Notice: Prescription Drug List (PDL) Multiple Additions 08-16-2018

August 16, 2018
Our file number: 18-109655-207

The purpose of this Notice of Amendment is to notify about the additions of Brigatinib, Bictegravir and Hemin to 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.

ALUNBIRG (brigatinib) is indicated as a monotherapy for use in adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), who have progressed on, or who were intolerant to an ALK inhibitor (crizotinib).

BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with no known substitution associated with resistance to the individual components of BIKTARVY.

PANHEMATIN (hemin) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate.

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: 343-998-9304
Facsimile: 613-941-1812
Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca