Notice: Prescription Drug List (PDL): Multiple additions [2018-07-25]

July 25^th, 2018
Our file number: 18-109017-258

The purpose of this Notice of Amendment is to notify about the additions of:

• Calcifediol, Tezacaftor, and Apalutamide to the Human and Veterinary Prescription Drug List (PDL)
• Iron isomaltoside 1000 to the “including (but not limited to)” column of iron derivatives of the Human Prescription Drug List (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.

RAYLADEE (calcifediol) is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adults with Stage 3 or 4 Chronic Kidney Disease (CKD) at initiation and low serum 25-hydroxyvitamin D levels.

SYMDEKO (tezacaftor/ivacaftor) is indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

ERLEADA (apalutamide) is indicated for the treatment of patients with castration-resistant prostate cancer who have no detectable distant metastases by either CT scan, MRO or technetium-99m bone scan.

MONOFERRIC (iron isomaltoside 1000) is indicated for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used and where there is a clinical need to deliver iron rapidly.

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
Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca