Notice: Prescription Drug List (PDL): Multiple Additions
Date: November 29, 2019
Our file number: 19-122114-257
The purpose of this Notice of Amendment is to notify about the additions of Bacillus Calmette-Guérin (BCG), edaravone, erdafitinib, plecanatide and talazoparib to the Prescription Drug List (PDL) for human and veterinary use.
The new drugs will be added to the PDL as the following:
|Drugs containing any of the following||Including (but not limited to)||Qualifier|
|Bacillus Calmette-Guérin (BCG)||Bacillus Calmette-Guérin (BCG), Strain TICE||when sold or recommended as an antineoplastic agent|
|Edaravone or its derivatives||-||-|
|Erdafitinib or its salts||-||-|
|Talazoparib or its salts||-||-|
These additions are effective at the time of posting.
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.
Bacillus Calmette-Guérin (BCG), Strain TICE (OncoTICE) is indicated for treatment of primary or relapsing flat urothelial cell carcinoma in situ (CIS) of the urinary bladder, and as an adjuvant therapy after a transurethral resection (TUR) of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage TA (grade 2 or 3) or T1 (grade 1, 2, or 3). It is only recommended for stage TA grade 1 papillary tumors, when there is judged to be a high risk of tumor recurrence.
Bacillus Calmette-Guérin (BCG), Strain TICE (OncoTICE) is not indicated for the treatment of invasive bladder cancer. It is not recommended for papillary tumors of stages higher than T1.
Edaravone (RADICAVA) is indicated for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Erdafitinib (BALVERSA) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC), whose tumors have susceptible fibroblast growth factor receptor (FGFR)2 or FGFR3 genetic alterations and who have disease progression during or following at least one line of prior chemotherapy, including within 12 months of neoadjuvant or adjuvant chemotherapy.
Plecanatide (TRULANCE) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Talazoparib (TALZENNA) is indicated as a monotherapy for the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)‑mutated human epidermal growth factor receptor 2 (HER2)‑negative locally advanced (not amendable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments.
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:
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
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