or its salts | N/A | N/A |
| Lebrikizumab | N/A | N/A |
| Talquetamab | N/A | N/A |
| Zilucoplan or its salts | N/A | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Capromorelin or its salts | 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.
Ebglyss (lebrikizumab injection) is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Elura (capromorelin) is indicated for body weight gain in cats with chronic kidney disease.
Talvey (talquetamab injection) is indicated for:
- the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on or after the last therapy.
Wainua (eplontersen injection) is indicated for:
- the treatment of polyneuropathy associated with stage 1 or stage 2 hereditary transthyretin-mediated amyloidosis (hATTR) in adults.
Zilbrysq (zilucoplan injection) is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
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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