Notice: Multiple additions to the Prescription Drug List (PDL) [2025-08-28]

August 28, 2025

Our file number: 25-105622-852

The purpose of this Notice of Amendment is to announce the addition of artesunate, crovalimab, osilodrostat, and quizartinib to the Prescription Drug List (PDL) for human and veterinary use (see Table 1), and the amendment to the qualifier of the "Benzoyl peroxide" PDL entry for human use (see Table 2).

Table 1: New medicinal ingredients to be added to the human and veterinary parts of the PDL

Drugs containing any of the following	Including (but not limited to)	Qualifier
Artesunate or its salts	N/A	N/A
Crovalimab	N/A	N/A
Osilodrostat or its salts	N/A	N/A
Quizartinib or its salts	N/A	N/A

Table 2: Amendment to the human part of the PDL (addition in bold)

Drugs containing any of the following	Including (but not limited to)	Qualifier
Benzoyl peroxide	N/A	in concentrations greater than 5% or when sold in combination with another medicinal ingredient or when sold for the treatment of rosacea

These additions and the amendment 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.

Amivas-Artesunate (artesunate) is indicated for:

• The initial treatment of severe malaria in adult and pediatric patients.

Epsolay (benzoyl peroxide cream) is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults.

Isturisa (osilodrostat) is indicated for:

• the treatment of adult patients with Cushing's disease who have persistent or recurrent hypercortisolism after primary pituitary surgery and/or irradiation, or for whom pituitary surgery is not an option.

Piasky (crovalimab for injection) is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and adolescents 13 years of age and older with a body weight of at least 40 kg.

Vanflyta (quizartinib) is indicated:

• in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA maintenance monotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3- ITD) positive.

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 regarding this notice, please contact:

Health Canada
Pharmaceutical Drugs Directorate
Bureau of Policy, Science and International Programs
Office of Science

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