Notice of Amendment: Iron derivatives for human use on the Prescription Drug List (PDL)
October 4, 2024
Our file number: 24-109388-925
The purpose of this Notice of Amendment is to notify about the addition of 'ferric carboxymaltose' to the "including (but not limited to)" column and 'ferric maltol' with a qualifier to the "including (but not limited to)" and "qualifier" columns of the "Iron derivatives" listing on the human part of the Prescription Drug List (PDL). This addition does not apply to veterinary drugs.
The previous listing read:
| Drugs containing any of the following | Including (but not limited to) | Qualifier | Effective date (yyyy-mm-dd) |
|---|---|---|---|
| Iron derivatives | Ferumoxytol Iron isomaltoside 1000 | for parenteral use only | 2013-12-20 |
The new listing reads:
| Drugs containing any of the following | Including (but not limited to) | Qualifier | Effective date (yyyy-mm-dd) |
|---|---|---|---|
| Iron derivatives | Ferumoxytol, Iron isomaltoside 1000, Ferric carboxymaltose, Ferric maltol |
|
2024-10-04 |
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.
Ferinject (ferric carboxymaltose) is indicated:
- for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older when oral iron preparations are not tolerated or are ineffective.
- for the treatment of iron deficiency (ID) in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity.
Accrufer (ferric maltol capsules) is indicated for the treatment of
- Iron deficiency anemia in adult patients who are unresponsive or intolerant to other oral iron preparations.
The addition of ferric maltol with a qualifier regarding its approved indication to the human part of the PDL does not affect the status of other oral iron supplements that are not sold for this indication, which are currently licenced under the Natural Health Products Regulations (NHPR). These products have been reviewed and approved as natural health products under the NHPR and are available without a prescription. This remains unchanged.
Next steps
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 this addition to the Prescription Drug List, please contact:
Health Canada
Pharmaceutical Drugs Directorate
Bureau of Policy, Science and International Programs
Office of Science
E-mail: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
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