Notice: Prescription Drug List (PDL): Multiple Additions

Janurary 4, 2018
Our reference number: 17-114235-356

The purpose of this Notice of Amendment is to notify about the additions of durvalumab, glycopyrrolate, letermovir, migalastat, netupitant/palonosetron hydrochloride to the Human and Veterinary Prescription Drug Lists (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.

Durvalumab (IMFINZI) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

• Have disease progression during or following platinum-containing chemotherapy.
• Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Glycopyrrolate (CUVPOSA) is indicated to reduce chronic severe drooling in patients aged 3-18 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

Letermovir (PREVYMIS) is indicated for the prophylaxis of cytomegalovirus (CMV) infection in adult CMV-seropositive recipients [R+] of an allogenic hematopoietic stem cell transplant (HSCT).

Migalastat (GALAFOLD) is indicated for the long-term treatment of adults with a confirmed diagnosis of Fabry disease [deficiency of α-galactosidase (α-Gal A)] and who have an α-Gal A mutation determined to be amenable by an in vitro assay.

Netupitant/palonosetron hydrochloride (AKYNZEO) in combination with dexamethasone, is indicated for once-per-cycle treatment in adult patients for:

• Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.
• Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 (serotonin) receptor antagonist alone.

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
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca