Notice: Prescription Drug List (PDL): Multiple Additions

Date: March 5, 2019
Our file number: 19-104186-899

The purpose of this Notice of Amendment is to notify about the additions of:

• celiponase alfa, decitabine, isavuconazole and safinamide to the Prescription Drug List (PDL) for human and veterinary use,
• latanoprostene bunod to the “including (but not limited to)” column of the “Prostaglandins or their salts or derivatives or analogues” entry on the PDL for human and veterinary use, and
• grapiprant to the PDL for veterinary use.

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.

BRINEURA (cerliponase alfa injection) is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.

DEMYLOCAN (decitabine injection) is indicated for the treatment of adult patients with:

• Myelodysplastic Syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.

GALLIPRANT (grapiprant tablets) is indicated for the treatment and control of pain and inflammation associated with osteoarthritis in dogs.

CRESEMBA (isavuconazole, as isavuconazonium sulfate) is an azole antifungal indicated for use in adults for the treatment of:

• Invasive aspergillosis
• Invasive mucormycosis

VYZULTA (latanoprostene bunod ophthalmic solution, 0.024%) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

ONSTRYV (safinamide tablets) is indicated as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD) in patients experiencing “off” episodes while on a stable dose of levodopa.

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

Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca
Telephone: 343-998-9304
Facsimile: 613-941-1812