Product monograph brand safety updates

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December 2020

Product Monograph Brand Safety Updates December 2020
(PDF, 103 KB, 3 pages)

December 2020
Brand Name Submission Number Ingredient(S) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Abilify Maintena 242346 Aripiprazole Otsuka Pharmaceutical Co Ltd No Yes No Yes No No No No
Accel-Sevelamer 239213 Sevelamer Carbonate Accel Pharma Inc No Yes No No No Yes Yes Yes
Adderall XR 241496 Amphetamine Aspartate, Dextroamphetamine Saccharate, Amphetamine Sulfate, Dextroamphetamine Sulfate Takeda Canada Inc No Yes No No Yes No No Yes
Advagraf 241431 Tacrolimus Astellas Pharma Canada Inc No No No No Yes No No Yes
Asmanex Twisthaler 241482 Mometasone Furoate Merck Canada Inc No Yes No No No Yes Yes Yes
Biktarvy 242750 Emtricitabine, Bictegravir Sodium, Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc No No No Yes No No No Yes
Caduet 241827 Atorvastatin Calcium, Amlodipine Besylate Upjohn Canada ULC Yes Yes No No Yes No No Yes
Caripul 241742 Epoprostenol Sodium Janssen Inc No Yes No No No No No Yes
Dexilant 241999 Dexlansoprazole Takeda Canada Inc No Yes No Yes No No No No
Duotrav PQ 242431 Travoprost, Timolol Maleate Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Erythrocin I.V. 241362 Erythromycin Lactobionate Amdipharm Limited Yes Yes Yes Yes Yes No No Yes
Gilenya 242144 Fingolimod Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes Yes No Yes
Idhifa 242218 Enasidenib Mesylate Celgene Inc No No No No Yes No No No
Imbruvica 235706 Ibrutinib Janssen Inc No Yes No Yes No Yes No Yes
Invanz 238455 Ertapenem Sodium Merck Canada Inc No Yes No No No No No Yes
Invega 241812 Paliperidone Janssen Inc No Yes No Yes No No No Yes
Invega Sustenna 241862 Paliperidone Palmitate Janssen Inc No Yes No Yes No No No Yes
Invega Trinza 241830 Paliperidone Palmitate Janssen Inc No Yes No Yes No No No Yes
Keppra 242697 Levetiracetam UCB Canada Inc No Yes No Yes No No No Yes
Kisqali 237555 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No No No Yes No No No No
Lenvima 242453 Lenvatinib Mesylate Eisai Limited No Yes No Yes Yes Yes No Yes
Lipitor 241951 Atorvastatin Calcium Upjohn Canada ULC Yes Yes No No Yes No No Yes
Luvox 238347 Fluvoxamine Maleate BGP Pharma ULC No Yes No No No No No No
Mavenclad 238626 Cladribine EMD Serono a Division of EMD Inc Canada Yes Yes No No No No No Yes
Moviprep 238575 Polyethylene Glycol 3350, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate, Sodium Sulfate Anhydrous Aralez Pharmaceuticals Canada Inc No Yes No No No No No Yes
Olmetec 241065 Olmesartan Medoxomil Merck Canada Inc Yes Yes No Yes Yes No No Yes
Olmetec Plus 241145 Hydrochlorothiazide, Olmesartan Medoxomil Merck Canada Inc Yes Yes No No Yes No Yes Yes
Onivyde 243509 Irinotecan Sucrose Octasulfate Servier Canada Inc No Yes No No No No No Yes
Onstryv 242236 Safinamide Valeo Pharma Inc No No No Yes No No No Yes
Pantoloc 242003 Pantoprazole Takeda Canada Inc No Yes No Yes No No No No
Pediapred 243283 Prednisolone Sodium Phosphate Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Prograf 241489 Tacrolimus Astellas Pharma Canada Inc No No No No Yes Yes No Yes
Prolensa 238790 Bromfenac Sodium Sesquihydrate Bausch & Lomb Inc No Yes No Yes No No No Yes
Remeron 242352 Mirtazapine Merck Canada Inc No Yes No Yes No No No Yes
Remeron RD 242354 Mirtazapine Merck Canada Inc No Yes No Yes No No No Yes
Rexulti 242419 Brexpiprazole Otsuka Pharmaceutical Co Ltd No Yes No Yes No No No Yes
Rifadin 241843 Rifampin Sanofi-Aventis Canada Inc No No No No Yes No No Yes
Risperdal 241861 Risperidone Janssen Inc No Yes No Yes No No No Yes
Risperdal Consta 241839 Risperidone Janssen Inc No Yes No Yes No No No Yes
Stribild 238174 Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, Elvitegravir Gilead Sciences Canada Inc Yes No No No No No No Yes
Tecta 242002 Pantoprazole Magnesium Takeda Canada Inc No Yes No Yes No No No No
Teva-Loperamide 240985 Loperamide Hcl Teva Canada Limited No Yes No No No No Yes Yes
Ultram 241841 Tramadol Hcl Janssen Inc No Yes No Yes No No No Yes

November 2020

Product Monograph Brand Safety Updates November 2020
(PDF, 91 KB, 2 pages)

November 2020
Brand Name Submission Number Ingredient(S) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Adlyxine 240740 Lixisenatide Sanofi-Aventis Canada Inc No No No No No Yes No Yes
Advil Cold & Sinus Convenience Pack 240564 Ibuprofen, Pseudoephedrine Hcl, Chlorpheniramine Maleate GlaxoSmithKline Consumer Healthcare Inc Yes Yes No No Yes No No Yes
Advil Day/Night Convenience Pack 240575 Ibuprofen, Diphenhydramine Hcl GlaxoSmithKline Consumer Healthcare Inc Yes Yes No Yes Yes No Yes Yes
Auro-Cefixime 239750 Cefixime Auro Pharma Inc No Yes No No No No No Yes
Avalide 241361 Hydrochlorothiazide, Irbesartan Sanofi-Aventis Canada Inc No Yes No Yes Yes No No Yes
Avapro 241360 Irbesartan Sanofi-Aventis Canada Inc No Yes No Yes Yes No No Yes
Azarga 242484 Timolol Maleate, Brinzolamide Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Carbaglu 227936 Carglumic Acid Recordati Rare Diseases No Yes No Yes Yes Yes Yes Yes
Claritin Kids Rapid Dissolve 228699 Loratadine Bayer Inc No No No No No Yes No Yes
Cold + Sinus Daytime Cold + Sinus Nighttime 239435 Ibuprofen, Pseudoephedrine Hcl Vita Health Products Inc Yes Yes Yes No Yes No No Yes
Depakene 242654 Valproic Acid BGP Pharma ULC No Yes No No No No No Yes
Descovy 234525 Emtricitabine, Tenofovir Alafenamide Gilead Sciences Canada Inc No Yes Yes Yes No Yes No Yes
Epclusa 233923 Velpatasvir, Sofosbuvir Gilead Sciences Canada Inc No Yes No Yes No Yes No Yes
Epival 242651 Divalproex Sodium BGP Pharma ULC No Yes No No No No No Yes
Erleada 241921 Apalutamide Janssen Inc No No No Yes No No No Yes
Genvoya 238172 Emtricitabine, Tenofovir Alafenamide Hemifumarate, Cobicistat, Elvitegravir Gilead Sciences Canada Inc Yes No No No Yes No No Yes
Jakavi 241484 Ruxolitinib Phosphate Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Lolo 238799 Ethinyl Estradiol, Norethindrone Acetate Allergan Inc No No No No No Yes No Yes
Lonsurf 235999 Tipiracil Hydrochloride, Trifluridine Taiho Pharma Canada, Inc. No Yes No Yes No Yes No Yes
Lupron, Lupron Depot 241744 Leuprolide Acetate Abbvie Corporation Yes Yes Yes Yes Yes Yes Yes Yes
Micro+6 Concentrate 237994 Manganese Sulfate, Chromic Chloride, Cupric Sulfate, Selenious Acid, Zinc Sulfate Heptahydrate, Sodium Iodide Sandoz Canada Incorporated No Yes No No No Yes Yes No
Mirena 243721 Levonorgestrel Bayer Inc No Yes No No No Yes No Yes
PMS-Fluticasone Propionate/Salmeterol DPI 242762 Fluticasone Propionate, Salmeterol Xinafoate Pharmascience Inc No No No No No No No Yes
Ravicti 241398 Glycerol Phenylbutyrate Horizon Therapeutics Ireland DAC No No No No No No No Yes
Rydapt 241284 Midostaurin Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No No
Sandostatin LAR, Sandostatin 240998 Octreotide, Octreotide Acetate Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes Yes No Yes
Sandoz Metoprolol SR 240568 Metoprolol Tartrate Sandoz Canada Incorporated No No No No Yes No No Yes
Sofracort 240569 Dexamethasone Sodium Metasulphobenzoate, Gramicidin, Framycetin Sulfate Sanofi-Aventis Canada Inc Yes Yes No Yes Yes No Yes Yes
Tagrisso 242157 Osimertinib Mesylate AstraZeneca Canada Inc No No No Yes No No No Yes
Tasigna 242015 Nilotinib Hydrochloride Monohydrate Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Tiazac XC 238542 Diltiazem Hcl Valeant Canada LP Valeant Canada S.E.C. Yes Yes No Yes No No Yes Yes
Xarelto 233166 Rivaroxaban Bayer Inc No Yes No Yes No Yes No Yes
Zytiga 241627 Abiraterone Acetate Janssen Inc No Yes No Yes Yes No No Yes

October 2020

Product Monograph Brand Safety Updates October 2020
(PDF, 70KB, 1 page)

October 2020
Brand Name Submission Number Ingredient(S) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Aubagio 239626 Teriflunomide Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No Yes No Yes Yes No No Yes
Elmiron 239842 Pentosan Polysulfate Sodium Janssen Inc Yes Yes Yes Yes No No No Yes
Ibuprofen Liquid Filled Capsules, Extra Strength Ibuprofen Liquid Filled Capsules 240415 Ibuprofen Apotex Inc Yes Yes No No Yes No No Yes
Imovane 240565 Zopiclone Sanofi-Aventis Canada Inc Yes Yes Yes Yes Yes No No Yes
Ketalar 238402 Ketamine Hydrochloride ERFA Canada 2012 Inc Yes Yes No Yes No Yes No No
Kisqali 233623 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No No
Maviret 234362 Pibrentasvir, Glecaprevir Abbvie Corporation No No No No No Yes No No
Plavix 239831 Clopidogrel Bisulfate Sanofi-Aventis Canada Inc No Yes No No Yes No No Yes
Prezcobix 240107 Darunavir Ethanolate, Cobicistat Janssen Inc No No No No Yes No No Yes
Prezista 240039 Darunavir Ethanolate Janssen Inc No No No No Yes No No Yes
Renagel 238457 Sevelamer Hydrochloride Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Renvela 238461 Sevelamer Carbonate Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Salazopyrin, Salazopyrin En-Tabs 239257 Sulfasalazine Pfizer Canada ULC No No No Yes No No No No
Symtuza 240432 Darunavir Ethanolate, Emtricitabine, Cobicistat, Tenofovir Alafenamide Hemifumarate Janssen Inc No No No No Yes No No Yes
Tagrisso 234607 Osimertinib Mesylate AstraZeneca Canada Inc No Yes No Yes No Yes No No
Talzenna 234108 Talazoparib Pfizer Canada ULC No Yes No Yes Yes Yes No No
Tenormin 239845 Atenolol AstraZeneca Canada Inc No Yes No No No No No No
Teva-Mexiletine 238065 Mexiletine Hcl Teva Canada Limited No Yes No No No No No No
Twynsta 239007 Telmisartan, Amlodipine Besylate Boehringer Ingelheim (Canada) Ltd Ltee Yes Yes No Yes Yes No Yes Yes
Zejula 237670 Niraparib GlaxoSmithKline Inc No Yes No Yes Yes Yes No Yes
Zerbaxa 238477 Ceftolozane Sulfate, Tazobactam Sodium Merck Canada Inc No Yes No No No No No Yes
Zofran, Zofran ODT 240200 Ondansetron Hydrochloride Dihydrate Novartis Pharmaceuticals Canada Inc No Yes No No No No No Yes

September 2020

Product Monograph Brand Safety Updates September 2020
(PDF, 72 KB, 1 page)

September 2020
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Aubagio 231739 Teriflunomide Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Dovato 233469 Dolutegravir, Lamivudine ViiV Healthcare ULC No No No Yes No No No No
Heartburn Control 238026 Omeprazole Apotex Inc Yes Yes No Yes Yes Yes Yes Yes
Imbruvica 233164 Ibrutinib Janssen Inc No Yes No No No Yes No No
Incruse Ellipta 222505 Umeclidinium Bromide GlaxoSmithKline Inc No No No No No No No Yes
Narcan Nasal Spray 234832 Naloxone Hcl Adapt Pharma Operations Limited No No No No No No No Yes
Plaquenil 238801 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Saphris 238694 Asenapine Merck Canada Inc No Yes No No No No No No
Soliqua 232504 Lixisenatide, Insulin Glargine Sanofi-Aventis Canada Inc No No No Yes No Yes No Yes
Synthroid 238350 Levothyroxine Sodium BGP Pharma ULC Yes Yes No No Yes Yes No Yes
Targin 237753 Naloxone Hcl, Oxycodone Hcl Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
Venclexta 234504 Venetoclax Abbvie Corporation No No No Yes No Yes No No
Zytiga 236834 Abiraterone Acetate Janssen Inc No No No Yes No No No No

August 2020

Product Monograph Brand Safety Updates August 2020
(PDF, 82 KB, 2 pages)

August 2020
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Brilinta 231818 Ticagrelor AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Butrans 237701 Buprenorphine Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
Clinimix E, Clinimix 239475 Nitrogen, Amino Acids, Dextrose Baxter Corporation No Yes No No No Yes No No
Codeine Contin 237940 Codeine, Codeine Sulfate Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
Epuris 238793 Isotretinoin Cipher Pharmaceuticals Inc No Yes No Yes No No No No
Hepsera 236397 Adefovir Dipivoxil Gilead Sciences Canada Inc No Yes No No Yes No No Yes
Invokamet 232307 Metformin Hcl, Canagliflozin Janssen Inc No Yes No Yes No Yes No Yes
Lokelma 231794 Sodium Zirconium Cyclosilicate AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Lotriderm 237862 Betamethasone Dipropionate, Clotrimazole Merck Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Lynparza 235698 Olaparib AstraZeneca Canada Inc No Yes No Yes Yes No No Yes
Mezavant 238836 Mesalazine Shire Pharma Canada ULC No No No Yes No No Yes Yes
Mirapex 234378 Pramipexole Dihydrochloride Monohydrate Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No Yes No Yes
MS Contin 237930 Morphine Sulfate Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
MS IR 237978 Morphine Sulfate Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
Otezla 233030 Apremilast Amgen Canada Inc No Yes No Yes No Yes No Yes
Oxy.IR 237807 Oxycodone Hcl Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
Oxyneo 237808 Oxycodone Hcl Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
Sonovue 231944 Sulfur Hexafluoride Bracco Imaging Canada No Yes No Yes No Yes No No
Sprycel 229858 Dasatinib Bristol-Myers Squibb Canada No Yes No Yes Yes Yes No Yes
Sudafed Sinus Advance 237300 Ibuprofen, Pseudoephedrine Hcl McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No No No No No Yes
Symdeko 237289 Tezacaftor, Ivacaftor Vertex Pharmaceuticals (Canada) Incorporated No Yes No No No No No No
Uniphyl 237977 Theophylline Purdue Pharma No Yes No No No Yes No Yes
Zydelig 240413 Idelalisib Gilead Sciences Canada Inc No Yes Yes Yes No No No Yes
Zytram XL 237703 Tramadol Hcl Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes

July 2020

Product Monograph Brand Safety Updates July 2020
(PDF, 77.9 KB, 2 pages)

July 2020
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings and Precautions Serious Warnings and Precautions Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Diflucan 237806 Fluconazole Pfizer Canada Inc No No No No Yes No No Yes
Dilaudid 237679 Hydromorphone Hcl Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
Enstilar 237303 Betamethasone Dipropionate, Calcipotriol Monohydrate Leo Pharma Inc No Yes No Yes No Yes No Yes
Hydromorph Contin 237700 Hydromorphone Hcl Purdue Pharma Yes Yes Yes Yes Yes Yes Yes Yes
Ninlaro 236958 Ixazomib Citrate Takeda Canada Inc No Yes No Yes No No No Yes
Oxaliplatin 236783 Oxaliplatin Pfizer Canada ULC Yes Yes No Yes No No No Yes
Precedex 237805 Dexmedetomidine Pfizer Canada ULC No No No Yes No No No No
Protopic 237801 Tacrolimus Leo Pharma Inc No Yes No No No Yes No Yes
Singulair 230733 Montelukast Sodium Merck Canada Inc No Yes Yes Yes No Yes No Yes
Smofkabiven Electrolyte Free, Smofkabiven Extra Nitrogen Electrolyte Free 230307 Fish Oil, Phenylalanine, Valine, Methionamine, Tyrosine, Threonine, Nitrogen, Dextrose, Glycine, Histidine, Isoleucine, Proline, Arginine, Lysine, Alanine, Serine, Olive Oil, Tryptophan, Leucine, Soybean Oil, Taurine, Medium-Chain Triglycerides Fresenius Kabi Canada Ltd No No No No No Yes No Yes
Smofkabiven, Smofkabiven Extra Nitrogen 230147 Fish Oil, Phenylalanine, Valine, Methionamine, Tyrosine, Threonine, Nitrogen, Dextrose, Glycine, Histidine, Isoleucine, Proline, Magnesium Sulfate, Potassium Chloride, Alanine, Arginine, Sodium Glycerophosphate, Lysine, Calcium Chloride Dihydrate, Serine, Olive Oil, Tryptophan, Sodium Acetate Trihydrate, Zinc Sulfate Heptahydrate, Leucine, Soybean Oil, Taurine, Medium-Chain Triglycerides Fresenius Kabi Canada Ltd No No No No No Yes No Yes
Suboxone 229217 Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate Indivior UK Limited No Yes Yes Yes No Yes No Yes
Teveten 237726 Eprosartan Mesylate BGP Pharma ULC No Yes No No Yes No No Yes
Teveten Plus 237724 Hydrochlorothiazide, Eprosartan Mesylate BGP Pharma ULC No Yes No No Yes No No Yes
Tiazac 237804 Diltiazem Hcl Valeant Canada LP Valeant Canada S.E.C. No Yes No Yes No No Yes Yes
Vfend 237769 Voriconazole Pfizer Canada ULC Yes Yes Yes Yes Yes No No Yes
Wellbutrin SR 237178 Bupropion Hcl Valeant Canada LP Valeant Canada S.E.C. No Yes No Yes No No Yes Yes
Wellbutrin XL 237179 Bupropion Hcl Valeant Canada LP Valeant Canada S.E.C. No Yes No Yes No No Yes Yes
Zyban 237455 Bupropion Hcl Valeant Canada LP Valeant Canada S.E.C. No Yes No No Yes No Yes Yes

June 2020

Product Monograph Brand Safety Updates June 2020
(PDF, 109.68 KB, 3 pages)

Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings and Precautions Serious Warnings and Precautions Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Advair Diskus 237271 Fluticasone Propionate, Salmeterol Xinafoate GlaxoSmithKline Inc No No No No No No No Yes
Aleve Tablets 237829 Naproxen Sodium Bayer Inc Yes Yes No No No No No Yes
Apo-Cefprozil 235587 Cefprozil Apotex Inc No Yes No No No No No Yes
235590 Cefprozil Apotex Inc No Yes No No No No No Yes
Caelyx 237448 Doxorubicin Hcl Janssen Inc No Yes No Yes No Yes No Yes
Calcimar 230132 Calcitonin (Salmon Synthetic) Sanofi-Aventis Canada Inc No Yes No Yes No Yes Yes No
Children's MOTRIN,
Infants' MOTRIN, Children's MOTRIN Chewable Tablets,
Junior Strength MOTRIN Chewable Tablets
237473 Ibuprofen McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes No No No Yes
Combogesic 237878 Ibuprofen, Acetaminophen Biosyent Pharma Inc No No No No No Yes No Yes
Copaxone 236453 Glatiramer Acetate Teva Canada Limited No Yes No Yes No No No Yes
Coversyl Plus, Coversyl Plus LD, Coversyl Plus HD 236978 Indapamide, Perindopril Erbumine Servier Canada Inc Yes Yes No Yes Yes No No Yes
Envarsus PA 237246 Tacrolimus Endo Ventures Ltd No Yes No Yes Yes Yes No Yes
Esbriet 237096 Pirfenidone Hoffmann-La Roche Limited No Yes No Yes No Yes No No
Extra Strength Tylenol Nighttime 237375 Acetaminophen, Diphenhydramine Hcl McNeil Consumer Healthcare Division of Johnson & Johnson Inc No No No Yes No No Yes No
Flagystatin 236509 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Forxiga 234304 Dapagliflozin Propanediol AstraZeneca Canada Inc Yes Yes Yes Yes No Yes No Yes
Imuran 236597 Azathioprine Sodium, Azathioprine Aspen Pharmacare Canada Inc. No Yes No Yes Yes Yes No Yes
Inhibace 235666 Cilazapril Monohydrate Cheplapharm Arzneimittel GmbH Yes Yes No No Yes No No Yes
Inhibace Plus 235667 Hydrochlorothiazide, Cilazapril Monohydrate Cheplapharm Arzneimittel GmbH Yes Yes No No Yes No No Yes
Jentadueto 229225 Metformin Hcl, Linagliptin Boehringer Ingelheim (Canada) Ltd Ltee Yes Yes No Yes Yes Yes No Yes
Keppra 237080 Levetiracetam UCB Canada Inc No Yes No Yes No No No Yes
Levothyroxine Sodium Injection 223344 Levothyroxine Sodium Fresenius Kabi Canada Ltd No No No No No No No Yes
Lozide 236979 Indapamide Servier Canada Inc Yes Yes No Yes Yes No No Yes
Lynparza 229268 Olaparib AstraZeneca Canada Inc No Yes No No Yes Yes No Yes
Maviret 229422 Pibrentasvir, Glecaprevir AbbVie Corporation No Yes No No Yes No No Yes
Micatin Miconazole Nitrate Cream 2% USP 235783 Miconazole Nitrate Wellspring Pharmaceutical Canada Corp Yes Yes No Yes No Yes No No
Micatin Powder Spray - Unscented 2% 235806 Miconazole Nitrate Wellspring Pharmaceutical Canada Corp Yes Yes No Yes No Yes No No
Motrin 200 Mg, Motrin 300 Mg, Motrin 400 Mg 237424 Ibuprofen McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes No No No Yes
Motrin Platinum Muscle and Body 237345 Methocarbamol, Ibuprofen McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes No No No Yes
Multaq 237496 Dronedarone Hydrochloride Sanofi-Aventis Canada Inc No Yes No No Yes Yes No Yes
Nitoman 236868 Tetrabenazine Valeant Canada LP Valeant Canada S.E.C. Yes Yes No Yes Yes Yes Yes Yes
Opsumit 236976 Macitentan Janssen Inc No Yes No Yes No No No Yes
Paxil 237146 Paroxetine Hcl GlaxoSmithKline Inc No Yes No Yes No No No Yes
Paxil CR 237155 Paroxetine Hcl GlaxoSmithKline Inc No Yes No Yes No No No Yes
Primaxin 229835 Cilastatin Sodium, Imipenem Merck Canada Inc No No No No No Yes No Yes
Ritalin, Ritalin SR 237335 Methylphenidate Hcl Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Rythmol 236662 Propafenone Hcl BGP Pharma ULC Yes Yes No No No No Yes Yes
Taxotere 237181 Docetaxel Sanofi-Aventis Canada Inc No Yes Yes Yes No No No Yes
Tegsedi 234581 Inotersen Sodium Akcea Therapeutics Inc No Yes No No No No No Yes
Trelegy Ellipta 236787 Umeclidinium Bromide, Fluticasone Furoate, Vilanterol Trifenatate GlaxoSmithKline Inc No No No Yes No No No Yes
Tridural 237295 Tramadol Hcl Paladin Labs Inc No Yes No No No No No Yes
Uptravi 229725 Selexipag Janssen Inc No No No No Yes Yes No Yes
Xerese 236613 Acyclovir, Hydrocortisone Valeant Canada LP Valeant Canada S.E.C. Yes Yes No No Yes No No Yes
Xtandi 233563 Enzalutamide Astellas Pharma Canada Inc No Yes No Yes No No No Yes

May 2020

Product Monograph Brand Safety Updates May 2020
(PDF, 123 KB, 4 pages)

Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Aczone 236260 Dapsone Valeant Canada LP Valeant Canada S.E.C. No No No Yes No No No Yes
Advil Liqui-Gels, Advil Extra Strength Liqui-Gels, Advil Arthritis Pain 236129 Ibuprofen Pfizer Consumer Healthcare A Division of Pfizer Canada ULC No Yes No No No No No No
Arthrotec 50, Arthrotec 75 235828 Misoprostol, Diclofenac Potassium Pfizer Canada ULC No Yes No Yes No No No Yes
Cabometyx 237444 Cabozantinib Ipsen Biopharmaceuticals Canada Inc No Yes No No No No No Yes
Cayston 234938 Aztreonam Gilead Sciences Canada Inc No Yes No No No No No Yes
Cefazolin for Injection 234941 Cefazolin Sodium Teva Canada Limited No Yes No No No No No Yes
Ceftin 234485 Cefuroxime Axetil GlaxoSmithKline Inc No Yes No No No No No Yes
Celebrex 236661 Celecoxib Pfizer Canada ULC No Yes No No No No No Yes
Crestor 235939 Rosuvastatin Calcium AstraZeneca Canada Inc Yes No No No Yes Yes No Yes
Cubicin, Cubicin RF 235553 Daptomycin Cubist Pharmaceuticals LLC No Yes No Yes No No No Yes
Dermatop Ointment, Dermatop Emollient Cream 236612 Prednicarbate Valeant Canada LP Valeant Canada S.E.C. No Yes No Yes No No No Yes
Diprosone 235123 Betamethasone Dipropionate Merck Canada Inc No Yes No Yes No Yes Yes Yes
Envarsus PA 236672 Tacrolimus Endo Ventures Ltd No No No No Yes No No Yes
Erivedge 236154 Vismodegib Hoffmann La Roche Limited No Yes Yes Yes No No No Yes
Erleada 236573 Apalutamide Janssen Inc No No No Yes No No No Yes
Fentora 236380 Fentanyl Citrate Teva Canada Limited No Yes No Yes Yes No No Yes
Genvoya 236379 Emtricitabine, Cobicistat, Tenofovir Alafenamide Hemifumarate, Elvitegravir Gilead Sciences Canada Inc No Yes No No Yes No No Yes
Hair Regrowth Treatment 235865 Minoxidil Apotex Inc No No No Yes No No Yes Yes
Hp-PAC 235886 Lansoprazole, Amoxicillin, Clarithromycin Takeda Pharmaceuticals America Inc No Yes No No No No No No
Invokamet 236214 Metformin Hcl, Canagliflozin Janssen Inc No Yes Yes Yes No No No Yes
Invokamet XR 236251 Metformin Hcl, Canagliflozin Janssen Inc No Yes Yes Yes No No No Yes
Invokana 236246 Canagliflozin Janssen Inc No Yes Yes Yes No No No Yes
Isoptin SR 236383 Verapamil Hcl BGP Pharma ULC No Yes No No No No No No
Lamictal 237004 Lamotrigine GlaxoSmithKline Inc No No No Yes Yes No No Yes
Lioresal 235825 Baclofen Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Lioresal Intrathecal 235751 Baclofen Novartis Pharmaceuticals Canada Inc No Yes No No No No No Yes
Lynparza 229261 Olaparib AstraZeneca Canada Inc No Yes No No Yes Yes No Yes
Metadol 236670 Methadone Hydrochloride Paladin Labs Inc No Yes Yes No No No Yes No
Nidagel 236355 Metronidazole Valeant Canada LP Valeant Canada S.E.C. No No No Yes No No No No
Norvasc 236351 Amlodipine Besylate Upjohn Canada ULC Yes Yes No No Yes No Yes Yes
Ofev 232923 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes No No No Yes
Olimel 4.4%, Olimel 5.7%, Olimel 7.6%, Periolimel 2.5% E, Olimel 3.3% E, Olimel 4.4% E, Olimel 5.7% E, Olimel 7.6% E 236356 Glutamic Acid,
L-Lysine Acetate, L-Phenylalanine, L-Proline,
Glucose, Magnesium Chloride Hexahydrate, Glycine, Potassium Chloride,
L-Alanine,
L-Isoleucine,
L-Leucine,
L-Methionine,
L-Threonine,
L-Tryptophan,
L-Valine,
Sodium Glycerophosphate, Calcium Chloride Dihydrate,
L-Aspartic Acid,
L-Histidine,
L-Serine,
Olive Oil,
L-Arginine, Sodium Acetate Trihydrate,
L-Tyrosine
Baxter Corporation No No No Yes No No No No
Paclitaxel for Injection 235717 Paclitaxel Pfizer Canada ULC No No No No Yes No No Yes
Pediapred 235344 Prednisolone Sodium Phosphate Sanofi-Aventis Canada Inc Yes Yes No Yes Yes No No Yes
Prevacid, Prevacid Fastab 235901 Lansoprazole Takeda Pharmaceuticals America Inc No Yes No No No No No No
Prevymis 235148 Letermovir Merck Canada Inc No No No No Yes No No No
Primaquine 226711 Primaquine Phosphate Sanofi-Aventis Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Probuphine 236555 Buprenorphine Hydrochloride Knight Therapeutics Inc. No Yes No No Yes No No Yes
Remeron 236043 Mirtazapine Merck Canada Inc Yes Yes No Yes Yes No No Yes
Remeron RD 236098 Mirtazapine Merck Canada Inc Yes Yes No Yes Yes No No Yes
Rosiver 235651 Ivermectin Galderma Canada Inc No Yes No Yes No No No Yes
Sofracort 236141 Dexamethasone Sodium Metasulphoben-
zoate, Gramicidin, Framycetin Sulfate
Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Stribild 236372 Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, Elvitegravir Gilead Sciences Canada Inc No Yes No No Yes No No Yes
Symdeko 234531 Tezacaftor, Ivacaftor Vertex Pharmaceuticals (Canada) Incorporated No No No No Yes No No Yes
Teva-Cefadroxil 234939 Cefadroxil Monohydrate Teva Canada Limited No Yes No No No No No Yes
Topamax 236926 Topiramate Janssen Inc No Yes No Yes No No No Yes
Topicort, Topicort Mild, Topicort Gel, Topicort Ointment 236312 Desoximetasone Bausch Health, Canada Inc. No Yes No Yes No No No No
Trajenta 229038 Linagliptin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Tybost 236347 Cobicistat Gilead Sciences Canada Inc Yes Yes No No Yes No No Yes
Visudyne 235318 Verteporfin Valeant Canada LP Valeant Canada S.E.C. No Yes No Yes No No No Yes
Zenhale 228615 Formoterol Fumarate Dihydrate, Mometasone Furoate Merck Canada Inc No Yes Yes No No Yes No Yes

April 2020

Product Monograph Brand Safety Updates April 2020
(PDF, 105 KB, 5 pages)

Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Abilify 234620 Aripiprazole Otsuka Pharmaceutical Co Ltd No Yes No Yes No No No Yes
Abilify Maintena 234625 Aripiprazole Otsuka Pharmaceutical Co Ltd No Yes No No No No No Yes
Asacol 235400 Mesalazine Allergan Inc No Yes No Yes No No No Yes
Asacol 800 235403 Mesalazine Allergan Inc No Yes No Yes No No No Yes
Bicillin L-A 234892 Penicillin G Benzathine Pfizer Canada ULC No Yes No Yes No No No No
Caprelsa 237613 Vandetanib Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Cefepime for Injection 234594 Cefepime Hcl Apotex Inc No Yes No No No No No Yes
Cefoxitin for Injection 234942 Cefoxitin Sodium Teva Canada Limited No Yes No No No No No Yes
Ceftriaxone Sodium for Injection 234479 Ceftriaxone Sodium Teva Canada Limited No Yes No No No No No Yes
Cefuroxime for Injection, USP 233970 Cefuroxime Sodium Fresenius Kabi Canada Ltd No Yes No No No No No Yes
Cetirizine Hydrochloride Capsules 233893 Cetirizine Hydrochloride Catalent Ontario Limited No No No Yes No No Yes Yes
Cisplatin Injection BP 235278 Cisplatin Pfizer Canada ULC No Yes No No Yes No No No
CLINIMIX E 8% Amino Acids (Blend D) with Electrolytes in 10% Dextrose with Calcium Injection, CLINIMIX E 8% Amino Acids (Blend D) with Electrolytes in 14% Dextrose with Calcium Injection, CLINIMIX 6% Amino Acids (Blend D) without Electrolytes in 5% Dextrose Injection, CLINIMIX 8% Amino Acids (Blend D) without Electrolytes in 10% Dextrose Injection, CLINIMIX 8% Amino Acids (Blend D) without Electrolytes in 14% Dextrose Injection 225011 L-Phenylalanine, L-Proline,
Sodium Chloride, Magnesium Chloride Hexahydrate, Glycine,
Histidine,
L-Lysine Hcl, Dextrose,
L-Alanine,
L-Isoleucine,
L-Leucine,
L-Methionine,
L-Threonine,
L-Tryptophan,
L-Valine,
Calcium Chloride Dihydrate, Potassium Phosphate Dibasic,
Serine,
L-Arginine,
L-Tyrosine
Baxter Corporation No Yes No No No Yes No Yes
Duratocin 236432 Carbetocin Ferring Inc Yes Yes No No Yes Yes Yes Yes
Forxiga 227213 Dapagliflozin Propanediol AstraZeneca Canada Inc No Yes No Yes Yes Yes No Yes
Glyxambi 235055 Linagliptin, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes Yes Yes No No No Yes
Imbruvica 235078 Ibrutinib Janssen Inc No Yes No Yes No No No Yes
Jardiance 235061 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes Yes Yes No No No Yes
Lopresor 235180 Metoprolol Tartrate Novartis Pharmaceuticals Canada Inc No Yes No No Yes No No Yes
Lorbrena 235243 Lorlatinib Pfizer Canada ULC No No No No Yes No No No
Lunesta 231283 Eszopiclone Sunovion Pharmaceuticals Canada Inc No No No No No No No Yes
Mezera 235405 Mesalazine Avir Pharma Inc No Yes No Yes No No No Yes
Moviprep 235769 Polyethylene Glycol 3350, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate, Sodium Sulfate Anhydrous Aralez Pharmaceuticals Canada Inc No Yes No No No No No Yes
Olumiant 235025 Baricitinib Eli Lilly Canada Inc No Yes No Yes No No No Yes
Onstryv 235000 Safinamide Valeo Pharma Inc No Yes No Yes Yes No No Yes
Perindopril Erbumine 235373 Perindopril Erbumine Sanis Health Inc No No No Yes No No No Yes
Piperacillin for Injection 233968 Piperacillin Sodium Fresenius Kabi Canada Ltd No Yes No No No No No Yes
Reactine 235677 Cetirizine Hydrochloride McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No Yes Yes Yes No Yes
Reyataz 236039 Atazanavir Sulfate Bristol-Myers Squibb Canada Yes No No No Yes No No Yes
Salofalk 235411 Mesalazine Aptalis Pharma Canada ULC No Yes No Yes No No No Yes
Salofalk Suppositories 235409 Mesalazine Aptalis Pharma Canada ULC No Yes No Yes No No No Yes
Salofalk Tablets 235406 Mesalazine Aptalis Pharma Canada ULC No Yes No Yes No No No Yes
Signifor 236660 Pasireotide Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Signifor LAR 236663 Pasireotide Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Spinraza 228080 Nusinersen Biogen Canada Inc No No No Yes No No No Yes
Synjardy 235200 Metformin Hcl, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No Yes Yes Yes No No No Yes
Tapazole 5 mg Tablet, Tapazole 233764 Methimazole Paladin Labs Inc No Yes No Yes No No No Yes
Teva-Modafinil 235652 Modafinil Teva Canada Limited Yes Yes No No No No No Yes
Tygacil 235179 Tigecycline Pfizer Canada ULC No Yes No Yes Yes No No Yes
Venclexta 228475 Venetoclax Abbvie Corporation No Yes No Yes No Yes No Yes
Xigduo 228055 Metformin Hcl, Dapagliflozin AstraZeneca Canada Inc No Yes No Yes No No No Yes
Zydelig 229315 Idelalisib Gilead Sciences Canada Inc No No No No No No No Yes

March 2020

Product Monograph Brand Safety Updates March 2020
(PDF, 103 KB, 3 pages)

Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
20% Prosol 235340 L-Lysine Acetate,
L-Phenylalanine, L-Proline, Glutamic Acid, Histidine, Glycine, L-Valine, L-Isoleucine, L-Leucine, L-Threonine,
L-Methionine, L-Tryptophan,
L-Alanine, L-Aspartic Acid, Serine, L-Arginine, L-Tyrosine
Baxter Corporation No Yes No No No Yes No No
Adempas 226431 Riociguat Bayer Inc No Yes No No Yes Yes No Yes
Advil Tablets, Advil Caplets, Advil Extra Strength Caplets, Advil Muscle And Joint, Advil 12 Hour, Advil Gel Caplets 234297 Ibuprofen Pfizer Consumer Healthcare a Division of Pfizer Canada ULC No Yes No No No No Yes No
Atriance 230597 Nelarabine Novartis Pharmaceuticals Canada Inc No No No No No Yes No Yes
Biktarvy 226658 Emtricitabine, Bictegravir Sodium, Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc No Yes No Yes Yes Yes No Yes
Brivlera 226734 Brivaracetam UCB Canada Inc No Yes No Yes No Yes No No
Camptosar 235201 Irinotecan Hydrochloride Pfizer Canada ULC No Yes No No No No No Yes
Cefotaxime Sodium for Injection, BP 233966 Cefotaxime Sodium Sterimax Inc No Yes No No No No No Yes
Clotrimazole-Fluconazole Combi-Pack 234086 Fluconazole, Clotrimazole Taro Pharmaceuticals Inc No Yes No Yes No No No Yes
Cyclen 235009 Ethinyl Estradiol, Norgestimate Janssen Inc No No No Yes Yes No No Yes
Depakene 234417 Valproic Acid BGP Pharma ULC No Yes No No No No No Yes
Efudex 235663 Fluorouracil Valeant Canada LP Valeant Canada S.E.C. Yes Yes No No No No No No
Epival 234416 Divalproex Sodium BGP Pharma ULC No Yes No No Yes No No Yes
Evra 235077 Norelgestromin, Ethinyl Estradiol Janssen Inc No No No No Yes No No Yes
Fuzeon 235288 Enfuvirtide Hoffmann La Roche Limited No Yes No No No No No No
Invirase 235283 Saquinavir Mesylate Hoffmann La Roche Limited No Yes No No No No No No
Kazano 229340 Metformin Hcl, Alogliptin Benzoate Takeda Canada Inc Yes Yes No Yes Yes Yes No Yes
Keflex 233620 Cephalexin Pendopharm Division of Pharmascience Inc No Yes No No No No No Yes
Kisqali 234283 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Latuda 234629 Lurasidone Hydrochloride Sunovion Pharmaceuticals Canada Inc No Yes No No No No No Yes
Maviret 227240 Pibrentasvir, Glecaprevir Abbvie Corporation No No No No No Yes No No
Nexavar 233760 Sorafenib Tosylate Bayer Inc No Yes No Yes No No No Yes
Novamoxin 233622 Amoxicillin Teva Canada Limited No Yes No No No No No Yes
Orilissa 233793 Elagolix Abbvie Corporation No Yes No Yes Yes Yes No Yes
Perindopril Erbumine 233925 Perindopril Erbumine Sivem Pharmaceuticals ULC No No No Yes No No No Yes
Piperacillin Sodium/Tazobactam Sodium Powder for Injection 233631 Piperacillin Sodium, Tazobactam Sodium Sandoz Canada Incorporated No Yes No No No No No Yes
Pradaxa 234514 Dabigatran Etexilate Mesilate Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes Yes No No Yes
Pravachol 234107 Pravastatin Sodium Bristol-Myers Squibb Canada No Yes No Yes No No No Yes
Sandoz Fingolimod 235223 Fingolimod Hydrochloride Sandoz Canada Incorporated No Yes No Yes Yes Yes No Yes
Septra Injection 224385 Trimethoprim, Sulfamethoxazole Aspen Pharmacare Canada Inc. Yes Yes Yes Yes Yes No No Yes
Stivarga 233755 Regorafenib Bayer Inc No Yes No Yes No No No Yes
Suprax 233967 Cefixime Odan Laboratories Ltd No Yes No No No No No Yes
Tagrisso 234409 Osimertinib Mesylate Astrazeneca Canada Inc No Yes No Yes No No No Yes
Tasigna 228181 Nilotinib Hydrochloride Monohydrate Novartis Pharmaceuticals Canada Inc No Yes Yes Yes No Yes No Yes
Tri-Cyclen 235045 Ethinyl Estradiol, Norgestimate Janssen Inc No No No Yes Yes No No Yes
Tri-Cyclen Lo 235080 Ethinyl Estradiol, Norgestimate Janssen Inc No No No Yes Yes No No Yes
Votrient 234074 Pazopanib Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes Yes Yes No No No Yes

February 2020

Product Monograph Brand Safety Updates February 2020
(PDF, 79 KB, 2 pages)

Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Atripla 235076 Emtricitabine, Tenofovir Disoproxil Fumarate, Efavirenz Gilead Sciences, LLC No No No No Yes No No Yes
Avelox I.V., Avelox 233350 Moxifloxacin Hydrochloride Bayer Inc No Yes No Yes No Yes No Yes
Backup Plan Onestep 234289 Levonorgestrel Apotex Inc No Yes No No Yes No No Yes
Cipro XL 233378 Ciprofloxacin Hydrochloride, Ciprofloxacin Bayer Inc No Yes No Yes No Yes No Yes
Cipro, Cipro Oral Suspension 233351 Ciprofloxacin Hydrochloride Bayer Inc No Yes No Yes No Yes No Yes
Clotrimaderm Vaginal 6, Clotrimaderm Vaginal 3 232921 Clotrimazole Taro Pharmaceuticals Inc Yes Yes No No No No No Yes
Dovato 233231 Dolutegravir, Lamivudine ViiV Healthcare ULC Yes Yes No No Yes Yes No Yes
Dovobet Gel 234060 Betamethasone Dipropionate, Calcipotriol Monohydrate Leo Pharma Inc No No No No No Yes No Yes
Duodopa 233778 Levodopa, Carbidopa Monohydrate Abbvie Corporation No Yes No Yes No No No Yes
Duratocin 225949 Carbetocin Ferring Inc Yes Yes No Yes Yes Yes Yes Yes
Effexor XR 226110 Venlafaxine Hcl Pfizer Canada ULC No Yes No Yes No No No Yes
Fycompa 225719 Perampanel Eisai Limited No Yes Yes Yes Yes Yes No Yes
Harvoni 224930 Ledipasvir, Sofosbuvir Gilead Sciences Canada Inc No Yes No Yes Yes Yes No Yes
Hemangiol 234158 Propranolol Hcl Pierre Fabre Dermo-Cosmetique Canada Inc Yes Yes No Yes Yes Yes No No
Hydrea 226144 Hydroxyurea Bristol-Myers Squibb Canada No Yes No Yes No No No Yes
Idhifa 233304 Enasidenib Mesylate Celgene Inc No Yes Yes No No No No No
Juluca 233259 Dolutegravir, Rilpivirine ViiV Healthcare ULC Yes Yes No No Yes Yes Yes Yes
Kisqali 225074 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes Yes No Yes
Kyprolis 233723 Carfilzomib Amgen Canada Inc No Yes No Yes No No No Yes
Levitra 234111 Vardenafil Hydrochloride Bayer Inc Yes No No No Yes No No Yes
Lixiana 233505 Edoxaban Tosylate Servier Canada Inc No No No Yes No No No Yes
Lupron, Lupron Depot 233585 Leuprolide Acetate Abbvie Corporation No Yes No No No No No Yes
Lynparza 230309 Olaparib Astrazeneca Canada Inc No Yes No Yes No Yes No Yes
Maviret 234128 Pibrentasvir, Glecaprevir Abbvie Corporation No No No Yes No No No Yes
Naproxen Capsules 200 mg 233389 Naproxen, Naproxen Sodium Catalent Ontario Limited No Yes Yes No Yes No No Yes
Nozinan 233434 Methotrimeprazine Hcl Sanofi-Aventis Canada Inc Yes Yes No Yes Yes Yes No Yes
Opsumit 233042 Macitentan Janssen Inc No No No No Yes No No No
Picato 233545 Ingenol Mebutate Leo Pharma Inc No No No Yes No No No Yes
Pristiq 225933 Desvenlafaxine Succinate Pfizer Canada ULC No Yes No Yes No No No Yes
Staxyn 234112 Vardenafil Hydrochloride Bayer Inc Yes No No No Yes No No Yes
Tivicay 233258 Dolutegravir ViiV Healthcare ULC Yes Yes No No Yes Yes No Yes
Tobradex 233347 Tobramycin, Dexamethasone Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No Yes
Tobrex 233358 Tobramycin Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No Yes
Triumeq 233245 Dolutegravir, Abacavir, Lamivudine ViiV Healthcare ULC Yes Yes No No Yes Yes No Yes
Volulyte 223031 Hydroxyethyl Starch Fresenius Kabi Canada Ltd Yes Yes No No No Yes No Yes
Voluven 222938 Hydroxyethyl Starch Fresenius Kabi Canada Ltd Yes Yes No No No Yes No Yes
Xiidra 224297 Lifitegrast Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No No
Yondelis 233902 Trabectedin Janssen Inc No No No Yes No No No No

January 2020

Product Monograph Brand Safety Updates January 2020
(PDF, 103 KB, 3 pages)

Brand name Submission number Ingredient(s) Manufacturer Contraindications Warnings and precautions Serious warnings and precautions Adverse reactions Drug interactions Dosage and administration Overdosage Consumer information
Advil Mini-Gels 232267 Ibuprofen Pfizer Consumer Healthcare a Division of Pfizer Canada ULC No Yes No No No No Yes No
Allegra-D 233901 Fexofenadine Hcl, Pseudoephedrine Hcl Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc No No No No No No No Yes
Ambisome 232288 Amphotericin B Astellas Pharma Canada Inc No No No No No Yes No No
Apo-Gain 232446 Minoxidil Apotex Inc No No No Yes No No Yes Yes
Atriance 225174 Nelarabine No vartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Avelox I.V. 230322 Moxifloxacin Hydrochloride Bayer Inc No Yes No No No No No Yes
Belkyra 234220 Deoxycholic Acid Kythera Biopharmaceuticals Inc No Yes No Yes No Yes No No
Biphentin 224342 Methylphenidate Hcl Purdue Pharma Yes Yes Yes Yes Yes Yes No Yes
Cipro XL 230325 Ciprofloxacin Bayer Inc No Yes No No No No No Yes
Cipro, Cipro Oral Suspension 230323 Ciprofloxacin Bayer Inc No Yes No No No No No Yes
Clavulin 232771 Clavulanic Acid, Amoxicillin Trihydrate Glaxosmithkline Inc No No No Yes No No No Yes
Clozaril 232767 Clozapine HLS Therapeutics Inc No Yes No Yes No No No No
Enstilar 232424 Betamethasone Dipropionate, Calcipotriol Monohydrate Leo Pharma Inc No No No No No Yes No Yes
Epclusa 224935 Velpatasvir, Sofosbuvir Gilead Sciences Canada Inc No Yes No Yes No Yes No Yes
Ibrance 234582 Palbociclib Pfizer Canada ULC No Yes No No No No No No
Intralipid 10%, Intralipid 20%, Intralipid 30% 233169 Soybean Oil Fresenius Kabi Canada Ltd No Yes No No No Yes No Yes
Invega 231833 Paliperidone Janssen Inc No Yes Yes Yes Yes Yes No Yes
Invega Sustenna 231845 Paliperidone Palmitate Janssen Inc No Yes Yes Yes Yes Yes No Yes
Invega Trinza 231762 Paliperidone Palmitate Janssen Inc No Yes Yes Yes Yes Yes No Yes
Invokana 229188 Canagliflozin Janssen Inc Yes Yes No Yes No Yes No Yes
Lamictal 228920 Lamotrigine Glaxosmithkline Inc No No No No No No No Yes
Lioresal 232773 Baclofen

Novartis Pharmaceuticals Canada Inc

No Yes Yes No No No No Yes
Lorbrena 232764 Lorlatinib Pfizer Canada ULC Yes Yes No Yes Yes No Yes Yes
Lyrica 232498 Pregabalin Pfizer Canada ULC No Yes Yes No Yes No No Yes
Mezavant 232656 Mesalazine Shire Pharma Canada ULC No Yes No Yes No No No Yes
Neurontin 232770 Gabapentin Pfizer Canada ULC No Yes Yes No Yes No No Yes
Ofev 232837 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Pentasa 232612 Mesalazine Ferring Inc No Yes No Yes No No No Yes
PMS-Hydrochlorothiazide 232155 Hydrochlorothiazide Pharmascience Inc No Yes No Yes No Yes No Yes
Precedex 232263 Dexmedetomidine Hcl Pfizer Canada ULC No Yes No No No No No No
Risperdal Consta 232009 Risperidone Janssen Inc No Yes No Yes No Yes Yes Yes
Sublocade 233256 Buprenorphine Indivior UK Limited No No No No No Yes No Yes
Tramacet 232815 Acetaminophen, Tramadol Hcl Janssen Inc No Yes No No Yes No No Yes
Ultram 232839 Tramadol Hcl Janssen Inc No Yes No No Yes No No Yes
Ultravist 240, Ultravist 300, Ultravist 370 234206 Iopromide Bayer Inc No No No No No Yes No Yes
Venclexta 224252 Venetoclax Abbvie Corporation No Yes No Yes No No No Yes
Vosevi 224937 Voxilaprevir, Velpatasvir, Sofosbuvir Gilead Sciences Canada Inc No Yes No Yes No Yes No Yes
Zykadia 224168 Ceritinib Novartis Pharmaceuticals Canada Inc No No No No Yes No No Yes
Zyprexa, Zyprexa Zydis, Zyprexa Intramuscular 232853 Olanzapine Eli Lilly Canada Inc No No 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 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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