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Product Monograph Brand Safety Updates

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May 2019

Product Monograph Brand Safety Updates May 2019
(PDF, 139 KB, 2 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Aerius Double Action 12 Hour 225003 pseudoephedrine sulfate, desloratadine Bayer Inc No No No No No No No Yes
Aldactazide 25, Aldactazide 50 224433 hydrochlorothiazide, spironolactone Pfizer Canada Ulc No Yes No Yes No No No Yes
Belkyra 225789 deoxycholic acid Kythera Biopharmaceuticals Inc No No No Yes No No No No
Biktarvy 224191 emtricitabine, tenofovir alafenamide, bictegravir Gilead Sciences Canada Inc No Yes No Yes No No No Yes
Brivlera 224666 brivaracetam UCB Canada Inc No Yes No Yes No No No Yes
Bydureon 224768 exenatide AstraZeneca Canada Inc No No No Yes No No No No
Caelyx 225464 doxorubicin hcl Janssen Inc No No No Yes No No No No
Claritin Allergy 225773 loratadine Bayer Inc Yes Yes No No No No No Yes
Claritin Allergy + Sinus 225712 pseudoephedrine sulfate, loratadine Bayer Inc Yes Yes No No No No No Yes
Claritin Allergy + Sinus Extra Strength 225242 pseudoephedrine sulfate, loratadine Bayer Inc No Yes No No No No No Yes
Claritin Kids 225774 loratadine Bayer Inc Yes Yes No No No No No Yes
Claritin Liquid Capsules 225631 loratadine Bayer Inc Yes Yes Yes No No Yes No Yes
Genvoya 224195 emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide Gilead Sciences Canada Inc No Yes No Yes No No No Yes
Gilenya 224273 fingolimod hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Glyxambi 224972 linagliptin, empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Invokamet 225038 metformin hcl, canagliflozin Janssen Inc No Yes No No No No No Yes
Invokamet Xr 225123 metformin hcl, canagliflozin Janssen Inc No Yes No Yes No No No Yes
Jentadueto 224836 metformin hcl, linagliptin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Kaletra 225124 ritonavir, lopinavir Abbvie Corporation Yes Yes No No Yes No No Yes
Lynparza 219799 olaparib AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Norvir 226180 ritonavir Abbvie Corporation Yes Yes Yes Yes Yes Yes Yes Yes
Odefsey 224194 emtricitabine, tenofovir alafenamide, rilpivirine Gilead Sciences Canada Inc No Yes No Yes No No No Yes
Olmetec Plus 224593 hydrochlorothiazide, olmesartan medoxomil Merck Canada Inc No Yes No Yes No No No Yes
Omniscan 225072 gadodiamide GE Healthcare Canada Inc No Yes No Yes No Yes No No
Orgalutran 224718 ganirelix acetate Merck Canada Inc No Yes No Yes No No Yes Yes
Parnate 222806 tranylcypromine sulfate GlaxoSmithKline Inc No Yes No No No No Yes No
Pms-Methotrexate 224788 methotrexate sodium Pharmascience Inc Yes Yes Yes Yes Yes Yes No Yes
Quinsair 224015 levofloxacin Horizon Pharma Ireland Ltd No Yes No No No No No Yes
Reactine Complete 224142 cetirizine hydrochloride, pseudoephedrine hcl McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes Yes Yes Yes No Yes Yes
Reactine, Reactine Allergy Liquid Gels, Reactine Fast Melt Junior, Reactine Rapid Dissolve 224044 cetirizine hydrochloride McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes Yes Yes Yes Yes Yes Yes
Revolade 217802 eltrombopag olamine Novartis Pharmaceuticals Canada Inc No No No Yes No Yes No Yes
Sensorcaine, Sensorcaine With Epinephrine 224469 bupivacaine hcl, epinephrine bitartrate Aspen Pharmacare Canada Inc. Yes Yes No Yes Yes Yes Yes Yes
Somatuline Autogel 225592 lanreotide Ipsen Biopharm Limited No No No No No No No Yes
Spiriva Respimat 224205 tiotropium bromide monohydrate Boehringer Ingelheim (Canada) Ltd Ltee No Yes No No Yes No No Yes
Steglujan 224047 sitagliptin phosphate, ertugliflozin Merck Canada Inc No Yes No No No Yes No Yes
Striverdi Respimat 224290 olodaterol hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Sublocade 224875 buprenorphine Indivior UK Limited No Yes Yes No Yes Yes Yes Yes
Trajenta 224835 linagliptin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Vemlidy 224496 tenofovir alafenamide Gilead Sciences Canada Inc No Yes No Yes No Yes Yes Yes
Zocor 224707 simvastatin Merck Canada Inc No Yes No No Yes No No Yes

April 2019

Product Monograph Brand Safety Updates April 2019
(PDF, 129 KB, 2 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Adriamycin Pfs 224489 doxorubicin hcl Pfizer Canada ULC No Yes No No No No No No
Aloxi 215829 palonosetron hydrochloride Purdue Pharma Yes Yes No Yes No Yes No Yes
Anandron 224467 nilutamide Sanofi-Aventis Canada Inc No No No No No No No Yes
Apo-Perindopril Arginine 223805 perindopril arginine Apotex Inc Yes Yes No No Yes No No Yes
Apresoline 223367 hydralazine hcl Sterimax Inc No Yes No No No Yes No No
Belsomra 224763 suvorexant Merck Canada Inc No No No Yes No No No Yes
Brilinta 223019 ticagrelor Astrazeneca Canada Inc No Yes No No Yes Yes Yes No
Carnitor 222342 levocarnitine Leadiant Biosciences, Inc. No Yes No Yes No No No Yes
Celebrex 206954 celecoxib Pfizer Canada Inc No Yes Yes No No No No No
Concerta 224296 methylphenidate hcl Janssen Inc No No No No Yes No No Yes
Depakene 225434 valproic acid Bgp Pharma ULC No No No No No Yes No Yes
Dexilant 215955 dexlansoprazole Takeda Canada Inc No Yes No Yes No Yes No Yes
Forxiga 217312 dapagliflozin Astrazeneca Canada Inc Yes Yes No Yes No Yes No Yes
Idamycin Pfs 224473 idarubicin hcl Pfizer Canada Ulc No Yes No No No No No No
Imodium Calming Liquid, Imodium Liqui-Gels, Imodium Quick Dissolve 222934 loperamide hcl Mcneil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No No No No Yes Yes
Imodium Complete Caplets 222936 loperamide hcl, simethicone Mcneil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No No No No Yes Yes
Invokana 225039 canagliflozin Janssen Inc No Yes No No No No No Yes
Jardiance 221628 empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes Yes No No Yes
Lanvis 223270 thioguanine Aspen Pharmacare Canada Inc. No No No No No Yes No Yes
Lomotil 222941 atropine sulfate, diphenoxylate hcl Pfizer Canada ULC No No No No No No No Yes
Mekinist 223527 trametinib Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Merrem 222507 meropenem trihydrate Pfizer Canada ULC No No No Yes No No No Yes
Natesto 223106 testosterone Acerus Biopharma Inc No No No No No Yes No Yes
Pepcid Ac, Maximum Strength Pepcid Ac 224006 famotidine Mcneil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes Yes Yes No Yes
Pepcid Complete 224012 calcium carbonate, famotidine, magnesium hydroxide Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc No Yes No No Yes Yes Yes Yes
Prezcobix 223917 darunavir ethanolate, cobicistat Janssen Inc Yes Yes No No Yes No No Yes
Prostin Vr Sterile Solution 222330 alprostadil Pfizer Canada ULC No No Yes No No No No Yes
Remeron 224165 mirtazapine Merck Canada Inc No No No Yes No No No Yes
Remeron Rd 224171 mirtazapine Merck Canada Inc No No No Yes No No No Yes
Singulair 223908 montelukast sodium Merck Canada Inc No Yes No Yes No No No Yes
Sporanox 216151 itraconazole Janssen Inc No Yes No No Yes Yes No Yes
Tafinlar 223526 dabrafenib Novartis Pharmaceuticals Canada Inc No No Yes Yes No No No Yes
Trintellix 223451 vortioxetine hydrobromide Lundbeck Canada Inc No No No Yes No No No Yes
Viibryd 222640 vilazodone hydrochloride Allergan Inc No No No Yes No No No Yes
Vinblastine Sulfate Injection 223754 vinblastine sulfate Pfizer Canada ULC No Yes No Yes Yes No No No
Xanax, Xanax Ts 223422 alprazolam Pfizer Canada ULC No Yes No Yes No Yes No No
Zytiga 224003 abiraterone acetate Janssen Inc No Yes No Yes No No No No

March 2019

Product Monograph Brand Safety Updates March 2019
(PDF, 135 KB, 2 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Accuretic 224313 hydrochlorothiazide, quinapril hcl Pfizer Canada Ulc No Yes No Yes No No No Yes
Advagraf 223040 tacrolimus Astellas Pharma Canada Inc No No Yes Yes Yes No No Yes
Aleve Nighttime 219322 diphenhydramine hcl, naproxen sodium Bayer Inc Yes No Yes No No No No Yes
Avalide 223037 hydrochlorothiazide, irbesartan Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Corvert 222103 ibutilide fumarate Pfizer Canada Ulc No No Yes No No No No Yes
Dificid 215516 fidaxomicin Merck Canada Inc No Yes No No No No No Yes
Ditropan XL 223169 oxybutynin chloride Janssen Inc No No No No Yes No No Yes
Dymista 223242 fluticasone propionate, azelastine hydrochloride BGP Pharma Ulc No No No No No No No Yes
Edurant 223865 rilpivirine Janssen Inc No Yes No No No No Yes Yes
Eliquis 222811 apixaban Bristol-Myers Squibb Canada No Yes No No Yes Yes No Yes
Foquest 214860 methylphenidate hcl Purdue Pharma Yes Yes No Yes No Yes No Yes
Galafold 215579 migalastat hydrochloride Amicus Therapeutics UK Ltd No No No Yes No Yes No Yes
Imbruvica 214952 ibrutinib Janssen Inc No No No Yes No Yes No Yes
Inlyta 207338 axitinib Pfizer Canada Ulc No Yes No No No Yes No No
Intelence 223906 etravirine Janssen Inc No Yes No No No No No Yes
Kinevac 223269 sincalide Bracco Imaging Canada No No No No No No No Yes
Lupron, Lupron Depot 215907 leuprolide acetate Abbvie Corporation No No No No No Yes No No
Lynparza 220476 olaparib Astrazeneca Canada Inc No Yes No Yes No No No Yes
Lynparza 224063 olaparib Astrazeneca Canada Inc No Yes No Yes No No No Yes
Metoject Subcutaneous 223139 methotrexate sodium Medexus Inc Yes Yes Yes Yes Yes Yes No Yes
Micardis Plus 222622 hydrochlorothiazide, telmisartan Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Naropin 222913 ropivacaine hcl Aspen Pharmacare Canada Inc. No No No No No No No Yes
Nitro-Dur 0.2, Nitro-Dur 0.4, Nitro-Dur 0.6, Nitro-Dur 0.8 223266 nitroglycerin Uspharma Ltd No No No No No No No Yes
Prezista 223905 darunavir Janssen Inc Yes Yes No Yes Yes No No Yes
Prograf 223039 tacrolimus Astellas Pharma Canada Inc No No Yes Yes Yes No No Yes
Segluromet 224031 metformin hcl, ertugliflozin Merck Canada Inc No Yes No Yes No Yes No Yes
Sudafed Sinus Advance 223272 ibuprofen, pseudoephedrine hcl McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No No No No No Yes
Symtuza 223719 emtricitabine, darunavir, cobicistat, tenofovir alafenamide Janssen Inc Yes Yes No Yes Yes No No Yes
Teveten Plus 223468 hydrochlorothiazide, eprosartan mesylate BGP Pharma Ulc No Yes No Yes No No No Yes
Thalomid 223254 thalidomide Celgene Inc No Yes No Yes No No No Yes
Topamax 222972 topiramate Janssen Inc No No No Yes No No Yes No
Trelegy Ellipta 215148 fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Glaxosmithkline Inc No Yes No Yes No No No Yes
Vermox 215898 mebendazole Janssen Inc No No No Yes No Yes No No

February 2019

Product Monograph Brand Safety Updates February 2019
(PDF, 131 KB, 3 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Accel-Sevelamer 222192 sevelamer carbonate Accel Pharma Inc Yes Yes No Yes No No No Yes
Advil Mini-Gels 209480 ibuprofen Pfizer Consumer Healthcare a Division of Pfizer Canada Inc No No No No No No No Yes
Altace HCT 221927 hydrochlorothiazide, ramipril Valeant Canada LP Valeant Canada S.E.C. No Yes No Yes No No No Yes
Androgel 222591 testosterone BGP Pharma Ulc No Yes No No No No No Yes
Apo-Amitriptyline 222937 amitriptyline hcl Apotex Inc Yes Yes Yes Yes Yes Yes Yes Yes
Ativan 221513 lorazepam Pfizer Canada Inc No Yes No Yes No No No Yes
Avelox, Avelox I.V. 219634 moxifloxacin Bayer Inc No Yes No No No No No Yes
Caduet 221348 amlodipine besylate, atorvastatin calcium Pfizer Canada Ulc Yes Yes No No Yes No No Yes
Certican 223038 everolimus Novartis Pharmaceuticals Canada Inc No No No No No No No Yes
Cipro XL 219637 ciprofloxacin Bayer Inc No Yes No No No No No Yes
Cipro, Cipro Oral Suspension 219636 ciprofloxacin Bayer Inc No Yes No No No No No Yes
Cubicin, Cubicin RF 214792 daptomycin Cubist Pharmaceuticals Llc No Yes No Yes No Yes No Yes
Depakene 221688 valproic acid BGP Pharma Ulc Yes Yes Yes Yes No Yes No Yes
Diovan-HCT 221691 hydrochlorothiazide, valsartan Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Epival 221687 divalproex sodium BGP Pharma Ulc Yes Yes Yes Yes No Yes No Yes
Flolan, Ph 12 Sterile Diluent For Flolan 218761 glycine, sodium chloride, water, epoprostenol sodium Glaxosmithkline Inc No No No No No Yes No Yes
Hycamtin 222202 topotecan hcl Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Imbruvica 218457 ibrutinib Janssen Inc No Yes No Yes Yes Yes No Yes
Imbruvica 223074 ibrutinib Janssen Inc No No No Yes No No No Yes
Nasacort Allergy 24hr 222895 triamcinolone acetonide Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Orap 215811 pimozide Aa Pharma Inc No No No No No No No Yes
Plavix 221850 clopidogrel bisulfate Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Pradaxa 214068 dabigatran etexilate mesilate Boehringer Ingelheim (Canada) Ltd Ltee Yes Yes No Yes No Yes No Yes
Quinsair 219665 levofloxacin Horizon Pharma Ireland Ltd No Yes No No No No No Yes
Renvela 211598 sevelamer carbonate Sanofi-Aventis Canada Inc No Yes No Yes No Yes Yes Yes
Resotran 221385 prucalopride succinate Janssen Inc No Yes No Yes Yes No No Yes
Revolade 214247 eltrombopag olamine Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes Yes No Yes
Rexulti 205854 brexpiprazole Otsuka Pharmaceutical Co Ltd No Yes No Yes Yes Yes No Yes
Stivarga 214314 regorafenib Bayer Inc No No No Yes No No No No
Travatan Z 222238 travoprost Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Venclexta 215852 venetoclax Abbvie Corporation No No No No Yes No No Yes
Xanax, Xanax TS 221500 alprazolam Pfizer Canada Inc No Yes No Yes Yes Yes Yes Yes
Zaxine 216973 rifaximin Salix Pharmaceuticals Inc No Yes No No No No No Yes

January 2019

Product Monograph Brand Safety Updates January 2019
(PDF, 131 KB, 3 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Atridox 211449 doxycycline Tolmar Inc No Yes No No No No No Yes
Bicillin L-A 222142 penicillin g Pfizer Canada ULC No Yes No No No Yes No Yes
Breo Ellipta 213290 fluticasone furoate, vilanterol trifenatate Glaxosmithkline Inc No No No Yes Yes No No Yes
Camptosar 221069 irinotecan hydrochloride Pfizer Canada Inc No No Yes Yes No No No Yes
Champix 221214 varenicline tartrate Pfizer Canada Inc No Yes No No No Yes No No
Clozaril 220847 clozapine HLS Therapeutics Inc No Yes No Yes No No No Yes
Coated Daily Low Dose ASA 81 Mg 221452 acetylsalicylic acid Apotex Inc Yes Yes No No Yes Yes Yes Yes
Dacarbazine for Injection BP 221511 dacarbazine Pfizer Canada Inc No Yes No Yes No No No No
Dilantin 222333 phenytoin sodium Pfizer Canada ULC No Yes No Yes No No No No
Dilantin Infatabs, Dilantin - 30 Suspension, Dilantin - 125 Suspension 222374 phenytoin Pfizer Canada ULC No Yes No Yes No No No No
Dobutamine Injection USP 220995 dobutamine HCl Pfizer Canada ULC Yes Yes No Yes Yes No No No
Duragesic 221461 fentanyl Janssen Inc No Yes No Yes Yes Yes Yes Yes
Eltroxin 222285 levothyroxine sodium Aspen Pharmacare Canada Inc. No No No No No No No Yes
Fluconazole-150 220320 fluconazole Apotex Inc No Yes No No No No No Yes
Glyxambi 222532 linagliptin, empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Heptovir 220131 lamivudine Glaxosmithkline Inc No Yes Yes No No No No Yes
Imuran 219779 azathioprine sodium Aspen Pharmacare Canada Inc. Yes Yes No No No No No Yes
Intuniv XR 221634 guanfacine HCl Shire Pharma Canada ULC No No No No Yes No No No
Jardiance 222104 empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Jinarc 213262 tolvaptan Otsuka Pharmaceutical Co Ltd No Yes Yes Yes No Yes No Yes
Kalydeco 218044 ivacaftor Vertex Pharmaceuticals (Canada) Incorporated No No No Yes No Yes No Yes
Kyprolis 212983 carfilzomib Amgen Canada Inc No Yes No Yes No No No Yes
Lipitor 221397 atorvastatin calcium Pfizer Canada ULC Yes Yes No No Yes No No Yes
Mozobil 213345 plerixafor Sanofi-Aventis Canada Inc No Yes No Yes No Yes No Yes
Nix Dermal Cream 221341 permethrin Glaxosmithkline Consumer Healthcare Inc No Yes No No No No No Yes
Norfloxacin 219632 norfloxacin Aa Pharma Inc No Yes No No No No No Yes
Potassium Chloride Injection 221674 potassium chloride Baxter Corporation No Yes No Yes Yes No No No
Prevymis 221005 letermovir Merck Canada Inc No No No No Yes No No No
Sandoz Perindopril Erbumine / Indapamide HD 221686 perindopril erbumine, indapamide Sandoz Canada Incorporated No No No No No No No Yes
Suboxone 214333 buprenorphine hydrochloride, naloxone hydrochloride dihydrate Indivior Uk Limited Yes Yes Yes No Yes Yes No Yes
Synjardy 222713 metformin HCl, empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Telzir 220647 fosamprenavir Viiv Healthcare ULC No Yes No Yes Yes No No Yes
Triumeq 220184 lamivudine, dolutegravir, abacavir Viiv Healthcare ULC No Yes Yes No No No No Yes
Vesicare 220842 solifenacin succinate Astellas Pharma Canada Inc No No No Yes No No No Yes
Xalkori 221245 crizotinib Pfizer Canada Inc No No No No No Yes No No
Xatral 221120 alfuzosin HCl Sanofi-Aventis Canada Inc No No No Yes No No No Yes
Xeljanz, Xeljanz XR 213578 tofacitinib Pfizer Canada Inc No Yes No Yes No No No Yes
Xtandi 221581 enzalutamide Astellas Pharma Canada Inc No Yes No No Yes No No Yes
Yondelis 221575 trabectedin Janssen Inc No Yes No No No No No No
Ziagen 220175 abacavir Viiv Healthcare ULC No Yes Yes No No No No Yes
Zofran, Zofran Odt 221541 ondansetron hydrochloride dihydrate Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes Yes Yes Yes

December 2018

Product Monograph Brand Safety Updates December 2018
(PDF, 131 KB, 3 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Aermony Respiclick 219965 Fluticasone Propionate Teva Canada Limited No Yes No Yes No No No Yes
Alesse 21, Alesse 28 219900 Ethinyl Estradiol, Levonorgestrel Pfizer Canada Inc No No No No No No No Yes
Arbesda Respiclick 220413 Fluticasone Propionate, Salmeterol Teva Canada Limited No Yes No Yes No No No Yes
Arixtra 219328 Fondaparinux Sodium Aspen Pharmacare Canada Inc. No No No No No No No Yes
Bosulif 211317 Bosutinib Pfizer Canada Inc Yes Yes No Yes Yes Yes No Yes
Brevicon 0.5/35, Brevicon 1/35 219920 Ethinyl Estradiol, Norethindrone Pfizer Canada Inc No No No No No No No Yes
Caripul 219189 Epoprostenol Sodium Janssen Inc No No No Yes No Yes No Yes
Cefotaxime Sodium for Injection, BP 218089 Cefotaxime Sodium Sterimax Inc No Yes No No No No No Yes
Cerdelga 212064 Eliglustat Tartrate Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No Yes No Yes Yes Yes No Yes
Cisplatin Injection BP 220132 Cisplatin Pfizer Canada Inc No Yes No Yes Yes No No No
Claritin 218906 Loratadine Bayer Inc No Yes Yes Yes No No No Yes
Claritin Kids 218907 Loratadine Bayer Inc No Yes Yes Yes No No No Yes
Claritin Rapid Dissolve 218908 Loratadine Bayer Inc No Yes Yes Yes No No No Yes
Claritin Rapid Dissolve 218909 Loratadine Bayer Inc No Yes Yes Yes No No No Yes
Complera 220924 Emtricitabine, Tenofovir Disoproxil Fumarate, Rilpivirine Gilead Sciences Canada Inc No Yes No No No No No Yes
Dalacin Vaginal Cream 220112 Clindamycin Phosphate Pfizer Canada ULC No Yes No No No No No Yes
Differin, Differin XP 219933 Adapalene Galderma Canada Inc Yes Yes No Yes No No No Yes
Diprivan 1% 219609 Propofol Aspen Pharmacare Canada Inc. No Yes No No No No No No
Eligard 220760 Leuprolide Acetate Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Fibristal 219076 Ulipristal Acetate Allergan Inc Yes Yes No No No No No Yes
Flonase Allergy Relief 220276 Fluticasone Propionate Glaxosmithkline Consumer Healthcare Inc No No No No No No No Yes
Iclusig 212521 Ponatinib Hydrochloride Ariad Pharmaceuticals Inc No Yes Yes Yes No Yes No Yes
Jentadueto 221654 Metformin HCl, Linagliptin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes Yes Yes Yes Yes
Kivexa 220138 Lamivudine, Abacavir ViiV Healthcare ULC No Yes No Yes Yes No No Yes
Lenvima 212989 Lenvatinib Mesylate Eisai Limited No Yes Yes Yes Yes Yes No Yes
Marvelon 220561 Desogestrel, Ethinyl Estradiol Merck Canada Inc No No No No No No No Yes
Min-Ovral 21, Min-Ovral 28 219902 Ethinyl Estradiol, Levonorgestrel Pfizer Canada Inc No No No No No No No Yes
Moviprep 219584 Polyethylene Glycol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Vitamin C, Sodium Sulfate Anhydrous Aralez Pharmaceuticals Canada Inc No No No No No No No Yes
Myleran 218805 Busulfan Aspen Pharmacare Canada Inc. No Yes No Yes Yes Yes No Yes
Odefsey 220727 Emtricitabine, Tenofovir Alafenamide, Rilpivirine Gilead Sciences Canada Inc No Yes No Yes Yes Yes No Yes
Onglyza 212634 Saxagliptin AstraZeneca Canada Inc No Yes No No No Yes No No
Orkambi 215032 Ivacaftor, Lumacaftor Vertex Pharmaceuticals (Canada) Incorporated No No No Yes Yes Yes No Yes
Paclitaxel for Injection 220211 Paclitaxel Pfizer Canada Inc No Yes No Yes Yes Yes No Yes
Pamidronate Disodium for Injection 220092 Pamidronate Disodium Pfizer Canada Inc No Yes No Yes No No No Yes
Select 1/35 (21 Day), Select 1/35 (28 Day) 219901 Ethinyl Estradiol, Norethindrone Pfizer Canada Inc No No No No No No No Yes
Singulair 219950 Montelukast Sodium Merck Canada Inc No No Yes Yes No No No Yes
Spinraza 220460 Nusinersen Biogen Canada Inc No Yes No Yes No No No Yes
Sporanox 220631 Itraconazole Janssen Inc Yes Yes No No Yes No Yes Yes
Sporanox 220658 Itraconazole Janssen Inc Yes Yes No No Yes No Yes Yes
Synjardy 219953 Metformin HCl, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes Yes Yes Yes Yes
Synphasic 219919 Ethinyl Estradiol, Norethindrone Pfizer Inc No No No No No No No Yes
Trintellix 212548 Vortioxetine Hydrobromide Lundbeck Canada Inc No Yes No Yes No No No Yes
Trintellix 219178 Vortioxetine Hydrobromide Lundbeck Canada Inc No No No Yes Yes No Yes Yes
Tykerb 220925 Lapatinib Ditosylate Monohydrate Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Velcade 221531 Bortezomib Mannitol Boronic Ester Janssen Inc No No No Yes No No No Yes
Xeljanz, Xeljanz XR 221632 Tofacitinib Pfizer Canada Inc No Yes No Yes Yes Yes No Yes
Xtandi 216719 Enzalutamide Astellas Pharma Canada Inc No Yes No Yes No No No Yes
Zaxine 209230 Rifaximin Salix Pharmaceuticals Inc No Yes No Yes Yes Yes No Yes
Zykadia 215945 Ceritinib Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes Yes No Yes

November 2018

Product Monograph Brand Safety Updates November 2018
(PDF, 131 KB, 3 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Advil Gel Caplets 215306 Ibuprofen Pfizer Consumer Healthcare a Division of Pfizer Canada Inc Yes Yes No No No No No Yes
Apo-Cefaclor 214441 Cefaclor Apotex Inc No Yes No No No No No Yes
Apo-Cefprozil 221403 Cefprozil Apotex Inc No Yes No No No No No Yes
Baraclude 220363 Entecavir Bristol-Myers Squibb Canada No Yes No No No Yes No Yes
Bydureon BCise 211975 Exenatide AstraZeneca Canada Inc No Yes No Yes Yes Yes Yes Yes
Canesten 1 Day Internal Cream, Canesten 3 Day Internal Cream, Canesten 6 Day Internal Cream, Canesten Combi 1 Day Comfortab + External Cream, Canesten Combi 1 Day Internal + External Creams, Canesten Combi 3 Day Comfortab + External Cream 219775 Clotrimazole Bayer Inc No No No No No No No Yes
Cellcept, Cellcept I.V. 219236 Mycophenolate Mofetil Hoffmann-La Roche Limited No Yes No Yes Yes No No Yes
Clindoxyl Gel, Clindoxyl Adv Gel 215840 Benzoyl Peroxide, Clindamycin Phosphate GlaxoSmithKline Inc No Yes No No No No No Yes
Demulen 30 219451 Ethynodiol Diacetate, Ethinyl Estradiol Pfizer Canada Inc No No No No No No No Yes
Dermotic Oil Ear Drops 220228 Fluocinolone Acetonide Hill Dermaceuticals Inc No No No Yes No No No Yes
Exjade 219572 Deferasirox Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No No
Gilenya 215423 Fingolimod Hydrochloride Novartis Pharmaceuticals Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Imuran 217494 Azathioprine, Azathioprine Sodium Aspen Pharmacare Canada Inc. Yes Yes Yes Yes Yes No No Yes
Jadenu 219573 Deferasirox Novartis Pharmaceuticals Canada Inc No No No No Yes No No Yes
Janumet, Janumet XR 211798 Metformin HCl, Sitagliptin Phosphate Monohydrate Merck Canada Inc No Yes No No No Yes No Yes
Januvia 211741 Sitagliptin Phosphate Monohydrate Merck Canada Inc No Yes No No No Yes No No
Jaydess 212240 Levonorgestrel Bayer Inc No Yes No No No Yes No Yes
Kisqali 220114 Ribociclib Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No No
Kuvan 214085 Sapropterin Dihydrochloride Biomarin Pharmaceutical Inc No No No No No Yes No Yes
Kyleena 212015 Levonorgestrel Bayer Inc No Yes No No No Yes No Yes
Lamictal 219439 Lamotrigine GlaxoSmithKline Inc No Yes No No No No No Yes
Latisse 218766 Bimatoprost Allergan Inc No Yes No Yes No Yes No Yes
Levitra 219672 Vardenafil Hydrochloride Bayer Inc Yes Yes No Yes Yes No No Yes
Lidocaine Hydrochloride Injection USP 219745 Lidocaine HCl Pfizer Canada Inc No Yes No No No Yes No No
Lumigan 219412 Bimatoprost Allergan Inc No No No No No Yes No Yes
Lumigan PF 219530 Bimatoprost Allergan Inc No No No No No Yes No Yes
Lumigan RC 218812 Bimatoprost Allergan Inc No No No No No Yes No Yes
Maviret 212162 Glecaprevir, Pibrentasvir Abbvie Corporation Yes Yes Yes Yes Yes Yes No Yes
Mifegymiso 220341 Misoprostol, Mifepristone Linepharma International Limited No No No Yes No No No No
Mirena 212421 Levonorgestrel Bayer Inc No Yes No No No Yes No Yes
Movantik 220843 Naloxegol Knight Therapeutics Inc. No No No Yes No No No Yes
Nasacort AG 216912 Triamcinolone Acetonide Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Pariet 220645 Rabeprazole Sodium Janssen Inc No Yes No Yes No No No Yes
Periostat 215842 Doxycycline Pendopharm Division of Pharmascience Inc No Yes No No No No No Yes
Prezcobix 219717 Darunavir Ethanolate, Cobicistat Janssen Inc Yes Yes No No Yes No No Yes
Prezista 219766 Darunavir Ethanolate Janssen Inc Yes Yes No No Yes No No Yes
Revlimid 220072 Lenalidomide Celgene Inc No Yes No Yes No No No Yes
Rexulti 219038 Brexpiprazole Otsuka Pharmaceutical Co Ltd No Yes No Yes No No No Yes
Sensipar 218728 Cinacalcet Hydrochloride Amgen Canada Inc Yes Yes No No No Yes No Yes
Seroquel, Seroquel XR 219301 Quetiapine Fumarate AstraZeneca Canada Inc No Yes No Yes No No No Yes
Staxyn 219678 Vardenafil Hydrochloride Bayer Inc Yes Yes No Yes Yes No No Yes
Sudafed Sinus Advance 219058 Ibuprofen, Pseudoephedrine HCl McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes Yes No No Yes
Topamax 219058 Topiramate Janssen Inc No No No Yes No No No No
Tussionex 219707 Phenyltoloxamine Citrate, Hydrocodone Bitartrate Sanofi-Aventis Canada Inc No Yes No No No Yes No Yes
Zemuron 220017 Rocuronium Bromide Merck Canada Inc No Yes No No No Yes No No

October 2018

Product Monograph Brand Safety Updates October 2018
(PDF, 133 KB, 2 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Advair, Advair Diskus 218142 Fluticasone Propionate, Salmeterol Xinafoate Glaxosmithkline Inc No Yes No No No No No Yes
Aerius 218962 Desloratadine Bayer Inc No No No No No No No Yes
Apo-Cefprozil 218218 Cefprozil Apotex Inc No Yes No No No No No Yes
Apo-Sulfatrim Tab, Apo Sulfatrim DS, Apo Sulfatrim Pediatric, Apo-Sulfatrim Oral Suspension 210871 Sulfamethoxazole, Trimethoprim Apotex Inc No Yes No No No No No Yes
Arnuity Ellipta 217172 Fluticasone Furoate Glaxosmithkline Inc No Yes No No Yes No No Yes
Avamys 218351 Fluticasone Furoate Glaxosmithkline Inc No Yes No No No No No Yes
Bevespi Aerosphere 217809 Formoterol Fumarate, Glycopyrronium Bromide AstraZeneca Canada Inc No No No Yes No No No Yes
Biaxin, Biaxin Bid, Biaxin XL 218738 Clarithromycin BGP Pharma ULC Yes Yes No No Yes No No Yes
Breo Ellipta 218271 Fluticasone Furoate, Vilanterol Trifenatate Glaxosmithkline Inc No Yes No Yes No No No Yes
Brilinta 217905 Ticagrelor AstraZeneca Canada Inc No Yes No No No Yes No Yes
Canesoral, Canesoral Combi 218335 Clotrimazole, Fluconazole Bayer Inc No Yes No Yes Yes No No Yes
Coversyl Plus HD 214373 Perindopril Erbumine, Indapamide Servier Canada Inc No No No No No No No Yes
Depakene 217988 Valproic Acid BGP Pharma ULC No No No Yes Yes No No Yes
Eliquis 198842 Apixaban Bristol-Myers Squibb Canada No Yes No No No Yes No No
Emend IV 218162 Fosaprepitant Dimeglumine Merck Canada Inc No Yes No No No No No Yes
Epival 218169 Divalproex Sodium BGP Pharma ULC No Yes No Yes No No No Yes
Flovent HFA, Flovent Diskus 218581 Fluticasone Propionate Glaxosmithkline Inc No Yes No No No No No Yes
GD-Varenicline 219175 Varenicline Tartrate Genmed a Division of Pfizer Canada Inc No Yes No Yes No No No No
Gemcitabine Injection 219022 Gemcitabine HCl Pfizer Canada Inc No Yes No Yes No No No No
Gilenya 218286 Fingolimod Hydrochloride Novartis Pharmaceuticals Canada Inc Yes Yes No Yes No No No Yes
Imovane 217812 Zopiclone Sanofi-Aventis Canada Inc No Yes Yes Yes Yes Yes No Yes
Invokamet 210969 Metformin HCl, Canagliflozin Janssen Inc No No No Yes No No No Yes
Invokana 210676 Canagliflozin Janssen Inc No Yes No Yes Yes Yes No Yes
Jakavi 216617 Ruxolitinib Phosphate Novartis Pharmaceuticals Canada Inc No No No Yes No No No No
Janumet, Janumet XR 218949 Metformin HCl, Sitagliptin Phosphate Monohydrate Merck Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Kazano 217455 Metformin HCl, Alogliptin Benzoate Takeda Canada Inc No No No Yes No No No Yes
Kyprolis 218596 Carfilzomib Amgen Canada Inc No Yes No No No No No Yes
Lederle Leucovorin 217726 Leucovorin Calcium Pfizer Canada Inc No Yes No Yes Yes Yes No Yes
Levofloxacin in 5% Dextrose Injection 219020 Levofloxacin Pfizer Canada Inc No Yes No No Yes No No Yes
Mitoxantrone Injection USP 220187 Mitoxantrone Hydrochloride Pfizer Canada Inc No Yes No Yes No No No No
Nesina 217457 Alogliptin Benzoate Takeda Canada Inc No No No Yes No No No Yes
Nexium 24 Hr 217405 Esomeprazole Magnesium Trihydrate Pfizer Consumer Healthcare a Division of Pfizer Canada Inc Yes Yes No No Yes No No Yes
Ocaliva 218565 Obeticholic Acid Intercept Pharmaceuticals Inc No No No No No Yes No Yes
Orfadin 215784 Nitisinone Swedish Orphan Biovitrum AB (Publ) No Yes No No Yes Yes No Yes
Picato 218185 Ingenol Mebutate Leo Pharma Inc No Yes No No No No No Yes
Propecia 218806 Finasteride Merck Canada Inc No No No Yes No No No Yes
Proscar 218801 Finasteride Merck Canada Inc No No No Yes No No No Yes
Reactine, Reactine Allergy Liquid Gels, Reactine Fast Melt Junior, Reactine Rapid Dissolve 217641 Cetirizine Hydrochloride McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes No No No Yes
Reyataz 218585 Atazanavir Sulfate Bristol-Myers Squibb Canada Yes No No No Yes No No Yes
Rifadin 217986 Rifampin Sanofi-Aventis Canada Inc No Yes No Yes Yes Yes No Yes
Rydapt 210496 Midostaurin Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Sensorcaine, Sensorcaine with Epinephrine 204198 Bupivacaine HCl, Epinephrine Aspen Pharmacare Canada Inc. No Yes No No No Yes No No
Sutent 218940 Sunitinib Malate Pfizer Canada Inc No No Yes Yes No No No Yes
Symtuza 217492 Emtricitabine, Darunavir Ethanolate, Cobicistat, Tenofovir Alafenamide Hemifumarate Janssen Inc Yes Yes No No Yes No No Yes
Tasigna 211052 Nilotinib Novartis Pharmaceuticals Canada Inc No Yes Yes Yes No Yes No Yes
Trajenta 194075 Linagliptin Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Trelegy Ellipta 218191 Fluticasone Furoate, Umeclidinium Bromide, Vilanterol Trifenatate Glaxosmithkline Inc No Yes No No No No No Yes
Viacoram 218438 Amlodipine Besylate, Perindopril Arginine Servier Canada Inc No Yes No Yes Yes No No Yes
Vimpat 218312 Lacosamide UCB Canada Inc No Yes No Yes Yes No No Yes
Xeljanz 209643 Tofacitinib Pfizer Canada Inc No Yes No Yes Yes Yes No Yes
Zeldox 217496 Ziprasidone HCl Pfizer Canada Inc No Yes No Yes No No No Yes

September 2018

Product Monograph Brand Safety Updates September 2018
(PDF, 135 KB, 2 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information

Acuvail

216960

ketorolac tromethamine

Allergan Inc

No

Yes

No

Yes

No

Yes

No

Yes

Alecensaro

211291

alectinib

Hoffmann La Roche Limited

No

Yes

No

No

Yes

Yes

No

Yes

Aptiom

209753

eslicarbazepine acetate

Sunovion Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

Yes

No

Yes

Buscopan

216733

hyoscine butylbromide

Sanofi-Aventis Canada Inc

Yes

No

No

No

No

No

No

Yes

Chloromycetin Succinate Injection

212536

chloramphenicol

Erfa Canada 2012 Inc

No

Yes

No

No

No

No

No

Yes

Clavulin

217568

clavulanate potassium, amoxicillin trihydrate

GlaxoSmithKline Inc

No

Yes

No

No

No

Yes

No

Yes

Codeine Contin

216666

codeine

Purdue Pharma

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

Cozaar

215619

losartan potassium

Merck Canada Inc

No

Yes

No

No

Yes

No

No

Yes

Cyklokapron

216111

tranexamic acid

Pfizer Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Duavive

210469

conjugated estrogens, bazedoxifene acetate

Pfizer Canada Inc

No

Yes

No

No

No

No

No

Yes

Flolan, Ph 12 Sterile Diluent for Flolan

216701

glycine, sodium chloride, water, epoprostenol sodium

GlaxoSmithKline Inc

No

No

No

Yes

No

No

No

Yes

Genvoya

217448

emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide hemifumarate

Gilead Sciences Canada Inc

No

Yes

No

No

Yes

No

No

No

Giotrif

209785

afatinib dimaleate

Boehringer Ingelheim (Canada) Ltd Ltee

No

No

No

No

No

No

No

Yes

Invega

217288

paliperidone

Janssen Inc

No

Yes

No

Yes

Yes

No

No

Yes

Invega Sustenna

217289

paliperidone palmitate

Janssen Inc

No

Yes

No

Yes

Yes

No

No

Yes

Invega Trinza

217315

paliperidone palmitate

Janssen Inc

No

Yes

No

Yes

Yes

No

No

Yes

Isentress, Isentress HD

210317

raltegravir potassium

Merck Canada Inc

No

Yes

No

Yes

Yes

No

No

Yes

Januvia

218647

sitagliptin phosphate monohydrate

Merck Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Kaletra

217633

ritonavir, lopinavir

Abbvie Corporation

Yes

No

No

Yes

No

No

No

Yes

Kayexalate

217331

sodium polystyrene sulfonate

Sanofi-Aventis Canada Inc

No

Yes

No

No

Yes

Yes

No

Yes

Keppra

217699

levetiracetam

Ucb Canada Inc

No

No

No

Yes

No

No

No

No

Lanvis

217284

thioguanine

Aspen Pharmacare Canada Inc.

No

Yes

No

No

No

Yes

No

Yes

Lectopam

216862

bromazepam

Hoffmann La Roche Limited

Yes

Yes

No

Yes

Yes

No

No

Yes

Lenvima

217205

lenvatinib mesylate

Eisai Limited

No

Yes

No

Yes

No

No

No

Yes

Lotensin

216946

benazepril hcl

Novartis Pharmaceuticals Canada Inc

Yes

Yes

No

No

Yes

No

No

Yes

Mekinist

213580

trametinib

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Nasacort Allergy 24hr

216913

triamcinolone acetonide

Sanofi-Aventis Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Neupro

216298

rotigotine

UCB Canada Inc

Yes

Yes

Yes

Yes

No

Yes

No

Yes

Norvir

217630

ritonavir

Abbvie Corporation

Yes

No

No

No

Yes

No

No

Yes

Nuvaring

217697

ethinyl estradiol, etonogestrel

Merck Canada Inc

No

No

No

No

Yes

No

No

Yes

Prevacid, Prevacid Fastab

209755

lansoprazole

Takeda Pharmaceuticals America Inc

No

No

No

No

No

Yes

No

No

Prevymis

216537

letermovir

Merck Canada Inc

Yes

No

No

No

Yes

No

No

Yes

Prezcobix

212389

darunavir ethanolate, cobicistat

Janssen Inc

No

Yes

No

No

No

Yes

No

No

Reactine Complete

215138

cetirizine hydrochloride, pseudoephedrine HCl

McNeil Consumer Healthcare Division of Johnson & Johnson Inc

Yes

Yes

No

Yes

No

No

No

Yes

Resonium Calcium

217338

calcium polystyrene sulphonate

Sanofi-Aventis Canada Inc

No

Yes

No

No

Yes

Yes

No

Yes

Risperdal

217309

risperidone

Janssen Inc

No

Yes

No

Yes

No

No

No

Yes

Risperdal Consta

217311

risperidone

Janssen Inc

No

Yes

No

Yes

No

No

No

Yes

Sectral

217282

acebutolol HCl

Sanofi-Aventis Canada Inc

No

No

No

Yes

Yes

No

Yes

Yes

Somatuline Autogel

217659

lanreotide

Ipsen Biopharm Limited

No

No

No

Yes

No

No

No

Yes

Stribild

217409

emtricitabine, tenofovir disoproxil fumarate, elvitegravir, cobicistat

Gilead Sciences Canada Inc

No

Yes

No

No

Yes

No

No

No

Tafinlar

213581

dabrafenib

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Tarceva

216181

erlotinib

Hoffmann La Roche Limited

No

Yes

No

No

No

Yes

No

Yes

Teveten

216410

eprosartan mesylate

BGP Pharma ULC

No

No

No

Yes

No

No

No

Yes

Teveten Plus

216411

hydrochlorothiazide, eprosartan mesylate

BGP Pharma ULC

No

No

No

Yes

No

No

No

Yes

Tybost

217447

cobicistat

Gilead Sciences Canada Inc

No

Yes

No

No

Yes

No

No

No

Venclexta

214078

venetoclax

Abbvie Corporation

No

Yes

No

Yes

No

No

No

Yes

Viagra

218856

sildenafil citrate

Pfizer Canada Inc

No

Yes

No

No

No

No

No

Yes

Volibris

215342

ambrisentan

GlaxoSmithKline Inc

No

No

No

No

No

No

No

Yes

Voltaren Emulgel Back & Muscle Pain

217849

diclofenac diethylamine

GlaxoSmithKline Consumer Healthcare Inc

No

Yes

No

No

No

No

No

Yes

Xalkori

209925

crizotinib

Pfizer Canada Inc

No

Yes

Yes

No

Yes

No

No

Yes

Xarelto

211611

rivaroxaban

Bayer Inc

Yes

Yes

No

Yes

Yes

Yes

No

Yes

Xeljanz

209522

tofacitinib

Pfizer Canada Inc

Yes

Yes

No

Yes

Yes

Yes

No

Yes

Xiidra

218601

lifitegrast

Shire Pharma Canada ULC

No

Yes

No

No

No

No

No

Yes

Zithromax

218645

azithromycin

Pfizer Canada Inc

No

Yes

No

No

Yes

No

No

Yes

August 2018

Product Monograph Brand Safety Updates August 2018
(PDF, 135 KB, 2 pages)

Brand Name List Submission Number Ingredient(S) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Acular, Acular LS 216595 Ketorolac Tromethamine Allergan Inc No No No Yes No No No Yes
Apo-Minocycline 210873 Minocycline Apotex Inc No Yes No No No No No Yes
Atripla 218063 Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine Gilead Sciences LLC Yes No No No Yes No No Yes
Baraclude 217518 Entecavir Bristol-Myers Squibb Canada No No No No No No No Yes
Belkyra 215414 Deoxycholic Acid Allergan Inc No Yes No Yes No No No Yes
Caduet 215359 Amlodipine Besylate, Atorvastatin Calcium Pfizer Canada Inc No No No No Yes No No No
Ceftriaxone Sodium for Injection 211848 Ceftriaxone Sodium Teva Canada Limited No Yes No No No No No Yes
Cefuroxime for Injection, USP 212082 Cefuroxime Sodium Fresenius Kabi Canada Ltd No Yes No No No No No Yes
Ditropan XL 216720 Oxybutynin Chloride Janssen Inc No No No Yes No No Yes No
Edurant 207249 Rilpivirine Hydrochloride Janssen Inc No Yes No Yes No Yes No Yes
Eloxatin 216163 Oxaliplatin Sanofi-Aventis Canada Inc No No No Yes No No No No
Flagyl 217063 Metronidazole Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Flagystatin 215051 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Flagystatin 217062 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Flamazine 211660 Silver Sulfadiazine Smith & Nephew Inc No Yes No No No No No Yes
Flarex 215934 Fluorometholone Acetate Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Fortaz 213619 Ceftazidime Glaxosmithkline Inc No Yes No No No No No Yes
Fosrenol 216237 Lanthanum Carbonate Hydrate Shire Pharma Canada ULC No Yes No No No No No Yes
Intelence 216634 Etravirine Janssen Inc No Yes No No No No No No
Juluca 217811 Rilpivirine Hydrochloride, Dolutegravir Sodium ViiV Healthcare ULC No Yes No Yes No No No Yes
Lamictal 215774 Lamotrigine Glaxosmithkline Inc No Yes No No No No No Yes
Leucovorin Calcium Injection 217983 Leucovorin Calcium Teva Canada Limited No No No No No Yes No No
Lomotil 217009 Atropine Sulfate, Diphenoxylate Hcl Pfizer Canada Inc No Yes No Yes Yes No Yes No
Macrobid 211659 Nitrofurantoin Allergan Pharma Co No Yes No No No No No Yes
Metadol 211399 Methadone Hydrochloride Paladin Labs Inc Yes Yes Yes Yes Yes Yes Yes Yes
Metadol-D 211395 Methadone Hydrochloride Paladin Labs Inc Yes Yes Yes Yes Yes Yes Yes Yes
Ofev 216277 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes Yes No No Yes
Onreltea 215929 Brimonidine Tartrate Galderma Canada Inc No Yes No No No Yes No Yes
Orgalutran 216695 Ganirelix Acetate Merck Canada Inc Yes Yes No No No Yes No Yes
Pediapred 218110 Prednisolone Sodium Phosphate Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Pristiq 209469 Desvenlafaxine Succinate Pfizer Canada Inc No Yes No No No No No No
Pylera 211658 Metronidazole, Tetracycline Hcl, Bismuth Subcitrate Potassium Aptalis Pharma Canada ULC No Yes No No No No No Yes
Remifentanil Hydrochloride for Injection 215290 Remifentanil Hcl Sterimax Inc Yes Yes Yes Yes Yes Yes No Yes
Signifor Lar 209345 Pasireotide Novartis Pharmaceuticals Canada Inc Yes Yes Yes Yes Yes Yes No Yes
Spinraza 209005 Nusinersen Biogen Canada Inc No Yes No Yes No No No No
Sufentanil Citrate Injection USP 215292 Sufentanil Citrate Sandoz Canada Incorporated Yes Yes Yes Yes Yes Yes No Yes
Tivicay 217790 Dolutegravir, Dolutegravir Sodium ViiV Healthcare ULC No Yes No Yes No No No Yes
Triumeq 216512 Lamivudine, Dolutegravir, Abacavir ViiV Healthcare ULC No Yes No Yes No No No Yes
Triumeq 217833 Lamivudine, Abacavir Sulfate, Dolutegravir Sodium ViiV Healthcare ULC No Yes No Yes No No No Yes
Vemlidy 209483 Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc No Yes Yes Yes Yes No No Yes
Viberzi 216236 Eluxadoline Allergan Pharma Co No Yes Yes Yes Yes No No Yes
Volulyte 216462 Hydroxyethyl Starch Fresenius Kabi Canada Ltd Yes No No No No No No No
Zeulide Depot 217418 Leuprolide Acetate Pendopharm Division of Pharmascience Inc No No No No No Yes No Yes
Zocor 215663 Simvastatin Merck Canada Inc No No No Yes No No No Yes

July 2018

Product Monograph Brand Safety Updates July 2018
(PDF, 135 KB, 2 pages)

Brand Name List

Submission Number

Ingredient(S)

Manufacturer

Contraindications

Warnings & Precautions

Serious Warnings & Precautions

Adverse Reactions

Drug Interactions

Dosage & Administration

Overdosage

Consumer Information

Aerius

215387

Desloratadine

Bayer Inc

No

No

No

Yes

No

No

No

Yes

Aerius Dual Action 12 Hour

215390

Pseudoephedrine Sulfate, Desloratadine

Bayer Inc

No

No

No

Yes

No

No

No

Yes

Aerius Kids

215388

Desloratadine

Bayer Inc

No

No

No

Yes

No

No

No

Yes

Apo-Fluconazole-150

215312

Fluconazole

Apotex Inc

No

Yes

No

No

No

No

No

Yes

Blexten

214883

Bilastine

Aralez Pharmaceuticals Trading DAC

No

No

No

Yes

No

No

No

Yes

Canesoral

214931

Fluconazole

Bayer Inc

No

Yes

No

No

No

No

No

Yes

Canesoral Combi-Pak

214932

Clotrimazole, Fluconazole

Bayer Inc

No

Yes

Yes

No

No

No

No

Yes

Cefazolin for Injection

212089

Cefazolin Sodium

Teva Canada Limited

No

Yes

No

No

No

No

No

Yes

Cefoxitin for Injection

212534

Cefoxitin Sodium

Teva Canada Limited

No

Yes

No

No

No

No

No

Yes

Cubicin, Cubicin RF

215429

Daptomycin

Cubist Pharmaceuticals LLC

No

No

No

Yes

No

No

No

No

Dilantin

215484

Phenytoin Sodium

Pfizer Canada Inc

Yes

Yes

No

No

No

No

Yes

No

Dilantin - 30 Suspension, Dilantin - 125 Suspension, Dilantin Infatabs

215486

Phenytoin

Pfizer Canada Inc

Yes

Yes

No

No

No

No

Yes

No

Durezol

215431

Difluprednate

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

Yes

No

No

Yes

Erivedge

215754

Vismodegib

Hoffmann La Roche Limited

No

Yes

No

Yes

No

Yes

No

No

Erythrocin I.V.

215232

Erythromycin Lactobionate

Amdipharm Limited

No

No

No

Yes

No

No

No

Yes

Etibi

210593

Ethambutol HCl

Valeant Canada LP Valeant Canada S.E.C.

No

Yes

No

No

No

No

No

Yes

Flagyl

214986

Metronidazole

Sanofi-Aventis Canada Inc

No

Yes

No

No

No

No

No

Yes

Idamycin PFS

216520

Idarubicin HCl

Pfizer Canada Inc

No

Yes

No

No

No

Yes

Yes

No

Imbruvica

212632

Ibrutinib

Janssen Inc

No

Yes

No

Yes

No

No

No

Yes

Inhibace

214793

Cilazapril Monohydrate

Hoffmann La Roche Limited

No

Yes

No

No

Yes

No

No

Yes

Inhibace Plus

214825

Hydrochlorothiazide, Cilazapril Monohydrate

Hoffmann La Roche Limited

No

Yes

No

No

Yes

No

No

Yes

Jinarc

214553

Tolvaptan

Otsuka Pharmaceutical Co Ltd

No

Yes

Yes

No

No

Yes

No

Yes

Nuvaring

215183

Ethinyl Estradiol, Etonogestrel

Merck Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Prinivil

215717

Lisinopril

Merck Canada Inc

No

Yes

No

No

Yes

No

No

Yes

Relenza

215337

Zanamivir

Glaxosmithkline Inc

No

Yes

No

Yes

Yes

No

Yes

Yes

Relistor

208302

Methylnaltrexone Bromide

Salix Pharmaceuticals Inc

No

Yes

No

No

No

Yes

No

Yes

Retrovir

215352

Zidovudine

ViiV Healthcare Ulc

No

No

No

No

No

Yes

No

Yes

Rofact

210961

Rifampin

Valeant Canada LP Valeant Canada S.E.C.

No

Yes

No

No

No

No

No

Yes

Samsca

214552

Tolvaptan

Otsuka Pharmaceutical Co Ltd

Yes

Yes

Yes

No

Yes

No

No

Yes

Select 1/35 (21 Day), Select 1/35 (28 Day)

215228

Ethinyl Estradiol, Norethindrone

Pfizer Canada Inc

No

No

No

No

Yes

No

No

No

Stribild

215298

Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat

Gilead Sciences Canada Inc

No

Yes

No

No

Yes

No

No

Yes

Synphasic

215187

Ethinyl Estradiol, Norethindrone

Pfizer Canada Inc

No

No

No

No

Yes

No

No

No

Tagrisso

211762

Osimertinib Mesylate

AstraZeneca Canada Inc

No

Yes

No

Yes

No

Yes

No

Yes

Tasigna

208682

Nilotinib

Novartis Pharmaceuticals Canada Inc

No

Yes

Yes

Yes

No

Yes

No

Yes

Teva-Cefadroxil

211316

Cefadroxil

Teva Canada Limited

No

Yes

No

No

No

No

No

Yes

Truvada

215258

Emtricitabine, Tenofovir Disoproxil Fumarate

Gilead Sciences Canada Inc

No

Yes

No

No

Yes

No

No

Yes

Venclexta

214135

Venetoclax

Abbvie Corporation

No

No

No

No

Yes

No

No

Yes

Viaderm KC Cream, Viaderm KC Ointment

214456

Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide

Taro Pharmaceuticals Inc

No

Yes

No

No

No

No

No

Yes

Voltaren Rapide

215252

Diclofenac Potassium

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Voltaren, Voltaren SR

215251

Diclofenac Sodium

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Zymar

211845

Gatifloxacin

Allergan Inc

No

Yes

No

No

No

No

No

Yes

June 2018

Product Monograph Brand Safety Updates June 2018
(PDF, 150KB, 4 pages)

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
4% astracaine dental with epinephrine 1:200,000, 4% astracaine dental with epinephrine forte 1:100,000 207235 articaine hcl, epinephrine bitartrate Dentsply Canada Limited Yes Yes No Yes Yes Yes No Yes
Alecensaro 210816 alectinib Hoffmann La Roche Limited No Yes No Yes No Yes No Yes
Alesse 21, alesse 28 215227 ethinyl estradiol, levonorgestrel Pfizer Canada Inc No No No No Yes Yes No Yes
Alkeran 214596 buffer solution, melphalan, melphalan hcl Aspen Pharmacare Canada Inc. Yes Yes No Yes Yes No No Yes
Alkeran 215145 melphalan Aspen Pharmacare Canada Inc. No No No No No No No Yes
Apprilon 214275 doxycycline monohydrate Galderma Canada Inc No Yes No Yes Yes Yes Yes Yes
Aptiom 208086 eslicarbazepine acetate Sunovion Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Arcosyl 213430 perindopril arginine Servier Canada Inc Yes Yes No No Yes No No Yes
Arcosyl plus, arcosyl plus ld 213434 indapamide, perindopril arginine Servier Canada Inc Yes Yes No No Yes No No Yes
Avalide 214424 hydrochlorothiazide, irbesartan Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Avapro 214433 irbesartan Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Brevicon 0.5/35, brevicon 1/35 215225 ethinyl estradiol, norethindrone Pfizer Canada Inc No No No No Yes No No No
Caelyx 214432 doxorubicin hcl Janssen Inc No No No Yes No No No Yes
Clozaril 214157 clozapine Hls Therapeutics Inc No Yes No Yes No No No No
Cyclen 214741 ethinyl estradiol, norgestimate Janssen Inc No No No No No No Yes Yes
Demulen 30 215221 ethynodiol diacetate, ethinyl estradiol Pfizer Canada Inc No No No No Yes No No No
Depakene 214828 valproic acid Bgp Pharma Ulc No Yes No Yes Yes No No Yes
Descovy 207964 emtricitabine, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc No Yes Yes Yes No No No Yes
Diflucan 207077 fluconazole Pfizer Canada Inc No Yes No No No No No No
Docetaxel injection usp 213007 docetaxel Pfizer Canada Inc No Yes Yes Yes No Yes No Yes
Elmiron 214593 pentosan polysulfate sodium Janssen Inc No Yes No Yes No No No Yes
Evra 214832 ethinyl estradiol, norelgestromin Janssen Inc No Yes No No Yes No No No
Fibristal 214324 ulipristal acetate Allergan Pharma Co. Yes Yes No No No No No Yes
Genvoya 207251 emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc No Yes Yes Yes Yes Yes No Yes
Hyzaar, hyzaar ds 214817 hydrochlorothiazide, losartan potassium Merck Canada Inc No Yes No No Yes No No Yes
Ibrance 207909 palbociclib Pfizer Canada Inc No Yes No No Yes Yes No No
Ifex 213560 ifosfamide Baxter Corporation No Yes Yes No No No No Yes
Imbruvica 214410 ibrutinib Janssen Inc No Yes No Yes Yes No No Yes
Imodium caplets, imodium quick dissolve, imodium calming liquid, imodium liqui-gels 213956 loperamide hcl Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc No No No No No No Yes No
Imodium complete caplets, imodium complete chewables 213957 loperamide hcl, simethicone Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc No No No No No No Yes No
Inspiolto respimat 213065 tiotropium bromide monohydrate, olodaterol hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes Yes No No No
Kyprolis 208296 carfilzomib Amgen Canada Inc No Yes No Yes No Yes No Yes
Lenvima 213705 lenvatinib mesylate Eisai Limited No Yes No Yes No No No Yes
Leucovorin calcium injection usp 215416 leucovorin calcium Pfizer Canada Inc No Yes Yes Yes Yes No No No
Lincocin 208095 lincomycin Pfizer Canada Inc No Yes No No Yes No No Yes
Lumigan 215827 bimatoprost Allergan Inc No Yes No Yes No No No Yes
Lumigan pf 216008 bimatoprost Allergan Inc No Yes No Yes No Yes Yes Yes
Mekinist 213866 trametinib Novartis Pharmaceuticals Canada Inc No Yes No No No No No No
Min-ovral 21, min-ovral 28 215223 ethinyl estradiol, levonorgestrel Pfizer Canada Inc No No No No Yes No No No
Naropin 215734 ropivacaine hcl Aspen Pharmacare Canada Inc. No Yes No No No No Yes No
Ocaliva 214061 obeticholic acid Intercept Pharmaceuticals Inc No Yes No Yes No Yes No Yes
Odefsey 207243 emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc No Yes Yes Yes Yes Yes Yes Yes
Pediapred 212653 prednisolone phosphate sodium Sanofi-Aventis Canada Inc No Yes No Yes No No No No
Periolimel 2.5% e, olimel 3.3 e, olimel 4.4%, olimel 4.4% e, olimel 5.7% e, olimel 7.6% e, olimel 5.7%, olimel 7.6% 211103 l-alanine, l-aspartic acid, glycine, l-arginine, l-glutamic acid, l-histidine, l-isoleucine, l-leucine, l-phenylalanine, l-proline, l-serine, l-threonine, l-tryptophan, l-valine, l-lysine acetate, l-methionine, olive oil, potassium chloride, sodium glycerophosphate, l-tyrosine, sodium acetate trihydrate, glucose, magnesium chloride hexahydrate, calcium chloride dihydrate Baxter Corporation No No No No No No No Yes
Rhinocort turbuhaler 215281 budesonide Astrazeneca Canada Inc No No No No Yes No No Yes
Sectral 214614 acebutolol hcl Sanofi-Aventis Canada Inc No Yes No No Yes No No Yes
Sofracort 214816 dexamethasone sodium metasulphobenzoate, framycetin sulfate, gramicidin Sanofi-Aventis Canada Inc No Yes No Yes No No No No
Sustiva 214820 efavirenz Bristol-Myers Squibb Canada Yes No No No Yes No No Yes
Tactupump, tactupump forte 215480 benzoyl peroxide, adapalene Galderma Canada Inc Yes Yes No Yes No No No Yes
Tasigna 215124 nilotinib hydrochloride monohydrate Novartis Pharmaceuticals Canada Inc No Yes No No No No No Yes
Tobradex 214254 dexamethasone, tobramycin Novartis Pharmaceuticals Canada Inc No Yes No No Yes No No Yes
Topamax 216637 topiramate Janssen Inc No Yes No No No No No Yes
Tracleer 213127 bosentan monohydrate Actelion Pharmaceuticals Ltd No No No No Yes No No No
Tri-cyclen 214757 ethinyl estradiol, norgestimate Janssen Inc No No No No No No Yes Yes
Tri-cyclen lo 214769 ethinyl estradiol, norgestimate Janssen Inc No No No No No No Yes Yes
Vaseretic 214771 hydrochlorothiazide, enalapril sodium Merck Canada Inc No Yes No No Yes No No Yes
Vasotec 214740 enalapril sodium Merck Canada Inc No Yes No No Yes No No Yes
Viacoram 213486 amlodipine besylate, perindopril arginine Servier Canada Inc Yes Yes No No Yes No No Yes
Viread 214437 tenofovir disoproxil fumarate Gilead Sciences Canada Inc No Yes No No Yes No No Yes
Visken 215735 pindolol Tribute Pharmaceuticals Canada Inc Yes Yes No No Yes No No Yes
Xyrem 214884 sodium oxybate Jazz Pharmaceuticals Ireland Limited No No No No No No No Yes
Zykadia 205116 ceritinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes

Non-Prescription Submissions Cleared in 2014

Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014
(PDF format, 62 KB, 1 pages)
Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Aerius, Aerius Kids 164302 Desloratadine Schering-Plough Canada Inc N/A N/A
Aspirin 81 Mg, Aspirin 81 MG Quick Chew, Aspirin Regular Strength 169398 Acetylsalicylic acid Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A N/A
Aspirin 81 MG, Aspirin 81 MG Quick Chews, Aspirin Regular Strength, Aspirin Extra Strength 172222 Acetylsalicylic acid Bayer Inc Consumer Care N/A N/A N/A N/A N/A
Bactroban 176769 Mupirocin GlaxoSmithKline Consumer Healthcare Inc N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus Extra Strength 167087 Pseudoephedrine sulfate, loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus, Claritin Allergy + Sinus Extra Strength 177692 Pseudoephedrine sulfate, loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus 168558 Pseudoephedrine sulfate, loratadine Schering-Plough Canada Inc N/A N/A N/A N/A N/A N/A N/A
Claritin, Claritin Kids 177690 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Liquid Capsules 177693 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Rapid Dissolve 177691 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Contingency 174868 Levonorgestrel Famy Care Ltd N/A N/A N/A N/A
Heartburn Control 178335 Omeprazole Apotex Incorporated N/A N/A N/A N/A
Next Choice 174352 Levonorgestrel Cobalt Pharmaceuticals Company N/A N/A N/A N/A
Plan B 174250 Levonorgestrel Teva Women's Health Inc N/A N/A N/A N/A
Reactine Fast Melt Junior 173699 Cetirizine hydrochloride McNeil Consumer Healthcare Division Of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A
Teva-Levonorgestrel 174883 Levonorgestrel Teva Canada Limited N/A N/A N/A N/A
Voltaren Emulgel Extra Strength 172960 Diclofenac diethylamine Novartis Consumer Health Canada Inc N/A N/A N/A N/A N/A N/A
Women's Rogaine Foam 5% 165769 Minoxidil Johnson & Johnson Inc N/A
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