Notice - Prescription Drug List (PDL): Multiple additions

February 10, 2017
Our file number: 17-101580-125

Prescription Drug List (PDL): Multiple additions

The purpose of this Notice of Amendment is to notify the additions of Apomorphine hydrochloride, Daclizumab beta, Edoxoban, Ivabradine hydrochloride and Rupatadine to the Human and 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 Regulations indicates that these drugs require prescription status.

Apomorphine hydrochloride injection (MOVAPO) is indicated for the acute, intermittent treatment of hypomobility “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) in patients with advanced Parkinson’s disease. Apomorphine hydrochloride should be initiated with use of a concomitant antiemetic and in a clinical setting where blood pressure and pulse can be closely monitored by medical personnel.

Daclizumab beta (ZINBRYTA) is indicated for the treatment of adult patients with active relapsing remitting multiple sclerosis (MS) who have had an inadequate response to, or who are unable to tolerate, one or more therapies indicated for the treatment of MS. Daclizumab beta is only available through a controlled distribution program called Biogen ONE® Support Program. Under this program, only prescribers and pharmacies registered with the program are able to prescribe and dispense the product.

Edoxaban (LIXIANA) is indicated for the prevention of stroke and systemic embolic events in patients with atrial fibrillation, in whom anticoagulation is appropriate as well as the treatment of venous thromboembolism (VTE) (deep vein thrombosis [DVT], pulmonary embolism [PE]) and the prevention of recurrent DVT and PE.

Ivabradine hydrochloride (CORLOVAN) is indicated for the treatment of stable chronic heart failure with reduced left ventricular ejection fraction (≤ 35%) in adult patients with NYHA Class II or III who are in sinus rhythm with a resting heart rate ≥ 77 beats per minute, to reduce the incidence of cardiovascular mortality and hospitalisations for worsening heart failure. Ivabradine hydrochloride should be administered in combination with standard chronic heart failure therapies. Ivabradine hydrochloride should be initiated and up-titrated under the supervision of a physician who is experienced with the treatment of patients with heart failure.

Rupatadine (RUPATADINE) is indicated for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients 2 years of age and older. Rupatadine is also indicated for the relief of symptoms associated with chronic spontaneous urticaria (for example [e.g.], pruritus and hives) in patients 2 years of age and older.

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: 613-957-1058
Facsimile: 613-941-1812
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca