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Product monograph brand safety updates

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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

September 2024

Product Monograph Brand Safety Updates - September 2024
(PDF, 78 KB, 2 pages)

Product Monograph Brand Safety Updates September 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Advagraf 286250 Tacrolimus Astellas Pharma Canada Inc No No No No Yes No No Yes
Balversa 280318 Erdafitinib Janssen Inc No Yes No Yes No Yes No Yes
Benvyon 287270 Bendamustine Hydrochloride Pfizer Canada ULC No No No Yes No No No Yes
Brilinta 286653 Ticagrelor AstraZeneca Canada Inc No No No No Yes No No Yes
Cabometyx 280615 Cabozantinib Malate Ipsen Biopharmaceuticals Canada Inc No No No No No No No Yes
Concerta 286261 Methylphenidate Hcl Janssen Inc No No No Yes No No No Yes
Constella 279169 Linaclotide Abbvie Corporation Yes Yes Yes Yes No Yes No Yes
Depo-Provera 286411 Medroxyprogesterone Acetate Pfizer Canada ULC No Yes No No No No No Yes
Docetaxel Injection USP 280749 Docetaxel Pfizer Canada ULC No Yes No No No No No Yes
Estradot 25, Estradot 37.5, Estradot 50, Estradot 75, Estradot 100 286712 Estradiol Sandoz Canada Incorporated No No No No Yes No No Yes
Hydrea 286140 Hydroxyurea Cheplapharm Arzneimittel GmbH No Yes No No Yes No No Yes
Ibrance 287136 Palbociclib Pfizer Canada ULC No No No Yes No No No Yes
Imovane 286391 Zopiclone Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Lynparza 281651 Olaparib AstraZeneca Canada Inc No No No No No No No Yes
Metoject Subcutaneous 285868 Methotrexate Sodium Medexus Pharmaceuticals Inc No Yes No No No No No Yes
Mounjaro Kwikpen 283968 Tirzepatide Eli Lilly Canada Inc Yes Yes No No No Yes No Yes
Ofev 286263 Nintedanib Esilate Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Ondansetron ODT 285751 Ondansetron Sandoz Canada Incorporated Yes Yes No Yes Yes Yes No Yes
Prograf 286251 Tacrolimus Astellas Pharma Canada Inc No No No No Yes No No Yes
Tegsedi 284567 Inotersen Sodium Akcea Therapeutics Inc No Yes Yes Yes No Yes No Yes
Teva-Domperidone 283070 Domperidone Teva Canada Limited No Yes No No No No No Yes
Trileptal 278353 Oxcarbazepine Novartis Pharmaceuticals Canada Inc No Yes No No No No No Yes
Vitrakvi 279970 Larotrectinib Sulfate Bayer Inc No Yes No Yes No No No Yes
Xalatan 286293 Latanoprost BGP Pharma ULC No No No Yes No No No No

August 2024

Product Monograph Brand Safety Updates - August 2024
(PDF, 83 KB, 2 pages)

Product Monograph Brand Safety Updates August 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
AA-Atenidone 283834 Chlorthalidone, Atenolol AA Pharma Inc No No Yes Yes Yes No Yes Yes
Carbaglu 279202 Carglumic Acid Recordati Rare Diseases No Yes No No No Yes No Yes
Doptelet 285407 Avatrombopag Maleate Swedish Orphan Biovitrum AB (Publ) No Yes No No Yes No No Yes
Erleada 285552 Apalutamide Janssen Inc No Yes No Yes No No No Yes
Jorveza 275976 Budesonide Avir Pharma Inc No Yes No Yes No No No Yes
Kinevac 285254 Sincalide Bracco Imaging Canada No Yes No No No No No No
Leqvio 283980 Inclisiran Sodium Novartis Pharmaceuticals Canada Inc No No No No No No No Yes
Loperacap 284276 Loperamide Hcl Bausch Health, Canada Inc. Yes Yes No Yes No Yes Yes Yes
Lumakras 276755 Sotorasib Amgen Canada Inc No Yes No Yes No No No No
Mavenclad 283635 Cladribine EMD Serono A Division of EMD Inc Canada No Yes No Yes No No Yes Yes
Mezera 284935 Mesalazine Avir Pharma Inc No Yes No Yes No No No Yes
MS Contin 285408 Morphine Sulfate Purdue Pharma No Yes No Yes No Yes No Yes
Nexavar 285359 Sorafenib Tosylate Bayer Inc No Yes No Yes No No No Yes
Paxlovid 285210 Ritonavir, Nirmatrelvir Pfizer Canada ULC No Yes No No Yes No No No
Piqray 278954 Alpelisib Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
PMS-Fluoxetine 284860 Fluoxetine Hydrochloride Pharmascience Inc No Yes Yes No No Yes Yes Yes
Precedex 279381 Dexmedetomidine Hydrochloride Pfizer Canada ULC No Yes Yes No Yes Yes No Yes
Pylera 285298 Metronidazole, Tetracycline Hcl, Bismuth Subcitrate Potassium Laboratoires Juvise Pharmaceuticals Yes Yes No Yes Yes No No Yes
Sandoz-Carbamazepine CR 285830 Carbamazepine Sandoz Canada Incorporated No Yes No No Yes No No No
Spravato 285417 Esketamine Hydrochloride Janssen Inc No Yes No Yes Yes Yes Yes Yes
Toradol 283292 Ketorolac Tromethamine AA Pharma Inc No Yes No No No No No Yes
Vermox 285206 Mebendazole Janssen Inc No Yes No Yes No No Yes Yes
Zeposia 285356 Ozanimod Bristol-Myers Squibb Canada No Yes No Yes No No Yes Yes

July 2024

Product Monograph Brand Safety Updates – July 2024
(PDF, 109 KB, 2 page)
Product Monograph Brand Safety Updates July 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Aleve Caplets 264895 Naproxen Sodium Bayer Inc No No No Yes No No No Yes
Alkeran 285163 Melphalan Hcl, Buffer Solution, Melphalan Aspen Pharmacare Canada Inc No Yes No Yes No No No Yes
Aspirin 81 mg, Aspirin 81 mg Quick Chews, Aspirin Regular Strength, Aspirin Extra Strength 280158 Acetylsalicylic Acid Bayer Inc Yes Yes Yes No Yes Yes No Yes
Bosulif 275812 Bosutinib Monohydrate Pfizer Canada ULC No Yes Yes Yes No No No Yes
Cabometyx 279079 Cabozantinib Malate Ipsen Biopharmaceuticals Canada Inc No Yes No No No No No No
Duratocin 284214 Carbetocin Ferring Inc No Yes No Yes No Yes No No
Flonase Allergy Relief 282043 Fluticasone Propionate Haleon Canada ULC Yes Yes No Yes Yes Yes Yes Yes
Inrebic 276471 Fedratinib Hydrochloride Bristol-Myers Squibb Canada No No No No Yes Yes No Yes
Mounjaro 283593 Tirzepatide Eli Lilly Canada Inc No Yes No Yes No No No Yes
Pepcid Complete 284021 Famotidine, Magnesium Hydroxide, Calcium Carbonate McNeil Consumer Healthcare Division of Johnson & Johnson Inc No No No No Yes No No Yes
Provera 284720 Medroxyprogesterone Acetate Pfizer Canada ULC No Yes No No No No No Yes
Qinlock 278324 Ripretinib Deciphera Pharmaceuticals. LLC No Yes No Yes No Yes No Yes
Reyataz 283745 Atazanavir Sulfate Bristol-Myers Squibb Canada Yes No No No Yes No No No
Rinvoq 278797 Upadacitinib Abbvie Corporation No Yes No No No No No No
Scemblix 283889 Asciminib Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Tagrisso 279138 Osimertinib Mesylate AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Tagrisso 282907 Osimertinib Mesylate AstraZeneca Canada Inc No No No Yes No No No Yes
Tasigna 286412 Nilotinib Hydrochloride Monohydrate Novartis Pharmaceuticals Canada Inc No No No No No Yes No Yes
Tracleer 283862 Bosentan Monohydrate Janssen Inc No Yes No No Yes Yes No Yes
Trikafta 282009 Elexacaftor, Ivacaftor, Tezacaftor Vertex Pharmaceuticals (Canada) Incorporated No No No No No No No Yes
Vepesid 284682 Etoposide Cheplapharm Arzneimittel GmbH No Yes Yes Yes No No No Yes
Xydalba 278103 Dalbavancin Endo Ventures Ltd No Yes No Yes No Yes No Yes
Xywav 285449 Magnesium Oxybate, Sodium Oxybate, Potassium Oxybate, Calcium Oxybate Jazz Pharmaceuticals Ireland Limited No No No No No Yes No No
Zaditor 279943 Ketotifen Fumarate Laboratoires Thea Yes Yes Yes Yes Yes Yes No Yes

June 2024

Product Monograph Brand Safety Updates – June 2024
(PDF, 97 KB, 1 page)
Product Monograph Brand Safety Updates June 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Alecensaro 282375 Alectinib Hydrochloride Hoffmann-La Roche Limited No Yes No Yes No Yes No Yes
Argatroban 282415 Argatroban Sandoz Canada Incorporated No No No No No Yes No Yes
Ceftin 279940 Cefuroxime Axetil Sandoz Canada Incorporated No Yes No Yes No No No Yes
Clavulin 283115 Amoxicillin Trihydrate, Clavulanate Potassium GlaxoSmithKline Inc No No No Yes No No No Yes
Depakene 283332 Sodium Valproate BGP Pharma ULC Yes Yes Yes No No Yes No Yes
Epival 283322 Divalproex Sodium BGP Pharma ULC Yes Yes Yes No No Yes No Yes
Eyezirgan 281912 Ganciclovir Laboratoires Thea No Yes No No No Yes No Yes
Ferinject 287221 Ferric Carboxymaltose Vifor (International) Inc No No No No No No No Yes
Gadovist 1.0 280292 Gadobutrol Bayer Inc No Yes No No No No No Yes
Gadovist 1.0 282773 Gadobutrol Bayer Inc No No No Yes No No No Yes
Magnevist 280423 Gadopentetate Dimeglumine Bayer Inc No Yes No No No No No Yes
Pentasa 281523 Mesalazine Ferring Inc No Yes No Yes No No No Yes
Primovist 275119 Gadoxetate Disodium Bayer Inc No Yes No No No No No Yes
Retevmo 283771 Selpercatinib Loxo Oncology Inc No Yes No Yes No No No Yes
Rezurock 280993 Belumosudil Mesylate Sanofi-Aventis Canada Inc No Yes No No Yes No No Yes
Sunosi 281424 Solriamfetol Hydrochloride Axsome Malta Ltd No Yes No No 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 Contraindications 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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