Notice: Multiple additions to the Prescription Drug List (PDL) [2026-02-26]
February 26, 2026
Our file number: 26-100917-526
The purpose of this Notice of Amendment is to announce the addition of nemolizumab, nipocalimab, olezarsen sodium, pegunigalsidase alfa, plozasiran, relfovetmab, tislelizumab, vosoritide, and zanidatamab to the Prescription Drug List (PDL) for human and/or veterinary use, and the status of aprocitentan by adding it to the "Including (but not limited to)" column of the "Macitentan or its derivatives" PDL entry for human and veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Macitentan or its derivatives | Aprocitentan | N/A |
| Nemolizumab | N/A | N/A |
| Nipocalimab | N/A | N/A |
| Olezarsen or its salts | N/A | N/A |
| Pegunigalsidase alfa | N/A | N/A |
| Plozasiran or its salts | N/A | N/A |
| Tislelizumab | N/A | N/A |
| Vosoritide | N/A | N/A |
| Zanidatamab | N/A | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Relfovetmab | 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.
Elfabrio (pegunigalsidase alfa for injection) is an enzyme replacement therapy indicated for the long-term treatment of adult patients with a confirmed diagnosis of Fabry disease (deficiency of α-galactosidase A).
Imaavy (nipocalimab) is indicated as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult and adolescent patients aged 12 years and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
Jeraygo (aprocitentan) is indicated for the treatment of resistant hypertension in adults as an adjunct to at least three antihypertensive medications from different classes.
Nemluvio (nemolizumab for injection) is indicated for:
- the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
- the treatment of adults with moderate-to-severe prurigo nodularis (PN) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Portela (relfovetmab) is indicated for the alleviation of pain associated with osteoarthritis in cats.
Redemplo (plozasiran injection) is indicated:
- as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate.
Tevimbra (tislelizumab for injection) in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).
Tryngolza (olezarsen injection) is indicated:
- as an adjunct to diet for the treatment of adult patients with familial chylomicronemia syndrome (FCS) to reduce triglyceride levels.
Voxzogo (vosoritide for injection) is indicated to increase linear growth in patients with achondroplasia who are 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.
Ziihera (zanidatamab for injection) is indicated for:
- the treatment of adults with previously treated, unresectable locally advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as monotherapy.
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