Notice: Prescription Drug List (PDL): Mometasone furoate
February 12, 2015
Our file number: 15-101776-40
The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to allow the nonprescription use of Mometasone furoate for the conditions listed below. Health Canada has conducted a scientific review of Mometasone furoate against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which has changed from what was proposed in the November 27, 2014 Notice of Consultation, is:
Drugs containing the following: Adrenocortical hormones or their salts or derivatives
Including (but not limited to): Hydrocortisone, Hydrocortisone acetate, Hydrocortisone valerate, Hydrocortisone sodium succinate, Clobetasone butyrate, Difluprednate and Mometasone furoate
Qualifier: Mometasone furoate for the treatment of allergic rhinitis in a nasal spray that delivers 50 mcg/spray for those 12 years of age and older.
Effective Date: Six months from date of this Notice
Consultation summary:
The proposal to amend the PDL was communicated to provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations through a Notice of Consultation posted on Health Canada’s website on November 27, 2014. The 75 day consultation period which ended February 9, 2015 has been completed.
Two comments were received and both were favourable. As a result of consultation, ‘monohydrate’ from the Mometasone furoate PDL listing has been removed to permit non-prescription status of bioequivalent forms of the drug.
This revision will be in effect six months from the date of this Notice through a Notice of Amendment posted on the Health Canada website.
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