Notice: Multiple additions to the Prescription Drug List (PDL) [2025-10-30]
- October 30, 2025
- Our file number: 25-107098-682
The purpose of this Notice of Amendment is to announce the addition of belantamab mafodotin, bulevirtide, delgocitinib, deutivacaftor, elinzanetant, garadacimab, lifileucel, mirevetuximab soravtansine, vamorolone, vanzacaftor, to the Prescription Drug List (PDL) for human and veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Belantamab mafodotin | N/A | N/A |
| Bulevirtide or its salts | N/A | N/A |
| Delgocitinib or its salts | N/A | N/A |
| Deutivacaftor or it salts | N/A | N/A |
| Elinzanetant | N/A | N/A |
| Garadacimab | N/A | N/A |
| Lifileucel | N/A | N/A |
| Mirvetuximab soravtansine | N/A | N/A |
| Vamorolone | N/A | N/A |
| Vanzacaftor 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.
Agamree (vamorolone oral suspension) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older.
Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Amtagvi (lifileucel) is a tumour-derived autologous T-cell immunotherapy indicated for:
- the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, and who have no satisfactory alternative treatment options.
Andembry (garadacimab injection) is indicated for routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients (aged 12 years and older).
Anzupgo (delgocitinib cream) is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or are not advisable.
Blenrep (belantamab mafodotin for injection) is indicated in combination with:
- bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
- pomalidomide and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including lenalidomide.
Elahere (mirvetuximab soravtansine for injection) as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
Hepcludex (bulevirtide) is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Lynkuet (elinzanetant) is indicated for:
- the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
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