Notice: Prescription Drug List: Multiple additions

May 11, 2018
Our file number: 18-105015-690

The purpose of this Notice of Amendment is to notify about the additions of Benralizumab, Brodalumab, Cidofovir, Flibanserin, Halofuginone (veterinary only), Inotuzumab ozogamicin, Ribociclib, Sucroferric oxyhydroxide, Methoxyfluran and Follitropin delta (added to the “Including’’ column of the “Follicle stimulating hormone entry’’) to the Human and/or 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.

FASENRA (benralizumab injection) is indicated as an add-on maintenance treatment of adult patients with severe eosinophilic asthma.

SILIQ (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Mar-Cidofovir is indicated for the treatment of cytomegalovirus (CMV) retinitis in adult patients having acquired immunodeficiency syndrome (AIDS). 

ADDYI (flibanserin) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire for a minimum of 6 months, which occurs 75-100% of the time, that causes marked distress or interpersonal difficulty and is NOT due to:

• A co-existing medical or psychiatric condition
• Problems within the relationship, or
• The effects of a medication or other drug substance

HALAGON (Halofuginone) is an anti-protozoal solution indicated as an aid in reducing clinical signs of cryptosporidiosis caused by Cryptosporidium parvum in newborn calves, when administered orally (after colostrum or milk/milk replacer feeding) for the first 7 days of life at a dosage of 100 µg of halofuginone base per kg of body weight.

BESPONSA (inotuzumab ozogamicin for injection) is indicated as a:

• Monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL)

KISQALI (ribociclib tablets) is indicated:

• in combination with letrozole for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as an initial endocrine-based therapy

Velphoro (sucroferric oxyhydroxide) is indicated for the control of serum phosphorus levels in adult patients with end-stage renal disease (ESRD) on dialysis.

PENTHROX (methoxyflurane) is indicated for short-term relief of moderate to severe acute pain, associated with trauma or interventional medical procedures, in conscious adult patients.

REKOVELLE (follitropin delta injection) is indicated for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

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