Notice - Prescription Drug List (PDL): Multiple additions

May 19, 2017
Our file number: 17-105533-859

The purpose of this Notice of Amendment is to notify the additions of atezolizumab, eliglustat and obeticholic acid to the Human and Veterinary Prescription Drug Lists (PDL). Health Canada is also adding ibogaine and its salts, derivatives or analogues to the Human and Veterinary 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.

Ibogaine is a psychoactive alkaloid extracted from the root bark of Tabernanthe iboga, a Central West African rain forest shrub. Ibogaine is not authorized for use in Canada.

Health Canada has received serious and fatal adverse reaction reports associated with the use of ibogaine. As a result, in June, 2015 Health Canada issued a risk communication to advise the public not to use ibogaine.  Health Canada is adding ibogaine to the PDL to mitigate the potential harms associated with the use of unauthorized ibogaine products.

The addition of ibogaine to the PDL would allow Health Canada to provide more effective risk-based oversight of ibogaine: by requiring sale only pursuant to a prescription, by restricting the compounding of products containing ibogaine, and by providing enforcement agents with increased authority to seize products which do not conform with the Canadian Food and Drugs Act and Regulations.

Atezolizumab (TECENTRIQ) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Eliglustat (CERDELGA) is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 poor metabolizers (PMs), intermediate metabolizers (IMs) or extensive metabolizers (EMs), as determined by CYP2D6 genotype testing.

Obeticholic acid (OCALIVA) is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

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