Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22]
- December 22, 2023
- Our file number: 23-111963-914
The purpose of this Notice of Amendment is to notify about the addition of avatrombopag, calaspargase pegol, efgartigimod alfa, evinacumab, odevixibat, relatlimab, relugolix and vutrisiran to the Prescription Drug List (PDL) for human and veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Avatrombopag or its salts | N/A | N/A |
| Calaspargase pegol | N/A | N/A |
| Efgartigimod alfa | N/A | N/A |
| Evinacumab | N/A | N/A |
| Odevixibat or its salts | N/A | N/A |
| Relatlimab | N/A | N/A |
| Relugolix or its salts | N/A | N/A |
| Vutrisiran 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.
Amvuttra (vutrisiran injection) is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
Asparlas (calaspargase pegol for injection) is indicated as:
- A component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) in pediatric and young adult patients age 1 to 21 years.
Bylvay (odevixibat) is indicated for:
- the treatment of pruritus in patients aged 6 months or older with progressive familial intrahepatic cholestasis (PFIC).
Doptelet (avatrombopag) is indicated for:
- the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.
- the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Evkeeza (evinacumab for injection) is indicated as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients aged 5 years and older with homozygous familial hypercholesterolemia (HoFH).
Myfembree (relugolix, estradiol, and norethindrone acetate tablets) is indicated in premenopausal women for the management of heavy menstrual bleeding associated with uterine fibroids and for the management of moderate to severe pain associated with endometriosis.
Opdualag (nivolumab and relatlimab) is indicated for:
- the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma.
Vyvgart (efgartigimod alfa for injection) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
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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