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Product monograph brand safety updates

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May 2022

Product Monograph Brand Safety Updates May 2022
(PDF, 109 KB, 3 pages)

Product Monograph Brand Safety Updates May 2022
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Adriamycin PFS 259714 Doxorubicin Hcl Pfizer Canada ULC No Yes Yes No No No No Yes
Alecensaro 260345 Alectinib Hydrochloride Hoffmann-La Roche Limited No Yes No No No Yes No No
Apo-Verap 258995 Verapamil Hcl Apotex Inc Yes Yes No Yes Yes Yes Yes Yes
Celestone Soluspan 259866 Betamethasone Acetate, Betamethasone Sodium Phosphate Organon Canada Inc. Yes Yes No Yes No No No Yes
Clobex Shampoo, Clobex Spray 259690 Clobetasol Propionate Galderma Canada Inc No Yes No Yes No Yes No Yes
Clozaril 259257 Clozapine HLS Therapeutics Inc No Yes No No No Yes No No
Concerta 257940 Methylphenidate Hcl Janssen Inc No Yes No Yes Yes No Yes Yes
Depo-Medrol With Lidocaine 259603 Methylprednisolone Acetate, Lidocaine Hcl Pfizer Canada ULC No Yes No Yes Yes Yes Yes Yes
Dermatop Ointment, Dermatop Emollient Cream 259325 Prednicarbate Bausch Health, Canada Inc. No Yes No Yes Yes Yes Yes Yes
Dymista 254371 Azelastine Hydrochloride, Fluticasone Propionate BGP Pharma ULC No No No No No No No Yes
Enstilar 259599 Betamethasone Dipropionate, Calcipotriol Monohydrate Leo Pharma Inc No No No Yes No No No No
Flagyl 259355 Metronidazole Sanofi-Aventis Canada Inc No Yes Yes Yes Yes Yes Yes Yes
Flagystatin 259350 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes Yes Yes Yes Yes Yes Yes
Fluphenazine 257193 Fluphenazine Hcl Aa Pharma Inc Yes Yes Yes No Yes Yes No No
Gleevec 259395 Imatinib Mesylate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Hydroxyzine 256974 Hydroxyzine Hcl AA Pharma Inc No Yes No No No Yes No No
Hydroxyzine Hydrochloride Injection USP 256978 Hydroxyzine Hcl Sandoz Canada Incorporated Yes Yes No Yes Yes Yes Yes Yes
Imodium Complete 259265 Loperamide Hcl, Simethicone McNeil Consumer Healthcare Division of Johnson & Johnson Inc Yes Yes No No No Yes Yes Yes
Jakavi 250022 Ruxolitinib Phosphate Novartis Pharmaceuticals Canada Inc No Yes Yes Yes Yes Yes No Yes
Jorveza 259435 Budesonide Avir Pharma Inc No No No Yes No No No Yes
Ketoprofen, Ketoprofen-E, Ketoprofen SR 258038 Ketoprofen AA Pharma Inc Yes Yes Yes Yes Yes Yes Yes Yes
Lenvima 253057 Lenvatinib Mesylate Eisai Limited No Yes No Yes Yes Yes No Yes
Lorbrena 255326 Lorlatinib Pfizer Canada ULC No No No No No No No Yes
Losec 255605 Omeprazole Cheplapharm Arzneimittel Gmbh No No No Yes No No No Yes
257614 Esomeprazole Magnesium Cheplapharm Arzneimittel Gmbh No No No Yes No No No Yes
Losec Mups 255606 Omeprazole Magnesium Cheplapharm Arzneimittel Gmbh No No No Yes No No No Yes
Mylan-Divalproex 258987 Valproic Acid Mylan Pharmaceuticals ULC Yes Yes No Yes Yes Yes No Yes
Nabumetone 259319 Nabumetone Apotex Inc Yes Yes No No Yes Yes No Yes
Nyda 255325 Dimethicone G. Pohl-Boskamp Gmbh & Co Kg No Yes No No No Yes Yes Yes
Oxpam 248567 Oxazepam Biomed Pharma No Yes Yes No Yes Yes No Yes
Paxlovid 261884 Ritonavir, Nirmatrelvir Pfizer Canada ULC No Yes No Yes No No No Yes
PMS-Metoclopramide Tablets, PMS-Metoclopramide Oral Solution 259250 Metoclopramide Hcl Pharmascience Inc Yes Yes No Yes No Yes No Yes
Prohance 252254 Gadoteridol Bracco Imaging Canada No Yes No Yes No Yes No Yes
Qinlock 252308 Ripretinib Deciphera Pharmaceuticals. LLC No No No No No Yes No Yes
Septra Pediatric Suspension, Septra Injection 259323 Trimethoprim, Sulfamethoxazole Aspen Pharmacare Canada Inc. Yes Yes Yes Yes Yes Yes No Yes
Tibella 259517 Tibolone Biosyent Pharma Inc Yes No No No No Yes No No
Trispan 259511 Triamcinolone Hexacetonide Medexus Inc No No Yes No No No No Yes
Xeljanz, Xeljanz XR 258173 Tofacitinib Citrate Pfizer Canada ULC No Yes No Yes No Yes No Yes
Zocor 259109 Simvastatin Organon Canada Inc. No Yes No Yes Yes No No Yes

April 2022

Product Monograph Brand Safety Updates April 2022
(PDF, 88.2 KB, 3 pages)

Product Monograph Brand Safety Updates April 2022
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Bijuva 257920 Estradiol Hemihydrate, Progesterone Knight Therapeutics Inc No No No Yes No No No Yes
Braftovi 258894 Encorafenib Pfizer Canada ULC No No No No Yes No No No
Cabometyx 257143 Cabozantinib Malate Ipsen Biopharmaceuticals Canada Inc No Yes No Yes No No No Yes
Caprelsa 258988 Vandetanib Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No Yes No Yes Yes No No Yes
Carboplatin Injection BP 257501 Carboplatin Pfizer Canada ULC No Yes No Yes No Yes No Yes
Cresemba 256812 Isavuconazonium Sulfate Avir Pharma Inc No Yes No Yes No No No Yes
Dilantin Infatabs, Dilantin-30 Suspension, Dilantin-125 Suspension 256638 Phenytoin Upjohn Canada ULC No No No Yes Yes No No Yes
Emla Cream, Emla Patch 258891 Lidocaine, Prilocaine Aspen Pharmacare Canada Inc No Yes No No No No Yes Yes
Enstilar 251305 Betamethasone Dipropionate, Calcipotriol Monohydrate Leo Pharma Inc No Yes No Yes No Yes No Yes
Gleevec 257566 Imatinib Mesylate Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Imovane 258560 Zopiclone Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Imuran 258189 Azathioprine, Azathioprine Sodium Aspen Pharmacare Canada Inc No No No Yes No No No Yes
Jardiance 256491 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No Yes No Yes
Ketorolac Tromethamine Injection USP 256941 Ketorolac Tromethamine Sandoz Canada Incorporated No Yes Yes Yes Yes Yes No Yes
Maviret 252251 Glecaprevir, Pibrentasvir Abbvie Corporation No No No Yes No No No No
Micardis Plus 258676 Hydrochlorothiazide, Telmisartan Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes Yes No No Yes
Pantoloc 255072 Pantoprazole Sodium, Pantoprazole Sodium Sesquihydrate Takeda Canada Inc No No No Yes No No No No
Pediapred 259452 Prednisolone Sodium Phosphate Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Precedex 257757 Dexmedetomidine Hcl Pfizer Canada ULC No No No No No Yes No No
Retevmo 257824 Selpercatinib Loxo Oncology Inc No Yes No No No No No No
Sensorcaine, Sensorcaine with Epinephrine 254303 Bupivacaine Hcl Aspen Pharmacare Canada Inc No Yes No Yes No No No Yes
Spiriva 258194 Tiotropium Bromide Monohydrate Boehringer Ingelheim (Canada) Ltd Ltee No Yes No No Yes Yes No Yes
Tecta 257213 Pantoprazole Magnesium Takeda Canada Inc No No No Yes No No No No
Toradol 256959 Ketorolac Tromethamine AA Pharma Inc No Yes Yes Yes Yes Yes No Yes
Toradol IM 256960 Ketorolac Tromethamine Atnahs Pharma UK Limited No Yes Yes Yes Yes Yes No Yes
Trikafta 255136 Elexacaftor, Ivacaftor, Tezacaftor Vertex Pharmaceuticals (Canada) Incorporated No No No Yes No Yes No Yes
Uptravi 258347 Selexipag Janssen Inc No No No Yes No No No Yes
Vascepa 252460 Icosapent Ethyl HLS Therapeutics Inc Yes Yes No No No Yes Yes Yes
Vimovo 258409 Naproxen, Esomeprazole AstraZeneca Canada Inc No Yes Yes No No No No No
Zeposia 248992 Ozanimod Celgene Inc No Yes No Yes Yes Yes No Yes

March 2022

Product Monograph Brand Safety Updates March 2022
(PDF, 95 KB, 2 pages)

Product Monograph Brand Safety Updates March 2022
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Bydureon BCise 257624 Exenatide AstraZeneca Canada Inc No Yes No Yes Yes Yes Yes Yes
Celebrex 255827 Celecoxib Upjohn Canada ULC Yes Yes Yes No Yes No No Yes
Combivir 251298 Lamivudine, Zidovudine ViiV Healthcare ULC No Yes No No No Yes Yes Yes
Contrave 257357 Bupropion Hcl, Naltrexone Hydrochloride Bausch Health, Canada Inc. No Yes Yes Yes No No No Yes
Desmopressin Spray 258711 Desmopressin Acetate AA Pharma Inc No No No No No Yes No No
Dilantin 256632 Phenytoin Sodium Upjohn Canada ULC No No No Yes Yes No No Yes
Duratocin 257210 Carbetocin Ferring Inc No Yes No Yes No No No No
Durela 255293 Tramadol Hcl Cipher Pharmaceuticals Inc No Yes No Yes No No Yes Yes
Effexor XR 257418 Venlafaxine Hcl Upjohn Canada ULC No Yes No Yes Yes Yes No Yes
Flurbiprofen 257529 Flurbiprofen AA Pharma Inc Yes Yes Yes No Yes Yes No Yes
Flutamide 257084 Flutamide AA Pharma Inc No Yes Yes Yes Yes Yes Yes Yes
Fosrenol 257792 Lanthanum Carbonate Hydrate Takeda Canada Inc Yes Yes No Yes Yes No No Yes
Idamycin PFS 258501 Idarubicin Hcl Pfizer Canada ULC No Yes No No No No No Yes
Imovane 254991 Zopiclone Sanofi-Aventis Canada Inc No Yes Yes Yes Yes Yes No Yes
Inqovi 258177 Cedazuridine, Decitabine Otsuka Pharmaceutical Co Ltd No Yes No Yes No Yes No Yes
Jakavi 252403 Ruxolitinib Phosphate Novartis Pharmaceuticals Canada Inc No No No No No Yes No No
Juxtapid 256310 Lomitapide Mesylate Aegerion Pharmaceuticals Canada Ltd No Yes No No No No No Yes
Kalydeco 255781 Ivacaftor Vertex Pharmaceuticals (Canada) Incorporated No Yes No No No Yes No Yes
Kazano 255701 Metformin Hydrochloride, Alogliptin Benzoate Takeda Canada Inc No Yes No Yes Yes Yes No Yes
Kinevac 256771 Sincalide Bracco Imaging Canada No Yes No No Yes No No No
Levulan Kerastick 257204 Aminolevulinic Acid Hydrochloride Dusa Pharmaceuticals Inc No Yes No Yes No No No Yes
Nasonex 256864 Mometasone Furoate Monohydrate Organon Canada Inc. No No No No No Yes No Yes
Pentasa 251582 Mesalazine Ferring Inc No Yes No Yes No No No Yes
PMS-Fluoxetine 256862 Fluoxetine Hcl Pharmascience Inc No Yes No No No Yes No Yes
Ralivia 256175 Tramadol Hcl Bausch Health, Canada Inc. No Yes No Yes Yes Yes No Yes
Sublinox 254996 Zolpidem Tartrate Bausch Health, Canada Inc. No Yes Yes Yes Yes Yes No Yes
Tagrisso 257918 Osimertinib Mesylate AstraZeneca Canada Inc Yes Yes Yes Yes Yes Yes Yes Yes
Tegsedi 256844 Inotersen Sodium Akcea Therapeutics Inc No Yes No Yes No No No Yes
Tramacet 256180 Tramadol Hcl, Acetaminophen Janssen Inc No Yes No Yes No No Yes Yes
Tridural 256185 Tramadol Hcl Paladin Labs Inc No Yes Yes Yes Yes No Yes Yes
Tykerb 257841 Lapatinib Ditosylate Novartis Pharmaceuticals Canada Inc No No No Yes Yes No No Yes
Ultram 256187 Tramadol Hcl Janssen Inc No Yes No No No Yes Yes Yes
Ultravist 300, Ultravist 370 257678 Iopromide Bayer Inc Yes Yes No Yes No No No No
Zymar 257117 Gatifloxacin Allergan Inc Yes Yes No Yes No Yes No Yes
Zytram Xl 256192 Tramadol Hcl Purdue Pharma No Yes No Yes No Yes No Yes

February 2022

Product Monograph Brand Safety Updates February 2022
(PDF, 108 KB, 3 pages)

Product Monograph Brand Safety Updates February 2022
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Arthrotec 50, Arthrotec 75 253532 Diclofenac Sodium, Misoprostol Pfizer Canada ULC Yes Yes Yes No No No No Yes
Allegra-D 253801 Pseudoephedrine Hcl, Fexofenadine Hcl Sanofi Consumer Health Inc Yes Yes No Yes Yes Yes Yes Yes
Arimidex 257191 Anastrozole AstraZeneca Canada Inc No No No No No No No Yes
Azilect 255783 Rasagiline Mesylate Teva Canada Limited Yes Yes No No Yes Yes No No
Bromocriptine 256286 Bromocriptine Mesylate AA Pharma Inc No No No Yes No No No Yes
Brukinsa 254556 Zanubrutinib Beigene Switzerland GmbH No Yes No Yes No No No Yes
Camptosar 257414 Irinotecan Hydrochloride Pfizer Canada ULC No Yes No No No Yes No Yes
Canesoral Combi, Canesoral, Canesoral Combi 1 Day 254558 Fluconazole, Clotrimazole Bayer Inc Yes No No Yes Yes No No Yes
Canesten 1 Day Internal Cream, Canesten 3 Day Internal Cream, Canesten 6 Day Internal Cream, Canesten External Antifungal Cream,
Canesten Extra Strength External Antifungal Cream,
Canesten Combi 3 Day, Canesten Combi 1 Day, Canesten Combi 1 Day Internal + External Creams		 254158 Clotrimazole Bayer Inc No No No Yes No No No Yes
Canesten 1% Topical Cream 254732 Clotrimazole Bayer Inc No No No Yes No No No Yes
Cefazolin for Injection 254395 Cefazolin Sodium Teva Canada Limited No Yes No No No No No Yes
Cimetidine 256184 Cimetidine AA Pharma Inc No No No No No Yes Yes No
Estrace 256633 Estradiol Acerus Pharmaceuticals Corporation Yes Yes Yes No Yes Yes No Yes
Ferrlecit 255327 Sodium Ferric Gluconate Complex in Sucrose Injection Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Flunarizine 256197 Flunarizine Hcl AA Pharma Inc No No No No Yes No No Yes
Glycopyrronium / Formoterol Fumarate Dihydrate Pressurized Inhalation Suspension 256804 Formoterol Fumarate Dihydrate, Glycopyrronium Bromide AstraZeneca Canada Inc No No No No No No No Yes
Lokelma 254186 Sodium Zirconium Cyclosilicate AstraZeneca Canada Inc No Yes No No No No No Yes
Lopresor SR 256174 Metoprolol Tartrate Novartis Pharmaceuticals Canada Inc No No No No Yes No No Yes
Lumigan RC 257194 Bimatoprost Allergan Inc No No No Yes No No No No
Lynparza 252153 Olaparib AstraZeneca Canada Inc No No No Yes No No No No
Lysodren 254415 Mitotane HRA Pharma Rare Diseases No Yes No Yes Yes Yes Yes No
Multihance 256502 Gadobenate Dimeglumine Bracco Imaging Canada No Yes No Yes No No No No
Nesina 255706 Alogliptin Benzoate Takeda Canada Inc No Yes No Yes Yes Yes No Yes
Olestyr 256040 Cholestyramine Resin Pharmascience Inc No No No Yes No No No Yes
Pennsaid 255809 Diclofenac Sodium Paladin Labs Inc Yes Yes Yes No Yes No No Yes
Pentamidine Isetionate for Injection BP 255613 Pentamidine Isetionate Pfizer Canada ULC No Yes No Yes No No No Yes
Plavix 256673 Clopidogrel Bisulfate Sanofi-Aventis Canada Inc No No No No Yes No No Yes
Sandoz Indomethacin 255837 Indomethacin Sandoz Canada Incorporated Yes Yes Yes Yes Yes Yes Yes Yes
Solu-Medrol 255703 Methylprednisolone Pfizer Canada ULC No Yes No No No No No Yes
Talzenna 250258 Talazoparib Pfizer Canada ULC No No No No No Yes No No
Teva-Indomethacin 255834 Indomethacin Teva Canada Limited No Yes Yes Yes Yes Yes No Yes
Teva-Ipratropium Sterinebs 253021 Ipratropium Bromide Teva Canada Limited Yes Yes No Yes Yes Yes Yes Yes
Velcade 257318 Bortezomib Mannitol Boronic Ester Janssen Inc No Yes No Yes Yes No No Yes
Vyndaqel 255167 Tafamidis Meglumine Pfizer Canada ULC No No No No No Yes No Yes
Zykadia 250707 Ceritinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Zyvoxam 256427 Linezolid Pfizer Canada ULC No Yes No Yes No No No Yes

January 2022

Product Monograph Brand Safety Updates January 2022
(PDF, 112 KB, 3 pages)

Product Monograph Brand Safety Updates January 2022
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
3TC 249461 Lamivudine ViiV Healthcare ULC No Yes Yes No No Yes Yes Yes
AA-Theo LA 254884 Theophylline AA Pharma Inc Yes Yes Yes Yes Yes Yes Yes Yes
Agrylin 255170 Anagrelide Hydrochloride Takeda Canada Inc No Yes No No No Yes No Yes
Aldactazide 25, Aldactazide 50 253092 Hydrochlorothiazide, Spironolactone Pfizer Canada ULC No Yes Yes No Yes Yes No Yes
Anafranil 255249 Clomipramine Hcl Apotex Incorporated No Yes Yes Yes Yes Yes Yes Yes
Anaprox, Anaprox DS 253450 Naproxen Sodium Atnahs Pharma UK Limited Yes Yes Yes No No No No Yes
Brilinta 255611 Ticagrelor AstraZeneca Canada Inc No Yes No No Yes No No Yes
Cipralex 253398 Escitalopram Oxalate Lundbeck Canada Inc No Yes No Yes Yes No No Yes
Dalacin C 255793 Clindamycin Hcl Pfizer Canada ULC No Yes No Yes No Yes No Yes
Dalacin C Flavoured Granules 255844 Clindamycin 2-Palmitate Hcl Pfizer Canada ULC No Yes No Yes No Yes No Yes
Dalacin C Phosphate 255973 Clindamycin Phosphate Pfizer Canada ULC No Yes No No No Yes No Yes
Daurismo 250530 Glasdegib Maleate Pfizer Canada ULC No No No No Yes Yes No No
Entrophen 325 mg Tablets, Entrophen Chewable, Entrophen 325 mg Caplets 255545 Acetylsalicylic Acid Pendopharm Division of Pharmascience Inc Yes No Yes Yes Yes No No Yes
Fampyra 249412 Fampridine Biogen Canada Inc Yes Yes No Yes Yes Yes No Yes
Men's Rogaine Foam 5%, Women's Rogaine Foam 5% 251296 Minoxidil Johnson & Johnson Inc Yes Yes Yes Yes Yes Yes Yes Yes
Micro +4 Regular Strength 250301 Chromium, Copper, Zinc, Manganese Sandoz Canada Incorporated No Yes No No No Yes Yes Yes
Micro +6 Concentrate 253937 Chromium, Selenium, Copper, Zinc, Manganese, Iodine Sandoz Canada Incorporated No Yes No No No Yes Yes Yes
Micro MN 250299 Manganese Sulfate Sandoz Canada Incorporated No Yes No No No Yes Yes Yes
Micro Plus 6 Pediatric, Micro Plus 6 Concentrate 250302 Chromium, Selenium, Copper, Zinc, Manganese, Iodine Sandoz Canada Incorporated No Yes No No No Yes Yes Yes
Myfortic 255453 Mycophenolate Sodium Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Naprosyn 255330 Naproxen Atnahs Pharma UK Limited Yes Yes Yes No No No No Yes
Octasa 252860 Mesalazine Tillotts Pharma AG No Yes No No No No No Yes
Pentoxifylline SR 254072 Pentoxifylline AA Pharma Inc No Yes No Yes Yes Yes No Yes
PMS-Meloxicam 255832 Meloxicam Pharmascience Inc Yes Yes Yes No No No No Yes
Potassium Chloride Injection 252640 Potassium Chloride Baxter Corporation No Yes No No No No No Yes
Retin-A 255590 Tretinoin Bausch Health, Canada Inc. No Yes No Yes No Yes No Yes
Rinvoq 251153 Upadacitinib Abbvie Corporation No Yes No No No No No No
Seroquel XR 255494 Quetiapine Fumarate AstraZeneca Canada Inc No Yes No Yes No No No Yes
Tagrisso 249994 Osimertinib Mesylate AstraZeneca Canada Inc Yes Yes Yes Yes Yes Yes Yes Yes
Teva-Profen 255829 Ibuprofen Teva Canada Limited Yes Yes Yes No No No No Yes
Trelegy Ellipta 255950 Umeclidinium Bromide, Fluticasone Furoate, Vilanterol Trifenatate GlaxoSmithKline Inc No No No Yes No No No Yes
Veklury 248928 Remdesivir Gilead Sciences Canada Inc No No No Yes No No No Yes
Verzenio 249557 Abemaciclib Eli Lilly Canada Inc No No No Yes No No No Yes
Voltaren Emulgel Extra Strength, Voltaren Emulgel Joint Pain Extra Strength 255275 Diclofenac Diethylamine GlaxoSmithKline Consumer Healthcare ULC No Yes No No No Yes No No
Voltaren Emulgel, Voltaren Emulgel Back & Muscle Pain, Voltaren Emulgel Joint Pain Regular Strength 252844 Diclofenac Diethylamine GlaxoSmithKline Consumer Healthcare ULC No Yes No No No Yes No No
Wellbutrin SR 251380 Bupropion Hcl Bausch Health, Canada Inc. Yes Yes Yes Yes Yes Yes Yes Yes
Xermelo 246356 Telotristat Etiprate Ipsen Biopharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Xofluza 253245 Baloxavir Marboxil Hoffmann-La Roche Limited No No No No No Yes No Yes
Xospata 256060 Gilteritinib Fumarate Astellas Pharma Canada Inc No No No No Yes No No Yes
Xtandi 256450 Enzalutamide Astellas Pharma Canada Inc Yes Yes No Yes No No No Yes
Zavesca 255321 Miglustat Janssen Inc No Yes No No No Yes No Yes

December 2021

Product Monograph Brand Safety Updates December 2021
(PDF, 105 KB, 3 pages)

Product Monograph Brand Safety Updates December 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Afinitor, Afinitor Disperz 255457 Everolimus Novartis Pharmaceuticals Canada Inc No No No Yes No No No No
Aromasin 255177 Exemestane Pfizer Canada ULC No No No Yes No No No Yes
Avamys 253941 Fluticasone Furoate GlaxoSmithKline Inc No No No No No No No Yes
Cambia 253454 Diclofenac Potassium Aralez Pharmaceuticals Canada Inc No Yes Yes No No No No Yes
Celexa 253406 Citalopram Hydrobromide Lundbeck Canada Inc No Yes No Yes Yes No No Yes
Chlorax 253149 Clidinium Bromide, Chlordiazepoxide Hcl AA Pharma Inc Yes Yes Yes Yes Yes Yes Yes Yes
Clorazepate 253157 Clorazepate Dipotassium AA Pharma Inc No Yes Yes Yes Yes Yes Yes Yes
Dovonex 252165 Calcipotriol Leo Pharma Inc Yes Yes No Yes No No Yes Yes
Fentora 254762 Fentanyl Citrate Teva Canada Limited No No No No Yes No Yes Yes
Galafold 247824 Migalastat Hydrochloride Amicus Therapeutics UK Ltd Yes Yes No Yes Yes Yes No Yes
Heptovir 254986 Lamivudine GlaxoSmithKline Inc No No No No No No Yes Yes
Imbruvica 255285 Ibrutinib Janssen Inc No Yes No Yes No No No Yes
Isoptin SR 253349 Verapamil Hcl BGP Pharma ULC No No No No Yes No Yes Yes
Isovue 200 Injection, Isovue 300 Injection, Isovue 370 Injection, Isovue Multipack-300, Isovue Multipack-370 254894 Iopamidol Bracco Imaging Canada No Yes Yes No Yes Yes No No
Lamictal 251591 Lamotrigine GlaxoSmithKline Inc No Yes No Yes No No No Yes
Latisse 254509 Bimatoprost Allergan Inc No No No Yes No No No Yes
Librax 253166 Clidinium Bromide, Chlordiazepoxide Hcl Bausch Health, Canada Inc. Yes Yes Yes Yes Yes Yes Yes Yes
Lixiana 244386 Edoxaban Tosylate Servier Canada Inc No Yes No Yes Yes Yes No Yes
Lorbrena 248101 Lorlatinib Pfizer Canada ULC No Yes No Yes Yes Yes No Yes
Mekinist 255274 Trametinib Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No Yes
Metoject Subcutaneous 251944 Methotrexate Sodium Medexus Inc No Yes No Yes Yes Yes No Yes
Mezera 252654 Mesalazine Avir Pharma Inc No Yes No Yes No No No Yes
Micro +5 Concentrate 250303 Chromium, Selenium, Copper, Zinc, Manganese Sandoz Canada Incorporated No Yes No No No Yes Yes Yes
Midazolam Injection SDZ 250749 Midazolam Sandoz Canada Incorporated No Yes Yes Yes Yes Yes No Yes
Nalcrom 253935 Cromolyn Sodium Sanofi-Aventis Canada Inc Yes Yes No No No Yes No Yes
Nolvadex-D 254849 Tamoxifen Citrate AstraZeneca Canada Inc No Yes No Yes No No No Yes
PDP-Amantadine Hydrochloride Syrup, PDP-Amantadine Hydrochloride Capsules 254156 Amantadine Hcl Pendopharm Division of Pharmascience Inc No No No No No No No Yes
Perindopril Erbumine / Indapamide, Perindopril Erbumine / Indapamide HD 254734 Indapamide, Perindopril Erbumine Sivem Pharmaceuticals ULC No Yes No Yes Yes No No Yes
Posanol 254862 Posaconazole Merck Canada Inc No Yes No No Yes No No Yes
Primaxin 253551 Cilastatin Sodium, Imipenem Merck Canada Inc No No No No No Yes No Yes
Sandoz Everolimus 255100 Everolimus Sandoz Canada Incorporated No Yes No Yes No No No Yes
Sonovue 255064 Sulfur Hexafluoride Bracco Imaging Canada No Yes No No No No No Yes
Suvexx 253456 Sumatriptan Succinate, Naproxen Sodium Aralez Pharmaceuticals Canada Inc Yes Yes Yes No No No No Yes
Tafinlar 255279 Dabrafenib Mesylate Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No Yes
Tepadina 252188 Thiotepa Adienne SA No No No No No Yes No Yes
Teva-Glatiramer Acetate 254069 Glatiramer Acetate Teva Canada Limited No Yes No Yes No No No Yes
Ticlopidine 251592 Ticlopidine Hcl Apotex Inc Yes Yes Yes Yes Yes Yes Yes Yes
Tivicay 254989 Dolutegravir Sodium ViiV Healthcare ULC No No No No No Yes No No
Tomudex 254888 Raltitrexed Pfizer Canada ULC No Yes No Yes Yes No No Yes
Triazolam 253167 Triazolam AA Pharma Inc Yes Yes Yes Yes Yes Yes Yes Yes
Trinipatch 0.2, Trinipatch 0.4, Trinipatch 0.6 254535 Nitroglycerin Paladin Labs Inc No Yes No No Yes No No Yes
Tylenol with Codeine No. 2, Tylenol with Codeine No. 3 258437 Acetaminophen, Caffeine, Codeine Phosphate Janssen Inc No No No No Yes No No No
Tylenol with Codeine No. 4 258440 Acetaminophen, Codeine Phosphate Janssen Inc No No No No Yes No No No
Votrient 255496 Pazopanib Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Xarelto 253313 Rivaroxaban Bayer Inc No Yes No No No No No No
Xeljanz, Xeljanz XR 252874 Tofacitinib Citrate Pfizer Canada ULC No Yes Yes Yes No No No Yes
Zeldox 255625 Ziprasidone Hydrochloride Monohydrate Upjohn Canada ULC No Yes No Yes Yes Yes No Yes
Zyban 255407 Bupropion Hcl Bausch Health, Canada Inc. No Yes No Yes Yes No No Yes

November 2021

Product Monograph Brand Safety Updates November 2021
(PDF, 86 KB, 2 pages)

Product Monograph Brand Safety Updates November 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Alertec 253513 Modafinil Teva Canada Limited No Yes No No No Yes No Yes
Atectura Breezhaler 246914 Mometasone Furoate, Indacaterol Acetate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Balversa 255246 Erdafitinib Janssen Inc No No No Yes No No No No
Bicnu 252245 Carmustine Marcan Pharmaceuticals Inc No No No No No No No Yes
Bosulif 253533 Bosutinib Monohydrate Pfizer Canada ULC No No No No No No No Yes
Caduet 253692 Atorvastatin Calcium, Amlodipine Besylate Upjohn Canada ULC Yes Yes No Yes Yes Yes Yes Yes
Cyklokapron 254356 Tranexamic Acid Pfizer Canada ULC Yes Yes No No No Yes No Yes
Depakene 253018 Sodium Valproate BGP Pharma ULC No Yes No Yes Yes No No Yes
Diflucan 252544 Fluconazole Pfizer Canada ULC No No No No Yes No No Yes
Diprivan 1% 253246 Propofol Aspen Pharmacare Canada Inc. No No No No Yes Yes No Yes
Enerzair Breezhaler 247486 Mometasone Furoate, Indacaterol Acetate, Glycopyrronium Bromide Novartis Pharmaceuticals Canada Inc No No No No No No No Yes
Fetzima 253804 Levomilnacipran Allergan Inc No Yes No Yes No No No Yes
IPG-Atenolol 250895 Atenolol Marcan Pharmaceuticals Inc No Yes No No No No No Yes
Keppra 254607 Levetiracetam UCB Canada Inc No Yes No Yes No No No Yes
Kuvan 242620 Sapropterin Dihydrochloride Biomarin International Limited No Yes No Yes No Yes No No
Lipitor 253694 Atorvastatin Calcium Upjohn Canada ULC No Yes No No No No No No
Lupron, Lupron Depot 254414 Leuprolide Acetate Abbvie Corporation No Yes No Yes No No No Yes
Maviret 247707 Pibrentasvir, Glecaprevir Abbvie Corporation No No No Yes No Yes No Yes
Midazolam Injection 250748 Midazolam Sandoz Canada Incorporated No Yes Yes Yes Yes Yes No Yes
PDP-Levetiracetam 250898 Levetiracetam Pendopharm Division of Pharmascience Inc No Yes No Yes No No No Yes
Pediapharm Naproxen Suspension 253528 Naproxen Medexus Pharmaceuticals Inc Yes Yes Yes No No No No Yes
Provocholine Inhalation Solution 249113 Methacholine Chloride Methapharm Inc Yes Yes Yes Yes Yes Yes No Yes
Restoril 248569 Temazepam AA Pharma Inc No Yes Yes Yes Yes Yes No Yes
Revolade 247826 Eltrombopag Olamine Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Salofalk 252272 Mesalazine Aptalis Pharma Canada ULC No Yes No Yes No No No Yes
Salofalk 252275 Mesalazine Aptalis Pharma Canada ULC No Yes No Yes No No No Yes
Salofalk 252276 Mesalazine Aptalis Pharma Canada ULC Yes Yes No Yes No No No No
Seroquel 254368 Quetiapine AstraZeneca Canada Inc No Yes No Yes No No No Yes
Triumeq 245210 Abacavir Sulfate, Dolutegravir Sodium, Lamivudine ViiV Healthcare ULC No Yes No Yes Yes Yes No No
Uptravi 254080 Selexipag Janssen Inc No Yes No Yes No No No Yes
Veklury 254319 Remdesivir Gilead Sciences Canada Inc No Yes No Yes No No No Yes
Wellbutrin XL 251299 Bupropion Hcl Bausch Health, Canada Inc. No Yes No Yes No No No No
Xtandi 245837 Enzalutamide Astellas Pharma Canada Inc No No No Yes No No No Yes
Zejula 247584 Niraparib GlaxoSmithKline Inc No No No No No Yes No Yes
Zofran, Zofran ODT 252778 Ondansetron Hydrochloride Dihydrate, Ondansetron Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Zytiga 254299 Abiraterone Acetate Janssen Inc Yes Yes Yes Yes Yes Yes No Yes

October 2021

Product Monograph Brand Safety Updates October 2021
(PDF, 101 KB, 2 pages)

Product Monograph Brand Safety Updates October 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Adderall XR 251964 Amphetamine Aspartate, Dextroamphetamine Saccharate, Amphetamine Sulfate, Dextroamphetamine Sulfate Takeda Canada Inc No No No Yes No No No Yes
Allegra Hives, Allegra 12 Hour, Allegra 24 Hour 252314 Fexofenadine Hcl Sanofi Consumer Health Inc Yes No No Yes No No Yes Yes
Biaxin Bid, Biaxin 253289 Clarithromycin BGP Pharma ULC Yes Yes No No Yes No No Yes
Bridion 234372 Sugammadex Merck Canada Inc Yes Yes Yes Yes Yes Yes No Yes
Buspirone 252361 Buspirone Hcl Apotex Inc No Yes Yes Yes Yes No No Yes
Cabometyx 245824 Cabozantinib Malate Ipsen Biopharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Cromolyn Eye Drops 252415 Cromolyn Sodium Pendopharm Division of Pharmascience Inc Yes Yes Yes Yes Yes Yes Yes Yes
Diflucan One 252521 Fluconazole Pfizer Canada ULC Yes No No No Yes No No Yes
Eltroxin 253114 Levothyroxine Sodium Aspen Pharmacare Canada Inc. Yes Yes No Yes Yes Yes No Yes
Enstilar 247673 Betamethasone Dipropionate, Calcipotriol Monohydrate Leo Pharma Inc No Yes No Yes No Yes No Yes
Epival 253012 Divalproex Sodium BGP Pharma ULC No Yes Yes Yes Yes No No Yes
Euthyrox 248518 Levothyroxine Sodium EMD Serono A Division of EMD Canada Inc No No No No No Yes No Yes
Ferriprox 244597 Deferiprone Chiesi Canada Corp. No Yes No Yes No No No Yes
Fluconazole 150 252705 Fluconazole Apotex Inc No Yes No Yes Yes No No Yes
Flurazepam 250741 Flurazepam Hcl AA Pharma Inc No Yes Yes Yes Yes Yes No Yes
Givlaari 253007 Givosiran Alnylam Netherlands B.V. No Yes No Yes No Yes No Yes
Inlyta 245813 Axitinib Pfizer Canada ULC No Yes No Yes No Yes No Yes
Intrarosa 253873 Prasterone Endoceutics Inc Yes No No Yes Yes Yes Yes Yes
Jardiance 246457 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee Yes Yes No Yes No Yes No Yes
Mavenclad 249245 Cladribine EMD Serono A Division of EMD Canada Inc No Yes No Yes No Yes No Yes
Mezera 251579 Mesalazine Avir Pharma Inc No Yes No No No No No Yes
Paxil 252405 Paroxetine Hcl GlaxoSmithKline Inc No Yes No No Yes No No Yes
Paxil CR 252407 Paroxetine Hcl GlaxoSmithKline Inc No Yes No No No No No Yes
Plaquenil 245822 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc No Yes No No Yes Yes No No
Rinvoq 245530 Upadacitinib Abbvie Corporation No Yes No Yes No Yes No Yes
Stromectol 253096 Ivermectin Merck Canada Inc No Yes No Yes No No Yes Yes
Suboxone 252770 Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate Indivior UK Limited No No No No No No Yes Yes
Synthroid 248519 Levothyroxine Sodium BGP Pharma ULC Yes Yes No Yes Yes Yes No Yes
Tecfidera 245515 Dimethyl Fumarate Biogen Canada Inc No Yes No Yes No No No Yes
Vfend 252675 Voriconazole Pfizer Canada ULC Yes Yes No No Yes No No Yes
Voltaren Rapide 253458 Diclofenac Potassium Novartis Pharmaceuticals Canada Inc Yes Yes Yes No No No No Yes
Voltaren, Voltaren SR 253534 Diclofenac Sodium Novartis Pharmaceuticals Canada Inc Yes Yes Yes No No No No Yes
Zeposia 253417 Ozanimod Celgene Inc No Yes No Yes No Yes No Yes

September 2021

Product Monograph Brand Safety Updates September 2021
(PDF, 96 KB, 2 pages)

September 2021
Brand Name Submission
Number		 Ingredient(s) Manufacturer Contraindications Warnings &
Precautions		 Serious Warnings &
Precautions		 Adverse
Reactions		 Drug
Interactions		 Dosage &
Administration		 Overdosage Consumer
Information
Accel-Sevelamer 249772 Sevelamer Carbonate Accel Pharma Inc No Yes No Yes No No No Yes
Biphentin 249146 Methylphenidate Hcl Elvium Life Sciences No Yes No Yes Yes No No Yes
Brilinta 252326 Ticagrelor AstraZeneca Canada Inc No Yes No Yes No No No Yes
Dexilant 251447 Dexlansoprazole Takeda Canada Inc No No No Yes No No No Yes
Differin, Differin XP 250710 Adapalene Galderma Canada Inc No No No Yes No No No Yes
Dovato 245212 Dolutegravir Sodium, Lamivudine ViiV Healthcare ULC No Yes No No No Yes No No
Entocort 251213 Budesonide Tillotts Pharma GmbH No Yes No No No No No Yes
Flagyl 251939 Metronidazole Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Flagystatin 251953 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Imitrex DF, Imitrex, Imitrex Nasal Spray 248682 Sumatriptan Succinate, Sumatriptan Hemisulfate GlaxoSmithKline Inc No Yes No No No Yes No No
Inrebic 253094 Fedratinib Hydrochloride Celgene Inc No No No No Yes No No Yes
Kivexa 243500 Abacavir, Lamivudine ViiV Healthcare ULC No Yes No No No Yes No No
Kyleena 251457 Levonorgestrel Bayer Inc No Yes No No No Yes No Yes
Mezavant 251581 Mesalazine Takeda Canada Inc No Yes No Yes No No No Yes
Mirena 251699 Levonorgestrel Bayer Inc No Yes No Yes Yes Yes No No
Monoferric 245637 Ferric Derisomaltose Pharmacosmos A/S Yes Yes Yes Yes Yes Yes No Yes
Nexium 251874 Esomeprazole Magnesium Trihydrate AstraZeneca Canada Inc No Yes No Yes No No No Yes
Prevacid, Prevacid Fastab 251460 Lansoprazole Takeda Pharmaceuticals America Inc No No No Yes No No No Yes
Spravato 244338 Esketamine Hydrochloride Janssen Inc No Yes No Yes No Yes No Yes
Treanda 251868 Bendamustine Hydrochloride Teva Canada Limited No Yes No Yes No No No Yes
Velphoro 244717 Sucroferric Oxyhydroxide Vifor Fresenius Medical Care Renal Pharma Ltd No No No Yes No No No Yes
Vimovo 252259 Naproxen, Esomeprazole AstraZeneca Canada Inc No Yes No Yes No No No Yes
Xofluza 253190 Baloxavir Marboxil Hoffmann-La Roche Limited No No No No Yes No No No
Zoloft 253527 Sertraline Hcl Upjohn Canada ULC No Yes No No Yes No No Yes
Zyloprim 248178 Allopurinol AA Pharma Inc No Yes Yes Yes No No No Yes

August 2021

Product Monograph Brand Safety Updates August 2021
(PDF, 88 KB, 2 pages)

August 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Atacand Plus 250812 Hydrochlorothiazide, Candesartan Cilexetil AstraZeneca Canada Inc No Yes No Yes No No No Yes
Atriance 248552 Nelarabine Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Blexten 241318 Bilastine Aralez Pharmaceuticals Canada Inc No No No Yes Yes Yes No Yes
Esbriet 249105 Pirfenidone Hoffmann-La Roche Limited No Yes No Yes No Yes No Yes
Forxiga 248367 Dapagliflozin Propanediol AstraZeneca Canada Inc Yes Yes No Yes No Yes No Yes
Genvoya 250387 Emtricitabine, Cobicistat, Tenofovir Alafenamide Hemifumarate, Elvitegravir Gilead Sciences Canada Inc No No No No Yes No No Yes
Hydrea 250623 Hydroxyurea Bristol-Myers Squibb Canada No Yes No Yes No No No Yes
Juluca 243354 Dolutegravir, Rilpivirine ViiV Healthcare ULC No Yes No Yes No No No No
Kalydeco 247481 Ivacaftor Vertex Pharmaceuticals (Canada) Incorporated No Yes No Yes Yes Yes No Yes
Kisqali 250667 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Levothyroxine Sodium for Injection, Levothyroxine Sodium Injection 246606 Levothyroxine Sodium Fresenius Kabi Canada Ltd Yes Yes No Yes Yes Yes No Yes
Mogadon 248565 Nitrazepam AA Pharma Inc No Yes Yes Yes Yes Yes No Yes
Moviprep 247990 Polyethylene Glycol 3350, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate, Sodium Sulfate Anhydrous Aralez Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Nucynta IR 247865 Tapentadol Hydrochloride Endo Ventures Ltd No Yes No Yes Yes Yes Yes Yes
Orilissa 250668 Elagolix Sodium Abbvie Corporation Yes Yes No No Yes No No Yes
Protopic 243249 Tacrolimus Leo Pharma Inc No Yes Yes No No No No Yes
Rythmol 251371 Propafenone Hcl BGP Pharma ULC No Yes No Yes No No No Yes
Trintellix 248464 Vortioxetine Hydrobromide Lundbeck Canada Inc No Yes No Yes Yes No No Yes
Tybost 250376 Cobicistat Gilead Sciences Canada Inc No No No No Yes No No Yes
Tygacil 251294 Tigecycline Pfizer Canada ULC No Yes No No No No No No
Uvadex 250515 Methoxsalen Therakos Inc No Yes No Yes No No Yes Yes
Veklury 250729 Remdesivir Gilead Sciences Canada Inc No No No Yes No Yes No Yes
Vimpat 251063 Lacosamide UCB Canada Inc No No No Yes No No No Yes
Votrient 251027 Pazopanib Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Zestoretic 250625 Hydrochlorothiazide, Lisinopril Searchlight Pharma Inc No Yes No Yes No No No Yes
Zeulide Depot 246754 Leuprolide Acetate Verity Pharmaceuticals Inc Yes Yes No No No Yes No Yes

July 2021

Product Monograph Brand Safety Updates July 2021
(PDF, 90 KB, 3 pages)

July 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Agrylin 245876 Anagrelide Hydrochloride Takeda Canada Inc No Yes Yes No No Yes No Yes
Alecensaro 250679 Alectinib Hydrochloride Hoffmann-La Roche Limited No No No Yes No No No Yes
Arimidex 250543 Anastrozole Astrazeneca Canada Inc No No No Yes No No No Yes
Axid 247715 Nizatidine Pendopharm Division of Pharmascience Inc No No No Yes No No No No
Brukinsa 242885 Zanubrutinib Beigene Switzerland Gmbh No No No Yes No No No Yes
Ceftin 249935 Cefuroxime Axetil GlaxoSmithKline Inc No Yes No No No Yes No Yes
Condyline 246341 Podophyllotoxin Sanofi-Aventis Canada Inc Yes Yes No Yes No No Yes No
Diacomit 248895 Stiripentol Biocodex SA No Yes No No No No No Yes
Edarbi 246524 Azilsartan Medoxomil Potassium Bausch Health, Canada Inc. No No No No No No No Yes
Edarbyclor 246568 Azilsartan Medoxomil Potassium, Chlorthalidone Bausch Health, Canada Inc. No Yes No No No No No Yes
Erleada 249685 Apalutamide Janssen Inc No Yes No No No No No No
Foradil 248892 Formoterol Fumarate Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Fosamax 247669 Alendronic Acid Organon Canada Inc. No Yes No No No Yes No Yes
Gilenya 249522 Fingolimod Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes Yes No Yes
Janumet, Janumet XR 242894 Sitagliptin, Metformin Hcl Merck Canada Inc No Yes No Yes No Yes No Yes
Januvia 242950 Sitagliptin Merck Canada Inc No Yes No Yes No Yes No Yes
Kaletra 249555 Lopinavir, Ritonavir Abbvie Corporation Yes No No No Yes No No Yes
Komboglyze 249064 Metformin Hcl, Saxagliptin AstraZeneca Canada Inc No No No Yes No No No Yes
Lenvima 243615 Lenvatinib Mesylate Eisai Limited No Yes No No No No No No
Luvox 248243 Fluvoxamine Maleate BGP Pharma ULC No Yes No Yes Yes No No Yes
Monurol 250260 Fosfomycin Tromethamine Paladin Labs Inc Yes Yes No No No Yes Yes Yes
Nerlynx 249980 Neratinib Maleate Knight Therapeutics Inc. No Yes No Yes No Yes No Yes
Norvir 249539 Ritonavir Abbvie Corporation Yes No No No Yes No No Yes
Nubeqa 243046 Darolutamide Bayer Inc No Yes No Yes Yes No No Yes
Nucynta Extended-Release 247847 Tapentadol Hydrochloride Endo Ventures Ltd No Yes No Yes Yes Yes Yes Yes
Ofev 249336 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No No No No No Yes No Yes
Plaquenil 250901 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc No Yes No Yes No No Yes Yes
Prezcobix 249902 Darunavir Ethanolate, Cobicistat Janssen Inc No No No No Yes No No Yes
Prezista 249945 Darunavir Ethanolate Janssen Inc No No No No Yes No No Yes
Procysbi 240671 Cysteamine Bitartrate Horizon Therapeutics Ireland DAC No Yes No Yes Yes Yes No Yes
Prozac 249549 Fluoxetine Hcl Eli Lilly Canada Inc No Yes No No No No No Yes
Qtern 249090 Saxagliptin, Dapagliflozin AstraZeneca Canada Inc No No No Yes No No No Yes
Rinvoq 250262 Upadacitinib Abbvie Corporation No Yes No Yes No No No Yes
Sandoz Fingolimod 249277 Fingolimod Hydrochloride Sandoz Canada Incorporated No Yes No Yes Yes Yes No Yes
Stribild 250381 Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, Elvitegravir Gilead Sciences Canada Inc No No No No Yes No No Yes
Symtuza 249912 Emtricitabine, Darunavir Ethanolate, Cobicistat, Tenofovir Alafenamide Hemifumarate Janssen Inc No No No No Yes No No Yes
Teva-Bromazepam 248570 Bromazepam Teva Canada Limited No Yes Yes Yes Yes Yes No Yes
Vizimpro 243393 Dacomitinib Monohydrate Pfizer Canada ULC No No No No Yes Yes No Yes
Volibris 248077 Ambrisentan GlaxoSmithKline Inc No Yes No No No No No Yes

June 2021

Product Monograph Brand Safety Updates June 2021
(PDF, 101 KB, 4 pages)

June 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Altace HCT 246597 Hydrochlorothiazide, Ramipril Bausch Health, Canada Inc No Yes No Yes No No No Yes
Aspirin 81 mg, Aspirin 81 mg Quick Chews, Aspirin Regular Strength, Aspirin Extra Strength 248124 Acetylsalicylic Acid Bayer Inc No Yes No Yes Yes No No No
Bricanyl Turbuhaler 239089 Terbutaline Sulfate AstraZeneca Canada Inc Yes Yes No No No No No Yes
Cellcept, Cellcept I.V. 248429 Mycophenolate Mofetil Hoffmann-La Roche Limited No Yes No No No No No Yes
Cipro XL 248371 Ciprofloxacin Hydrochloride Bayer Inc Yes No No No No Yes No Yes
Cipro, Cipro Oral Suspension 248370 Ciprofloxacin Hydrochloride Bayer Inc Yes No No No No Yes No Yes
Clozaril 247538 Clozapine HLS Therapeutics Inc No Yes Yes No No Yes No Yes
Combogesic 248697 Ibuprofen, Acetaminophen Biosyent Pharma Inc No No No Yes No Yes No No
Efudex 246337 Fluorouracil Bausch Health, Canada Inc Yes Yes Yes Yes Yes Yes Yes Yes
Epclusa 247195 Velpatasvir, Sofosbuvir Gilead Sciences Canada Inc No No No Yes No No No Yes
Erleada 241210 Apalutamide Janssen Inc No Yes No Yes No Yes No Yes
Harvoni 247194 Ledipasvir, Sofosbuvir Gilead Sciences Canada Inc No No No Yes No No No Yes
Hemangiol 247151 Propranolol Hcl Pierre Fabre Dermo-Cosmetique Canada Inc No Yes No Yes No No No Yes
Idamycin PFS 249085 Idarubicin Hcl Pfizer Canada ULC No No No Yes No No No Yes
Imbruvica 248172 Ibrutinib Janssen Inc No Yes No Yes No No No Yes
Inderal-LA 248972 Propranolol Hcl Pfizer Canada ULC No No No Yes No No No Yes
Jakavi 247787 Ruxolitinib Phosphate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Lorbrena 247174 Lorlatinib Pfizer Canada ULC No Yes No Yes No Yes No Yes
Lynparza 249369 Olaparib AstraZeneca Canada Inc No No No Yes No No No Yes
Manerix 246047 Moclobemide Bausch Health, Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Maxidol Liquid Gels 248432 Naproxen Sodium Bayer Inc No No No Yes No No No Yes
Nerlynx 242449 Neratinib Maleate Knight Therapeutics Inc No Yes No Yes Yes Yes No Yes
Ofev 241747 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No Yes No No Yes No No Yes
Orgalutran 248614 Ganirelix Acetate Organon Canada Inc Yes Yes No Yes No Yes No Yes
Pat-Galantamine ER 248978 Galantamine Hydrobromide Janssen Inc No Yes No Yes No Yes No Yes
Piqray 248616 Alpelisib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Ralivia 246159 Tramadol Hcl Bausch Health, Canada Inc No Yes No Yes No No Yes Yes
Retrovir (AZT) 249459 Zidovudine ViiV Healthcare ULC No Yes Yes No Yes Yes Yes Yes
Rinvoq 241253 Upadacitinib Abbvie Corporation No Yes No Yes No Yes No Yes
Rivotril 245341 Clonazepam Hoffmann-La Roche Limited No Yes Yes Yes Yes Yes No Yes
Rydapt 247829 Midostaurin Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Sandoz Zopiclone Tablet 247527 Zopiclone Sandoz Canada Incorporated No Yes Yes Yes No Yes No Yes
Sovaldi 247196 Sofosbuvir Gilead Sciences Canada Inc No No No Yes No No No Yes
Synalar 247002 Fluocinolone Acetonide Bausch Health, Canada Inc No Yes No Yes No No No Yes
Tapazole 246350 Methimazole Paladin Labs Inc No Yes No No No No Yes Yes
Toviaz 248542 Fesoterodine Fumarate Pfizer Canada ULC Yes Yes No Yes Yes Yes No No
Trileptal 247670 Oxcarbazepine Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No Yes
Valium 245343 Diazepam Hoffmann-La Roche Limited No Yes Yes Yes Yes Yes No Yes
Vaseretic 247516 Enalapril Maleate, Hydrochlorothiazide Organon Canada Inc No Yes No No Yes No No Yes
Vasotec 247519 Enalapril Maleate Organon Canada Inc No Yes No No Yes No No Yes
Wellbutrin XL 247849 Bupropion Hcl Bausch Health, Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Zyban 247564 Bupropion Hcl Bausch Health, Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Zyvoxam 248930 Linezolid Pfizer Canada ULC No Yes No Yes No 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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