Notice: Prescription Drug List (PDL): Multiple Additions

Date: November 15, 2021
Our file number: 21-119409-776

The purpose of this Notice of Amendment is to notify about the additions of Dequalinium chloride, Enfortumab vedotin, Somatrogon, and Tralokinumab to the Prescription Drug List (PDL) for human and veterinary use.

The new medicinal ingredients will be added to the PDL as the following:

Drugs containing any of the following Including (but not limited to) Qualifier
Dequalinium chloride - when sold for the treatment of bacterial vaginosis
Enfortumab vedotin - -
Somatrogon - -
Tralokinumab - -

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.

ADTRALZA (tralokinumab injection) is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

NGENLA (somatrogon) is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency).

PADCEV (enfortumab vedotin for injection) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and programmed death receptor- or programmed death-ligand 1 inhibitor therapy.

VABLYS (dequalinium chloride) is indicated for the treatment of bacterial vaginosis in adult women under 55 years of age. Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

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
Therapeutic Products Directorate
Office of Science

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

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