Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26]
October 26, 2023
Our file number: 23-109746-618
The purpose of this Notice of Amendment is to notify about the addition of isoeugenol (veterinary), maralixibat, mirikizumab, somapacitan, teclistamab and tremelimumab to the Prescription Drug List (PDL) for human and/or veterinary use.
The new medicinal ingredients will be added to the human and veterinary parts of the PDL as the following:
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Maralixibat or its salts | N/A | N/A |
| Mirikizumab | N/A | N/A |
| Somapacitan | N/A | N/A |
| Teclistamab | N/A | N/A |
| Tremelimumab | N/A | N/A |
The new medicinal ingredient will be added to the veterinary part of the PDL as the following:
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Isoeugenol or its 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.
Aqui-s (isoeugenol) is indicated:
- for sedation and anesthesia of salmonids.
Imjudo (tremelimumab for injection) in combination with durvalumab is indicated for the first-line treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who require systemic therapy.
Livmarli (maralixibat oral solution) is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
Omvoh (mirikizumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.
Sogroya (somapacitan injection) is indicated for:
- the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (Growth Hormone Deficiency (GHD)).
- the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
Tecvayli (teclistamab 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 who have demonstrated disease progression on the last therapy.
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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