Notice: Prescription Drug List (PDL): Multiple additions

March 12, 2018

Our file number: 18-102696-288

The purpose of this Notice of Amendment is to notify about the additions of avelumab, dupilumab, guselkumab, lifitegrast, lotilaner, olaratumab, sebelipase alfa, semaglutide, tipiracil to the Human and/or Veterinary Prescription Drug Lists (PDL). 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 Regulationsindicates that these drugs require prescription status.

Avelumab for injection (BAVENCIO) is indicated for the treatment of metastatic Merkel cell carcinoma (MCC) in previously treated adults.

Dupilumab (DUPIXENT) is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Guselkumab (TREMFYA) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Lifitegrast (XIIDRA) is indicated for the treatment of the signs and symptoms of dry eye disease.

Lotilaner (CREDELIO) is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (Lone Star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged or deer tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies (Veterinary PDL only).

Olaratumab (LARTRUVO) is indicated: In combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and for whom treatment with an anthracycline-containing regimen is appropriate.

Sebelipase alfa (KANUMA), is indicated for the treatment of infants, children and adults diagnosed with lysosomal acid lipase (LAL) deficiency.

Semaglutide (OZEMPIC) is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with:

  • diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance
  • metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control
  • metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control
  • basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control

Tipiracil from ((LONGSURF), composed of trifluridine and tipiracil [as tipiracil hydrochloride] tablets) is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.

Note: As Trifluridine is already on the PDL, only tipiracil will be added at this time.

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
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 343-998-9304
Facsimile: 613-941-1812
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

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