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Product monograph brand safety updates - Canada.ca
2025-04-18 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?wbdisable=false
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Product monograph brand safety updates - Canada.ca

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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

May 2024

Product Monograph Brand Safety Updates – May 2024
(PDF, 82 KB, 2 pages)
Product Monograph Brand Safety Updates May 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Albrioza 286779 Ursodoxicoltaurine, Sodium Phenylbutyrate Amylyx Pharmaceuticals Inc No No Yes No No No No Yes
Bicillin L-A 282429 Penicillin G Benzathine Pfizer Canada ULC No Yes No Yes No No No Yes
Dantrium Intravenous 282340 Dantrolene Sodium Endo Par Innovation Company, LLC No Yes No Yes Yes No No Yes
Dexedrine, Dexedrine Spansule 282449 Dextroamphetamine Sulfate Paladin Pharma Inc Yes Yes No Yes Yes Yes Yes Yes
Envarsus PA 282281 Tacrolimus Endo Operations Ltd No Yes No No Yes No No Yes
Gavreto 274645 Pralsetinib Hoffmann-La Roche Limited No Yes No Yes No Yes No No
Gavreto 276254 Pralsetinib Hoffmann-La Roche Limited No Yes No No Yes Yes No Yes
Heartburn Control 281509 Omeprazole Apotex Inc Yes Yes No Yes Yes Yes Yes Yes
Inrebic 283036 Fedratinib Hydrochloride Bristol-Myers Squibb Canada No Yes Yes Yes No Yes No Yes
Kisqali 276012 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No Yes No No Yes Yes No No
Lioresal Intrathecal 282411 Baclofen Novartis Pharmaceuticals Canada Inc No Yes Yes Yes Yes Yes Yes Yes
Mavenclad 272844 Cladribine EMD Serono A Division of EMD Inc Canada No Yes No No Yes No No Yes
Mekinist 282628 Trametinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Orilissa 282297 Elagolix Sodium Abbvie Corporation No No No No No No No Yes
Tafinlar 282625 Dabrafenib Mesylate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Toviaz 282751 Fesoterodine Fumarate Pfizer Canada ULC No No No Yes No No No Yes
Trintellix 274021 Vortioxetine Hydrobromide Lundbeck Canada Inc No Yes Yes Yes No Yes Yes Yes
Veklury 275344 Remdesivir Gilead Sciences Canada Inc No Yes No Yes No Yes No Yes
Vfend 281994 Voriconazole Pfizer Canada ULC No No No No No Yes No Yes
Xcopri 282136 Cenobamate Endo Operations Ltd No Yes No Yes No Yes No Yes
Zoladex LA 275599 Goserelin Acetate Tersera Therapeutics LLC No No No Yes No Yes No Yes

April 2024

Product Monograph Brand Safety Updates – April 2024
(PDF, 80 KB, 1 pages)
Product Monograph Brand Safety Updates April 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Albrioza 273437 Ursodoxicoltaurine, Sodium Phenylbutyrate Amylyx Pharmaceuticals Inc No No No Yes No No No Yes
Caelyx 280737 Doxorubicin Hcl Baxter Corporation No Yes No Yes No No No Yes
Canesten Soft Capsule 1, Canesten Combi 1 Day Soft Capsule + Extra Strength External Cream 275801 Clotrimazole Bayer Inc No Yes No Yes No Yes No Yes
Dalacin C 282148 Clindamycin Hcl Pfizer Canada ULC No Yes No Yes No Yes No Yes
Floctafenine 279654 Floctafenine AA Pharma Inc Yes Yes Yes No No No No Yes
Norlutate 281063 Norethindrone Acetate Searchlight Pharma Inc Yes Yes No Yes Yes Yes No Yes
Opsynvi 281575 Macitentan, Tadalafil Janssen Inc No Yes No Yes No Yes No Yes
Penthrox 280781 Methoxyflurane Endo Ventures Ltd No Yes No Yes No Yes Yes Yes
Piperacillin and Tazobactam for Injection 277995 Piperacillin Sodium, Tazobactam Sodium Sandoz Canada Incorporated No Yes No Yes No No No Yes
Ponstan 279651 Mefenamic Acid AA Pharma Inc Yes Yes Yes Yes Yes Yes No Yes
Ponvory 280858 Ponesimod Janssen Inc No Yes No No Yes Yes No No
Renagel 276247 Sevelamer Hydrochloride Sanofi-Aventis Canada Inc No No No No No Yes No Yes
Septra Injection 275805 Trimethoprim Sulfate, Sulfamethoxazole Aspen Pharmacare Canada Inc No Yes Yes Yes Yes No No Yes
Veltassa 280775 Patiromer Sorbitex Calcium Vifor Fresenius Medical Care Renal Pharma Ltd No Yes No No No Yes No No
Voltaren Emulgel Extra Strength, Voltaren Emulgel Joint Pain Extra Strength 280155 Diclofenac Diethylamine GlaxoSmithKline Consumer Healthcare ULC No Yes No No No Yes Yes Yes
Xeljanz, Xeljanz XR 271059 Tofacitinib Citrate Pfizer Canada ULC No Yes No Yes No Yes No Yes
Zomig, Zomig Rapimelt, Zomig Nasal Spray 273863 Zolmitriptan Xediton Pharmaceuticals Inc No Yes Yes Yes Yes Yes Yes Yes

March 2024

Product Monograph Brand Safety Updates – March 2024
(PDF, 81 KB, 1 pages)
Product Monograph Brand Safety Updates March 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Caldolor 279655 Ibuprofen Cumberland Pharmaceuticals Inc No Yes Yes No No No No Yes
Caripul 279971 Epoprostenol Sodium Janssen Inc No Yes No No No No No Yes
Cysview 273436 Hexaminolevulinate Hydrochloride Photocure ASA No No No Yes No Yes No Yes
Depo-Medrol with Lidocaine 280541 Methylprednisolone Acetate, Lidocaine Hcl Pfizer Canada ULC No No No Yes No No No Yes
Depo-Medrol 280641 Methylprednisolone Acetate Pfizer Canada ULC No No No Yes No Yes No Yes
Estrogel 280464 Estradiol Hemihydrate Organon Canada Inc No No No No Yes No No Yes
Flolan 278168 Epoprostenol Sodium, Glycine, Sodium Chloride, Water GlaxoSmithKline Inc No Yes No No Yes Yes No Yes
Fosrenol 280152 Lanthanum Carbonate Hydrate Takeda Canada Inc No No No No No No No Yes
Ibrance 273901 Palbociclib Pfizer Canada ULC No Yes No Yes No Yes No Yes
Intelence 280475 Etravirine Janssen Inc No No No No No Yes No Yes
Invokamet 280097 Canagliflozin, Metformin Hydrochloride Janssen Inc No Yes No No No Yes No Yes
Invokana 280099 Canagliflozin Janssen Inc No Yes No No No Yes No Yes
Lamictal 280095 Lamotrigine GlaxoSmithKline Inc No Yes Yes Yes No No No Yes
Lupron Depot 280431 Leuprolide Acetate Abbvie Corporation No Yes No Yes No No No Yes
Lyrica 279480 Pregabalin BGP Pharma ULC No Yes No No No No No Yes
Medrol 280540 Methylprednisolone Pfizer Canada ULC No No No Yes No No No Yes
Methotrexate Injection USP 280068 Methotrexate Sodium Pfizer Canada ULC No Yes No Yes No No No Yes
Minipress 277885 Prazosin Hcl AA Pharma Inc No Yes No Yes No No No Yes
Mirapex 281270 Pramipexole Dihydrochloride Monohydrate Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Nexplanon 280417 Etonogestrel Organon Canada Inc No No No Yes No No No Yes
Prevymis 273906 Letermovir Merck Canada Inc No No No Yes No Yes No No
Prohance 276177 Gadoteridol Bracco Imaging Canada No Yes No No No No No Yes
Solu-Medrol 280527 Methylprednisolone Sodium Succinate Pfizer Canada ULC No No No Yes No No No Yes
Spinraza 281187 Nusinersen Biogen Canada Inc No No No Yes No No No Yes
Tepmetko 274967 Tepotinib Hydrochloride EMD Serono A Division of EMD Inc Canada No Yes No Yes Yes No No Yes
Trelstar 280867 Triptorelin Pamoate Knight Therapeutics Inc No Yes No No No Yes No Yes
Vraylar 271975 Cariprazine Hydrochloride Abbvie Corporation No Yes No No Yes Yes No Yes
Vyvanse 280611 Lisdexamfetamine Dimesylate Takeda Canada Inc No Yes No Yes No No No No
Xarelto 280484 Rivaroxaban Bayer Inc No Yes No Yes No No No Yes
Xpovio 276287 Selinexor Forus Therapeutics Inc No No No No Yes No No No
Zepzelca 273321 Lurbinectedin Jazz Pharmaceuticals Ireland Limited No Yes No No Yes Yes 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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