Notice: Multiple additions to the Prescription Drug List (PDL) [2025-02-26]
February 26, 2025
Our file number: 25-101236-477
The purpose of this Notice of Amendment is to notify about (1) the addition of fezolinetant, iptacopan, and zolbetuximab to the Prescription Drug List (PDL) for human and veterinary use, and (2) the status of segesterone acetate by adding it to the “Including (but not limited to)” column of the “Sex hormones (Natural or synthetic)” PDL entry for human use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Fezolinetant or its salts | N/A | N/A |
| Iptacopan or its salts | N/A | N/A |
| Zolbetuximab | N/A | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Sex hormones (Natural or synthetic) | Conjugated estrogens, desogestrel, dienogest, estradiol benzoate, estradiol(hemihydrate), estrone, ethinyl estradiol, ethynodiol diacetate, etonogestrel, levonorgestrel, medroxyprogesterone acetate, norelgestromin, norethindrone acetate, norgestimate, progesterone, segesterone acetate | except the following: Androisoxazole, androstanolone, androstenediol or its derivatives, bolandiol or its derivatives, bolasterone, bolazine, boldenone or its derivatives, bolenol, calusterone, clostebol or its derivatives, drostanolone or its derivatives, enestebol, epitiostanol, ethylestrenol, fluoxymesterone, formebolone, furazabol, 4-Hydroxy-19-nortestosterone or its derivatives, levonorgestrel when sold as a single ingredient in an oral dosage form containing no more than 1.5 milligrams, mebolazine,mesabolone, mesterolone, metandienone, metenolone or its derivatives, methandriol, methyltestosterone or its derivatives, metribolone, mibolerone, nandrolone or its derivatives, norboletone, norclostebol or its derivatives, norethandrolone, oxabolone or its derivatives, oxandrolone, oxymesterone, oxymetholone, prasterone, quinbolone, stanozolol, stenbolone or its derivatives, testosterone or its derivatives, tibolone, tiomesterone, trenbolone or its derivatives, zeranol |
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.
Fabhalta (iptacopan capsules) is indicated as:
- monotherapy in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia.
Ringza (segesterone acetate and ethinyl estradiol vaginal system) is indicated for use by women of reproductive potential to prevent pregnancy.
Veozah (fezolinetant film-coated tablets) is indicated for:
- The treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
Vyloy (zolbetuximab for injection), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive as determined by a validated test.
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 regarding this notice, please contact:
Health Canada
Pharmaceutical Drugs Directorate
Bureau of Policy, Science and International Programs
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
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