Notice: Multiple additions to the Prescription Drug List (PDL) [2025-04-29]
April 29, 2025
Our file number: 25-102881-952
The purpose of this Notice of Amendment is to notify about the addition of efanesoctocog alfa, fecal microbiota (human), inavolisib, loncastuximab tesirine, retifanlimab, rozanolixizumab, sipavibart, tofersen, and vaborbactam to the Prescription Drug List (PDL) for human and/or veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Efanesoctocog alfa | Recombinant coagulation factor VIII Fc - von Willebrand factor - XTEN fusion protein (rFVIIIFc-VWF-XTEN) | N/A |
| Inavolisib or its salts | N/A | N/A |
| Loncastuximab tesirine | N/A | N/A |
| Retifanlimab | N/A | N/A |
| Rozanolixizumab | N/A | N/A |
| Sipavibart | N/A | N/A |
| Tofersen | N/A | N/A |
| Vaborbactam | N/A | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Fecal microbiota | 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.
Altuviiio (Antihemophilic Factor VIII (Recombinant, B-Domain deleted), Fc-VWF-XTEN fusion protein) is indicated in adults, adolescents and children with hemophilia A (congenital Factor VIII [FVIII] deficiency) for:
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- Treatment and control of bleeding episodes
- Perioperative management of bleeding (surgical prophylaxis)
Itovebi (inavolisib film-coated tablets), in combination with palbociclib and fulvestrant, is indicated for:
- the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment.
Kavigale (sipavibart injection) is indicated for the preexposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents aged 12 years and older weighing at least 40 kg and:
- who are immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments or
- for whom COVID-19 vaccination is not recommended
Qalsody (tofersen injection) is indicated for:
- The treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
Rebyota (fecal microbiota) is indicated for the prevention of:
- recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI.
- Rebyota is not indicated for the treatment of CDI.
Rystiggo (rozanolixizumab injection) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase inhibitor (MuSK) antibody positive.
Vabomere (meropenem and vaborbactam) is indicated in adults for the treatment of the following infections known or suspected to be caused by carbapenem-resistant, vaborbactam/meropenem-susceptible Gram-negative bacteria
- Complicated urinary tract infections (cUTI), including pyelonephritis
- Complicated intra-abdominal infection (cIAI)
- Hospital acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
- Bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
- Other infections with limited treatment options.
Zynlonta (loncastuximab tesirine) as monotherapy is indicated for:
- the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, or high-grade B-cell lymphoma, who have received two or more lines of systemic therapy and have previously received or are unable to receive CAR-T cell therapy.
Zynyz (retifanlimab for injection), as monotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation 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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