Notice: Prescription Drug List (PDL): Fluticasone propionate

February 26, 2016
Our file number: 16-101933-448

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 exempt certain uses of Fluticasone propionate. Health Canada has conducted a scientific review of Fluticasone propionate 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 remains unchanged from what was proposed in the November 27, 2015 Notice of Consultation, is:

Drugs containing any of the following: Adrenocortical hormones or their salts or derivatives

Including (but not limited to): Betamethasone valerate, betamethasone sodium, betamethasone phosphate, betamethasone dipropionate, budesonide, ciclesonide, clobetasone, cortisone, dexamethasone sodium, dexamethasone phosphate, dexamethasone acetate, difluprednate, fludrocortisone acetate, flunisolide, fluticasone propionate, fluticasone furoate, hydrocortisone acetate, hydrocortisone aceponate, hydrocortisone sodium, methylprednisolone acetate, methylprednisolone, methylprednisolone succinate, methylprednisolone sodium, mometasone furoate, prednisolone acetate, prednisolone sodium, prednisolone phosphate, prednisone, triamcinolone acetonide, triamcinolone hexacetonide

Qualifier: Fluticasone propionate for the treatment of allergic rhinitis in a nasal spray that delivers 50 microgram/spray for those 18 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, 2015. The 75 day consultation period which ended February 10, 2016 has been completed.

Only one comment was received and it was favourable.

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, 2^nd 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: 613-941-1812