← HealthArchive.ca
Product monograph brand safety updates - Canada.ca
2026-04-11 www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/label-safety-assessment-update/product-monograph-brand-safety-updates.html
Independent archive · Not an official government website · Archived content may be outdated
View replayView diffDetailsMetadata JSONCiteReport issueAll snapshots
Product monograph brand safety updates - Canada.ca

Language selection

Government of Canada / Gouvernement du Canada

Search

Product monograph brand safety updates

On this page

March 2026

Product Monograph Brand Safety Updates – March 2026
(PDF, 98 KB, 2 pages)
Product Monograph Brand Safety Updates March 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Burinex 300221 Bumetanide Karo Pharma AB No Yes Yes Yes No No No Yes
Dalacin C Flavoured Granules 302992 Clindamycin 2-Palmitate Hcl Pfizer Canada ULC No No No Yes No No No No
Depo-Provera 303474 Medroxyprogesterone Acetate Pfizer Canada ULC No Yes No No No No No Yes
Erleada 303988 Apalutamide Janssen Inc No Yes No Yes No Yes No Yes
Gen-Clozapine 301204 Clozapine Mylan Pharmaceuticals ULC No Yes Yes Yes Yes Yes No Yes
Invokamet 302110 Canagliflozin, Metformin Hydrochloride Janssen Inc No Yes No No Yes No No Yes
Jublia 301714 Efinaconazole Bausch Health, Canada Inc No Yes No No No No No Yes
Kisqali 300035 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No No No No Yes No No Yes
Lazcluze 304266 Lazertinib Mesylate Janssen Inc No No No Yes No No No No
Lipiodol Ultra Fluid 302675 Iodine Guerbet No Yes No Yes No No No Yes
Lokelma 297017 Sodium Zirconium Cyclosilicate AstraZeneca Canada Inc No Yes No Yes No No No Yes
Malarone, Malarone Pediatric 302795 Atovaquone, Proguanil Hydrochloride GlaxoSmithKline Inc No Yes No Yes No No No Yes
Mepron 302092 Atovaquone GlaxoSmithKline Inc No Yes No No No No No Yes
Ojjaara 303806 Momelotinib Dihydrochloride GlaxoSmithKline Inc No No No Yes No No No Yes
Onureg 302935 Azacitidine Bristol-Myers Squibb Canada No No No Yes No No No Yes
Paxlovid 303524 Ritonavir, Nirmatrelvir Pfizer Canada ULC No No No No Yes No No Yes
Skyclarys 302250 Omaveloxolone Biogen Canada Inc No Yes No No No No No No
Tepadina 299984 Thiotepa Adienne SA No No No No No Yes No Yes
Valtrex 302417 Valacyclovir Hydrochloride GlaxoSmithKline Inc No Yes No Yes No No No Yes
Vanflyta 304290 Quizartinib Hydrochloride Daiichi Sankyo Pharma Canada Limited No No No No Yes Yes No Yes
Wellbutrin XL 303598 Bupropion Hcl Bausch Health, Canada Inc No Yes Yes Yes Yes No Yes Yes
Voltaren Emulgel Extra Strength, Voltaren Emulgel Joint Pain Extra Strength 302636 Diclofenac Diethylamine Haleon Canada ULC No No No No No No No Yes

February 2026

Product Monograph Brand Safety Updates - February 2026
(PDF, 147 KB, 2 pages)

Product Monograph Brand Safety Updates February 2026
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Advil Flu 299797 Diphenhydramine Hcl, Ibuprofen Haleon Canada ULC Yes Yes No Yes Yes No Yes Yes
Arava 302223 Leflunomide Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Avapro 301515 Irbesartan Sanofi-Aventis Canada Inc No No No No No Yes No Yes
Brilinta 301482 Ticagrelor AstraZeneca Canada Inc No No No No Yes No No No
Cellcept, Cellcept I.V. 301684 Mycophenolate Mofetil Hoffmann-La Roche Limited Yes Yes No Yes No No No Yes
Cibinqo 295649 Abrocitinib Pfizer Canada ULC No Yes No Yes Yes No Yes Yes
Crestor 301623 Rosuvastatin Calcium AstraZeneca Canada Inc No No No No Yes No No No
Endometrin 289215 Progesterone Ferring Inc No Yes No No No No No Yes
Entresto 302188 Valsartan, Sacubitril Novartis Pharmaceuticals Canada Inc No No No No Yes No No Yes
Flagyl 301739 Metronidazole Sanofi-Aventis Canada Inc No No No Yes No No No Yes
Kaletra 300861 Ritonavir, Lopinavir Abbvie Corporation No No No No Yes Yes No Yes
Koselugo 296426 Selumetinib Sulfate Alexion Pharma GmbH No Yes No Yes No Yes No Yes
Lorbrena 302451 Lorlatinib Pfizer Canada ULC No No No No No Yes No Yes
Mekinist 302302 Trametinib Dimethyl Sulfoxide Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Mektovi 303277 Binimetinib Pfizer Canada ULC No No No Yes No No No No
Nexium 24Hr 301457 Esomeprazole Magnesium Trihydrate Haleon Canada ULC No No No Yes Yes No No Yes
Nexplanon 296676 Etonogestrel Organon Canada Inc No Yes No No No Yes No Yes
Quillivant ER Chewable Tablets, Quillivant ER Oral Suspension 293983 Methylphenidate Hcl Kye Pharmaceuticals Inc No Yes No Yes Yes No No Yes
Retevmo 299183 Selpercatinib Eli Lilly Canada Inc No No No No No Yes No Yes
Retevmo 302404 Selpercatinib Eli Lilly Canada Inc No No No Yes No No No No
Tafinlar 302308 Dabrafenib Mesylate Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Talzenna 295977 Talazoparib Tosylate Pfizer Canada ULC No Yes Yes Yes No Yes No Yes
Tepadina 294703 Thiotepa Adienne SA No Yes No Yes Yes Yes No Yes
Velsipity 301821 Etrasimod L-Arginine Pfizer Canada ULC No Yes No No No Yes No No
Zepbound 300243 Tirzepatide Eli Lilly Canada Inc No No No No No No No Yes

January 2026

Product Monograph Brand Safety Updates - January 2026
(PDF, 122 KB, 1 page)

Product Monograph Brand Safety Updates January 2026
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Apo-Warfarin 299674 Warfarin Sodium Apotex Inc Yes Yes No Yes Yes No No Yes
Apo-Warfarin 299719 Warfarin Sodium Apotex Inc Yes Yes No Yes Yes No No Yes
Canesoral, Canesoral Combi 1 Day 301044 Fluconazole, Clotrimazole Bayer Inc Yes Yes No Yes Yes Yes Yes Yes
Estring 299282 Estradiol Pfizer Canada ULC No Yes No No No No No Yes
Gleevec 300958 Imatinib Mesylate Novartis Pharmaceuticals Canada Inc No No No No Yes No Yes Yes
Jornay PM 299588 Methylphenidate Hcl Knight Therapeutics Inc No Yes Yes No No No No Yes
Kerendia 295025 Finerenone Bayer Inc No Yes No Yes No Yes No Yes
Livmarli 292796 Maralixibat Chloride Mirum Pharmaceuticals, Inc Yes Yes No Yes No Yes Yes Yes
Plaquenil 301591 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Primaquine 301045 Primaquine Phosphate Sanofi-Aventis Canada Inc No No No No Yes No No No
Prostin VR Sterile Solution 299636 Alprostadil Pfizer Canada ULC No Yes No No No Yes No Yes
Provera 299285 Medroxyprogesterone Acetate Pfizer Canada ULC No Yes No No No No No Yes
Talzenna 288630 Talazoparib Tosylate Pfizer Canada ULC No Yes No Yes No No No No
Teva-Glatiramer Acetate 299580 Glatiramer Acetate Teva Canada Limited No Yes Yes No No No No Yes
Trikafta 300668 Elexacaftor, Ivacaftor, Tezacaftor Vertex Pharmaceuticals (Canada) Incorporated No No No No Yes Yes No Yes
Xtandi 300782 Enzalutamide Astellas Pharma Canada Inc No No No Yes Yes No No Yes

December 2025

Product Monograph Brand Safety Updates - December 2025
(PDF, 203 KB, 2 pages)

Product Monograph Brand Safety Updates December 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Advagraf 300193 Tacrolimus Astellas Pharma Canada Inc No Yes No Yes No No No Yes
Amvuttra 294120 Vutrisiran Sodium Alnylam Netherlands B.V. No No No Yes No Yes No Yes
Apo-Tizanidine 298082 Tizanidine Hcl Apotex Inc Yes Yes No No No Yes No Yes
Balversa 291396 Erdafitinib Janssen Inc No Yes No Yes Yes Yes No Yes
Cabometyx 300158 Cabozantinib Malate Ipsen Biopharmaceuticals Canada Inc No Yes No Yes No Yes No No
Celexa 299602 Citalopram Hydrobromide Lundbeck Canada Inc No No No Yes No No No Yes
Cymbalta 294797 Duloxetine Hydrochloride Eli Lilly Canada Inc No Yes Yes Yes No No No Yes
Estradot 299281 Estradiol Sandoz Canada Incorporated No Yes No No No No No Yes
Glycopyrrolate Injection USP 299602 Glycopyrrolate Sandoz Canada Incorporated Yes No No No No No No Yes
Imbruvica 300329 Ibrutinib Janssen Inc No Yes No Yes No No No Yes
Imitrex DF, Imitrex 299824 Sumatriptan Hemisulfate, Sumatriptan Succinate GlaxoSmithKline Inc No Yes No Yes No No No Yes
Imovane 300774 Zopiclone Sanofi-Aventis Canada Inc No Yes No No No No Yes Yes
Lipidil EZ 298755 Fenofibrate BGP Pharma ULC Yes No No No Yes No No Yes
Maviret 298254 Glecaprevir, Pibrentasvir Abbvie Corporation No Yes No Yes No No No Yes
Moviprep 300484 Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Ascorbic Acid, Sodium Chloride, Sodium Ascorbate, Potassium Chloride Aralez Pharmaceuticals Canada Inc No Yes No No No No No Yes
Naprosyn 300479 Naproxen Searchlight Pharma Inc No Yes No No No No No Yes
Plendil 297826 Felodipine Glenwood GmbH Pharmazeutische Erzeugnisse Yes Yes No Yes Yes No No Yes
Prograf 300195 Tacrolimus Astellas Pharma Canada Inc No Yes No Yes No No No Yes
Qinlock 300383 Ripretinib Deciphera Pharmaceuticals. LLC No Yes No No Yes No No Yes
Rinvoq 299754 Upadacitinib Abbvie Corporation No Yes No No No No No Yes
Sandoz-Carbamazepine CR 299179 Carbamazepine Sandoz Canada Incorporated No Yes No No No No No No
Soliqua 300152 Lixisenatide, Insulin Glargine Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Sublocade 292450 Buprenorphine Indivior UK Limited No Yes Yes Yes Yes Yes No Yes
Volibris 299437 Ambrisentan GlaxoSmithKline Inc No Yes No No No No No No

November 2025

Product Monograph Brand Safety Updates - November 2025
(PDF, 272 KB, 2 pages)

Product Monograph Brand Safety Updates November 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Advil Cold and Sinus Convenience Pack 296106 Pseudoephedrine Hcl, Chlorpheniramine Maleate, Ibuprofen GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes Yes Yes Yes Yes Yes
Aldactone 298870 Spironolactone Pfizer Canada ULC Yes No No No Yes No No Yes
Butrans 298420 Buprenorphine Purdue Pharma No Yes Yes Yes Yes No Yes Yes
Cambia 298910 Diclofenac Potassium Aralez Pharmaceuticals Canada Inc No Yes No Yes No No No No
Cosmegen 297595 Dactinomycin Recordati Rare Diseases Canada Inc No Yes No No No No No Yes
Hydrea 300417 Hydroxyurea Cheplapharm Arzneimittel GmbH No No No No No Yes No Yes
Lupron Depot 290766 Leuprolide Acetate Abbvie Corporation No No No Yes No Yes No No
Multihance 296195 Gadobenate Dimeglumine Bracco Imaging Canada No Yes Yes No No No No Yes
Nolvadex-D 299438 Tamoxifen Citrate AstraZeneca Canada Inc No Yes No No No No No Yes
Nucynta Extended-Release 298761 Tapentadol Hydrochloride Endo Operations Ltd No Yes No No Yes Yes Yes Yes
Prohance 296655 Gadoteridol Bracco Imaging Canada No Yes Yes No No No No Yes
Stivarga 300067 Regorafenib Bayer Inc No Yes Yes Yes No No No Yes
Tygacil 298649 Tigecycline Pfizer Canada ULC No Yes No No No No No Yes
Xeljanz, Xeljanz XR 300057 Tofacitinib Citrate Pfizer Canada ULC No Yes No No No No No Yes
Zoryve 292646 Roflumilast Arcutis Canada, Inc No No No Yes No No No Yes
Zytram XL 298434 Tramadol Hcl Purdue Pharma Yes Yes Yes Yes No No No Yes

October 2025

Product Monograph Brand Safety Updates - October 2025
(PDF, 111 KB, 2 pages)

Product Monograph Brand Safety Updates October 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Aleve Caplets, Aleve Liquid Gels, Aleve Back and Body Pain 296196 Naproxen Sodium Bayer Inc Yes Yes Yes Yes No No No Yes
Aleve Nighttime 296075 Diphenhydramine Hcl, Naproxen Sodium Bayer Inc No Yes No Yes No No No Yes
Ceftin 297795 Cefuroxime Axetil Sandoz Canada Incorporated No Yes Yes Yes No No Yes Yes
Cipro Oral Suspension 297788 Ciprofloxacin Bayer Inc No Yes No Yes No No No Yes
Depakene 289819 Sodium Valproate BGP Pharma ULC No Yes Yes Yes No No No Yes
Dotarem 295809 Gadoterate Meglumine Guerbet No Yes Yes No No No No Yes
Dovato 298499 Lamivudine, Dolutegravir Sodium ViiV Healthcare ULC No No No Yes No No No No
Edarbi 298416 Azilsartan Medoxomil Potassium Bausch Health, Canada Inc. No Yes No Yes No No No Yes
Edarbyclor 298417 Chlorthalidone, Azilsartan Medoxomil Potassium Bausch Health, Canada Inc. No Yes No Yes No No No Yes
Epival 289818 Divalproex Sodium BGP Pharma ULC No Yes Yes Yes No No No Yes
Estrogel 299284 Estradiol Hemihydrate Organon Canada Inc. No Yes No No No No Yes Yes
Glatect 297891 Glatiramer Acetate Pharmascience Inc No Yes Yes Yes No Yes No Yes
Intuniv XR 298089 Guanfacine Hcl Takeda Canada Inc No No No Yes No No Yes No
Itovebi 297792 Inavolisib Hoffmann-La Roche Limited No Yes Yes Yes No No No Yes
Juluca 298480 Rilpivirine Hydrochloride, Dolutegravir Sodium ViiV Healthcare ULC No No No Yes No No No Yes
Maxidol Liquid Gels 296058 Naproxen Sodium Bayer Inc No Yes Yes Yes No No No Yes
Men's Rogaine, Men's Rogaine Foam 5%, Women's Rogaine Foam 5% 294680 Minoxidil Johnson & Johnson Inc No Yes No Yes No Yes Yes Yes
Nucynta IR 298081 Tapentadol Hydrochloride Endo Operations Ltd. No Yes No No Yes Yes Yes Yes
Octasa 298159 Mesalazine Tillotts Pharma AG No Yes No Yes No No No Yes
Octasa 298195 Mesalazine Tillotts Pharma AG No Yes No Yes No No No Yes
Omniscan 296299 Gadodiamide GE Healthcare Canada Inc No Yes Yes No No No No Yes
Opzelura 292164 Ruxolitinib Phosphate Incyte Corporation No Yes No Yes No Yes No Yes
Pediapharm Naproxen Suspension 298245 Naproxen Medexus Pharmaceuticals Inc. No No No No Yes Yes No No
Piqray 293549 Alpelisib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Prezcobix 298215 Darunavir Ethanolate, Cobicistat Janssen Inc No Yes No No No No No Yes
Reactine Allergy Liquid Gels 292612 Cetirizine Hydrochloride McNeil Consumer Healthcare Division of Johnson & Johnson Inc No No No No No No No Yes
Sandoz Fingolimod 299178 Fingolimod Hydrochloride Sandoz Canada Incorporated No Yes No No No No No Yes
Septra Injection, Septra Pediatric Suspension 264277 Sulfamethoxazole, Trimethoprim Aspen Pharmacare Canada Inc. No Yes No No No Yes No Yes
Scemblix 294344 Asciminib Hydrochloride Novartis Pharmaceuticals Canada Inc No No No No Yes No No Yes
Tivicay 298477 Dolutegravir Sodium ViiV Healthcare ULC No No No Yes No No No Yes
Triumeq 298484 Abacavir Sulfate, Lamivudine, Dolutegravir Sodium ViiV Healthcare ULC No No No Yes No No No No
Truqap 298048 Capivasertib AstraZeneca Canada Inc No Yes No Yes No No No Yes
Voydeya 292907 Danicopan Alexion Pharma GmbH No No No Yes Yes Yes No Yes
Zolinza 298605 Vorinostat Merck Canada Inc No Yes No No No No No Yes

September 2025

Product Monograph Brand Safety Updates - September 2025
(PDF, 83 KB, 2 pages)

Product Monograph Brand Safety Updates September 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Adderall XR 296552 Dextroamphetamine Sulfate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Takeda Canada Inc No No No No Yes No No Yes
Advil Mini-Gels 291312 Ibuprofen Haleon Canada ULC Yes Yes Yes No No No No Yes
Aleve Back and Body Pain, Aleve Liquid Gels, Aleve Caplets 291309 Naproxen Sodium Bayer Inc Yes Yes Yes No No No No Yes
Aleve Nighttime 291310 Diphenhydramine Hcl, Naproxen Sodium Bayer Inc No Yes Yes No No No No Yes
Backup Plan Onestep 296514 Levonorgestrel Apotex Inc Yes Yes Yes Yes Yes Yes Yes Yes
Calquence 291668 Acalabrutinib Maleate AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Contrave 296775 Bupropion Hcl, Naltrexone Hydrochloride Bausch Health, Canada Inc No No No No No No No Yes
Daybue 296865 Trofinetide Acadia Pharmaceuticals Inc No No No No Yes No No Yes
Delstrigo 297704 Doravirine, Tenofovir Disoproxil Fumarate, Lamivudine Merck Canada Inc No No No Yes No No No Yes
Elocom 295432 Mometasone Furoate Organon Canada Inc. No No No No No No No Yes
Etibi 295216 Ethambutol Hcl Bausch Health, Canada Inc No Yes Yes Yes Yes No No Yes
Flagyl 297546 Metronidazole Sanofi-Aventis Canada Inc No Yes Yes Yes No No No Yes
Flagystatin 297536 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes Yes Yes No No No Yes
Magnevist 296001 Gadopentetate Dimeglumine Bayer Inc No Yes Yes No No No No Yes
Methotrexate Tablets, USP 294607 Methotrexate Pfizer Canada ULC No Yes No No No No No No
Naropin 295134 Ropivacaine Hcl Aspen Pharmacare Canada Inc No Yes No No No No No No
Neuleptil 297466 Periciazine Searchlight Pharma Inc Yes Yes No Yes Yes Yes No Yes
Opsumit 282456 Macitentan Janssen Inc No Yes No Yes No Yes No Yes
Pifeltro 297710 Doravirine Merck Canada Inc No No No Yes No No No Yes
Spinraza 291208 Nusinersen Sodium Biogen Canada Inc No No No Yes No No No No
Tracleer 297201 Bosentan Monohydrate Janssen Inc No Yes No Yes No No No Yes
Ventolin Diskus 296330 Salbutamol Sulfate GlaxoSmithKline Inc No Yes No No No No No Yes
Vyvanse 296290 Lisdexamfetamine Dimesylate Takeda Canada Inc Yes No No No Yes No Yes No
Xarelto 297542 Rivaroxaban Bayer Inc No Yes No Yes Yes No No Yes

August 2025

Product Monograph Brand Safety Updates - August 2025
(PDF, 81.4 KB, 2 pages)

Product Monograph Brand Safety Updates August 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Abilify Asimtufii 294960 Aripiprazole Otsuka Pharmaceutical Co Ltd No Yes Yes No No No No Yes
Abilify Maintena 295837 Aripiprazole Otsuka Pharmaceutical Co Ltd No Yes Yes No No Yes No Yes
Advil Plus Acetaminophen 289055 Acetaminophen, Ibuprofen Haleon Canada ULC Yes Yes Yes No No No Yes Yes
Androgel 289983 Testosterone BGP Pharma ULC No Yes No Yes Yes Yes No Yes
Brevicon 0.5/35 Tablets (21 Day Pack), Brevicon 1/35 Tablets (21 Day Pack), Brevicon 0.5/35 Tablets (28 Day Pack), Brevicon 1/35 Tablets (28 Day Pack) 294278 Ethinyl Estradiol, Norethindrone Pfizer Canada ULC No No No No No No No Yes
Evrysdi 287978 Risdiplam Hoffmann-La Roche Limited No No No No Yes Yes No Yes
Min-Ovral 21, Min-Ovral 28 294279 Levonorgestrel, Ethinyl Estradiol Pfizer Canada ULC No No No No Yes No No Yes
Nubeqa 291388 Darolutamide Bayer Inc No Yes No Yes No Yes No Yes
Optiray 300, Optiray 320, Optiray 350 293582 Ioversol Liebel-Flarsheim Company LLC No Yes No Yes Yes Yes No Yes
Paxlovid 289904 Ritonavir, Nirmatrelvir Pfizer Canada ULC No Yes No No No No No Yes
Rinvoq 290301 Upadacitinib Abbvie Corporation No No No Yes No Yes No Yes
Select 1/35 (21-Day), Select 1/35 (28-Day) 294280 Ethinyl Estradiol, Norethindrone Pfizer Canada ULC No Yes No No No No No Yes
Stivarga 294657 Regorafenib Bayer Inc No No No Yes No No No Yes
Synphasic 21 Tablets, Synphasic 28 Tablets 294281 Ethinyl Estradiol, Norethindrone Pfizer Canada ULC No Yes No No No No No Yes
Tri-Cira 21, Tri-Cira 28 294283 Norgestimate, Ethinyl Estradiol Apotex Inc No No No No Yes No No Yes
Tri-Cira Lo 21, Tri-Cira Lo 28 294285 Norgestimate, Ethinyl Estradiol Apotex Inc No No No No Yes No No Yes
Tri-Jordyna 21, Tri-Jordyna 28 294286 Norgestimate, Ethinyl Estradiol Glenmark Pharmaceuticals Canada Inc No No No No Yes No No Yes
Ubrelvy 291488 Ubrogepant Abbvie Corporation No Yes No No Yes No No Yes
Veklury 290210 Remdesivir Gilead Sciences Canada Inc No No No No Yes No Yes Yes
Ventolin HFA 295222 Salbutamol Sulfate GlaxoSmithKline Inc No Yes No No No Yes No Yes
Ventolin Respirator Solution 295683 Salbutamol Sulfate GlaxoSmithKline Inc No Yes No No No No No Yes
Wainua 290319 Eplontersen Sodium AstraZeneca Canada Inc No No No Yes No No No No

July 2025

Product Monograph Brand Safety Updates – July 2025
(PDF, 91 KB, 3 pages)
Product Monograph Brand Safety Updates July 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Apo-Pravastatin 294008 Pravastatin Sodium Apotex Inc No Yes No Yes No No No No
Auro-Levocarb 295334 Carbidopa, Levodopa Auro Pharma Inc No No No Yes No No No Yes
Avalide 295055 Hydrochlorothiazide, Irbesartan Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Avapro 294898 Irbesartan Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Braftovi 292474 Encorafenib Pfizer Canada ULC No Yes No Yes No Yes No Yes
Bridion 289615 Sugammadex Merck Canada Inc No Yes No Yes No Yes No Yes
Bylvay 289602 Odevixibat Medison Pharma Canada Inc. No Yes No Yes No Yes No Yes
Caduet 294004 Amlodipine Besylate, Atorvastatin Calcium BGP Pharma ULC No Yes No Yes No No No No
Celebrex 295417 Celecoxib BGP Pharma ULC No Yes No Yes No No No No
Clopixol, Clopixol Acuphase, Clopixol Depot 294958 Zuclopenthixol Acetate, Zuclopenthixol Decanoate, Zuclopenthixol Hydrochloride Lundbeck Canada Inc No Yes Yes No Yes No No Yes
Clotrimaderm Vaginal 3, Clotrimaderm Vaginal 6 294676 Clotrimazole Taro Pharmaceuticals Inc Yes Yes No Yes Yes Yes Yes Yes
Clozaril 293275 Clozapine HLS Therapeutics Inc No Yes Yes Yes Yes Yes No Yes
Depo-Medrol With Lidocaine 295207 Lidocaine Hydrochloride, Methylprednisolone Acetate Pfizer Canada ULC No Yes No Yes No No No Yes
Diprivan 1% 295642 Propofol Aspen Pharmacare Canada Inc. No No No Yes Yes No No Yes
Eltroxin 292656 Levothyroxine Sodium Aspen Pharmacare Canada Inc. No No No No No Yes No No
Etoposide Injection 293630 Etoposide Teva Canada Limited No Yes No Yes Yes No No Yes
Ibrance 293492 Palbociclib Pfizer Canada ULC No No No No Yes No No Yes
Jardiance 295840 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Kadian 293099 Morphine Sulfate BGP Pharma ULC No Yes No Yes Yes Yes Yes Yes
Lipitor 294009 Atorvastatin Calcium BGP Pharma ULC No Yes No Yes No No No No
Lovastatin 294001 Lovastatin AA Pharma Inc No Yes No Yes No No No No
Lupron Depot 295706 Leuprolide Acetate Abbvie Corporation No Yes No Yes No No No Yes
Maxidol Liquid Gels 291311 Naproxen Sodium Bayer Inc Yes Yes Yes Yes No Yes Yes Yes
Onivyde 294527 Irinotecan Sucrose Octasulfate Ipsen Biopharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Pomalyst 294588 Pomalidomide Bristol-Myers Squibb Canada No Yes No Yes No No No Yes
Prometrium 295264 Progesterone Organon Canada Inc. Yes Yes No Yes Yes Yes No Yes
Retevmo 289289 Selpercatinib Loxo Oncology Inc No Yes No Yes No No No No
Scemblix 290676 Asciminib Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Sunlenca 295418 Lenacapavir Sodium Gilead Sciences Canada Inc No Yes No No No Yes No Yes
Synjardy 295892 Metformin Hydrochloride, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Teva-Fluvastatin 294005 Fluvastatin Sodium Teva Canada Limited No Yes No Yes No No No No
Thalomid 294589 Thalidomide Bristol-Myers Squibb Canada No No No Yes No No No Yes
Topamax 289202 Topiramate Janssen Inc No Yes No No No No No No
TPOXX 289138 Tecovirimat Monohydrate Siga Technologies, Inc. No No No No Yes No No Yes
Trileptal 294648 Oxcarbazepine Novartis Pharmaceuticals Canada Inc No Yes No No No No No No
Venclexta 289982 Venetoclax Abbvie Corporation Yes Yes Yes Yes Yes Yes No Yes
Verzenio 293494 Abemaciclib Eli Lilly Canada Inc No No No No Yes No No Yes

June 2025

Product Monograph Brand Safety Updates – June 2025
(PDF, 113 KB, 3 pages)
Product Monograph Brand Safety Updates June 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Allegra 12 Hour,
Allegra 24 Hour,
Allegra Hives		 293133 Fexofenadine Hcl Sanofi Consumer Health Inc No No No No Yes No No Yes
Apretude 288201 Cabotegravir, Cabotegravir Sodium ViiV Healthcare ULC No Yes No Yes No No No Yes
Benazepril 293832 Benazepril Hcl AA Pharma Inc No Yes No Yes Yes No No Yes
Biktarvy 288709 Emtricitabine, Tenofovir Alafenamide Hemifumarate, Bictegravir Sodium Gilead Sciences Canada Inc No No No Yes No No No Yes
Calquence 289986 Acalabrutinib Maleate AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Camcevi 290136 Leuprolide Mesylate Accord Healthcare Inc No No No No No Yes No No
Depo-Medrol (With Preservative),
Depo-Medrol		 295247 Methylprednisolone Acetate Pfizer Canada ULC No Yes No Yes No No No Yes
Firdapse 288056 Amifampridine Phosphate Kye Pharmaceuticals Inc No Yes No Yes No Yes No Yes
Kisqali 283993 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No Yes Yes Yes Yes Yes No Yes
Lynparza 294774 Olaparib AstraZeneca Canada Inc No Yes No No No No No Yes
Mayzent 294322 Siponimod Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Medrol 295241 Methylprednisolone Pfizer Canada ULC No Yes No Yes No No No Yes
Mekinist 289306 Trametinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Midamor 292158 Amiloride Hydrochloride AA Pharma Inc Yes Yes Yes Yes Yes Yes No Yes
Nexavar 292117 Sorafenib Tosylate Bayer Inc No No No Yes No No No Yes
Oxlumo 293368 Lumasiran Sodium Alnylam Netherlands B.V. No No No Yes No No No No
Premarin 294742 Conjugated Estrogens Pfizer Canada ULC No Yes No No No No No Yes
Primaquine 294983 Primaquine Phosphate Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Qulipta 293559 Atogepant Abbvie Corporation No Yes No No No No No Yes
Seaford
Nifedipine and Lidocaine
Hydrochloride Cream		 293819 Lidocaine Hydrochloride, Nifedipine Seaford Pharmaceuticals Inc No No No No No Yes No Yes
Solu-Medrol 295242 Methylprednisolone Sodium Succinate Pfizer Canada ULC No Yes No Yes No No No Yes
Sporanox 288116 Itraconazole Janssen Inc No No No Yes No No No Yes
Sprycel 292496 Dasatinib Bristol-Myers Squibb Canada No No No Yes No No No Yes
Tafinlar 289305 Dabrafenib Mesylate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Teva-Loperamide 294203 Loperamide Hcl Teva Canada Limited Yes Yes No Yes No Yes Yes Yes
Thalomid 293383 Thalidomide Bristol-Myers Squibb Canada No Yes No No No No No Yes
Wellbutrin SR 294437 Bupropion Hcl Bausch Health, Canada Inc No Yes No Yes Yes No No Yes
Zenhale 293335 Formoterol Fumarate Dihydrate, Mometasone Furoate Organon Canada Inc No No No Yes No Yes Yes Yes

May 2025

Product Monograph Brand Safety Updates – May 2025
(PDF, 94 KB, 2 pages)
Product Monograph Brand Safety Updates May 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Absorica LD 290603 Isotretinoin Sun Pharmaceutical Industries Limited No Yes No No No No No Yes
Accutane Roche 290601 Isotretinoin Hoffmann-La Roche Limited No Yes No Yes No No No Yes
Allegra-D 293299 Pseudoephedrine Hcl, Fexofenadine Hcl Sanofi Consumer Health Inc Yes Yes No No Yes Yes No Yes
Amiodarone Hydrochloride for Injection 291661 Amiodarone Hcl Sandoz Canada Incorporated No Yes Yes Yes No No No Yes
Apo-Hydralazine 293554 Hydralazine Hcl Apotex Inc Yes Yes No Yes Yes Yes No Yes
Belkyra 293372 Deoxycholic Acid Abbvie Corporation No No No Yes No No Yes Yes
Bicnu 291447 Carmustine Marcan Pharmaceuticals Inc Yes No No No No Yes No Yes
Caprelsa 293185 Vandetanib Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Cequa 292888 Cyclosporine Sun Pharmaceutical Industries Limited No Yes No Yes No No No Yes
Empaveli 292934 Pegcetacoplan Swedish Orphan Biovitrum AB (Publ) No Yes Yes Yes No No No Yes
Epuris 290612 Isotretinoin Cipher Pharmaceuticals Inc No Yes No Yes No No No Yes
Flagyl 293271 Metronidazole Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Flagystatin 293279 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Fluorouracil Injection 290778 Fluorouracil Sandoz Canada Incorporated No Yes Yes No Yes No No Yes
ISDN 293852 Isosorbide Dinitrate AA Pharma Inc Yes Yes No Yes Yes Yes Yes Yes
Lenvima 290940 Lenvatinib Mesylate Eisai Limited No No No Yes No Yes No No
Leucovorin Calcium Injection 294459 Leucovorin Calcium Teva Canada Limited No Yes Yes Yes Yes Yes Yes Yes
Mefloquine 292881 Mefloquine Hcl AA Pharma Inc No Yes No Yes Yes No No Yes
Neurontin 293626 Gabapentin BGP Pharma ULC No Yes No No No No No Yes
Nordimet 293317 Methotrexate Sodium Nordic Group B.V. No Yes No Yes No No No Yes
Norfloxacin 293433 Norfloxacin AA Pharma Inc No Yes Yes Yes Yes No No Yes
Novamoxin, Novamoxin (Sugar Reduced) 288472 Amoxicillin Trihydrate Teva Canada Limited No Yes No Yes No No Yes Yes
Orladeyo 287743 Berotralstat Hydrochloride Biocryst Pharmaceuticals Inc No No No Yes Yes No No Yes
Qulipta 288095 Atogepant Abbvie Corporation No No No No Yes No No Yes
Sandoz Amiodarone 291660 Amiodarone Hcl Sandoz Canada Incorporated No Yes Yes Yes No No No Yes
Signifor 293622 Pasireotide Diaspartate Recordati Rare Diseases Canada Inc No Yes No Yes No No No Yes
Signifor LAR 293586 Pasireotide Pamoate Recordati Rare Diseases Canada Inc No Yes No Yes No No No Yes
Spravato 293518 Esketamine Hydrochloride Janssen Inc No Yes No Yes No No No Yes
Timolol 293856 Timolol Maleate AA Pharma Inc Yes Yes Yes Yes Yes Yes Yes Yes
Trikafta 293416 Elexacaftor, Ivacaftor, Tezacaftor Vertex Pharmaceuticals (Canada) Incorporated No Yes Yes Yes No Yes Yes Yes
VFEND 293822 Voriconazole Pfizer Canada ULC Yes No No No Yes No No Yes
Xofluza 292965 Baloxavir Marboxil Hoffmann-La Roche Limited No No No No No No No Yes
Zejula 293823 Niraparib Tosylate GlaxoSmithKline Inc No No No No Yes No No Yes
Zyban 293583 Bupropion Hcl Bausch Health, Canada Inc. No Yes No Yes Yes No No Yes

April 2025

Product Monograph Brand Safety Updates – April 2025
(PDF, 86 KB, 2 pages)
Product Monograph Brand Safety Updates April 2025
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Advil Cold & Sinus Liqui-Gels, Advil Cold and Sinus, Advil Cold and Sinus Daytime, Children's Advil Cold, Advil Cold & Sinus Extra Strength Liqui-Gels 282832 Pseudoephedrine Hcl, Ibuprofen GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes No No No Yes Yes
Advil Headache & Migraine Caplets, Advil Headache & Migraine Extra Strength, Advil Headache & Migraine Tablets 289065 Ibuprofen Sodium Dihydrate GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes No No No No Yes
Advil Nighttime 285289 Diphenhydramine Hcl, Ibuprofen GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes No No No No Yes
Camcevi 292277 Leuprolide Mesylate Accord Healthcare Inc No Yes No Yes No No No Yes
Copaxone 292223 Glatiramer Acetate Teva Canada Limited Yes Yes Yes Yes No No No Yes
Duavive 293164 Bazedoxifene Acetate, Conjugated Estrogens Pfizer Canada ULC No No No No No No No Yes
Eligard 292718 Leuprolide Acetate Tolmar International Ltd No Yes No Yes No No No Yes
Florinef 293281 Fludrocortisone 21-Acetate Endo Operations Ltd No Yes No Yes Yes Yes Yes Yes
Gadovist 1.0 292479 Gadobutrol Bayer Inc No Yes Yes No No No No Yes
Gilenya 291855 Fingolimod Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No Yes
Ibsrela 291930 Tenapanor Knight Therapeutics Inc No No No Yes No No No Yes
Linessa 21, Linessa 28 290093 Desogestrel, Ethinyl Estradiol Aspen Pharmacare Canada Inc No No No No No No No Yes
Lithmax 291317 Lithium Carbonate AA Pharma Inc Yes Yes Yes Yes Yes Yes Yes Yes
Lynparza 286243 Olaparib AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Pantoprazole for Injection 292119 Pantoprazole Sodium Sesquihydrate Fresenius Kabi Canada Ltd No Yes No Yes No No No Yes
Pradaxa 292587 Dabigatran Etexilate Mesilate Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Primovist 292476 Gadoxetate Disodium Bayer Inc No Yes Yes No No Yes No Yes
Proglycem 293995 Diazoxide Merck Canada Inc No Yes No Yes No No No Yes
Rinvoq 286973 Upadacitinib Abbvie Corporation No Yes No Yes No Yes No No
Robax Platinum 285287 Methocarbamol, Ibuprofen GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes No No No No Yes
Soriatane 292616 Acitretin Allergan Inc No Yes Yes Yes No No No Yes
Tagrisso 288417 Osimertinib Mesylate AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Tegretol, Tegretol CR, Tegretol Suspension 292773 Carbamazepine Novartis Pharmaceuticals Canada Inc No Yes No No No No No No
Veklury 284988 Remdesivir Gilead Sciences Canada Inc No Yes No No No No No Yes
Zeulide Depot 293009 Leuprolide Acetate Verity Pharmaceuticals Inc No Yes No Yes No No No Yes

Non-Prescription Submissions Cleared in 2014

Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014
(PDF format, 62 KB, 1 pages)

Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014
Brand Name Submission number Ingredient Manufacturer Contra-
indications		 Warning and Precautions Serious Warnings and Precautions Box Adverse reactions Drug interactions Dosage and Administration Overdosage Consumer information
Aerius, Aerius Kids 164302 Desloratadine Schering-Plough Canada Inc N/A N/A
Aspirin 81 Mg, Aspirin 81 MG Quick Chew, Aspirin Regular Strength 169398 Acetylsalicylic acid Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A N/A
Aspirin 81 MG, Aspirin 81 MG Quick Chews, Aspirin Regular Strength, Aspirin Extra Strength 172222 Acetylsalicylic acid Bayer Inc Consumer Care N/A N/A N/A N/A N/A
Bactroban 176769 Mupirocin GlaxoSmithKline Consumer Healthcare Inc N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus Extra Strength 167087 Pseudoephedrine sulfate, loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus, Claritin Allergy + Sinus Extra Strength 177692 Pseudoephedrine sulfate, loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus 168558 Pseudoephedrine sulfate, loratadine Schering-Plough Canada Inc N/A N/A N/A N/A N/A N/A N/A
Claritin, Claritin Kids 177690 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Liquid Capsules 177693 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Rapid Dissolve 177691 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Contingency 174868 Levonorgestrel Famy Care Ltd N/A N/A N/A N/A
Heartburn Control 178335 Omeprazole Apotex Incorporated N/A N/A N/A N/A
Next Choice 174352 Levonorgestrel Cobalt Pharmaceuticals Company N/A N/A N/A N/A
Plan B 174250 Levonorgestrel Teva Women's Health Inc N/A N/A N/A N/A
Reactine Fast Melt Junior 173699 Cetirizine hydrochloride McNeil Consumer Healthcare Division Of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A
Teva-Levonorgestrel 174883 Levonorgestrel Teva Canada Limited N/A N/A N/A N/A
Voltaren Emulgel Extra Strength 172960 Diclofenac diethylamine Novartis Consumer Health Canada Inc N/A N/A N/A N/A N/A N/A
Women's Rogaine Foam 5% 165769 Minoxidil Johnson & Johnson Inc N/A

Page details

2026-04-07