Notice: Prescription Drug List (PDL): Multiple Additions

Date: December 21, 2020
Our file number: 20-117402-338

The purpose of this Notice of Amendment is to notify about the additions of fostamatinib, givosiran, lemborexant, luspatercept, ozanimod, trientine, and voretigene neparvovec 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
Fostamatinib or its salts - -
Givosiran or its salts - -
Lemborexant or its salts - -
Luspatercept - -
Ozanimod or its salts - -
Trientine or its salts - -
Voretigene neparvovec - -

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.

DAYVIGO (lemborexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, with or without associated impairment in daily functioning.

GIVLAARI (givosiran) is indicated for the treatment of acute hepatic porphyria (AHP) in adults and adolescents 12 years and older.

LUXTURNA (voretigene neparvovec) is indicated for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

MAR-TRIENTINE (trientine hydrochloride) is indicated in the treatment of patients with Wilson's disease who are intolerant to penicillamine.

REBLOZYL (luspatercept for injection) is an erythroid maturation agent indicated for the treatment of adult patients with beta(β)-thalassemia-associated anemia who require red blood cell (RBC) transfusions.

TAVALISSE (fostamatinib disodium hexahydrate) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments.

ZEPOSIA (ozanimod) is indicated for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations.

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

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