Product monograph brand safety updates
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- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- Non-Prescription Submissions Cleared in 2014
December 2020
Product Monograph Brand Safety Updates December 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
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)
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)
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)
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)
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)
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
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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