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Product monograph brand safety updates

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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

March 2025

Product Monograph Brand Safety Updates – March 2025
(PDF, 108 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
Advil Pediatric Drops, Advil Pediatric Drops Fever from Colds or Flu, Children's Advil Chewable Tablets, Children's Advil, Children's Advil Fever from Colds or Flu, Junior Strength Advil, Junior Strength Advil Fever from Colds or Flu 285281 Ibuprofen GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes No No No No Yes
Akeega 285890 Niraparib Tosylate, Abiraterone Acetate Janssen Inc No Yes No Yes No No No Yes
Alecensaro 287835 Alectinib Hydrochloride Hoffmann-La Roche Limited No Yes No No No No No Yes
Apo-Fluticasone 290809 Fluticasone Propionate Apotex Inc No No No No No No Yes Yes
Cardizem CD 291522 Diltiazem Hcl Bausch Health, Canada Inc No No No No Yes No No Yes
Coated Daily Low Dose ASA 81 Mg 290777 Acetylsalicylic Acid Apotex Inc Yes Yes Yes Yes Yes Yes Yes Yes
Codeine Contin 288909 Codeine Sulfate, Codeine Monohydrate Purdue Pharma No Yes No Yes Yes No Yes Yes
Decapeptyl 291110 Triptorelin Acetate Ferring Inc No Yes No Yes No No No Yes
Ibrance 292325 Palbociclib Pfizer Canada ULC No No No Yes No No No Yes
Imbruvica 291962 Ibrutinib Janssen Inc No Yes No Yes No No No Yes
Kaletra 291449 Ritonavir, Lopinavir Abbvie Corporation No No No No Yes No No Yes
Koselugo 285333 Selumetinib Sulfate Alexion Pharma GmbH No Yes No Yes Yes Yes No Yes
Lamictal 291590 Lamotrigine GlaxoSmithKline Inc No Yes No Yes Yes Yes No Yes
Naproxen Capsules 200 Mg 290404 Naproxen Catalent Ontario Limited Yes No No Yes No Yes Yes Yes
Norvir 291456 Ritonavir Abbvie Corporation No No No No Yes No No Yes
Opsynvi 291515 Macitentan, Tadalafil Janssen Inc No Yes No Yes No No No No
Pepcid AC, Maximum Strength Pepcid AC 284010 Famotidine McNeil Consumer Healthcare Division of Johnson & Johnson Inc Yes Yes No Yes Yes Yes Yes Yes
Rinvoq 292377 Upadacitinib Abbvie Corporation No Yes No No No No No Yes
Tiazac XC 291450 Diltiazem Hcl Bausch Health, Canada Inc No No No No Yes No No Yes
Velsipity 289505 Etrasimod L-Arginine Pfizer Canada ULC No Yes No No No No No Yes
Zoryve 285437 Roflumilast Arcutis Canada, Inc No No No Yes No No No Yes

February 2025

Product Monograph Brand Safety Updates - February 2025
(PDF, 85 KB, 2 pages)

Product Monograph Brand Safety Updates February 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 284572 Dextroamphetamine Sulfate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Takeda Canada Inc Yes Yes No Yes No Yes Yes Yes
Apo-Cefuroxime 290040 Cefuroxime Axetil Apotex Inc No Yes No Yes No No No Yes
Apo-Levofloxacin 289861 Levofloxacin Hemihydrate Apotex Inc No Yes No Yes Yes Yes Yes Yes
Arava 290800 Leflunomide Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Bicnu 280995 Carmustine Marcan Pharmaceuticals Inc Yes No No No No Yes No Yes
Biktarvy 284007 Emtricitabine, Tenofovir Alafenamide Hemifumarate, Bictegravir Sodium Gilead Sciences Canada Inc No Yes No Yes Yes No No Yes
Cefuroxime for Injection, USP 289915 Cefuroxime Sodium Fresenius Kabi Canada Ltd No No No No No Yes No Yes
Entrophen Chewable, Entrophen 325mg Caplets, Entrophen 325mg Tablets 290249 Acetylsalicylic Acid Pendopharm Division of Pharmascience Inc Yes Yes Yes No Yes Yes No Yes
Iclusig 290949 Ponatinib Hydrochloride Takeda Pharmaceuticals U.S.A., Inc No No No No No Yes No No
Inrebic 292227 Fedratinib Hydrochloride Bristol-Myers Squibb Canada No Yes No Yes No No No Yes
Mifegymiso 289927 Mifepristone, Misoprostol Linepharma International Limited No Yes No Yes No No No Yes
Nexium 24Hr 290208 Esomeprazole Magnesium Trihydrate GlaxoSmithKline Consumer Healthcare ULC Yes Yes No No Yes Yes No Yes
Oxy.IR 290991 Oxycodone Hydrochloride Purdue Pharma No Yes No Yes No No Yes Yes
Oxyneo 290992 Oxycodone Hydrochloride Purdue Pharma No Yes No Yes No No Yes Yes
Plaquenil 287053 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Provera 290936 Medroxyprogesterone Acetate Pfizer Canada ULC No Yes No No No No No No
Ralivia 290350 Tramadol Hcl Bausch Health, Canada Inc No Yes No Yes Yes No No Yes
Rinvoq 290768 Upadacitinib Abbvie Corporation No No No Yes No No No No
Silenor 290257 Doxepin Hcl Endo Operations Ltd No No No Yes Yes Yes Yes Yes
Tiazac 290862 Diltiazem Hcl Bausch Health, Canada Inc No No No No Yes No No Yes
Wakix 284477 Pitolisant Hydrochloride Endo Ventures Ltd No Yes No Yes No Yes No Yes

January 2025

Product Monograph Brand Safety Updates - January 2025
(PDF, 86 KB, 2 pages)

Product Monograph Brand Safety Updates January 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, Abilify Maintena 266917 Aripiprazole Otsuka Pharmaceutical Co Ltd Yes Yes No Yes Yes Yes Yes Yes
Advil Cold and Sinus Nighttime, Advil Cold & Sinus Plus, Advil Cold, Sinus & Flu Extra Strength, Children's Advil Cold & Flu Multi-Symptom 279937 Pseudoephedrine Hcl, Chlorpheniramine Maleate, Ibuprofen GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes Yes Yes No Yes Yes
Advil Tablets, Advil Caplets, Advil Extra Strength Caplets, Advil Muscle and Joint, Advil 12 Hour 282796 Ibuprofen GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes No No Yes No Yes
Dayvigo 281784 Lemborexant Eisai Limited No Yes No Yes No Yes Yes Yes
Depo-Medrol (with Preservative), Depo-Medrol 290456 Methylprednisolone Acetate Pfizer Canada ULC No Yes No No Yes No No Yes
Depo-Medrol with Lidocaine 290493 Methylprednisolone Acetate, Lidocaine Hcl Pfizer Canada ULC No Yes No No Yes No No Yes
Eliquis 288960 Apixaban Bristol-Myers Squibb Canada No Yes No Yes No No No Yes
Forxiga 288938 Dapagliflozin Propanediol Monohydrate AstraZeneca Canada Inc No Yes No No No Yes No Yes
Gen-Clozapine 284195 Clozapine Mylan Pharmaceuticals ULC No Yes No No No Yes No Yes
Lumakras 274523 Sotorasib Amgen Canada Inc No Yes No No No Yes No Yes
Medrol 290421 Methylprednisolone Pfizer Canada ULC No Yes No No Yes No No Yes
Monoferric 276473 Ferric Derisomaltose Pharmacosmos A/S No Yes No Yes No Yes No Yes
Myfortic 289913 Mycophenolate Sodium Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Orgalutran 289424 Ganirelix Acetate Organon Canada Inc Yes Yes No No No Yes No Yes
Oxlumo 290990 Lumasiran Sodium Alnylam Netherlands B.V. No Yes No Yes No No No Yes
Penthrox 283985 Methoxyflurane Endo Operations Ltd No Yes No Yes Yes No No Yes
PMS-Methotrexate 285869 Methotrexate Disodium Pharmascience Inc No Yes No No No No No Yes
Retevmo 288545 Selpercatinib Loxo Oncology Inc No Yes No No Yes Yes No No
Septanest N, Septanest SP 288534 Epinephrine Bitartrate, Articaine Hcl Septodont Yes Yes Yes Yes Yes Yes Yes Yes
Solu-Medrol 290511 Methylprednisolone Sodium Succinate Pfizer Canada ULC No Yes No No Yes No No Yes
Talzenna 271537 Talazoparib Tosylate Pfizer Canada ULC No Yes No Yes Yes Yes No Yes
Truqap 289562 Capivasertib AstraZeneca Canada Inc No Yes Yes No No Yes No Yes
Xigduo 288937 Dapagliflozin Propanediol Monohydrate, Metformin Hydrochloride AstraZeneca Canada Inc No Yes No No No Yes No Yes
Xyrem 289933 Sodium Oxybate Jazz Pharmaceuticals Ireland Limited No Yes No No No Yes No Yes

December 2024

Product Monograph Brand Safety Updates - December 2024
(PDF, 86 KB, 2 pages)

Product Monograph Brand Safety Updates December 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Advil Liqui-Gels, Advil Extra Strength Liqui-Gels, Advil Arthritis Pain 282804 Ibuprofen GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes No No No No Yes
Aricept 288646 Donepezil Hydrochloride Pfizer Canada ULC Yes Yes No Yes Yes Yes Yes Yes
Arimidex 289564 Anastrozole AstraZeneca Canada Inc No No No No No No No Yes
Biaxin BID, Biaxin 288756 Clarithromycin BGP Pharma ULC Yes Yes No No Yes No No Yes
Brukinsa 286962 Zanubrutinib Beigene Switzerland GmbH No No No No No Yes No Yes
Cerebyx 288605 Fosphenytoin Sodium Searchlight Pharma Inc No Yes No Yes No Yes No Yes
Combogesic 285323 Acetaminophen, Ibuprofen Biosyent Pharma Inc No Yes Yes No No No No Yes
Delstrigo 287870 Doravirine, Tenofovir Disoproxil Fumarate, Lamivudine Merck Canada Inc No Yes No Yes No No No Yes
Evra 286304 Ethinyl Estradiol, Norelgestromin Searchlight Pharma Inc No No No No Yes No No Yes
Florinef 286587 Fludrocortisone 21-Acetate Endo Operations Ltd No No No Yes Yes Yes No Yes
Ibrance 290029 Palbociclib Pfizer Canada ULC No No No No Yes Yes No Yes
Lysodren 289533 Mitotane HRA Pharma Rare Diseases No Yes No No No No No Yes
Mekinist 288807 Trametinib Dimethyl Sulfoxide Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Nextstellis 286306 Drospirenone, Estetrol Monohydrate Searchlight Pharma Inc No No No No No No No Yes
Pifeltro 287877 Doravirine Merck Canada Inc No Yes No Yes No No No Yes
Ryaltris 286560 Olopatadine Hcl, Mometasone Furoate Monohydrate Glenmark Specialty SA No No No No No Yes No Yes
Tafinlar 288803 Dabrafenib Mesylate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Trulance 279583 Plecanatide Bausch Health, Canada Inc No Yes No Yes No No No Yes
Vinblastine Sulfate Injection 288620 Vinblastine Sulfate Pfizer Canada ULC Yes Yes No No No Yes Yes Yes
Welireg 282593 Belzutifan Merck Canada Inc No Yes No Yes Yes Yes No Yes
Wellbutrin SR 287465 Bupropion Hcl Bausch Health, Canada Inc No Yes No Yes Yes Yes No Yes
Wellbutrin XL 287467 Bupropion Hcl Bausch Health, Canada Inc No Yes No Yes Yes Yes No Yes
Xtandi 289427 Enzalutamide Astellas Pharma Canada Inc No Yes No Yes No Yes No Yes
Xylocard 288946 Lidocaine Hcl Aspen Pharmacare Canada Inc No Yes No Yes No No No Yes

November 2024

Product Monograph Brand Safety Updates - November 2024
(PDF, 90 KB, 2 pages)

Product Monograph Brand Safety Updates November 2024
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 Extra Strength Liqui-Gels, Advil Cold & Sinus Liqui-Gels, Advil Cold and Sinus, Advil Cold and Sinus Daytime, Children's Advil Cold 274716 Pseudoephedrine Hcl, Ibuprofn GlaxoSmithKline Consumer Healthcare ULC Yes Yes Yes Yes Yes Yes Yes Yes
Balversa 282212 Erdafitinib Janssen Inc No No No Yes Yes No No Yes
Bijuva 286076 Estradiol Hemihydrate, Progesterone Knight Therapeutics Inc No Yes No No No No No Yes
Cabazitaxel for Injection 286854 Cabazitaxel Sandoz Canada Incorporated No No No Yes No No No Yes
Cibinqo 278770 Abrocitinib Pfizer Canada ULC No Yes No Yes Yes Yes No Yes
Cresemba 280928 Isavuconazonium Sulfate Avir Pharma Inc No Yes No Yes No Yes No Yes
Dovato 281486 Lamivudine, Dolutegravir Sodium ViiV Healthcare ULC No Yes No No No Yes No Yes
Dymista 287374 Azelastine Hydrochloride, Fluticasone Propionate BGP Pharma ULC No Yes No No No No No Yes
Edurant 288112 Rilpivirine Hydrochloride Janssen Inc No Yes No No No No No Yes
Eltroxin 287631 Levothyroxine Sodium Aspen Pharmacare Canada Inc No Yes No No No No No Yes
Galafold 281056 Migalastat Hydrochloride Amicus Therapeutics Canada Inc No No No Yes No Yes No Yes
Gavreto 284240 Pralsetinib Hoffmann-La Roche Limited No No No No No Yes No No
Gemcitabine Injection 287075 Gemcitabine Hydrochloride Pfizer Canada ULC No Yes No Yes No No No Yes
IFEX 286852 Ifosfamide Baxter Corporation No Yes No No Yes No No Yes
Juluca 281490 Rilpivirine Hydrochloride, Dolutegravir Sodium ViiV Healthcare ULC No Yes No No No Yes No Yes
Levothyroxine Sodium for Injection, Levothyroxine Sodium Injection 287632 Levothyroxine Sodium Fresenius Kabi Canada Ltd No Yes No No No No No Yes
Livtencity 287353 Maribavir Takeda Canada Inc No Yes No No Yes Yes No No
Marvelon 21, Marvelon 28 286308 Desogestrel, Ethinyl Estradiol Organon Canada Inc No No No No Yes No No Yes
Maviret 281371 Glecaprevir, Pibrentasvir Abbvie Corporation Yes No No No Yes No No No
Micardis Plus 287669 Hydrochlorothiazide, Telmisartan Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No No
Nolvadex - D 288795 Tamoxifen Citrate AstraZeneca Canada Inc No Yes No No No No No Yes
Nortriptyline 287666 Nortriptyline Hcl Apotex Inc No Yes No Yes Yes No No Yes
Nuvaring 286307 Ethinyl Estradiol, Etonogestrel Organon Canada Inc No No No No No No No Yes
Plan B 280947 Levonorgestrel Foundation Consumer Healthcare, LLC Yes Yes Yes Yes Yes Yes No Yes
Quviviq 281384 Daridorexant Hydrochloride Idorsia Pharmaceuticals Ltd No Yes No No Yes No No Yes
Sohonos 288312 Palovarotene Ipsen Biopharmaceuticals Canada Inc No Yes No Yes Yes Yes No Yes
Tavneos 287202 Avacopan Vifor Fresenius Medical Care Renal Pharma Ltd No Yes No Yes Yes No No Yes
Tivicay 281488 Dolutegravir Sodium ViiV Healthcare ULC No Yes No No No Yes No Yes
Triumeq 281500 Abacavir Sulfate, Lamivudine, Dolutegravir Sodium ViiV Healthcare ULC No Yes No No No Yes No Yes
Twynsta 287674 Amlodipine Besylate, Telmisartan Boehringer Ingelheim (Canada) Ltd Ltee Yes Yes No Yes Yes No Yes Yes

October 2024

Product Monograph Brand Safety Updates - October 2024
(PDF, 86 KB, 2 pages)

Product Monograph Brand Safety Updates October 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Amoxicillin Sodium and Potassium Clavulanate for Injection 286649 Amoxicillin Sodium, Clavulanate Potassium Sandoz Canada Incorporated No Yes No Yes Yes Yes No Yes
Apo-Amoxicillin 286363 Amoxicillin Apotex Inc No Yes No Yes No No No Yes
Arava 287680 Leflunomide Sanofi-Aventis Canada Inc No No No No No Yes No Yes
Crestor 286971 Rosuvastatin Calcium AstraZeneca Canada Inc No No No No Yes No No Yes
Duavive 287357 Bazedoxifene Acetate, Conjugated Estrogens Pfizer Canada ULC No No No No Yes No No Yes
Estalis 140/50 mcg, Estalis 250/50 mcg 286803 Norethindrone Acetate, Estradiol Sandoz Canada Incorporated No No No No Yes No No Yes
Euthyrox 287630 Levothyroxine Sodium EMD Serono a Division of EMD Inc Canada No No No No No No No Yes
Evrysdi 284770 Risdiplam Hoffmann-La Roche Limited No Yes No Yes No Yes No Yes
Extra Strength Tylenol Nighttime 287258 Diphenhydramine Hcl, Acetaminophen McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes Yes No No Yes No Yes
Imvexxy 286037 Estradiol Hemihydrate Knight Therapeutics Inc No Yes No No No No No Yes
Jardiance 285974 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No No No Yes No Yes
Lolo 286305 Norethindrone Acetate, Ethinyl Estradiol Abbvie Corporation No No No No Yes No No No
Lumakras 276210 Sotorasib Amgen Canada Inc No No No No No Yes No Yes
Metronidazole Injection, USP 286761 Metronidazole Baxter Corporation No Yes No Yes No No No Yes
Multaq 286505 Dronedarone (Dronedarone Hydrochloride) Sanofi-Aventis Canada Inc No Yes No No Yes No No Yes
Naropin 283752 Ropivacaine Hcl Aspen Pharmacare Canada Inc No Yes Yes No No No No Yes
Premarin 287505 Conjugated Estrogens Pfizer Canada ULC No No No No Yes No No Yes
Reactine 20 mg Tablet 286899 Cetirizine Hydrochloride McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes Yes Yes No Yes
Retevmo 280820 Selpercatinib Loxo Oncology Inc No Yes No Yes No No No Yes
Reyataz 287317 Atazanavir Sulfate Bristol-Myers Squibb Canada Yes No No No Yes No No No
Summit Ultra 285337 Methocarbamol, Ibuprofen Pendopharm Division of Pharmascience Inc Yes Yes Yes Yes Yes Yes Yes Yes
Synjardy 285975 Metformin Hydrochloride, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No No No Yes No Yes
Synthroid 287633 Levothyroxine Sodium BGP Pharma ULC No No No No No No No Yes
Zevtera 285584 Ceftobiprole Avir Pharma Inc No Yes Yes No No No No Yes
Zoryve 280534 Roflumilast Arcutis Canada, Inc No Yes No Yes Yes 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

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2025-10-08