Notice –Prescription Drug List (PDL): Multiple Additions

December 24, 2014

Our file number: 14-115587-311

Notice

The purpose of this Notice of Amendment is to notify the addition of Vortioxetine hydrobromide, Obinutuzumab, Siltuximab, Alpha Hydroxy Acids and Salicyclic Acid to both the Human and Veterinary Prescription Drug List (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.

Vortioxetine hydrobromide (BRINTELLIX) is indicated for the treatment of major depressive disorder (MDD) in adults. Vortioxetine hydrobromide should only be prescribed by physicians who are experienced in the diagnosis and management of Major Depressive Disorder, and can assess the benefit to risk of prescribing this drug to their patients.

Obinutuzumab (GAZYVA) in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL). CLL is diagnosed by the physicians with specific laboratory tests. GAZYVA should be administered as an intravenous infusion through a dedicated line in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced physician.

Siltuximab (SYLVANT) is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative. SYLVANT should be administered via intravenous infusion (IV) by qualified healthcare professionals, as patients may suffer serious infusion-related adverse drug reactions during treatment with Siltuximab.

Alpha hydroxyl acids are used, alone or in combination with other ingredients, as part of an in-office chemical peel procedure. Chemical peels with a high concentration of acids or a low pH are commonly used in clinical practice. Due to the complexity as well as risks associated with these procedures, peels are best performed and/or supervised by dermatologists and plastic surgeons.

Salicylic acid is used, alone or in combination with other ingredients, as part of in-office chemical peel procedures, indicated mostly for the treatment and/or management of hyperpigmentation, melasma and moderate comedonal or inflammatory acne. Chemical peels with a high concentration of acids or a low pH are commonly used in clinical practice. Due to the complexity as well as risks associated with these procedures, peels are best performed and/or supervised by dermatologists and plastic surgeons.

Additional information on how Health Canada now 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: 613-941-5035
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca