Notice: Prescription Drug List (PDL): Multiple additions

July 2, 2014
Our file number: 14-108336-461

The purpose of this Notice of Amendment is to notify the addition of Tafluprost, Canagliflozin, Fluralaner and Taliglucerase alfa to both the Human and Veterinary Prescription Drug List (PDL). These additions are effective at the time of posting.

Tafluprost is already covered on the PDL under

  • Prostaglandins or their salts or derivatives
  • Canagliflozin
  • Fluralaner
  • Taliglucerase alfa

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.

Tafluprost ophthalmic solution (SAFLUTAN) is indicated for the reduction of elevated intraocular pressure. Glaucoma is a serious disease not easily diagnosed by the public. Practitioner supervision is required for diagnosis, treatment and monitoring.

Canagliflozin (INVOKANA) is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients with type 2 diabetes mellitus. Deterioration in renal function occurs at therapeutic doses which require initial assessment and regular monitoring.

Fluralaner (BRAVECTO) is indicated for the treatment and prevention of flea and tick infestations. It is a parasiticide that contains carbamoyl benzamide phenyl isoxazoline which is a new chemical entity with no previous safety or efficacy experience.

Taliglucerase alfa (ELELYSO) is a long-term enzyme replacement therapy (ERT) for patients with Gaucher disease. Patients receiving Taliglucerase alfa should be supervised by a physician experienced in the management of patients with Gaucher disease. Patients may exhibit severe allergic reactions to taliglucerase alfa.

Additional information on how Health Canada now 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: 613-957-1058
Facsimile: 613-941-5035
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

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