Notice - Prescription Drug List (PDL): Multiple additions

March 29, 2017
Our file number: 17-103107-174

The purpose of this Notice of Amendment is to notify the additions of Eluxadoline, Peramivir, Propiverine hydrochloride and Sarilumab 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.

Eluxadoline (VIBERZI) is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Peramivir (RAPIVAB) is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older, who have been symptomatic for no more than 2 days.

Propiverine hydrochloride (MICTORYL/MICTORYL Pediatric) is indicated for symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder (OAB).

Sarilumab (KEVZARA) is indicated in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

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

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