Product monograph brand safety updates

February 2024

Product Monograph Brand Safety Updates – February 2024
(PDF, 81 KB, 1 pages)

Product Monograph Brand Safety Updates February 2024
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 279263 Diclofenac Sodium, Misoprostol Pfizer Canada ULC No Yes No Yes No No No Yes
Balversa 278912 Erdafitinib Janssen Inc No No No Yes Yes No No Yes
Braftovi 276870 Encorafenib Pfizer Canada ULC No No No No Yes No No Yes
Camzyos 272517 Mavacamten Bristol-Myers Squibb Canada No Yes Yes Yes Yes Yes No Yes
Depo-Provera 279255 Medroxyprogesterone Acetate Pfizer Canada ULC No No No No No Yes No Yes
Janumet, Janumet XR 276836 Sitagliptin Phosphate Monohydrate, Metformin Hydrochloride Merck Canada Inc No No No No No No No Yes
Januvia 276833 Sitagliptin Phosphate Monohydrate Merck Canada Inc No No No No No No No Yes
Levofloxacin in 5% Dextrose Injection 279109 Levofloxacin Pfizer Canada ULC No No No Yes No No No Yes
Mezera 269884 Mesalazine Avir Pharma Inc No No No Yes Yes Yes No Yes
Mirena 273103 Levonorgestrel Bayer Inc Yes Yes No Yes No Yes No Yes
Mozobil 280337 Plerixafor Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Nexium 24 Hr 277914 Esomeprazole Magnesium Trihydrate GlaxoSmithKline Consumer Healthcare ULC Yes Yes No Yes Yes Yes Yes Yes
Ninlaro 279731 Ixazomib Citrate Takeda Canada Inc No Yes No Yes No No No Yes
Pristiq 279179 Desvenlafaxine Succinate Pfizer Canada ULC No Yes No No No Yes Yes No
Quelicin 280413 Succinylcholine Chloride Pfizer Canada ULC Yes Yes No No No No No No
Seasonale 279010 Levonorgestrel, Ethinyl Estradiol Teva Canada Limited No No No Yes Yes No No Yes
Seasonique 279038 Levonorgestrel, Ethinyl Estradiol Teva Canada Limited No No No Yes Yes No No Yes
Tegretol 273178 Carbamazepine Novartis Pharmaceuticals Canada Inc No Yes Yes No Yes Yes No Yes
Vancocin 278879 Vancomycin Hydrochloride Searchlight Pharma Inc No Yes No No No No No No
Zofran ODT 278769 Ondansetron Sandoz Canada Incorporated Yes Yes No Yes Yes Yes No Yes
Zyvoxam 279230 Linezolid Pfizer Canada ULC No Yes No Yes No No No Yes

January 2024

Product Monograph Brand Safety Updates - January 2024
(PDF, 104 KB, 2 pages)

Product Monograph Brand Safety Updates January 2024
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Alesse 21, Alesse 28 278783 Levonorgestrel, Ethinyl Estradiol Pfizer Canada ULC No No No No No No No Yes
Aleve Nighttime 271910 Diphenhydramine Hcl, Naproxen Sodium Bayer Inc Yes Yes No No No Yes No Yes
Crestor 272268 Rosuvastatin Calcium AstraZeneca Canada Inc Yes Yes No No No Yes No Yes
Eligard 275867 Leuprolide Acetate Tolmar International Ltd No No No No No Yes No Yes
Erleada 278563 Apalutamide Janssen Inc No No No Yes No No No Yes
Ezetrol 278401 Ezetimibe Organon Canada Inc Yes Yes Yes Yes Yes Yes No Yes
Jardiance 270652 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee Yes Yes Yes Yes No Yes No Yes
Levothyroxine Sodium for Injection, Levothyroxine Sodium Injection 278894 Levothyroxine Sodium Fresenius Kabi Canada Ltd Yes Yes No No Yes Yes No Yes
Lixiana 278099 Edoxaban Tosylate Servier Canada Inc No Yes No Yes Yes No No Yes
Lupron Depot 279025 Leuprolide Acetate Abbvie Corporation No Yes No Yes No No No Yes
Mekinist 279055 Trametinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No No
Nortriptyline 277464 Nortriptyline Hcl Apotex Inc No Yes No Yes Yes Yes Yes Yes
Olumiant 270684 Baricitinib Eli Lilly Canada Inc Yes Yes No Yes Yes Yes No Yes
Orgalutran 276208 Ganirelix Acetate Organon Canada Inc No Yes No Yes No No No No
Prozac 277882 Fluoxetine Hcl Eli Lilly Canada Inc No Yes No No No No No Yes
Quviviq 276525 Daridorexant Hydrochloride Idorsia Pharmaceuticals Ltd No Yes No Yes No No No Yes
Reactine Complete 275440 Pseudoephedrine Hcl, Cetirizine Hydrochloride McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes Yes Yes No Yes
Rexulti 272694 Brexpiprazole Otsuka Pharmaceutical Co Ltd No Yes Yes Yes No Yes No Yes
Sandoz Bisoprolol Tablets 243497 Bisoprolol Fumarate Sandoz Canada Incorporated Yes Yes No Yes No Yes No Yes
Tafinlar 279062 Dabrafenib Mesylate Novartis Pharmaceuticals Canada Inc No No No Yes No No No No
Tagrisso 277035 Osimertinib Mesylate AstraZeneca Canada Inc No Yes No Yes No No No Yes
Trelstar 277098 Triptorelin Pamoate Knight Therapeutics Inc No Yes No Yes No Yes No Yes
Vyndaqel 277026 Tafamidis Meglumine Pfizer Canada ULC No No No Yes No No No Yes
Wakix 270856 Pitolisant Hydrochloride Endo Ventures Ltd No Yes No Yes No Yes No Yes
Xtandi 277282 Enzalutamide Astellas Pharma Canada Inc No Yes No Yes No Yes No Yes

December 2023

Product Monograph Brand Safety Updates - December 2023
(PDF, 86 KB, 2 pages)

Product Monograph Brand Safety Updates December 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Aleve Liquid Gels, Aleve Back and Body Pain 268984 Naproxen Sodium Bayer Inc Yes Yes Yes Yes Yes Yes Yes Yes
Brivlera 276673 Brivaracetam UCB Canada Inc No No No No No Yes No No
Amzyos 277020 Mavacamten Bristol-Myers Squibb Canada No Yes No No No No No Yes
Caprelsa 278499 Vandetanib Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Cosopt, Cosopt Preservative-Free 274763 Dorzolamide Hydrochloride, Timolol Maleate Elvium Life Sciences No No No Yes No Yes No Yes
Dantrium Capsules 277023 Dantrolene Sodium Endo Par Innovation Company, LLC Yes Yes Yes No Yes Yes No Yes
Diprivan 1% 276556 Propofol Aspen Pharmacare Canada Inc No Yes No No No No No Yes
Flomax CE 277510 Tamsulosin Hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
FML 277095 Fluorometholone Abbvie Corporation No No No Yes No No No Yes
Lanvis 276764 Thioguanine Aspen Pharmacare Canada Inc No Yes No Yes Yes No No Yes
Lokelma 277220 Sodium Zirconium Cyclosilicate AstraZeneca Canada Inc No No No Yes No No No Yes
Lynparza 271885 Olaparib AstraZeneca Canada Inc No No No Yes No No No Yes
Mezavant 274590 Mesalazine Takeda Canada Inc No No No Yes No No No Yes
Mezera 275493 Mesalazine Avir Pharma Inc No Yes No Yes No No No Yes
Mirapex 276406 Pramipexole Dihydrochloride Monohydrate Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Motrin Platinum Muscle & Body 265379 Methocarbamol, Ibuprofen McNeil Consumer Healthcare Division of Johnson & Johnson Inc Yes Yes Yes Yes No Yes Yes Yes
Mycobutin 277546 Rifabutin Pfizer Canada ULC Yes Yes No No Yes No No Yes
Nifedipine 271662 Nifedipine AA Pharma Inc Yes Yes No Yes Yes Yes No Yes
Omnipaque 240, Omnipaque 300, Omnipaque 350 268527 Iohexol GE Healthcare Canada Inc No Yes No Yes No Yes No Yes
Oxyneo 274782 Oxycodone Hcl Purdue Pharma No Yes No Yes No Yes No Yes
Ozurdex 277147 Dexamethasone Abbvie Corporation Yes Yes No Yes No No No Yes
Paxlovid 277393 Ritonavir, Nirmatrelvir Pfizer Canada ULC No Yes No Yes No No No No
Plaquenil 277166 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Reactine (10 mg), Reactine (Children's Syrup), Reactine Allergy, Reactine Allergy Liquid Gels, Reactine Fast Melt Junior, Reactine Rapid Dissolve, Reactine (5 mg) 275437 Cetirizine Hydrochloride McNeil Consumer Healthcare Division of Johnson & Johnson Inc No No No Yes No No No No
Sandoz Perindopril Erbumine 276661 Perindopril Erbumine Sandoz Canada Incorporated Yes Yes No Yes Yes No No Yes
Scemblix 276134 Asciminib Hydrochloride Novartis Pharmaceuticals Canada Inc No No No No Yes No No Yes
Sulfamethoxazole and Trimethoprim for Injection, USP 275808 Trimethoprim, Sulfamethoxazole Trimethoprim, Sulfamethoxazole No Yes No Yes No No No Yes
T-Lo, Timolol Maleate-EX 273147 Timolol Maleate Sandoz Canada Incorporated No No No No No No No Yes
Tobi 275742 Tobramycin BGP Pharma ULC No Yes No No No No No Yes
Trusopt, Trusopt Preservative-Free 274767 Dorzolamide Hydrochloride Elvium Life Sciences No No No Yes No Yes No Yes
Verzenio 270898 Abemaciclib Eli Lilly Canada Inc No Yes No Yes No No No Yes
Viagra 274068 Sildenafil Citrate BGP Pharma ULC No No No Yes Yes Yes No Yes
Viibryd 275222 Vilazodone Hydrochloride Abbvie Corporation No Yes Yes No No No No Yes
Zaxine 275623 Rifaximin Salix Pharmaceuticals Inc No Yes No Yes No No No Yes
Zeposia 269878 Ozanimod Hydrochloride Bristol-Myers Squibb Canada No Yes No No No Yes No Yes
Zepzelca 269295 Lurbinectedin Jazz Pharmaceuticals Ireland Limited No No No Yes No No No No
Zyban 276730 Bupropion Hcl Bausch Health, Canada Inc No Yes No Yes Yes Yes No Yes
Zytram XL 274793 Tramadol Hcl Purdue Pharma No Yes No Yes Yes Yes No Yes

November 2023

Product Monograph Brand Safety Updates - November 2023
(PDF, 91 KB, 2 pages)

Product Monograph Brand Safety Updates November 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Biltricide 275643 Praziquantel Bayer Inc No Yes Yes No Yes Yes No Yes
Brilinta 276332 Ticagrelor AstraZeneca Canada Inc No Yes No No No Yes No Yes
Cabenuva, Vocabria 277655 Rilpivirine, Cabotegravir, Cabotegravir Sodium ViiV Healthcare ULC No No No Yes No Yes No Yes
Carbolith 275931 Lithium Carbonate Bausch Health, Canada Inc. Yes Yes Yes Yes Yes Yes No Yes
Cerdelga 275984 Eliglustat Tartrate Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No No No Yes No No No Yes
Clavulin 276859 Amoxicillin Trihydrate, Clavulanate Potassium GlaxoSmithKline Inc No Yes Yes Yes Yes No No Yes
Edarbi 276197 Azilsartan Medoxomil Potassium Bausch Health, Canada Inc No Yes No Yes No No No No
Edarbyclor 276262 Chlorthalidone, Azilsartan Medoxomil Potassium Bausch Health, Canada Inc No Yes No Yes No No No No
Esbriet 276617 Pirfenidone Hoffmann-La Roche Limited No Yes No Yes No Yes No Yes
Fycompa 275884 Perampanel Eisai Limited No Yes No Yes Yes Yes Yes Yes
Kalydeco 273575 Ivacaftor Vertex Pharmaceuticals (Canada) Incorporated No Yes No Yes No Yes No Yes
Ketorolac Tromethamine Injection USP 276270 Ketorolac Tromethamine Sandoz Canada Incorporated No No No Yes Yes No No Yes
Komboglyze 277042 Metformin Hydrochloride, Saxagliptin Hydrochloride AstraZeneca Canada Inc No Yes No Yes Yes Yes Yes Yes
Mounjaro 276224 Tirzepatide Eli Lilly Canada Inc No Yes No Yes No No No Yes
Nubeqa 277149 Darolutamide Bayer Inc No Yes No Yes No No No Yes
Omniscan 274137 Gadodiamide GE Healthcare Canada Inc No Yes No No No No No Yes
Oxy.IR 274772 Oxycodone Hcl Purdue Pharma No Yes No Yes No Yes No Yes
Piqray 270700 Alpelisib Novartis Pharmaceuticals Canada Inc No No No No Yes No No No
Propecia 275154 Finasteride Organon Canada Inc. No Yes No Yes No No No Yes
Rozlytrek 271291 Entrectinib Hoffmann-La Roche Limited No No No No No Yes No Yes
Sohonos 268140 Palovarotene Ipsen Biopharmaceuticals Canada Inc No Yes Yes Yes Yes Yes Yes Yes
Teva-Mexiletine 272846 Mexiletine Hcl Teva Canada Limited No Yes Yes Yes Yes Yes No Yes
Teva-Trimel, Teva-Trimel DS 274420 Trimethoprim, Sulfamethoxazole Teva Canada Limited Yes Yes Yes Yes Yes No No Yes
Vagifem 10 276051 Estradiol Novo Nordisk Canada Inc No No No Yes No No No Yes
Veklury 270659 Remdesivir Gilead Sciences Canada Inc No Yes No Yes No Yes No Yes
Waymade-Trientine 276415 Trientine Hydrochloride Waymade PLC No No No No No Yes No Yes
Xigduo 277286 Dapagliflozin Propanediol Monohydrate, Metformin Hydrochloride AstraZeneca Canada Inc No Yes No Yes No No No Yes
Zestoretic 274456 Hydrochlorothiazide, Lisinopril Searchlight Pharma Inc No Yes No Yes Yes Yes No Yes
Zestril 268405 Lisinopril Searchlight Pharma Inc Yes Yes No No Yes No No Yes

October 2023

Product Monograph Brand Safety Updates - October 2023
(PDF, 87 KB, 2 pages)

Product Monograph Brand Safety Updates October 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
APO-Sulfatrim Oral Suspension 274417 Trimethoprim, Sulfamethoxazole Apotex Inc No Yes Yes Yes No No No Yes
Canesten Combi 1 Day Comforatab + Extra Strength External Cream 271681 Clotrimazole Bayer Inc No No No No No Yes No Yes
Effexor XR 276199 Venlafaxine Hcl BGP Pharma ULC No Yes Yes No Yes Yes Yes Yes
Envarsus PA 275821 Tacrolimus Endo Ventures Ltd No Yes No Yes No No No Yes
Exelon 273941 Rivastigmine Hydrogen Tartrate Knight Therapeutics Inc Yes Yes No No Yes No No Yes
Forxiga 268982 Dapagliflozin Propanediol Monohydrate AstraZeneca Canada Inc No Yes No Yes Yes No No Yes
Iclusig 277221 Ponatinib Hydrochloride Takeda Pharmaceuticals U.S.A., Inc No No Yes No No Yes No Yes
Isentress, Isentress HD 276444 Raltegravir Potassium Merck Canada Inc No No No No No No No Yes
Losec 275360 Omeprazole Cheplapharm Arzneimittel GmbH No Yes No Yes No No No Yes
Losec Mups 275395 Esomeprazole Magnesium Cheplapharm Arzneimittel GmbH No Yes No Yes No No No Yes
Lumakras 269156 Sotorasib Amgen Canada Inc No No No No Yes Yes No Yes
Lynparza 270095 Olaparib AstraZeneca Canada Inc No No No No No No No Yes
Movapo 275253 Apomorphine Hcl Paladin Labs Inc No Yes No Yes No No No Yes
Multihance 272850 Gadopentetate Dimeglumine Bracco Imaging Canada No Yes No No No No No Yes
Neurontin 275525 Gabapentin BGP Pharma ULC No Yes No Yes No No No Yes
Octasa 275500 Mesalazine Tillotts Pharma AG No Yes No Yes No No No Yes
Octasa 275820 Mesalazine Tillotts Pharma AG No Yes Yes Yes Yes No No Yes
Paxlovid 274571 Ritonavir, Nirmatrelvir Pfizer Canada ULC No Yes No No No No No Yes
Retevmo 273779 Selpercatinib Loxo Oncology, Inc No Yes Yes Yes No Yes No Yes
Rinvoq 267554 Upadacitinib Abbvie Corporation No No No Yes Yes Yes No Yes
Rinvoq 275958 Upadacitinib Abbvie Corporation No Yes No No No Yes No Yes
Sporanox 275453 Itraconazole Janssen Inc No No No Yes Yes No No Yes
Sporanox 275526 Itraconazole Janssen Inc No No No Yes Yes No No Yes
Targin 273393 Naloxone Hcl, Oxycodone Hcl Purdue Pharma No Yes No Yes Yes Yes Yes Yes
Teva-Gemfibrozil 274886 Gemfibrozil Teva Canada Limited Yes Yes No No Yes Yes No Yes
Tobi Podhaler 275647 Tobramycin BGP Pharma ULC Yes Yes No Yes Yes Yes No Yes
Toviaz 274307 Fesoterodine Fumarate Pfizer Canada ULC No No No Yes No No No Yes
Tpoxx 269158 Tecovirimat Monohydrate SIGA Technologies, Inc No No No No No Yes No Yes
Trikafta 271750 Elexacaftor, Ivacaftor, Tezacaftor Vertex Pharmaceuticals (Canada) Incorporated No Yes No Yes No Yes No Yes
Viacoram 275866 Amlodipine Besylate, Perindopril Arginine Servier Canada Inc No No No No No No Yes Yes

September 2023

Product Monograph Brand Safety Updates - September 2023
(PDF, 83 KB, 2 pages)

Product Monograph Brand Safety Updates September 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Apo-Amoxi Sugar Free 272483 Amoxicillin Apotex Inc No Yes Yes Yes Yes No No Yes
Arnuity Ellipta 274458 Fluticasone Furoate GlaxoSmithKline Inc No No No Yes No No No Yes
Biphentin 272109 Methylphenidate Hcl Elvium Life Sciences Yes No No Yes Yes Yes No Yes
Cabometyx 273691 Cabozantinib Malate Ipsen Biopharmaceuticals Canada Inc No Yes No Yes No No No Yes
Cipralex 274368 Escitalopram Oxalate Lundbeck Canada Inc Yes Yes Yes No No Yes No Yes
Cisplatin Injection BP 275069 Cisplatin Pfizer Canada ULC No Yes Yes Yes No No No Yes
Eligard 269016 Leuprolide Acetate Tolmar International Ltd. No Yes No Yes No Yes No Yes
Fludara 268846 Fludarabine Phosphate Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Givlaari 275066 Givosiran Sodium Alnylam Netherlands B.V. No No No No No No No Yes
Imovane 275116 Zopiclone Sanofi-Aventis Canada Inc No Yes No No No Yes No Yes
Imuran 273848 Azathioprine, Azathioprine Sodium Aspen Pharmacare Canada Inc No Yes No Yes No No No Yes
Incruse Ellipta 274613 Umeclidinium Bromide GlaxoSmithKline Inc No No No Yes No No No Yes
Invega Sustenna 272733 Paliperidone Palmitate Janssen Inc No No No No No Yes No Yes
Invega Trinza 272848 Paliperidone Palmitate Janssen Inc No No No No No Yes No Yes
Leqvio 273923 Inclisiran Sodium Novartis Pharmaceuticals Canada Inc No No No No No No No Yes
Linessa 21, Linessa 28 273119 Desogestrel, Ethinyl Estradiol Aspen Pharmacare Canada Inc Yes Yes No No Yes No No Yes
Lysodren 275256 Mitotane HRA Pharma Rare Diseases Yes Yes No Yes Yes Yes No Yes
Prevymis 272553 Letermovir Merck Canada Inc No Yes No Yes No Yes No Yes
Reyataz 272597 Atazanavir Sulfate Bristol-Myers Squibb Canada Yes No No No Yes Yes No Yes
Trelegy Ellipta 274281 Vilanterol Trifenatate, Fluticasone Furoate, Umeclidinium Bromide GlaxoSmithKline Inc No No No Yes No No No Yes
Ultibro Breezhaler 273926 Glycopyrronium Bromide, Indacaterol Maleate Novartis Pharmaceuticals Canada Inc No No No No No No No Yes
Veltassa 266183 Patiromer Sorbitex Calcium Vifor Fresenius Medical Care Renal Pharma Ltd No No No No Yes Yes No Yes
Ventolin Respirator Solution 273936 Salbutamol Sulfate GlaxoSmithKline Inc No Yes No No No No No Yes

August 2023

Product Monograph Brand Safety Updates - August 2023
(PDF, 115 KB, 3 pages)

Product Monograph Brand Safety Updates August 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Abraxane for Injectable Suspension 272786 Paclitaxel Celgene Inc Yes Yes No No Yes Yes No Yes
Apo-Amoxicillin 270923 Amoxicillin Apotex Inc No Yes Yes Yes Yes No No Yes
Bryhali 272985 Halobetasol Propionate Bausch Health, Canada Inc. No Yes No No No No No Yes
Carboplatin Injection BP 274117 Carboplatin Pfizer Canada ULC No Yes No No No No No No
Clinoleic 20% 273081 Olive Oil, Soybean Oil Baxter Corporation Yes Yes No No No No No Yes
Concerta 274279 Methylphenidate Hcl Janssen Inc No No No Yes No No No Yes
Contrave 273726 Bupropion Hcl, Naltrexone Hydrochloride Bausch Health, Canada Inc. No Yes No Yes No Yes No Yes
Depo-Medrol 273199 Methylprednisolone Acetate Pfizer Canada ULC No Yes No Yes No No No Yes
Diamicron MR 273026 Gliclazide Servier Canada Inc No No No No No No No Yes
Dilaudid 273917 Hydromorphone Hcl Purdue Pharma No Yes No No Yes Yes No Yes
Erleada 270698 Apalutamide Janssen Inc No No No No No Yes No Yes
Estrogel 272196 Estradiol Hemihydrate Organon Canada Inc. No Yes No No Yes Yes No Yes
Eucrisa 267872 Crisaborole Pfizer Canada ULC No No No Yes No Yes No Yes
Euthyrox 274121 Levothyroxine Sodium EMD Serono A Division of EMD Inc Canada No Yes No No Yes No No Yes
Exelon Patch 273433 Rivastigmine Knight Therapeutics Inc. Yes Yes Yes No Yes No No Yes
Fetzima 272055 Levomilnacipran Abbvie Corporation No Yes Yes Yes Yes Yes No Yes
Fluconazole-150 272465 Fluconazole Sanis Health Inc Yes Yes No Yes Yes No No Yes
Foquest 272098 Methylphenidate Hcl Elvium Life Sciences No No No Yes No No No Yes
Fosamax 273860 Alendronate Sodium Organon Canada Inc. No Yes No Yes No No No Yes
Fosavance 273858 Alendronate Sodium Trihydrate, Vitamin D3 Organon Canada Inc. No Yes No Yes No No No Yes
Hydromorph Contin 273931 Hydromorphone Hcl Purdue Pharma No Yes No No Yes Yes No Yes
Imbruvica 266710 Ibrutinib Janssen Inc No Yes Yes Yes Yes Yes No Yes
Infants' Motrin, Children's Motrin, Children's Motrin Chewable Tablets, Junior Strength Motrin Chewable Tablets 265393 Ibuprofen McNeil Consumer Healthcare Division of Johnson & Johnson Inc Yes Yes Yes Yes Yes Yes Yes Yes
Mounjaro 273626 Tirzepatide Eli Lilly Canada Inc No No No No No Yes No Yes
MS Contin 273271 Morphine Sulfate Purdue Pharma No Yes No Yes No No No Yes
Onivyde 273110 Irinotecan Sucrose Octasulfate Servier Canada Inc No Yes No Yes No Yes No Yes
Paxlovid 267963 Ritonavir, Nirmatrelvir Pfizer Canada ULC No Yes No Yes No No No Yes
Pediapred 272958 Prednisolone Sodium Phosphate Sanofi-Aventis Canada Inc No No No Yes No No No Yes
Perindopril Erbumine / Indapamide, Perindopril Erbumine / Indapamide HD 272698 Indapamide, Perindopril Erbumine Sivem Pharmaceuticals ULC Yes Yes No Yes Yes No No Yes
Proglycem 271481 Diazoxide Merck Canada Inc No Yes No Yes No No No Yes
Sandomigran DS 272965 Pizotifen Malate Paladin Labs Inc Yes Yes No Yes Yes Yes Yes Yes
Sustiva 273530 Efavirenz Bristol-Myers Squibb Canada No Yes No No Yes No No Yes
Synthroid 275351 Levothyroxine Sodium BGP Pharma ULC No Yes No No Yes No No Yes
Tepmetko 270905 Tepotinib Hydrochloride EMD Serono A Division of EMD Inc Canada No No No No Yes No No Yes
Vitrakvi 274854 Larotrectinib Sulfate Bayer Inc No Yes No Yes Yes Yes No Yes
Xeljanz,
Xeljanz XR
272662 Tofacitinib Citrate Pfizer Canada ULC No Yes No Yes No No No Yes
Zejula 271862 Niraparib GlaxoSmithKline Inc No No No No Yes No No No

July 2023

Product Monograph Brand Safety Updates – July 2023
(PDF, 93 KB, 3 pages)

Product Monograph Brand Safety Updates July 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Adlyxine 271345 Lixisenatide Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Alertec 272079 Modafinil Teva Canada Limited No Yes No Yes Yes Yes No Yes
Butrans 270953 Buprenorphine Purdue Pharma Yes Yes No No No Yes No Yes
Cabenuva, Vocabria 272178 Rilpivirine, Cabotegravir, Cabotegravir Sodium ViiV Healthcare ULC No Yes No Yes No No No Yes
Celexa 271454 Citalopram Hydrobromide Lundbeck Canada Inc No Yes Yes Yes No No No Yes
Celsentri 272471 Maraviroc ViiV Healthcare ULC No No No No No No No Yes
Clindamycin IV Infusion 272119 Clindamycin Phosphate Sandoz Canada Incorporated No Yes No Yes No Yes No Yes
Crestor 272238 Rosuvastatin Calcium AstraZeneca Canada Inc No Yes No Yes Yes Yes No Yes
Crinone 263969 Progesterone EMD Serono A Division of EMD Inc Canada Yes Yes Yes Yes Yes Yes Yes Yes
Delstrigo 266249 Doravirine, Tenofovir Disoproxil Fumarate, Lamivudine Merck Canada Inc No Yes No Yes No Yes No Yes
Dotarem 269429 Gadoterate Meglumine Guerbet No Yes No No No No No Yes
Eltroxin 273170 Levothyroxine Sodium Aspen Pharmacare Canada Inc. No Yes No No Yes No No Yes
Esamuze 273258 Bendamustine Hydrochloride Dr Reddys Laboratories Ltd No No No Yes No No No Yes
Juluca 272255 Rilpivirine Hydrochloride, Dolutegravir Sodium ViiV Healthcare ULC No Yes No No No No No Yes
Kyprolis 267413 Carfilzomib Amgen Canada Inc No Yes No Yes No No No Yes
Lenvima 267356 Lenvatinib Mesylate Eisai Limited No Yes No Yes No No No Yes
Lynparza 265427 Olaparib AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Mayzent 272088 Siponimod Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Medrol 272859 Methylprednisolone Pfizer Canada ULC No Yes No Yes No No No Yes
Mekinist 270386 Trametinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Olimel 4.4% E, Olimel 5.7% E, Olimel 7.6% E, Olimel 3.3% E, Periolimel 2.5% E 273104 Glutamic Acid, L-Proline, L-Glutamic Acid, L-Arginine, L-Aspartic Acid, Calcium Chloride Dihydrate, Alanine, L-Tyrosine, L-Leucine, Dextrose, L-Threonine, Glycine, Magnesium Chloride, Sodium Glycerophosphate, L-Lysine Acetate, Sodium Acetate Trihydrate, Tryptophan, Histidine, Serine, Potassium Chloride, L-Valine, Olive Oil, Methionine, Calcium Chloride, L-Phenylalanine, L-Isoleucine, Soybean Oil, Magnesium Chloride Hexahydrate Baxter Corporation Yes Yes No No No No No Yes
Olimel 4.4%, Olimel 5.7%, Olimel 7.6% 273075 L-Glutamic Acid, L-Proline, Glutamic Acid, L-Arginine, L-Aspartic Acid, L-Tyrosine, L-Leucine, Alanine, Dextrose, L-Threonine, Glycine, L-Histidine, L-Tryptophan, L-Lysine Acetate, Tryptophan, Lysine, Serine, L-Valine, Olive Oil, Histidine, L-Alanine, Methionine, L-Phenylalanine, L-Isoleucine, Soybean Oil Baxter Corporation Yes Yes No No No No No Yes
Pepcid Complete 269619 Famotidine, Magnesium Hydroxide, Calcium Carbonate McNeil Consumer Healthcare Division of Johnson & Johnson Inc Yes Yes No Yes Yes Yes No Yes
Rinvoq 257284 Upadacitinib Abbvie Corporation No No No Yes Yes Yes No Yes
Scemblix 267000 Asciminib Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Solu-Medrol 272836 Methylprednisolone Sodium Succinate Pfizer Canada ULC No Yes No Yes No No No Yes
Suprane 272121 Desflurane Baxter Corporation No Yes Yes Yes No Yes Yes Yes
Tafinlar 270381 Dabrafenib Mesylate Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Triumeq 272330 Abacavir Sulfate, Lamivudine, Dolutegravir Sodium ViiV Healthcare ULC No Yes No No No No No Yes
Tygacil 272000 Tigecycline Pfizer Canada ULC No No Yes No No No No Yes
Vfend 272725 Voriconazole Pfizer Canada ULC No Yes No Yes No No No Yes
Voltaren Emulgel, Voltaren Emulgel Back & Muscle Pain, Voltaren Emulgel Joint Pain Regular Strength 270680 Diclofenac Diethylamine GlaxoSmithKline Consumer Healthcare ULC No Yes No No No No Yes Yes
Welireg 270609 Belzutifan Merck Canada Inc No No No Yes No No No Yes
Ziagen 272514 Abacavir Sulfate ViiV Healthcare ULC No Yes No No No No No Yes
Zocor 272761 Simvastatin Organon Canada Inc. No Yes No Yes No No No Yes

June 2023

Product Monograph Brand Safety Updates - June 2023
(PDF, 92 KB, 3 pages)

Product Monograph Brand Safety Updates June 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
AA-Levocarb CR 271120 Carbidopa, Levodopa AA Pharma Inc No Yes No No Yes Yes No Yes
Adalat XL 270254 Nifedipine Bayer Inc No No No No Yes No No Yes
Aubagio 270681 Teriflunomide Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No Yes No Yes No No No No
Bicnu 269821 Carmustine Marcan Pharmaceuticals Inc No No No No No No No Yes
Dayvigo 266529 Lemborexant Eisai Limited No Yes No No Yes No No Yes
Dianeal PD 101 CAPD Solution w 0.5% Dextrose, Dianeal PD 101 CAPD Solution w 1.5% Dextrose, Dianeal PD 101 CAPD Solution w 2.5% Dextrose, Dianeal PD 101 CAPD Solution w 4.25% Dextrose, Dianeal PD4 CAPD Solution with 1.5% Dextrose and 2.5meq/L Calcium, Dianeal PD4 CAPD Solution with 2.5% Dextrose and 2.5meq/L Calcium, Dianeal PD4 CAPD Solution with 4.25% Dextrose and 2.5meq/L Calcium 271738 Sodium Lactate, Dextrose, Sodium Chloride, Magnesium Chloride, Calcium Chloride Baxter Corporation No Yes No No No No No Yes
Docetaxel Injection USP 272292 Docetaxel Pfizer Canada ULC No Yes No No No No No Yes
Dovato 272489 Lamivudine, Dolutegravir Sodium ViiV Healthcare ULC No Yes No No No No No Yes
Fentora 271126 Fentanyl Citrate Teva Canada Limited No Yes No No Yes No Yes Yes
Fiorinal 270273 Caffeine, Acetylsalicylic Acid, Butalbital Aralez Pharmaceuticals Canada Inc Yes Yes No No No No No Yes
Invokamet 272538 Canagliflozin, Metformin Hydrochloride Janssen Inc No No No Yes Yes Yes No Yes
Invokana 272516 Canagliflozin Janssen Inc No No No No Yes No No Yes
Jevtana 272486 Cabazitaxel, Acetone Solvate Sanofi-Aventis Canada Inc No Yes No No No No No No
Luxa-D 271535 Vitamin D3 Orimed Pharma Inc No No No No No Yes No Yes
Mayzent 266318 Siponimod Novartis Pharmaceuticals Canada Inc No Yes No No Yes No No No
Metadol-D 270632 Methadone Hydrochloride Paladin Labs Inc No Yes No Yes Yes Yes Yes No
Metronidazole 270506 Metronidazole AA Pharma Inc Yes Yes No Yes Yes Yes No Yes
Onpattro 266240 Patisiran Sodium Alnylam Netherlands B.V. No Yes No No No Yes No Yes
Pataday 266071 Olopatadine Hcl Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Paxlovid 272114 Ritonavir, Nirmatrelvir Pfizer Canada ULC Yes No No Yes Yes No No Yes
Pristiq 260474 Desvenlafaxine Succinate Pfizer Canada ULC No Yes Yes Yes Yes Yes Yes Yes
Retrovir (AZT) 271660 Zidovudine ViiV Healthcare ULC No Yes No No No No No Yes
Salofalk 269735 Mesalazine Abbvie Corporation No Yes No Yes No No No Yes
Salofalk 269753 Mesalazine Abbvie Corporation No Yes No Yes No No No Yes
Salofalk 269756 Mesalazine Abbvie Corporation No Yes No Yes No No No Yes
Soliqua 271298 Lixisenatide, Insulin Glargine Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Somatuline Autogel 272093 Lanreotide Acetate Ipsen Biopharmaceuticals Canada Inc No Yes No Yes No No No Yes
Statex 271305 Morphine Sulfate Paladin Labs Inc No Yes No No Yes Yes Yes Yes
Tabrecta 266465 Capmatinib Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Tenormin 270737 Atenolol Searchlight Pharma Inc No Yes Yes No No No No Yes
Tivicay 272507 Dolutegravir Sodium ViiV Healthcare ULC No Yes No No No No No Yes
Topamax 269755 Topiramate Janssen Inc No No No No Yes No No Yes
Veklury 266313 Remdesivir Gilead Sciences Canada Inc No Yes No Yes Yes Yes No Yes
Xenical 271974 Orlistat Cheplapharm Arzneimittel GmbH Yes No No Yes Yes No No Yes
Zynrelef 268374 Bupivacaine, Meloxicam Heron Therapeutics, Inc. No No No No No No No Yes

May 2023

Product Monograph Brand Safety Updates - May 2023
(PDF, 80 KB, 3 pages)

Product Monograph Brand Safety Updates May 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
3TC 270742 Lamivudine ViiV Healthcare ULC No Yes No No No Yes No Yes
Anafranil 268209 Clomipramine Hcl Apotex Inc Yes Yes Yes No Yes Yes No Yes
Belkyra 272776 Deoxycholic Acid Abbvie Corporation No Yes No Yes No No No Yes
Bricanyl Turbuhaler 270964 Terbutaline Sulfate AstraZeneca Canada Inc No Yes No No No Yes No Yes
Brukinsa 264963 Zanubrutinib Beigene Switzerland GmbH No Yes No Yes Yes Yes No Yes
Combivir 271609 Lamivudine, Zidovudine ViiV Healthcare ULC No Yes No No No No No Yes
Concerta 272391 Methylphenidate Hcl Janssen Inc No Yes No Yes No No No Yes
Diacetylmorphine Hydrochloride 270525 Diamorphine Hcl Pharmascience Inc No No No No No Yes No No
Elavil 268308 Amitriptyline Hcl AA Pharma Inc No Yes Yes Yes Yes No Yes Yes
Enalapril Maleate /Hctz 270203 Hydrochlorothiazide, Enalapril Maleate AA Pharma Inc Yes Yes No Yes Yes Yes No Yes
Eraxis 262044 Anidulafungin Pfizer Canada ULC No Yes No Yes No Yes Yes Yes
Ibsrela 268905 Tenapanor Knight Therapeutics Inc. No No No No Yes Yes No Yes
Jakavi 269250 Ruxolitinib Phosphate Novartis Pharmaceuticals Canada Inc No Yes No No No No No Yes
Jardiance 261909 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No Yes No No
Kivexa 271805 Abacavir Sulfate, Lamivudine ViiV Healthcare ULC No Yes No No No No No Yes
Marcaine E 269757 Epinephrine Bitartrate, Bupivacaine Hcl Pfizer Canada ULC No Yes Yes Yes No No No Yes
Marcaine, Marcaine Spinal 269793 Bupivacaine Hcl Pfizer Canada ULC No Yes Yes Yes No No No Yes
Mifegymiso 270410 Mifepristone, Misoprostol Linepharma International Limited No No No No Yes Yes No No
Novamoxin, Novamoxin (Sugar Reduced) 268379 Amoxicillin Trihydrate Teva Canada Limited No Yes Yes Yes Yes No No Yes
Oxaliplatin 270750 Oxaliplatin Pfizer Canada ULC No Yes No No No No No Yes
Oxlumo 265088 Lumasiran Sodium Alnylam Netherlands B.V. No Yes No Yes No Yes No Yes
Perseris 253442 Risperidone HLS Therapeutics Inc No Yes No No No Yes No Yes
Pifeltro 264733 Doravirine Merck Canada Inc No Yes No Yes No Yes No Yes
Rinvoq 264612 Upadacitinib Abbvie Corporation No No No Yes No Yes No Yes
Rukobia 271766 Fostemsavir Tromethamine ViiV Healthcare ULC No Yes No No No No No Yes
Sandoz Perindopril Erbumine/ Indapamide, Sandoz Perindopril Erbumine/ Indapamide HD, Sandoz Perindopril Erbumine/ Indapamide LD 270365 Indapamide, Perindopril Erbumine Sandoz Canada Incorporated Yes Yes No Yes Yes No No Yes
Selexid 270390 Pivmecillinam Hcl Knight Therapeutics Inc. No Yes Yes Yes Yes No No Yes
Spinraza 262687 Nusinersen Sodium Biogen Canada Inc No No No No No Yes No No
Sporanox 269455 Itraconazole Janssen Inc Yes No No No Yes No No Yes
Sporanox 269501 Itraconazole Janssen Inc Yes No No No Yes No No Yes
Tecfidera 259869 Dimethyl Fumarate Biogen Canada Inc No Yes No Yes No No No Yes
Wakix 270929 Pitolisant Hydrochloride Endo Ventures Ltd Yes Yes No Yes No Yes No Yes
Xeljanz 264582 Tofacitinib Citrate Pfizer Canada ULC No No No Yes No Yes No Yes
Zoloft 270222 Sertraline Hcl Upjohn Canada ULC No No No Yes No No No Yes

April 2023

Product Monograph Brand Safety Updates - April 2023
(PDF, 112 KB, 2 pages)

Product Monograph Brand Safety Updates April 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
AA-Clozapine 269276 Clozapine AA Pharma Inc No Yes Yes No No Yes No Yes
Balversa 269952 Erdafitinib Janssen Inc No Yes No Yes No Yes No No
Bicillin L-A 268414 Penicillin G Benzathine Pfizer Canada ULC No Yes Yes No No Yes No Yes
Biktarvy 264207 Emtricitabine, Tenofovir Alafenamide Hemifumarate, Bictegravir Sodium Gilead Sciences Canada Inc No No No Yes No No No No
Breztri Aerosphere 257897 Glycopyrronium Bromide, Formoterol Fumarate Dihydrate, Budesonide AstraZeneca Canada Inc No No No No No Yes No Yes
Brivlera 269819 Brivaracetam UCB Canada Inc No Yes No No No No No Yes
Entocort Enema 268828 Budesonide Tillotts Pharma GmbH No Yes No Yes No No No Yes
Fosrenol 270959 Lanthanum Carbonate Hydrate Takeda Canada Inc No Yes No No No No No Yes
Glyxambi 269916 Linagliptin, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No No No No Yes No No Yes
Mekinist 270103 Trametinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Motrin 200 mg, Motrin 300 mg, Motrin 400 mg 265403 Ibuprofen McNeil Consumer Healthcare Division of Johnson & Johnson Inc Yes Yes Yes Yes Yes Yes Yes Yes
Nortriptyline 269184 Nortriptyline Hcl Apotex Inc Yes Yes Yes Yes Yes Yes No Yes
Orkambi 264825 Ivacaftor, Lumacaftor Vertex Pharmaceuticals (Canada) Incorporated No Yes No Yes Yes Yes No Yes
Slynd 271309 Drospirenone Duchesnay Inc No Yes No Yes No No No No
Tafinlar 270100 Dabrafenib Mesylate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Tapazole 270311 Methimazole Paladin Labs Inc No Yes No No No Yes No Yes
Toradol 267475 Ketorolac Tromethamine AA Pharma Inc No No No Yes Yes No No Yes
Toradol IM 267937 Ketorolac Tromethamine Atnahs Pharma UK Limited No No No Yes Yes No No Yes
Voltaren Ophtha 269518 Diclofenac Sodium Novartis Pharmaceuticals Canada Inc No Yes No No No No No Yes
Vyvanse 267643 Lisdexamfetamine Dimesylate Takeda Canada Inc Yes Yes No Yes Yes No No Yes
Xalkori 270202 Crizotinib Pfizer Canada ULC No No No Yes No No No Yes
Xarelto 268349 Rivaroxaban Bayer Inc No No No Yes No Yes No Yes
Xigduo 269795 Dapagliflozin Propanediol Monohydrate, Metformin Hydrochloride AstraZeneca Canada Inc Yes Yes No Yes Yes Yes No Yes
Zinecard 267046 Dexrazoxane Pfizer Canada ULC Yes Yes Yes Yes Yes Yes No Yes
Zithromax 270217 Azithromycin Dihydrate Pfizer Canada ULC No Yes No No No Yes No No

March 2023

Product Monograph Brand Safety Updates - March 2023
(PDF, 112 KB, 2 pages)

Product Monograph Brand Safety Updates March 2023
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
AA-Amilzide 268237 Hydrochlorothiazide, Amiloride Hcl AA Pharma Inc No Yes No Yes Yes Yes No Yes
Adderall XR 269618 Mixed Salts Amphetamine Takeda Canada Inc No Yes No Yes Yes No No Yes
Albrioza 268337 Ursodoxicoltaurine, Sodium Phenylbutyrate Amylyx Pharmaceuticals Inc No Yes No No No No No No
Anoro Ellipta 268656 Vilanterol Trifenatate, Umeclidinium Bromide GlaxoSmithKline Inc Yes No No Yes Yes No No Yes
Atacand Plus 268325 Hydrochlorothiazide, Candesartan Cilexetil AstraZeneca Canada Inc No Yes No Yes Yes No No Yes
Cotellic 265306 Cobimetinib Fumarate Hoffmann-La Roche Limited No Yes No Yes No No No Yes
Dexilant 266967 Dexlansoprazole Takeda Canada Inc No Yes No Yes No No No Yes
Diovan 267351 Valsartan Novartis Pharmaceuticals Canada Inc No Yes No No Yes No No Yes
Diovan-HCT 266715 Hydrochlorothiazide, Valsartan Novartis Pharmaceuticals Canada Inc No Yes No No Yes No No Yes
Entocort 268608 Budesonide Tillotts Pharma GmbH No Yes No Yes No No No Yes
Erleada 269676 Apalutamide Janssen Inc No Yes No No No No No Yes
Ferriprox, Ferriprox MR 261912 Deferiprone Chiesi Canada Corp No No No No Yes Yes No Yes
Galafold 262810 Migalastat Hydrochloride Amicus Therapeutics UK Ltd No Yes No Yes No Yes No Yes
Imbruvica 263702 Ibrutinib Janssen Inc No Yes No Yes No Yes No Yes
Istodax 254316 Romidepsin Celgene Inc No No Yes No No No No Yes
Jardiance 268326 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No No No No Yes Yes No Yes
Keppra 268666 Levetiracetam UCB Canada Inc No Yes No Yes No No No No
Naproxen Capsules 200 Mg 268717 Naproxen Apotex Inc Yes Yes No Yes Yes No No Yes
Pantoloc 266961 Pantoprazole Sodium Takeda Canada Inc No Yes No Yes No No No Yes
Precedex 269163 Dexmedetomidine Hcl Pfizer Canada ULC No Yes No No No No No Yes
Prevacid, Prevacid Fastab 267149 Lansoprazole Takeda Pharmaceuticals America Inc No Yes No Yes No No No Yes
Prezcobix 268359 Darunavir Ethanolate, Cobicistat Janssen Inc No No No Yes No No No Yes
Prezista 268362 Darunavir Ethanolate Janssen Inc No No No Yes No No No Yes
Purinethol 264179 Mercaptopurine Teva Canada Limited No Yes Yes Yes Yes Yes No Yes
Retevmo 266679 Selpercatinib Loxo Oncology Inc No No No Yes Yes No No Yes
Rydapt 270748 Midostaurin Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Suboxone 269182 Naloxone Hcl, Naloxone Hydrochloride Dihydrate, Buprenorphine Hydrochloride Indivior UK Limited No Yes No No Yes Yes No Yes
Symtuza 268406 Emtricitabine, Darunavir Ethanolate, Cobicistat, Tenofovir Alafenamide Hemifumarate Janssen Inc No No No Yes No No No Yes
Synjardy 268593 Metformin Hydrochloride, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee Yes Yes No No Yes Yes No Yes
Tagrisso 263672 Osimertinib Mesylate AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Tecta 266960 Pantoprazole Magnesium Takeda Canada Inc No Yes No Yes No No No Yes
Vitrakvi 266965 Larotrectinib Sulfate Bayer Inc No Yes No No No No No Yes
Vyxeos 262151 Daunorubicin, Cytarabine Jazz Pharmaceuticals Ireland Limited No Yes No No No Yes No Yes
Xtandi 263476 Enzalutamide Astellas Pharma Canada Inc No No No No Yes No No No

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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