Notice: Prescription Drug List (PDL): Multiple additions

August 22, 2014
Our file number: 14-110337-38

The purpose of this Notice of Amendment is to notify the addition of Bosutinib, Eslicarbasepine acetate, Icatibant acetate, Oclacitinib maleate, Elosulfase alfa, and Afoxolaner to both the Human and Veterinary Prescription Drug List (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 Regulations indicates that these drugs require prescription status.

Bosutinib (BOSULIF) is indicated for the treatment of leukemia in adult patients with resistance or intolerance to other therapies. Bosutinib should only be prescribed by a qualified healthcare professional who is experienced in the treatment of chronic myeloid leukemia.

Eslicarbasepine acetate (APTIOM) is indicated as adjunctive therapy in the treatment of epilepsy. After a suitable individualized dose for the patient has been established, patients are usually evaluated from time to time by the physician.

Icatibant acetate (FIRAZYR) is indicated for treatment of acute attacks of Hereditary Angioedema (HAE) in adults. HAE is a rare, inheritable disease that will require a physician to diagnose and follow up treatment for patient care.

Oclacitinib maleate (APOQUEL) tablets are indicated for the control of pruritus associated with allergic dermatitis and for the control of atopic dermatitis in dogs at least 12 months of age. This drug is known to modulate immune function and affect tumour growth and development. The dose and dosing interval for this drug is dependent on the observed clinical effect. For these reasons this product needs to be administered by a veterinarian.

Elosulfase alfa (VIMIZIM) is indicated for patients with Mucopolysaccharidosis IVA. Mucopolysaccharidosis IVA is a serious, progressive and life threatening disease which may be easily misdiagnosed by the public.

Afoxolaner (NEXGARD) is indicated for the treatment and control of fleas and ticks in dogs and puppies 8 weeks of age or older. Distinguishing tick types requires special identification by a veterinarian.

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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