Notice: Prescription Drug List (PDL): Diclofenac

August 22, 2014
Our file number: 14-110340-685

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for diclofenac on the Prescription Drug List (PDL). Only the Human part of the PDL was revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of diclofenac against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which remains unchanged from what was proposed in the November 5, 2013 Notice of Consultation, is:

Drugs containing any of the following: Diclofenac or its salts

Including (but not limited to): Diclofenac diethylamine, Diclofenac sodium, Diclofenac potassium

Qualifier: except when sold as a single medicinal ingredient for topical use on the skin in a concentration equivalent to 2% or less of diclofenac for not more than 7 days.

Effective Date: from the date of this Notice

Should you have any questions on this update to the Prescription Drug List, please contact:

Prescription Drug Status Committee
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9

Email: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca
Phone: 613-957-1058
Fax: 613-941-5035