Notice: Prescription Drug List (PDL): Multiple additions

August 12, 2015

Our file number: 15-109116-589

The purpose of this Notice of Amendment is to notify the addition of Albiglutide, Mifepristone, Nintedanib esilate and Vilazodone to both the Human and Veterinary Prescription Drug List (PDL). These additions and amendments are effective at the time of posting. Health Canada is also amending the names of the listings for Sex hormones to include synthetic forms and for Prostaglandins to include analogues on the Human Prescription Drug List.

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.

Albiglutide (EPERZAN) is indicated for once-weekly administration for the treatment of adults with type 2 diabetes mellitus. Patients taking Albiglutide require regular monitoring for HbA1c and blood glucose under the supervision of practitioner to achieve better control of hyperglycemia and to prevent long term complications for diabetes are necessary.

Mifepristone (with Misoprostol in the product MIFEGYMISO) is indicated for the medical termination of a developing intra-uterine pregnancy. Physician supervision is required for initial assessment and follow-up to ensure termination of pregnancy is confirmed.

Nintedanib esilate (OFEV) is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a specific form of chronic, progressive, life-threatening interstitial lung disease of unknown etiology. Patients with IPF taking Nintedanib should be monitored by a practitioner to monitor potential adverse events involving gastrointestinal and liver function.

Vilazodone (VIIBRYD) is indicated for the symptomatic relief of Major Depressive Disorder (MDD). Practitioner expertise is necessary to reassess patients periodically to determine the need for maintenance treatment and the appropriate dose for treatment.

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