Product monograph brand safety updates
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February 2024
Product Monograph Brand Safety Updates – February 2024
(PDF, 81 KB, 1 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Arthrotec 50, Arthrotec 75 | 279263 | Diclofenac Sodium, Misoprostol | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Balversa | 278912 | Erdafitinib | Janssen Inc | No | No | No | Yes | Yes | No | No | Yes |
Braftovi | 276870 | Encorafenib | Pfizer Canada ULC | No | No | No | No | Yes | No | No | Yes |
Camzyos | 272517 | Mavacamten | Bristol-Myers Squibb Canada | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Depo-Provera | 279255 | Medroxyprogesterone Acetate | Pfizer Canada ULC | No | No | No | No | No | Yes | No | Yes |
Janumet, Janumet XR | 276836 | Sitagliptin Phosphate Monohydrate, Metformin Hydrochloride | Merck Canada Inc | No | No | No | No | No | No | No | Yes |
Januvia | 276833 | Sitagliptin Phosphate Monohydrate | Merck Canada Inc | No | No | No | No | No | No | No | Yes |
Levofloxacin in 5% Dextrose Injection | 279109 | Levofloxacin | Pfizer Canada ULC | No | No | No | Yes | No | No | No | Yes |
Mezera | 269884 | Mesalazine | Avir Pharma Inc | No | No | No | Yes | Yes | Yes | No | Yes |
Mirena | 273103 | Levonorgestrel | Bayer Inc | Yes | Yes | No | Yes | No | Yes | No | Yes |
Mozobil | 280337 | Plerixafor | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Nexium 24 Hr | 277914 | Esomeprazole Magnesium Trihydrate | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Ninlaro | 279731 | Ixazomib Citrate | Takeda Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Pristiq | 279179 | Desvenlafaxine Succinate | Pfizer Canada ULC | No | Yes | No | No | No | Yes | Yes | No |
Quelicin | 280413 | Succinylcholine Chloride | Pfizer Canada ULC | Yes | Yes | No | No | No | No | No | No |
Seasonale | 279010 | Levonorgestrel, Ethinyl Estradiol | Teva Canada Limited | No | No | No | Yes | Yes | No | No | Yes |
Seasonique | 279038 | Levonorgestrel, Ethinyl Estradiol | Teva Canada Limited | No | No | No | Yes | Yes | No | No | Yes |
Tegretol | 273178 | Carbamazepine | Novartis Pharmaceuticals Canada Inc | No | Yes | Yes | No | Yes | Yes | No | Yes |
Vancocin | 278879 | Vancomycin Hydrochloride | Searchlight Pharma Inc | No | Yes | No | No | No | No | No | No |
Zofran ODT | 278769 | Ondansetron | Sandoz Canada Incorporated | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Zyvoxam | 279230 | Linezolid | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
January 2024
Product Monograph Brand Safety Updates - January 2024
(PDF, 104 KB, 2 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Alesse 21, Alesse 28 | 278783 | Levonorgestrel, Ethinyl Estradiol | Pfizer Canada ULC | No | No | No | No | No | No | No | Yes |
Aleve Nighttime | 271910 | Diphenhydramine Hcl, Naproxen Sodium | Bayer Inc | Yes | Yes | No | No | No | Yes | No | Yes |
Crestor | 272268 | Rosuvastatin Calcium | AstraZeneca Canada Inc | Yes | Yes | No | No | No | Yes | No | Yes |
Eligard | 275867 | Leuprolide Acetate | Tolmar International Ltd | No | No | No | No | No | Yes | No | Yes |
Erleada | 278563 | Apalutamide | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Ezetrol | 278401 | Ezetimibe | Organon Canada Inc | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Jardiance | 270652 | Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | Yes | Yes | Yes | Yes | No | Yes | No | Yes |
Levothyroxine Sodium for Injection, Levothyroxine Sodium Injection | 278894 | Levothyroxine Sodium | Fresenius Kabi Canada Ltd | Yes | Yes | No | No | Yes | Yes | No | Yes |
Lixiana | 278099 | Edoxaban Tosylate | Servier Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Lupron Depot | 279025 | Leuprolide Acetate | Abbvie Corporation | No | Yes | No | Yes | No | No | No | Yes |
Mekinist | 279055 | Trametinib | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | No |
Nortriptyline | 277464 | Nortriptyline Hcl | Apotex Inc | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Olumiant | 270684 | Baricitinib | Eli Lilly Canada Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Orgalutran | 276208 | Ganirelix Acetate | Organon Canada Inc | No | Yes | No | Yes | No | No | No | No |
Prozac | 277882 | Fluoxetine Hcl | Eli Lilly Canada Inc | No | Yes | No | No | No | No | No | Yes |
Quviviq | 276525 | Daridorexant Hydrochloride | Idorsia Pharmaceuticals Ltd | No | Yes | No | Yes | No | No | No | Yes |
Reactine Complete | 275440 | Pseudoephedrine Hcl, Cetirizine Hydrochloride | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Rexulti | 272694 | Brexpiprazole | Otsuka Pharmaceutical Co Ltd | No | Yes | Yes | Yes | No | Yes | No | Yes |
Sandoz Bisoprolol Tablets | 243497 | Bisoprolol Fumarate | Sandoz Canada Incorporated | Yes | Yes | No | Yes | No | Yes | No | Yes |
Tafinlar | 279062 | Dabrafenib Mesylate | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | No |
Tagrisso | 277035 | Osimertinib Mesylate | AstraZeneca Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Trelstar | 277098 | Triptorelin Pamoate | Knight Therapeutics Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Vyndaqel | 277026 | Tafamidis Meglumine | Pfizer Canada ULC | No | No | No | Yes | No | No | No | Yes |
Wakix | 270856 | Pitolisant Hydrochloride | Endo Ventures Ltd | No | Yes | No | Yes | No | Yes | No | Yes |
Xtandi | 277282 | Enzalutamide | Astellas Pharma Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
December 2023
Product Monograph Brand Safety Updates - December 2023
(PDF, 86 KB, 2 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Aleve Liquid Gels, Aleve Back and Body Pain | 268984 | Naproxen Sodium | Bayer Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Brivlera | 276673 | Brivaracetam | UCB Canada Inc | No | No | No | No | No | Yes | No | No |
Amzyos | 277020 | Mavacamten | Bristol-Myers Squibb Canada | No | Yes | No | No | No | No | No | Yes |
Caprelsa | 278499 | Vandetanib | Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Cosopt, Cosopt Preservative-Free | 274763 | Dorzolamide Hydrochloride, Timolol Maleate | Elvium Life Sciences | No | No | No | Yes | No | Yes | No | Yes |
Dantrium Capsules | 277023 | Dantrolene Sodium | Endo Par Innovation Company, LLC | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
Diprivan 1% | 276556 | Propofol | Aspen Pharmacare Canada Inc | No | Yes | No | No | No | No | No | Yes |
Flomax CE | 277510 | Tamsulosin Hydrochloride | Boehringer Ingelheim (Canada) Ltd Ltee | No | No | No | Yes | No | No | No | Yes |
FML | 277095 | Fluorometholone | Abbvie Corporation | No | No | No | Yes | No | No | No | Yes |
Lanvis | 276764 | Thioguanine | Aspen Pharmacare Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Lokelma | 277220 | Sodium Zirconium Cyclosilicate | AstraZeneca Canada Inc | No | No | No | Yes | No | No | No | Yes |
Lynparza | 271885 | Olaparib | AstraZeneca Canada Inc | No | No | No | Yes | No | No | No | Yes |
Mezavant | 274590 | Mesalazine | Takeda Canada Inc | No | No | No | Yes | No | No | No | Yes |
Mezera | 275493 | Mesalazine | Avir Pharma Inc | No | Yes | No | Yes | No | No | No | Yes |
Mirapex | 276406 | Pramipexole Dihydrochloride Monohydrate | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | No | No | No | Yes |
Motrin Platinum Muscle & Body | 265379 | Methocarbamol, Ibuprofen | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
Mycobutin | 277546 | Rifabutin | Pfizer Canada ULC | Yes | Yes | No | No | Yes | No | No | Yes |
Nifedipine | 271662 | Nifedipine | AA Pharma Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Omnipaque 240, Omnipaque 300, Omnipaque 350 | 268527 | Iohexol | GE Healthcare Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Oxyneo | 274782 | Oxycodone Hcl | Purdue Pharma | No | Yes | No | Yes | No | Yes | No | Yes |
Ozurdex | 277147 | Dexamethasone | Abbvie Corporation | Yes | Yes | No | Yes | No | No | No | Yes |
Paxlovid | 277393 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | No |
Plaquenil | 277166 | Hydroxychloroquine Sulfate | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Reactine (10 mg), Reactine (Children's Syrup), Reactine Allergy, Reactine Allergy Liquid Gels, Reactine Fast Melt Junior, Reactine Rapid Dissolve, Reactine (5 mg) | 275437 | Cetirizine Hydrochloride | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | No | No | No | Yes | No | No | No | No |
Sandoz Perindopril Erbumine | 276661 | Perindopril Erbumine | Sandoz Canada Incorporated | Yes | Yes | No | Yes | Yes | No | No | Yes |
Scemblix | 276134 | Asciminib Hydrochloride | Novartis Pharmaceuticals Canada Inc | No | No | No | No | Yes | No | No | Yes |
Sulfamethoxazole and Trimethoprim for Injection, USP | 275808 | Trimethoprim, Sulfamethoxazole | Trimethoprim, Sulfamethoxazole | No | Yes | No | Yes | No | No | No | Yes |
T-Lo, Timolol Maleate-EX | 273147 | Timolol Maleate | Sandoz Canada Incorporated | No | No | No | No | No | No | No | Yes |
Tobi | 275742 | Tobramycin | BGP Pharma ULC | No | Yes | No | No | No | No | No | Yes |
Trusopt, Trusopt Preservative-Free | 274767 | Dorzolamide Hydrochloride | Elvium Life Sciences | No | No | No | Yes | No | Yes | No | Yes |
Verzenio | 270898 | Abemaciclib | Eli Lilly Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Viagra | 274068 | Sildenafil Citrate | BGP Pharma ULC | No | No | No | Yes | Yes | Yes | No | Yes |
Viibryd | 275222 | Vilazodone Hydrochloride | Abbvie Corporation | No | Yes | Yes | No | No | No | No | Yes |
Zaxine | 275623 | Rifaximin | Salix Pharmaceuticals Inc | No | Yes | No | Yes | No | No | No | Yes |
Zeposia | 269878 | Ozanimod Hydrochloride | Bristol-Myers Squibb Canada | No | Yes | No | No | No | Yes | No | Yes |
Zepzelca | 269295 | Lurbinectedin | Jazz Pharmaceuticals Ireland Limited | No | No | No | Yes | No | No | No | No |
Zyban | 276730 | Bupropion Hcl | Bausch Health, Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Zytram XL | 274793 | Tramadol Hcl | Purdue Pharma | No | Yes | No | Yes | Yes | Yes | No | Yes |
November 2023
Product Monograph Brand Safety Updates - November 2023
(PDF, 91 KB, 2 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Biltricide | 275643 | Praziquantel | Bayer Inc | No | Yes | Yes | No | Yes | Yes | No | Yes |
Brilinta | 276332 | Ticagrelor | AstraZeneca Canada Inc | No | Yes | No | No | No | Yes | No | Yes |
Cabenuva, Vocabria | 277655 | Rilpivirine, Cabotegravir, Cabotegravir Sodium | ViiV Healthcare ULC | No | No | No | Yes | No | Yes | No | Yes |
Carbolith | 275931 | Lithium Carbonate | Bausch Health, Canada Inc. | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Cerdelga | 275984 | Eliglustat Tartrate | Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc | No | No | No | Yes | No | No | No | Yes |
Clavulin | 276859 | Amoxicillin Trihydrate, Clavulanate Potassium | GlaxoSmithKline Inc | No | Yes | Yes | Yes | Yes | No | No | Yes |
Edarbi | 276197 | Azilsartan Medoxomil Potassium | Bausch Health, Canada Inc | No | Yes | No | Yes | No | No | No | No |
Edarbyclor | 276262 | Chlorthalidone, Azilsartan Medoxomil Potassium | Bausch Health, Canada Inc | No | Yes | No | Yes | No | No | No | No |
Esbriet | 276617 | Pirfenidone | Hoffmann-La Roche Limited | No | Yes | No | Yes | No | Yes | No | Yes |
Fycompa | 275884 | Perampanel | Eisai Limited | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Kalydeco | 273575 | Ivacaftor | Vertex Pharmaceuticals (Canada) Incorporated | No | Yes | No | Yes | No | Yes | No | Yes |
Ketorolac Tromethamine Injection USP | 276270 | Ketorolac Tromethamine | Sandoz Canada Incorporated | No | No | No | Yes | Yes | No | No | Yes |
Komboglyze | 277042 | Metformin Hydrochloride, Saxagliptin Hydrochloride | AstraZeneca Canada Inc | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Mounjaro | 276224 | Tirzepatide | Eli Lilly Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Nubeqa | 277149 | Darolutamide | Bayer Inc | No | Yes | No | Yes | No | No | No | Yes |
Omniscan | 274137 | Gadodiamide | GE Healthcare Canada Inc | No | Yes | No | No | No | No | No | Yes |
Oxy.IR | 274772 | Oxycodone Hcl | Purdue Pharma | No | Yes | No | Yes | No | Yes | No | Yes |
Piqray | 270700 | Alpelisib | Novartis Pharmaceuticals Canada Inc | No | No | No | No | Yes | No | No | No |
Propecia | 275154 | Finasteride | Organon Canada Inc. | No | Yes | No | Yes | No | No | No | Yes |
Rozlytrek | 271291 | Entrectinib | Hoffmann-La Roche Limited | No | No | No | No | No | Yes | No | Yes |
Sohonos | 268140 | Palovarotene | Ipsen Biopharmaceuticals Canada Inc | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Teva-Mexiletine | 272846 | Mexiletine Hcl | Teva Canada Limited | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Teva-Trimel, Teva-Trimel DS | 274420 | Trimethoprim, Sulfamethoxazole | Teva Canada Limited | Yes | Yes | Yes | Yes | Yes | No | No | Yes |
Vagifem 10 | 276051 | Estradiol | Novo Nordisk Canada Inc | No | No | No | Yes | No | No | No | Yes |
Veklury | 270659 | Remdesivir | Gilead Sciences Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Waymade-Trientine | 276415 | Trientine Hydrochloride | Waymade PLC | No | No | No | No | No | Yes | No | Yes |
Xigduo | 277286 | Dapagliflozin Propanediol Monohydrate, Metformin Hydrochloride | AstraZeneca Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Zestoretic | 274456 | Hydrochlorothiazide, Lisinopril | Searchlight Pharma Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Zestril | 268405 | Lisinopril | Searchlight Pharma Inc | Yes | Yes | No | No | Yes | No | No | Yes |
October 2023
Product Monograph Brand Safety Updates - October 2023
(PDF, 87 KB, 2 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
APO-Sulfatrim Oral Suspension | 274417 | Trimethoprim, Sulfamethoxazole | Apotex Inc | No | Yes | Yes | Yes | No | No | No | Yes |
Canesten Combi 1 Day Comforatab + Extra Strength External Cream | 271681 | Clotrimazole | Bayer Inc | No | No | No | No | No | Yes | No | Yes |
Effexor XR | 276199 | Venlafaxine Hcl | BGP Pharma ULC | No | Yes | Yes | No | Yes | Yes | Yes | Yes |
Envarsus PA | 275821 | Tacrolimus | Endo Ventures Ltd | No | Yes | No | Yes | No | No | No | Yes |
Exelon | 273941 | Rivastigmine Hydrogen Tartrate | Knight Therapeutics Inc | Yes | Yes | No | No | Yes | No | No | Yes |
Forxiga | 268982 | Dapagliflozin Propanediol Monohydrate | AstraZeneca Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Iclusig | 277221 | Ponatinib Hydrochloride | Takeda Pharmaceuticals U.S.A., Inc | No | No | Yes | No | No | Yes | No | Yes |
Isentress, Isentress HD | 276444 | Raltegravir Potassium | Merck Canada Inc | No | No | No | No | No | No | No | Yes |
Losec | 275360 | Omeprazole | Cheplapharm Arzneimittel GmbH | No | Yes | No | Yes | No | No | No | Yes |
Losec Mups | 275395 | Esomeprazole Magnesium | Cheplapharm Arzneimittel GmbH | No | Yes | No | Yes | No | No | No | Yes |
Lumakras | 269156 | Sotorasib | Amgen Canada Inc | No | No | No | No | Yes | Yes | No | Yes |
Lynparza | 270095 | Olaparib | AstraZeneca Canada Inc | No | No | No | No | No | No | No | Yes |
Movapo | 275253 | Apomorphine Hcl | Paladin Labs Inc | No | Yes | No | Yes | No | No | No | Yes |
Multihance | 272850 | Gadopentetate Dimeglumine | Bracco Imaging Canada | No | Yes | No | No | No | No | No | Yes |
Neurontin | 275525 | Gabapentin | BGP Pharma ULC | No | Yes | No | Yes | No | No | No | Yes |
Octasa | 275500 | Mesalazine | Tillotts Pharma AG | No | Yes | No | Yes | No | No | No | Yes |
Octasa | 275820 | Mesalazine | Tillotts Pharma AG | No | Yes | Yes | Yes | Yes | No | No | Yes |
Paxlovid | 274571 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Retevmo | 273779 | Selpercatinib | Loxo Oncology, Inc | No | Yes | Yes | Yes | No | Yes | No | Yes |
Rinvoq | 267554 | Upadacitinib | Abbvie Corporation | No | No | No | Yes | Yes | Yes | No | Yes |
Rinvoq | 275958 | Upadacitinib | Abbvie Corporation | No | Yes | No | No | No | Yes | No | Yes |
Sporanox | 275453 | Itraconazole | Janssen Inc | No | No | No | Yes | Yes | No | No | Yes |
Sporanox | 275526 | Itraconazole | Janssen Inc | No | No | No | Yes | Yes | No | No | Yes |
Targin | 273393 | Naloxone Hcl, Oxycodone Hcl | Purdue Pharma | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Teva-Gemfibrozil | 274886 | Gemfibrozil | Teva Canada Limited | Yes | Yes | No | No | Yes | Yes | No | Yes |
Tobi Podhaler | 275647 | Tobramycin | BGP Pharma ULC | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Toviaz | 274307 | Fesoterodine Fumarate | Pfizer Canada ULC | No | No | No | Yes | No | No | No | Yes |
Tpoxx | 269158 | Tecovirimat Monohydrate | SIGA Technologies, Inc | No | No | No | No | No | Yes | No | Yes |
Trikafta | 271750 | Elexacaftor, Ivacaftor, Tezacaftor | Vertex Pharmaceuticals (Canada) Incorporated | No | Yes | No | Yes | No | Yes | No | Yes |
Viacoram | 275866 | Amlodipine Besylate, Perindopril Arginine | Servier Canada Inc | No | No | No | No | No | No | Yes | Yes |
September 2023
Product Monograph Brand Safety Updates - September 2023
(PDF, 83 KB, 2 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Apo-Amoxi Sugar Free | 272483 | Amoxicillin | Apotex Inc | No | Yes | Yes | Yes | Yes | No | No | Yes |
Arnuity Ellipta | 274458 | Fluticasone Furoate | GlaxoSmithKline Inc | No | No | No | Yes | No | No | No | Yes |
Biphentin | 272109 | Methylphenidate Hcl | Elvium Life Sciences | Yes | No | No | Yes | Yes | Yes | No | Yes |
Cabometyx | 273691 | Cabozantinib Malate | Ipsen Biopharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Cipralex | 274368 | Escitalopram Oxalate | Lundbeck Canada Inc | Yes | Yes | Yes | No | No | Yes | No | Yes |
Cisplatin Injection BP | 275069 | Cisplatin | Pfizer Canada ULC | No | Yes | Yes | Yes | No | No | No | Yes |
Eligard | 269016 | Leuprolide Acetate | Tolmar International Ltd. | No | Yes | No | Yes | No | Yes | No | Yes |
Fludara | 268846 | Fludarabine Phosphate | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Givlaari | 275066 | Givosiran Sodium | Alnylam Netherlands B.V. | No | No | No | No | No | No | No | Yes |
Imovane | 275116 | Zopiclone | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | Yes | No | Yes |
Imuran | 273848 | Azathioprine, Azathioprine Sodium | Aspen Pharmacare Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Incruse Ellipta | 274613 | Umeclidinium Bromide | GlaxoSmithKline Inc | No | No | No | Yes | No | No | No | Yes |
Invega Sustenna | 272733 | Paliperidone Palmitate | Janssen Inc | No | No | No | No | No | Yes | No | Yes |
Invega Trinza | 272848 | Paliperidone Palmitate | Janssen Inc | No | No | No | No | No | Yes | No | Yes |
Leqvio | 273923 | Inclisiran Sodium | Novartis Pharmaceuticals Canada Inc | No | No | No | No | No | No | No | Yes |
Linessa 21, Linessa 28 | 273119 | Desogestrel, Ethinyl Estradiol | Aspen Pharmacare Canada Inc | Yes | Yes | No | No | Yes | No | No | Yes |
Lysodren | 275256 | Mitotane | HRA Pharma Rare Diseases | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Prevymis | 272553 | Letermovir | Merck Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Reyataz | 272597 | Atazanavir Sulfate | Bristol-Myers Squibb Canada | Yes | No | No | No | Yes | Yes | No | Yes |
Trelegy Ellipta | 274281 | Vilanterol Trifenatate, Fluticasone Furoate, Umeclidinium Bromide | GlaxoSmithKline Inc | No | No | No | Yes | No | No | No | Yes |
Ultibro Breezhaler | 273926 | Glycopyrronium Bromide, Indacaterol Maleate | Novartis Pharmaceuticals Canada Inc | No | No | No | No | No | No | No | Yes |
Veltassa | 266183 | Patiromer Sorbitex Calcium | Vifor Fresenius Medical Care Renal Pharma Ltd | No | No | No | No | Yes | Yes | No | Yes |
Ventolin Respirator Solution | 273936 | Salbutamol Sulfate | GlaxoSmithKline Inc | No | Yes | No | No | No | No | No | Yes |
August 2023
Product Monograph Brand Safety Updates - August 2023
(PDF, 115 KB, 3 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Abraxane for Injectable Suspension | 272786 | Paclitaxel | Celgene Inc | Yes | Yes | No | No | Yes | Yes | No | Yes |
Apo-Amoxicillin | 270923 | Amoxicillin | Apotex Inc | No | Yes | Yes | Yes | Yes | No | No | Yes |
Bryhali | 272985 | Halobetasol Propionate | Bausch Health, Canada Inc. | No | Yes | No | No | No | No | No | Yes |
Carboplatin Injection BP | 274117 | Carboplatin | Pfizer Canada ULC | No | Yes | No | No | No | No | No | No |
Clinoleic 20% | 273081 | Olive Oil, Soybean Oil | Baxter Corporation | Yes | Yes | No | No | No | No | No | Yes |
Concerta | 274279 | Methylphenidate Hcl | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Contrave | 273726 | Bupropion Hcl, Naltrexone Hydrochloride | Bausch Health, Canada Inc. | No | Yes | No | Yes | No | Yes | No | Yes |
Depo-Medrol | 273199 | Methylprednisolone Acetate | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Diamicron MR | 273026 | Gliclazide | Servier Canada Inc | No | No | No | No | No | No | No | Yes |
Dilaudid | 273917 | Hydromorphone Hcl | Purdue Pharma | No | Yes | No | No | Yes | Yes | No | Yes |
Erleada | 270698 | Apalutamide | Janssen Inc | No | No | No | No | No | Yes | No | Yes |
Estrogel | 272196 | Estradiol Hemihydrate | Organon Canada Inc. | No | Yes | No | No | Yes | Yes | No | Yes |
Eucrisa | 267872 | Crisaborole | Pfizer Canada ULC | No | No | No | Yes | No | Yes | No | Yes |
Euthyrox | 274121 | Levothyroxine Sodium | EMD Serono A Division of EMD Inc Canada | No | Yes | No | No | Yes | No | No | Yes |
Exelon Patch | 273433 | Rivastigmine | Knight Therapeutics Inc. | Yes | Yes | Yes | No | Yes | No | No | Yes |
Fetzima | 272055 | Levomilnacipran | Abbvie Corporation | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Fluconazole-150 | 272465 | Fluconazole | Sanis Health Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Foquest | 272098 | Methylphenidate Hcl | Elvium Life Sciences | No | No | No | Yes | No | No | No | Yes |
Fosamax | 273860 | Alendronate Sodium | Organon Canada Inc. | No | Yes | No | Yes | No | No | No | Yes |
Fosavance | 273858 | Alendronate Sodium Trihydrate, Vitamin D3 | Organon Canada Inc. | No | Yes | No | Yes | No | No | No | Yes |
Hydromorph Contin | 273931 | Hydromorphone Hcl | Purdue Pharma | No | Yes | No | No | Yes | Yes | No | Yes |
Imbruvica | 266710 | Ibrutinib | Janssen Inc | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Infants' Motrin, Children's Motrin, Children's Motrin Chewable Tablets, Junior Strength Motrin Chewable Tablets | 265393 | Ibuprofen | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Mounjaro | 273626 | Tirzepatide | Eli Lilly Canada Inc | No | No | No | No | No | Yes | No | Yes |
MS Contin | 273271 | Morphine Sulfate | Purdue Pharma | No | Yes | No | Yes | No | No | No | Yes |
Onivyde | 273110 | Irinotecan Sucrose Octasulfate | Servier Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Paxlovid | 267963 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Pediapred | 272958 | Prednisolone Sodium Phosphate | Sanofi-Aventis Canada Inc | No | No | No | Yes | No | No | No | Yes |
Perindopril Erbumine / Indapamide, Perindopril Erbumine / Indapamide HD | 272698 | Indapamide, Perindopril Erbumine | Sivem Pharmaceuticals ULC | Yes | Yes | No | Yes | Yes | No | No | Yes |
Proglycem | 271481 | Diazoxide | Merck Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Sandomigran DS | 272965 | Pizotifen Malate | Paladin Labs Inc | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Sustiva | 273530 | Efavirenz | Bristol-Myers Squibb Canada | No | Yes | No | No | Yes | No | No | Yes |
Synthroid | 275351 | Levothyroxine Sodium | BGP Pharma ULC | No | Yes | No | No | Yes | No | No | Yes |
Tepmetko | 270905 | Tepotinib Hydrochloride | EMD Serono A Division of EMD Inc Canada | No | No | No | No | Yes | No | No | Yes |
Vitrakvi | 274854 | Larotrectinib Sulfate | Bayer Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Xeljanz, Xeljanz XR |
272662 | Tofacitinib Citrate | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Zejula | 271862 | Niraparib | GlaxoSmithKline Inc | No | No | No | No | Yes | No | No | No |
July 2023
Product Monograph Brand Safety Updates – July 2023
(PDF, 93 KB, 3 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Adlyxine | 271345 | Lixisenatide | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Alertec | 272079 | Modafinil | Teva Canada Limited | No | Yes | No | Yes | Yes | Yes | No | Yes |
Butrans | 270953 | Buprenorphine | Purdue Pharma | Yes | Yes | No | No | No | Yes | No | Yes |
Cabenuva, Vocabria | 272178 | Rilpivirine, Cabotegravir, Cabotegravir Sodium | ViiV Healthcare ULC | No | Yes | No | Yes | No | No | No | Yes |
Celexa | 271454 | Citalopram Hydrobromide | Lundbeck Canada Inc | No | Yes | Yes | Yes | No | No | No | Yes |
Celsentri | 272471 | Maraviroc | ViiV Healthcare ULC | No | No | No | No | No | No | No | Yes |
Clindamycin IV Infusion | 272119 | Clindamycin Phosphate | Sandoz Canada Incorporated | No | Yes | No | Yes | No | Yes | No | Yes |
Crestor | 272238 | Rosuvastatin Calcium | AstraZeneca Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Crinone | 263969 | Progesterone | EMD Serono A Division of EMD Inc Canada | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Delstrigo | 266249 | Doravirine, Tenofovir Disoproxil Fumarate, Lamivudine | Merck Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Dotarem | 269429 | Gadoterate Meglumine | Guerbet | No | Yes | No | No | No | No | No | Yes |
Eltroxin | 273170 | Levothyroxine Sodium | Aspen Pharmacare Canada Inc. | No | Yes | No | No | Yes | No | No | Yes |
Esamuze | 273258 | Bendamustine Hydrochloride | Dr Reddys Laboratories Ltd | No | No | No | Yes | No | No | No | Yes |
Juluca | 272255 | Rilpivirine Hydrochloride, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Kyprolis | 267413 | Carfilzomib | Amgen Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Lenvima | 267356 | Lenvatinib Mesylate | Eisai Limited | No | Yes | No | Yes | No | No | No | Yes |
Lynparza | 265427 | Olaparib | AstraZeneca Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Mayzent | 272088 | Siponimod | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Medrol | 272859 | Methylprednisolone | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Mekinist | 270386 | Trametinib | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Olimel 4.4% E, Olimel 5.7% E, Olimel 7.6% E, Olimel 3.3% E, Periolimel 2.5% E | 273104 | Glutamic Acid, L-Proline, L-Glutamic Acid, L-Arginine, L-Aspartic Acid, Calcium Chloride Dihydrate, Alanine, L-Tyrosine, L-Leucine, Dextrose, L-Threonine, Glycine, Magnesium Chloride, Sodium Glycerophosphate, L-Lysine Acetate, Sodium Acetate Trihydrate, Tryptophan, Histidine, Serine, Potassium Chloride, L-Valine, Olive Oil, Methionine, Calcium Chloride, L-Phenylalanine, L-Isoleucine, Soybean Oil, Magnesium Chloride Hexahydrate | Baxter Corporation | Yes | Yes | No | No | No | No | No | Yes |
Olimel 4.4%, Olimel 5.7%, Olimel 7.6% | 273075 | L-Glutamic Acid, L-Proline, Glutamic Acid, L-Arginine, L-Aspartic Acid, L-Tyrosine, L-Leucine, Alanine, Dextrose, L-Threonine, Glycine, L-Histidine, L-Tryptophan, L-Lysine Acetate, Tryptophan, Lysine, Serine, L-Valine, Olive Oil, Histidine, L-Alanine, Methionine, L-Phenylalanine, L-Isoleucine, Soybean Oil | Baxter Corporation | Yes | Yes | No | No | No | No | No | Yes |
Pepcid Complete | 269619 | Famotidine, Magnesium Hydroxide, Calcium Carbonate | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Rinvoq | 257284 | Upadacitinib | Abbvie Corporation | No | No | No | Yes | Yes | Yes | No | Yes |
Scemblix | 267000 | Asciminib Hydrochloride | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Solu-Medrol | 272836 | Methylprednisolone Sodium Succinate | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Suprane | 272121 | Desflurane | Baxter Corporation | No | Yes | Yes | Yes | No | Yes | Yes | Yes |
Tafinlar | 270381 | Dabrafenib Mesylate | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Triumeq | 272330 | Abacavir Sulfate, Lamivudine, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Tygacil | 272000 | Tigecycline | Pfizer Canada ULC | No | No | Yes | No | No | No | No | Yes |
Vfend | 272725 | Voriconazole | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Voltaren Emulgel, Voltaren Emulgel Back & Muscle Pain, Voltaren Emulgel Joint Pain Regular Strength | 270680 | Diclofenac Diethylamine | GlaxoSmithKline Consumer Healthcare ULC | No | Yes | No | No | No | No | Yes | Yes |
Welireg | 270609 | Belzutifan | Merck Canada Inc | No | No | No | Yes | No | No | No | Yes |
Ziagen | 272514 | Abacavir Sulfate | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Zocor | 272761 | Simvastatin | Organon Canada Inc. | No | Yes | No | Yes | No | No | No | Yes |
June 2023
Product Monograph Brand Safety Updates - June 2023
(PDF, 92 KB, 3 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
AA-Levocarb CR | 271120 | Carbidopa, Levodopa | AA Pharma Inc | No | Yes | No | No | Yes | Yes | No | Yes |
Adalat XL | 270254 | Nifedipine | Bayer Inc | No | No | No | No | Yes | No | No | Yes |
Aubagio | 270681 | Teriflunomide | Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | No |
Bicnu | 269821 | Carmustine | Marcan Pharmaceuticals Inc | No | No | No | No | No | No | No | Yes |
Dayvigo | 266529 | Lemborexant | Eisai Limited | No | Yes | No | No | Yes | No | No | Yes |
Dianeal PD 101 CAPD Solution w 0.5% Dextrose, Dianeal PD 101 CAPD Solution w 1.5% Dextrose, Dianeal PD 101 CAPD Solution w 2.5% Dextrose, Dianeal PD 101 CAPD Solution w 4.25% Dextrose, Dianeal PD4 CAPD Solution with 1.5% Dextrose and 2.5meq/L Calcium, Dianeal PD4 CAPD Solution with 2.5% Dextrose and 2.5meq/L Calcium, Dianeal PD4 CAPD Solution with 4.25% Dextrose and 2.5meq/L Calcium | 271738 | Sodium Lactate, Dextrose, Sodium Chloride, Magnesium Chloride, Calcium Chloride | Baxter Corporation | No | Yes | No | No | No | No | No | Yes |
Docetaxel Injection USP | 272292 | Docetaxel | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Dovato | 272489 | Lamivudine, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Fentora | 271126 | Fentanyl Citrate | Teva Canada Limited | No | Yes | No | No | Yes | No | Yes | Yes |
Fiorinal | 270273 | Caffeine, Acetylsalicylic Acid, Butalbital | Aralez Pharmaceuticals Canada Inc | Yes | Yes | No | No | No | No | No | Yes |
Invokamet | 272538 | Canagliflozin, Metformin Hydrochloride | Janssen Inc | No | No | No | Yes | Yes | Yes | No | Yes |
Invokana | 272516 | Canagliflozin | Janssen Inc | No | No | No | No | Yes | No | No | Yes |
Jevtana | 272486 | Cabazitaxel, Acetone Solvate | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | No |
Luxa-D | 271535 | Vitamin D3 | Orimed Pharma Inc | No | No | No | No | No | Yes | No | Yes |
Mayzent | 266318 | Siponimod | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | Yes | No | No | No |
Metadol-D | 270632 | Methadone Hydrochloride | Paladin Labs Inc | No | Yes | No | Yes | Yes | Yes | Yes | No |
Metronidazole | 270506 | Metronidazole | AA Pharma Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Onpattro | 266240 | Patisiran Sodium | Alnylam Netherlands B.V. | No | Yes | No | No | No | Yes | No | Yes |
Pataday | 266071 | Olopatadine Hcl | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | Yes |
Paxlovid | 272114 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | Yes | No | No | Yes | Yes | No | No | Yes |
Pristiq | 260474 | Desvenlafaxine Succinate | Pfizer Canada ULC | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Retrovir (AZT) | 271660 | Zidovudine | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Salofalk | 269735 | Mesalazine | Abbvie Corporation | No | Yes | No | Yes | No | No | No | Yes |
Salofalk | 269753 | Mesalazine | Abbvie Corporation | No | Yes | No | Yes | No | No | No | Yes |
Salofalk | 269756 | Mesalazine | Abbvie Corporation | No | Yes | No | Yes | No | No | No | Yes |
Soliqua | 271298 | Lixisenatide, Insulin Glargine | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Somatuline Autogel | 272093 | Lanreotide Acetate | Ipsen Biopharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Statex | 271305 | Morphine Sulfate | Paladin Labs Inc | No | Yes | No | No | Yes | Yes | Yes | Yes |
Tabrecta | 266465 | Capmatinib Hydrochloride | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Tenormin | 270737 | Atenolol | Searchlight Pharma Inc | No | Yes | Yes | No | No | No | No | Yes |
Tivicay | 272507 | Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Topamax | 269755 | Topiramate | Janssen Inc | No | No | No | No | Yes | No | No | Yes |
Veklury | 266313 | Remdesivir | Gilead Sciences Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Xenical | 271974 | Orlistat | Cheplapharm Arzneimittel GmbH | Yes | No | No | Yes | Yes | No | No | Yes |
Zynrelef | 268374 | Bupivacaine, Meloxicam | Heron Therapeutics, Inc. | No | No | No | No | No | No | No | Yes |
May 2023
Product Monograph Brand Safety Updates - May 2023
(PDF, 80 KB, 3 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
3TC | 270742 | Lamivudine | ViiV Healthcare ULC | No | Yes | No | No | No | Yes | No | Yes |
Anafranil | 268209 | Clomipramine Hcl | Apotex Inc | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
Belkyra | 272776 | Deoxycholic Acid | Abbvie Corporation | No | Yes | No | Yes | No | No | No | Yes |
Bricanyl Turbuhaler | 270964 | Terbutaline Sulfate | AstraZeneca Canada Inc | No | Yes | No | No | No | Yes | No | Yes |
Brukinsa | 264963 | Zanubrutinib | Beigene Switzerland GmbH | No | Yes | No | Yes | Yes | Yes | No | Yes |
Combivir | 271609 | Lamivudine, Zidovudine | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Concerta | 272391 | Methylphenidate Hcl | Janssen Inc | No | Yes | No | Yes | No | No | No | Yes |
Diacetylmorphine Hydrochloride | 270525 | Diamorphine Hcl | Pharmascience Inc | No | No | No | No | No | Yes | No | No |
Elavil | 268308 | Amitriptyline Hcl | AA Pharma Inc | No | Yes | Yes | Yes | Yes | No | Yes | Yes |
Enalapril Maleate /Hctz | 270203 | Hydrochlorothiazide, Enalapril Maleate | AA Pharma Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Eraxis | 262044 | Anidulafungin | Pfizer Canada ULC | No | Yes | No | Yes | No | Yes | Yes | Yes |
Ibsrela | 268905 | Tenapanor | Knight Therapeutics Inc. | No | No | No | No | Yes | Yes | No | Yes |
Jakavi | 269250 | Ruxolitinib Phosphate | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | No | No | No | Yes |
Jardiance | 261909 | Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | No | No | No | Yes | No | Yes | No | No |
Kivexa | 271805 | Abacavir Sulfate, Lamivudine | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Marcaine E | 269757 | Epinephrine Bitartrate, Bupivacaine Hcl | Pfizer Canada ULC | No | Yes | Yes | Yes | No | No | No | Yes |
Marcaine, Marcaine Spinal | 269793 | Bupivacaine Hcl | Pfizer Canada ULC | No | Yes | Yes | Yes | No | No | No | Yes |
Mifegymiso | 270410 | Mifepristone, Misoprostol | Linepharma International Limited | No | No | No | No | Yes | Yes | No | No |
Novamoxin, Novamoxin (Sugar Reduced) | 268379 | Amoxicillin Trihydrate | Teva Canada Limited | No | Yes | Yes | Yes | Yes | No | No | Yes |
Oxaliplatin | 270750 | Oxaliplatin | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Oxlumo | 265088 | Lumasiran Sodium | Alnylam Netherlands B.V. | No | Yes | No | Yes | No | Yes | No | Yes |
Perseris | 253442 | Risperidone | HLS Therapeutics Inc | No | Yes | No | No | No | Yes | No | Yes |
Pifeltro | 264733 | Doravirine | Merck Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Rinvoq | 264612 | Upadacitinib | Abbvie Corporation | No | No | No | Yes | No | Yes | No | Yes |
Rukobia | 271766 | Fostemsavir Tromethamine | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Sandoz Perindopril Erbumine/ Indapamide, Sandoz Perindopril Erbumine/ Indapamide HD, Sandoz Perindopril Erbumine/ Indapamide LD | 270365 | Indapamide, Perindopril Erbumine | Sandoz Canada Incorporated | Yes | Yes | No | Yes | Yes | No | No | Yes |
Selexid | 270390 | Pivmecillinam Hcl | Knight Therapeutics Inc. | No | Yes | Yes | Yes | Yes | No | No | Yes |
Spinraza | 262687 | Nusinersen Sodium | Biogen Canada Inc | No | No | No | No | No | Yes | No | No |
Sporanox | 269455 | Itraconazole | Janssen Inc | Yes | No | No | No | Yes | No | No | Yes |
Sporanox | 269501 | Itraconazole | Janssen Inc | Yes | No | No | No | Yes | No | No | Yes |
Tecfidera | 259869 | Dimethyl Fumarate | Biogen Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Wakix | 270929 | Pitolisant Hydrochloride | Endo Ventures Ltd | Yes | Yes | No | Yes | No | Yes | No | Yes |
Xeljanz | 264582 | Tofacitinib Citrate | Pfizer Canada ULC | No | No | No | Yes | No | Yes | No | Yes |
Zoloft | 270222 | Sertraline Hcl | Upjohn Canada ULC | No | No | No | Yes | No | No | No | Yes |
April 2023
Product Monograph Brand Safety Updates - April 2023
(PDF, 112 KB, 2 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
AA-Clozapine | 269276 | Clozapine | AA Pharma Inc | No | Yes | Yes | No | No | Yes | No | Yes |
Balversa | 269952 | Erdafitinib | Janssen Inc | No | Yes | No | Yes | No | Yes | No | No |
Bicillin L-A | 268414 | Penicillin G Benzathine | Pfizer Canada ULC | No | Yes | Yes | No | No | Yes | No | Yes |
Biktarvy | 264207 | Emtricitabine, Tenofovir Alafenamide Hemifumarate, Bictegravir Sodium | Gilead Sciences Canada Inc | No | No | No | Yes | No | No | No | No |
Breztri Aerosphere | 257897 | Glycopyrronium Bromide, Formoterol Fumarate Dihydrate, Budesonide | AstraZeneca Canada Inc | No | No | No | No | No | Yes | No | Yes |
Brivlera | 269819 | Brivaracetam | UCB Canada Inc | No | Yes | No | No | No | No | No | Yes |
Entocort Enema | 268828 | Budesonide | Tillotts Pharma GmbH | No | Yes | No | Yes | No | No | No | Yes |
Fosrenol | 270959 | Lanthanum Carbonate Hydrate | Takeda Canada Inc | No | Yes | No | No | No | No | No | Yes |
Glyxambi | 269916 | Linagliptin, Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | No | No | No | No | Yes | No | No | Yes |
Mekinist | 270103 | Trametinib | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Motrin 200 mg, Motrin 300 mg, Motrin 400 mg | 265403 | Ibuprofen | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Nortriptyline | 269184 | Nortriptyline Hcl | Apotex Inc | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Orkambi | 264825 | Ivacaftor, Lumacaftor | Vertex Pharmaceuticals (Canada) Incorporated | No | Yes | No | Yes | Yes | Yes | No | Yes |
Slynd | 271309 | Drospirenone | Duchesnay Inc | No | Yes | No | Yes | No | No | No | No |
Tafinlar | 270100 | Dabrafenib Mesylate | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Tapazole | 270311 | Methimazole | Paladin Labs Inc | No | Yes | No | No | No | Yes | No | Yes |
Toradol | 267475 | Ketorolac Tromethamine | AA Pharma Inc | No | No | No | Yes | Yes | No | No | Yes |
Toradol IM | 267937 | Ketorolac Tromethamine | Atnahs Pharma UK Limited | No | No | No | Yes | Yes | No | No | Yes |
Voltaren Ophtha | 269518 | Diclofenac Sodium | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | No | No | No | Yes |
Vyvanse | 267643 | Lisdexamfetamine Dimesylate | Takeda Canada Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Xalkori | 270202 | Crizotinib | Pfizer Canada ULC | No | No | No | Yes | No | No | No | Yes |
Xarelto | 268349 | Rivaroxaban | Bayer Inc | No | No | No | Yes | No | Yes | No | Yes |
Xigduo | 269795 | Dapagliflozin Propanediol Monohydrate, Metformin Hydrochloride | AstraZeneca Canada Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Zinecard | 267046 | Dexrazoxane | Pfizer Canada ULC | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Zithromax | 270217 | Azithromycin Dihydrate | Pfizer Canada ULC | No | Yes | No | No | No | Yes | No | No |
March 2023
Product Monograph Brand Safety Updates - March 2023
(PDF, 112 KB, 2 pages)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
AA-Amilzide | 268237 | Hydrochlorothiazide, Amiloride Hcl | AA Pharma Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Adderall XR | 269618 | Mixed Salts Amphetamine | Takeda Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Albrioza | 268337 | Ursodoxicoltaurine, Sodium Phenylbutyrate | Amylyx Pharmaceuticals Inc | No | Yes | No | No | No | No | No | No |
Anoro Ellipta | 268656 | Vilanterol Trifenatate, Umeclidinium Bromide | GlaxoSmithKline Inc | Yes | No | No | Yes | Yes | No | No | Yes |
Atacand Plus | 268325 | Hydrochlorothiazide, Candesartan Cilexetil | AstraZeneca Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Cotellic | 265306 | Cobimetinib Fumarate | Hoffmann-La Roche Limited | No | Yes | No | Yes | No | No | No | Yes |
Dexilant | 266967 | Dexlansoprazole | Takeda Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Diovan | 267351 | Valsartan | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Diovan-HCT | 266715 | Hydrochlorothiazide, Valsartan | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Entocort | 268608 | Budesonide | Tillotts Pharma GmbH | No | Yes | No | Yes | No | No | No | Yes |
Erleada | 269676 | Apalutamide | Janssen Inc | No | Yes | No | No | No | No | No | Yes |
Ferriprox, Ferriprox MR | 261912 | Deferiprone | Chiesi Canada Corp | No | No | No | No | Yes | Yes | No | Yes |
Galafold | 262810 | Migalastat Hydrochloride | Amicus Therapeutics UK Ltd | No | Yes | No | Yes | No | Yes | No | Yes |
Imbruvica | 263702 | Ibrutinib | Janssen Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Istodax | 254316 | Romidepsin | Celgene Inc | No | No | Yes | No | No | No | No | Yes |
Jardiance | 268326 | Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | No | No | No | No | Yes | Yes | No | Yes |
Keppra | 268666 | Levetiracetam | UCB Canada Inc | No | Yes | No | Yes | No | No | No | No |
Naproxen Capsules 200 Mg | 268717 | Naproxen | Apotex Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Pantoloc | 266961 | Pantoprazole Sodium | Takeda Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Precedex | 269163 | Dexmedetomidine Hcl | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Prevacid, Prevacid Fastab | 267149 | Lansoprazole | Takeda Pharmaceuticals America Inc | No | Yes | No | Yes | No | No | No | Yes |
Prezcobix | 268359 | Darunavir Ethanolate, Cobicistat | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Prezista | 268362 | Darunavir Ethanolate | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Purinethol | 264179 | Mercaptopurine | Teva Canada Limited | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Retevmo | 266679 | Selpercatinib | Loxo Oncology Inc | No | No | No | Yes | Yes | No | No | Yes |
Rydapt | 270748 | Midostaurin | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | Yes |
Suboxone | 269182 | Naloxone Hcl, Naloxone Hydrochloride Dihydrate, Buprenorphine Hydrochloride | Indivior UK Limited | No | Yes | No | No | Yes | Yes | No | Yes |
Symtuza | 268406 | Emtricitabine, Darunavir Ethanolate, Cobicistat, Tenofovir Alafenamide Hemifumarate | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Synjardy | 268593 | Metformin Hydrochloride, Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | Yes | Yes | No | No | Yes | Yes | No | Yes |
Tagrisso | 263672 | Osimertinib Mesylate | AstraZeneca Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Tecta | 266960 | Pantoprazole Magnesium | Takeda Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Vitrakvi | 266965 | Larotrectinib Sulfate | Bayer Inc | No | Yes | No | No | No | No | No | Yes |
Vyxeos | 262151 | Daunorubicin, Cytarabine | Jazz Pharmaceuticals Ireland Limited | No | Yes | No | No | No | Yes | No | Yes |
Xtandi | 263476 | Enzalutamide | Astellas Pharma Canada Inc | No | No | No | No | Yes | No | No | No |
Non-Prescription Submissions Cleared in 2014
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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