Notice: Prescription Drug List (PDL): Multiple additions [2017-08-04]

August 4, 2017
Our file number: 17-108135-629

The purpose of this Notice of Amendment is to notify the additions of Cysteamine (Mercaptamine) and Nusinersen to the Human and Veterinary Prescription Drug Lists (PDL). 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.

Cysteamine (Mercaptamine) delayed-release capsules (PROCYSBI) is indicated for the treatment of nephropathic cystinosis. PROCYSBI treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis.

Nusinersen (SPINRAZA) is indicated for the treatment of 5q Spinal Muscular Atrophy (SMA).

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: 343-998-9304
Facsimile: 613-941-1812
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

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