Notice: Multiple additions to the Prescription Drug List (PDL) [2026-04-30]
April 30, 2026
Our file number: 26-102300-470
The purpose of this Notice of Amendment is to announce the addition of atinvicitinib, mosunetuzumab, nadofaragene firadenovec, palopegteriparatide, relebactam, rifapentine, and sevabertinib to the Prescription Drug List (PDL) for human and/or veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Mosunetuzumab | N/A | N/A |
| Nadofaragene firadenovec | N/A | N/A |
| Palopegteriparatide | N/A | N/A |
| Relebactam or its salts | N/A | N/A |
| Rifapentine or its salts | N/A | N/A |
| Sevabertinib | N/A | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Atinvicitinib or its salts | N/A | N/A |
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.
Adstiladrin (nadofaragene firadenovec) is indicated for:
- Treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
Hyrnuo (sevabertinib) is indicated for:
- the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations and who have received a prior systemic therapy.
Lunsumio (mosunetuzumab for injection) is indicated:
- As monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (Grades 1 – 3a) who have received at least two prior lines of systemic therapy.
Numelvi (atinvicitinib) is indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older and weighing 2 kg or greater.
Recarbrio (relebactam) is indicated for the treatment of patients with the following infections caused by the designated susceptible Gram-negative microorganisms:
- Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)
Recarbrio is indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Acinetobacter calcoaceticus-baumannii complex, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.
- Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
Recarbrio is indicated in patients 18 years of age and older who have limited or no alternative treatment options for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
- Complicated Intra-abdominal Infections (cIAI)
Recarbrio is indicated in patients 18 years of age and older who have limited or no alternative treatment options for the treatment of complicated intra-abdominal infections (cIAI) caused by Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis, and Pseudomonas aeruginosa.
Rifapentine tablets (rifapentine) are indicated for:
- the treatment of latent tuberculosis infection (LTBI) caused by Mycobacterium tuberculosis in combination with isoniazid in patients 2 years of age and older at high risk of progression to tuberculosis disease.
Yorvipath (palopegteriparatide injection) is a parathyroid hormone (PTH) replacement therapy indicated for the treatment of chronic hypoparathyroidism in adults.
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