Notice - Prescription Drug List (PDL): Multiple additions

April 21, 2017
Our file number: 17-104599-650

The purpose of this Notice of Amendment is to notify the additions of Brexpiprazole, Necitumumab, Pegaspargase, and Vernakalant hydrochloride to the Human and Veterinary Prescription Drug Lists (PDL). Health Canada is also adding Ceftolozane to Cephalosporin C's salts and derivatives. 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.

Brexpiprazole (REXULTI) is indicated for treatment of schizophrenia in adults.

Ceftolozane, in combination with tazobactam (ZERBAXA) is indicated for the treatment of complicated intra-abdominal and urinary tract infections, including pyelonephritis in patients 18 years of age or older.

Necitumumab (PORTRAZZA) is indicated, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.

Pegaspargase (ONCASPAR) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukaemia (ALL).

Vernakalant hydrochloride (BRINAVESS) is indicated for rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm, for non-surgery patients with duration of AF less than or equal to 7 days, and for post-cardiac surgery patients with duration of AF less than or equal to 3 days.

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: 613-957-1058
Facsimile: 613-941-1812
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

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