Notice: Prescription Drug List (PDL): Multiple Additions
Date: September 10, 2021
Our file number: 21-116232-170
The purpose of this Notice of Amendment is to notify about the additions of:
- Elexacaftor, Inclisiran, Ospemifene, Pralsetinib and Tafasitamab to the Prescription Drug List (PDL) for human and veterinary use, and
- Frunevetmab to the PDL for veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Elexacaftor or its salts | - | - |
| Frunevetmab | - | - |
| Inclisiran or its salts | - | - |
| Ospemifene | - | - |
| Pralsetinib or its salts | - | - |
| Tafasitamab | - | - |
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.
Gavreto (pralsetinib) is indicated for the treatment of adult patients with rearranged during transfection (RET) fusion-positive locally advanced unresectable or metastatic non-small cell lung cancer.
Leqvio (inclisiran) is indicated as an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) level in adults with the following conditions who are on maximally tolerated dose of a statin, with or without other LDL-C-lowering therapies:
- Heterozygous familial hypercholesterolemia, or
- Non-familial hypercholesterolemia with atherosclerotic cardiovascular disease
Minjuvi (tafasitamab) is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant.
Osphena (ospemifene tablets) is indicated in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy, a component of genitourinary syndrome of menopause.
Solensia (frunevetmab) is indicated for the alleviation of pain associated with osteoarthritis in cats.
Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets are indicated for the treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
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 on these amendments to the Prescription Drug List please contact:
Health Canada
Therapeutic Products Directorate
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
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