Product monograph brand safety updates
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February 2023
Product Monograph Brand Safety Updates - February 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Agrylin | 267307 | Anagrelide Hydrochloride | Takeda Canada Inc | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Azopt | 266542 | Brinzolamide | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | No |
Brilinta | 267405 | Ticagrelor | AstraZeneca Canada Inc | No | Yes | No | No | No | No | No | No |
Depakene | 266468 | Valproic Acid | BGP Pharma ULC | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
Diflucan | 268015 | Fluconazole | Pfizer Canada ULC | No | No | No | No | Yes | No | No | Yes |
Diflucan One | 268032 | Fluconazole | Pfizer Canada ULC | No | No | No | No | Yes | No | No | Yes |
Effexor XR | 267926 | Venlafaxine Hydrochloride | Upjohn Canada ULC | No | No | No | No | No | No | No | Yes |
Ella | 268164 | Ulipristal Acetate | Laboratoire HRA Pharma | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Epival | 266467 | Divalproex Sodium | BGP Pharma ULC | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
Ferrlecit | 268223 | Sodium Ferric Gluconate Complex in Sucrose Injection | Sanofi-Aventis Canada Inc | No | No | No | No | No | No | Yes | Yes |
Fluphenazine | 268839 | Fluphenazine Hydrochloride | AA Pharma Inc | Yes | Yes | No | No | Yes | No | No | Yes |
Frova | 267525 | Frovatriptan Succinate | Endo Pharmaceuticals Inc | No | Yes | No | No | Yes | Yes | No | Yes |
Glumetza, Glumetza (SB) | 264310 | Metformin Hydrochloride | Bausch Health, Canada Inc | Yes | Yes | No | No | No | Yes | No | Yes |
Invokamet | 268206 | Canagliflozin, Metformin Hydrochloride | Janssen Inc | No | Yes | No | No | No | No | No | Yes |
Invokamet XR | 268719 | Canagliflozin, Metformin Hydrochloride | Janssen Inc | No | Yes | No | No | No | No | No | Yes |
Invokana | 268213 | Canagliflozin | Janssen Inc | No | Yes | No | No | No | No | No | Yes |
IPG-Cetirizine | 267528 | Cetirizine Hydrochloride | Marcan Pharmaceuticals Inc | No | Yes | No | No | Yes | Yes | No | Yes |
Kisqali | 262779 | Ribociclib Succinate | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | Yes | No | Yes |
Ledaga | 268101 | Chlormethine | Recordati Rare Diseases Canada Inc | No | Yes | No | No | No | No | No | Yes |
Lipitor | 267313 | Atorvastatin Calcium | Upjohn Canada ULC | No | No | No | No | No | No | No | Yes |
Lixiana | 257921 | Edoxaban Tosylate | Servier Canada Inc | No | Yes | No | No | Yes | Yes | No | Yes |
Mayzent | 267968 | Siponimod | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Metvix | 262828 | Methyl Aminolevulinate Hydrochloride | Galderma Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Mezavant | 266708 | Mesalazine | Takeda Canada Inc | No | Yes | No | No | No | No | No | No |
Neoral, Sandimmune I.V. | 268008 | Cyclosporine | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Neurontin | 267676 | Gabapentin | Upjohn Canada ULC | No | Yes | No | No | Yes | No | No | Yes |
Norvasc | 265428 | Amlodipine Besylate | Upjohn Canada ULC | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Sandoz Deferasirox | 268744 | Deferasirox | Sandoz Canada Incorporated | No | Yes | Yes | No | No | Yes | Yes | No |
Sandoz Deferasirox (Type J) |
268669 | Deferasirox | Sandoz Canada Incorporated | No | Yes | Yes | No | No | Yes | Yes | No |
Tiazac XC | 266470 | Diltiazem Hydrochloride | Bausch Health, Canada Inc | Yes | Yes | No | No | Yes | No | No | Yes |
Trisenox | 267796 | Arsenic Trioxide | Teva Canada Limited | No | Yes | No | No | No | No | No | Yes |
Urso, Urso DS | 268229 | Ursodiol | Aptalis Pharma Canada ULC | No | Yes | No | No | No | No | No | Yes |
Venofer | 263718 | Iron Sucrose | American Regent, Inc | No | Yes | No | Yes | No | No | No | Yes |
January 2023
Product Monograph Brand Safety Updates January - 2023
(PDF, 74 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-Atenidone | 265715 | Chlorthalidone, Atenolol | AA Pharma Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Altace HCT | 265837 | Hydrochlorothiazide, Ramipril | Bausch Health, Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Amoxicillin Sodium and Potassium Clavulanate for Injection | 261365 | Amoxicillin Sodium, Clavulanate Potassium | Sandoz Canada Incorporated | Yes | Yes | No | Yes | No | No | No | Yes |
Avalide | 265405 | Hydrochlorothiazide, Irbesartan | Sanofi-Aventis Canada Inc | No | No | No | Yes | Yes | No | No | Yes |
Butorphanol Nasal Spray | 266559 | Butorphanol Tartrate | AA Pharma Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Fluconazole-150 | 265946 | Fluconazole | Sanis Health Inc | No | No | No | Yes | Yes | No | Yes | Yes |
Nabumetone | 266570 | Nabumetone | Apotex Inc | Yes | Yes | No | No | Yes | Yes | No | Yes |
Nix Creme Rinse | 263926 | Permethrin | Insight Pharmaceuticals LLC | No | Yes | No | Yes | Yes | No | Yes | Yes |
Plaquenil | 268016 | Hydroxychloroquine Sulfate | Sanofi-Aventis Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Spravato | 267246 | Esketamine Hydrochloride | Janssen Inc | No | Yes | No | Yes | Yes | No | No | No |
Treanda | 268351 | Bendamustine Hydrochloride | Teva Canada Limited | No | No | No | Yes | No | No | No | Yes |
Trelegy Ellipta | 266712 | Vilanterol Trifenatate, Fluticasone Furoate, Umeclidinium Bromide | GlaxoSmithKline Inc | No | No | No | Yes | No | No | No | Yes |
Xalacom | 267276 | Timolol Maleate, Latanoprost | Upjohn Canada ULC | No | No | No | Yes | No | No | No | Yes |
Xalatan | 267268 | Latanoprost | Upjohn Canada ULC | No | No | No | Yes | No | No | No | Yes |
Zaroxolyn | 265721 | Metolazone | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Zolpidem Tartrate ODT | 264338 | Zolpidem Tartrate | Bausch Health, Canada Inc. | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
December 2022
Product Monograph Brand Safety Updates - December 2022
(PDF, 88 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Accupril | 266170 | Quinapril Hcl | Pfizer Canada ULC | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Accuretic | 265148 | Hydrochlorothiazide, Quinapril Hcl | Pfizer Canada ULC | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Advagraf | 263330 | Tacrolimus | Astellas Pharma Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Aldactone | 265344 | Spironolactone | Pfizer Canada ULC | No | Yes | No | Yes | Yes | Yes | No | Yes |
Apo-Fluconazole-150 | 265794 | Fluconazole | Apotex Inc | Yes | Yes | No | Yes | Yes | No | Yes | Yes |
Ativan | 267182 | Lorazepam | Pfizer Canada ULC | No | Yes | Yes | Yes | No | Yes | No | Yes |
Azarga | 266539 | Timolol Maleate, Brinzolamide | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Cabenuva, Vocabria | 258574 | Rilpivirine, Cabotegravir, Cabotegravir Sodium | ViiV Healthcare ULC | No | No | No | Yes | No | Yes | No | Yes |
Caverject Sterile Powder | 264876 | Alprostadil | Pfizer Canada ULC | No | Yes | No | No | No | Yes | No | Yes |
Evrysdi (Risdiplam) | 259796 | Risdiplam | Hoffmann-La Roche Limited | No | Yes | No | Yes | No | No | No | Yes |
Ferrlecit | 263714 | Sodium Ferric Gluconate Complex in Sucrose Injection | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Imodium Calming Liquid, Imodium Quick Dissolve, Imodium Liqui-Gels | 265788 | Loperamide Hcl | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Isovue Multipack-300, Isovue Multipack-370 | 264222 | Iopamidol | Bracco Imaging Canada | No | No | No | No | No | No | No | Yes |
Kisqali | 261467 | Ribociclib Succinate | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | No |
Kynmobi | 264434 | Apomorphine Hcl | Sunovion Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Leucovorin Calcium Injection USP | 267164 | Leucovorin Calcium | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Mifegymiso | 266828 | Mifepristone, Misoprostol | Linepharma International Limited | No | Yes | No | No | No | No | No | Yes |
Paxlovid | 266236 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | No | No | No | Yes | Yes | No | No | Yes |
Prograf | 263332 | Tacrolimus | Astellas Pharma Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Reddy-Clobetasol Shampoo | 266848 | Clobetasol Propionate | Dr Reddy's Laboratories Canada Inc | No | No | No | No | No | No | No | Yes |
Simbrinza | 266538 | Brimonidine Tartrate, Brinzolamide | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Somatuline Autogel | 266724 | Lanreotide Acetate | Ipsen Biopharmaceuticals Canada Inc | No | Yes | No | No | No | No | No | Yes |
Tiazac | 266363 | Diltiazem Hcl | Bausch Health, Canada Inc | Yes | Yes | No | No | Yes | No | No | Yes |
Timoptic-XE | 265527 | Timolol Maleate | Elvium Life Sciences | No | Yes | No | No | No | No | No | No |
Zepzelca | 265287 | Lurbinectedin | Jazz Pharmaceuticals Ireland Limited | No | Yes | No | Yes | No | Yes | No | Yes |
November 2022
Product Monograph Brand Safety Updates - November 2022
(PDF, 117 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Aerius, Aerius Kids |
263344 | Desloratadine | Bayer Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Arimidex | 263092 | Anastrozole | AstraZeneca Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Aromasin | 263093 | Exemestane | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Avapro | 265391 | Irbesartan | Sanofi-Aventis Canada Inc | No | No | No | Yes | No | No | No | Yes |
Claritin Allergy + Sinus, Claritin Allergy + Sinus Extra Strength |
265671 | Loratadine, Pseudoephedrine Sulfate | Bayer Inc | Yes | Yes | No | Yes | Yes | No | Yes | Yes |
Clavulin | 235606 | Amoxicillin Trihydrate, Clavulanate Potassium | GlaxoSmithKline Inc | No | Yes | No | Yes | No | No | No | Yes |
Clolar | 265390 | Clofarabine | Sanofi-Aventis Canada Inc | No | Yes | Yes | No | No | Yes | No | Yes |
Daurismo | 265952 | Glasdegib Maleate | Pfizer Canada ULC | No | Yes | No | No | No | Yes | No | No |
Docetaxel Injection USP | 265951 | Docetaxel | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Dovato | 259156 | Lamivudine, Dolutegravir Sodium | ViiV Healthcare ULC | No | No | No | Yes | No | No | No | Yes |
Doxorubicin | 265420 | Doxorubicin Hcl | Pfizer Canada ULC | No | Yes | No | No | No | No | No | No |
Erleada | 265021 | Apalutamide | Janssen Inc | No | Yes | No | No | No | No | No | Yes |
Flamazine | 261568 | Silver Sulfadiazine | Smith & Nephew Inc | Yes | Yes | Yes | Yes | No | Yes | No | Yes |
GD-Tranexamic Acid | 265002 | Tranexamic Acid | Genmed a Division of Pfizer Canada ULC | Yes | Yes | No | No | No | Yes | No | Yes |
Hyzaar, Hyzaar DS |
265018 | Hydrochlorothiazide, Losartan Potassium | Organon Canada Inc. | No | Yes | No | Yes | No | No | No | Yes |
Kisqali | 265992 | Ribociclib Succinate | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Lyrica | 256455 | Pregabalin | Upjohn Canada ULC | No | Yes | No | No | No | No | No | No |
Monoferric | 263715 | Ferric Derisomaltose | Pharmacosmos A/S | No | Yes | No | Yes | No | No | No | Yes |
PMS-Iron Sucrose | 263716 | Iron Sucrose | Pharmascience Inc | No | Yes | No | Yes | No | No | No | Yes |
Radicava | 261904 | Edaravone | Mitsubishi Tanabe Pharma Corporation | No | Yes | No | Yes | Yes | Yes | No | Yes |
Ravicti | 259175 | Glycerol Phenylbutyrate | Horizon Therapeutics Ireland DAC | Yes | Yes | No | Yes | No | Yes | No | Yes |
Sofracort | 264976 | Framycetin Sulfate, Dexamethasone Sodium Metasulphobenzoate, Gramicidin | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Vaseretic | 265020 | Hydrochlorothiazide, Enalapril Maleate | Organon Canada Inc. | No | Yes | No | Yes | No | Yes | No | Yes |
Vesanoid | 263752 | Tretinoin | Cheplapharm Arzneimittel Gmbh | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Vfend | 265608 | Voriconazole | Pfizer Canada ULC | No | Yes | No | No | Yes | No | No | Yes |
Vimovo | 263084 | Naproxen, Esomeprazole | Xediton Pharmaceuticals Inc | No | Yes | No | No | No | No | No | Yes |
Zyvoxam | 263413 | Linezolid | Pfizer Canada ULC | No | Yes | No | Yes | Yes | Yes | No | Yes |
October 2022
Product Monograph Brand Safety Updates - October 2022
(PDF, 103 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
ACT Citalopram | 261419 | Citalopram Hydrobromide | Sunovion Pharmaceuticals Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Adempas | 262975 | Riociguat | Bayer Inc | Yes | No | No | No | Yes | No | No | Yes |
Arava | 264125 | Leflunomide | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Clotrimazole Topical | 263851 | Clotrimazole | Taro Pharmaceuticals Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Coversyl | 264109 | Perindopril Erbumine | Servier Canada Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Coversyl Plus LD, Coversyl Plus, Coversyl Plus HD | 264225 | Indapamide, Perindopril Erbumine | Servier Canada Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Femara | 263091 | Letrozole | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Iclusig | 258641 | Ponatinib Hydrochloride | Takeda Pharmaceuticals U.S.A., Inc. | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Intelence | 264392 | Etravirine | Janssen Inc | No | No | No | No | No | Yes | No | Yes |
Ivozfo | 256308 | Fosfomycin Sodium | Verity Pharmaceuticals Inc | No | Yes | Yes | Yes | No | Yes | No | Yes |
Lasix Special | 264709 | Furosemide | Sanofi-Aventis Canada Inc | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Lederle Leucovorin | 263375 | Leucovorin Calcium | Pfizer Canada ULC | No | Yes | Yes | No | Yes | Yes | No | Yes |
Lokelma | 264260 | Sodium Zirconium Cyclosilicate | AstraZeneca Canada Inc | No | No | No | No | Yes | No | No | Yes |
Lunesta | 262661 | Eszopiclone | Sunovion Pharmaceuticals Canada Inc | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Micardis | 264047 | Telmisartan | Boehringer Ingelheim (Canada) Ltd Ltee | No | No | No | Yes | No | Yes | No | Yes |
Micardis Plus | 264042 | Hydrochlorothiazide, Telmisartan | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | No | Yes | No | Yes |
Nexplanon | 264491 | Etonogestrel | Organon Canada Inc. | No | Yes | No | Yes | Yes | Yes | No | Yes |
Ninlaro | 258196 | Ixazomib Citrate | Takeda Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Oxy.IR | 264865 | Oxycodone Hcl | Purdue Pharma | No | Yes | No | Yes | Yes | No | No | Yes |
Plavix | 264401 | Clopidogrel Bisulfate | Sanofi-Aventis Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Prezcobix | 264790 | Darunavir Ethanolate, Cobicistat | Janssen Inc | No | Yes | No | No | Yes | No | No | Yes |
Prezista | 264786 | Darunavir Ethanolate | Janssen Inc | No | Yes | No | No | Yes | No | No | Yes |
Seebri Breezhaler | 264064 | Glycopyrronium Bromide | Novartis Pharmaceuticals Canada Inc | No | No | No | No | No | No | No | Yes |
Sporanox | 263993 | Itraconazole | Janssen Inc | Yes | No | No | No | Yes | No | No | Yes |
Sporanox | 264069 | Itraconazole | Janssen Inc | Yes | No | No | No | Yes | No | No | Yes |
Symtuza | 264784 | Emtricitabine, Darunavir Ethanolate, Cobicistat, Tenofovir Alafenamide Hemifumarate | Janssen Inc | No | No | No | No | Yes | No | No | Yes |
Tagamet Prevent | 256549 | Cimetidine | GlaxoSmithKline Consumer Healthcare ULC | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Timoptic | 264123 | Timolol Maleate | Elvium Life Sciences | No | Yes | No | No | No | No | No | No |
Tivicay | 264438 | Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Twynsta | 264045 | Amlodipine Besylate, Telmisartan | Boehringer Ingelheim (Canada) Ltd Ltee | No | No | No | Yes | No | Yes | No | Yes |
Viacoram | 264090 | Amlodipine Besylate, Perindopril Arginine | Servier Canada Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Vyndaqel | 258993 | Tafamidis Meglumine | Pfizer Canada ULC | No | No | No | No | Yes | No | No | No |
Xyrem | 263466 | Sodium Oxybate | Jazz Pharmaceuticals Ireland Limited | No | Yes | No | No | No | Yes | Yes | Yes |
Zaditen | 261731 | Ketotifen Fumarate | Teva Canada Limited | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Zoloft | 265271 | Sertraline Hcl | Upjohn Canada ULC | No | Yes | Yes | No | Yes | No | No | Yes |
September 2022
Product Monograph Brand Safety Updates - September 2022
(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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Alkeran | 261646 | Buffer Solution, Melphalan | Aspen Pharmacare Canada Inc | No | No | No | No | No | Yes | No | Yes |
Apresoline | 263009 | Hydralazine Hcl | Sterimax Inc | No | Yes | Yes | Yes | Yes | No | No | Yes |
Aubagio | 261221 | Teriflunomide | Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Cabometyx | 264498 | Cabozantinib Malate | Ipsen Biopharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Definity | 263241 | Perflutren | Lantheus MI Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Depo-Provera | 262875 | Medroxyprogesterone Acetate | Pfizer Canada ULC | No | No | No | No | No | Yes | No | Yes |
Diarrhea Relief | 263048 | Loperamide Hcl | Vita Health Products Inc | No | No | No | No | No | No | Yes | Yes |
Diflunisal | 262252 | Diflunisal | AA Pharma Inc | Yes | Yes | Yes | No | No | Yes | No | Yes |
Digoxin Injection C.S.D. | 262879 | Digoxin | Sandoz Canada Incorporated | No | No | No | No | No | Yes | No | Yes |
Dovato | 263492 | Lamivudine, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Foquest | 257460 | Methylphenidate Hcl | Elvium Life Sciences | No | Yes | Yes | Yes | Yes | No | Yes | Yes |
Gd-Diclofenac/Misoprostol 50, Gd-Diclofenac/Misoprostol 75 |
261769 | Diclofenac Sodium, Misoprostol | Genmed A Division of Pfizer Canada ULC | Yes | Yes | Yes | No | No | No | No | Yes |
Gleevec | 264052 | Imatinib Mesylate | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | Yes |
Ibuprofen 200 mg, Ibuprofen 400 mg | 259462 | Ibuprofen | Jamp Pharma Corporation | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
Idarubicin | 265011 | Idarubicin Hcl | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Inrebic | 263696 | Fedratinib Hydrochloride | Celgene Inc | No | Yes | No | No | No | No | No | Yes |
Juluca | 263286 | Rilpivirine Hydrochloride, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Lasix Oral Solution | 261791 | Furosemide | Sanofi-Aventis Canada Inc | Yes | Yes | Yes | Yes | Yes | No | No | Yes |
Metronidazole Injection, USP | 263478 | Metronidazole | Baxter Corporation | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Minox | 263345 | Minoxidil | Laboratoire Riva Inc | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
Nasacort Allergy 24 Hr | 261449 | Triamcinolone Acetonide | Sanofi Consumer Health Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Nasacort AQ | 261994 | Triamcinolone Acetonide | Sanofi Consumer Health Inc | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
Nozinan | 262758 | Methotrimeprazine Hcl | Sanofi-Aventis Canada Inc | Yes | Yes | Yes | No | No | No | No | Yes |
Nubeqa | 262749 | Darolutamide | Bayer Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Ocaliva | 257222 | Obeticholic Acid | Intercept Pharmaceuticals Inc | No | No | No | Yes | No | No | No | No |
Opsumit | 263077 | Macitentan | Janssen Inc | No | Yes | No | No | No | No | No | Yes |
Opsynvi | 263058 | Macitentan, Tadalafil | Janssen Inc | No | Yes | No | No | No | No | No | Yes |
Paxil | 263621 | Paroxetine Hydrochloride Hemihydrate | GlaxoSmithKline Inc | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
Paxil CR | 263624 | Paroxetine Hydrochloride Hemihydrate | GlaxoSmithKline Inc | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
Rapamune | 262058 | Sirolimus | Pfizer Canada ULC | No | Yes | No | No | Yes | No | No | Yes |
Tamiflu | 255281 | Oseltamivir Phosphate | Hoffmann-La Roche Limited | No | Yes | No | No | No | Yes | No | Yes |
Teva-Rasagiline | 263230 | Rasagiline Mesylate | Teva Canada Limited | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Teveten Plus | 263867 | Hydrochlorothiazide, Eprosartan Mesylate | BGP Pharma ULC | No | Yes | No | Yes | No | No | No | Yes |
Trelstar | 263704 | Triptorelin Pamoate | Knight Therapeutics Inc | No | Yes | Yes | No | No | Yes | No | Yes |
Triumeq | 263863 | Abacavir Sulfate, Lamivudine, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | No | No | Yes |
Valtrex | 259374 | Valacyclovir Hydrochloride | GlaxoSmithKline Inc | No | Yes | No | Yes | No | No | No | Yes |
Vimpat | 263188 | Lacosamide | UCB Canada Inc | No | Yes | No | No | No | No | No | Yes |
August 2022
Product Monograph Brand Safety Updates August 2022
(PDF, 103 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Acet 120, Acet 160, Acet 325, Acet 650 |
259254 | Acetaminophen | Pendopharm Division of Pharmascience Inc | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Bystolic | 261660 | Nebivolol Hcl | Allergan Inc | No | Yes | No | No | No | Yes | No | Yes |
Cervidil | 263036 | Dinoprostone | Ferring Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Descovy | 261849 | Emtricitabine, Tenofovir Alafenamide Hemifumarate | Gilead Sciences Canada Inc | No | Yes | No | No | No | No | No | Yes |
Dom-Meloxicam | 261586 | Meloxicam | Dominion Pharmacal | Yes | Yes | Yes | No | No | No | No | Yes |
Epclusa | 256301 | Sofosbuvir, Velpatasvir | Gilead Sciences Canada Inc | No | No | No | Yes | Yes | No | No | No |
Exjade | 260689 | Deferasirox | Novartis Pharmaceuticals Canada Inc | No | Yes | Yes | Yes | No | Yes | Yes | Yes |
Fluconazole 150 | 261558 | Fluconazole | Apotex Inc | Yes | No | No | Yes | Yes | No | Yes | Yes |
Fluconazole 150, Clotrimaderm-Fluconazole Combi-Pack | 263240 | Fluconazole, Clotrimazole | Taro Pharmaceuticals Inc | Yes | No | No | Yes | Yes | No | No | Yes |
Folic Acid Injection, USP | 255875 | Folic Acid | Fresenius Kabi Canada Ltd | Yes | Yes | No | No | Yes | Yes | No | Yes |
Inhibace Plus | 262136 | Hydrochlorothiazide, Cilazapril Monohydrate | Cheplapharm Arzneimittel Gmbh | No | Yes | No | Yes | No | No | No | Yes |
Jadenu | 260690 | Deferasirox | Novartis Pharmaceuticals Canada Inc | No | Yes | Yes | Yes | No | Yes | Yes | Yes |
Jevtana | 257684 | Cabazitaxel | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Levofloxacin in 5% Dextrose Injection | 262499 | Levofloxacin | Pfizer Canada ULC | No | Yes | No | Yes | Yes | No | No | Yes |
Lidocaine Hydrochloride Injection USP | 254627 | Lidocaine Hcl | Pfizer Canada ULC | No | No | No | Yes | Yes | Yes | No | Yes |
Lynparza | 263013 | Olaparib | Astrazeneca Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Mayzent | 261460 | Siponimod | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | No | No | No | Yes |
Ocaliva | 256228 | Obeticholic Acid | Intercept Pharmaceuticals Inc | Yes | Yes | Yes | No | No | Yes | No | Yes |
Pariet | 261225 | Rabeprazole Sodium | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Pediapred | 263497 | Prednisolone Sodium Phosphate | Sanofi-Aventis Canada Inc | No | No | No | Yes | No | No | No | Yes |
Prezcobix | 262563 | Darunavir Ethanolate, Cobicistat | Janssen Inc | Yes | No | No | No | Yes | No | No | Yes |
Prezista | 262568 | Darunavir Ethanolate | Janssen Inc | No | No | No | No | Yes | No | No | Yes |
Reactine Allergy Liquid Gels, Reactine Rapid Dissolve, Reactine Fast Melt Junior, Reactine (Children's Syrup), Reactine Allergy, Reactine (5 mg), Reactine (10 mg) |
257441 | Cetirizine Hydrochloride | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | No | Yes | No | No | No | Yes | No | Yes |
Revlimid | 261854 | Lenalidomide | Celgene Inc | No | Yes | No | No | No | No | No | Yes |
Rinvoq | 262176 | Upadacitinib | Abbvie Corporation | No | Yes | Yes | Yes | Yes | No | No | Yes |
Som-Pam | 250756 | Flurazepam Hcl | Biomed Pharma | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Symtuza | 262573 | Emtricitabine, Darunavir Ethanolate, Cobicistat, Tenofovir Alafenamide Hemifumarate | Janssen Inc | Yes | No | No | No | Yes | No | No | Yes |
Temodal | 256104 | Temozolomide | Merck Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Teva-Piroxicam | 259318 | Piroxicam | Teva Canada Limited | No | Yes | Yes | No | Yes | No | No | Yes |
Teva-Sulindac | 261999 | Sulindac | Teva Canada Limited | Yes | Yes | Yes | No | No | No | No | Yes |
Teva-Tiaprofenic Acid | 261587 | Tiaprofenic Acid | Teva Canada Limited | Yes | Yes | Yes | No | No | No | No | Yes |
Vyndamax | 256231 | Tafamidis | Pfizer Canada ULC | No | No | No | No | Yes | No | No | No |
Waymade-Naproxen | 261366 | Naproxen | Waymade Plc | Yes | Yes | Yes | No | No | No | No | Yes |
July 2022
Product Monograph Brand Safety Updates July 2022
(PDF, 103 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Actonel, Actonel DR |
261847 | Risedronate Sodium Hemi-Pentahydrate | Allergan Inc | No | No | No | No | No | Yes | No | Yes |
Alphagan | 260046 | Brimonidine Tartrate | Allergan Inc | No | No | No | No | No | No | No | Yes |
Alunbrig | 257113 | Brigatinib | Takeda Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Clotrimaderm Topical, Clotrimaderm Topical Solution 1% USP | 252209 | Clotrimazole | Taro Pharmaceuticals Inc | No | No | No | Yes | No | No | No | Yes |
Coated Daily Low Dose ASA 81 Mg | 260524 | Acetylsalicylic Acid | Apotex Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Constella | 261787 | Linaclotide | Allergan Inc | No | Yes | No | No | No | No | No | Yes |
Cozaar | 260621 | Losartan Potassium | Organon Canada Inc | No | No | No | No | Yes | No | No | Yes |
Depakene | 261210 | Sodium Valproate | BGP Pharma ULC | No | Yes | Yes | No | Yes | Yes | No | Yes |
Diflucan | 260081 | Fluconazole | Pfizer Canada ULC | No | Yes | No | No | Yes | No | No | Yes |
Diflucan One | 260080 | Fluconazole | Pfizer Canada ULC | Yes | Yes | No | Yes | Yes | No | No | Yes |
Epival | 261209 | Divalproex Sodium | BGP Pharma ULC | No | Yes | Yes | No | Yes | Yes | No | Yes |
Hyzaar, Hyzaar DS |
260625 | Hydrochlorothiazide, Losartan Potassium | Organon Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Kuvan | 259723 | Sapropterin Dihydrochloride | Biomarin International Limited | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Lynparza | 259417 | Olaparib | AstraZeneca Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Marvelon 21, Marvelon 28 | 261227 | Desogestrel, Ethinyl Estradiol | Organon Canada Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Mekinist | 256554 | Trametinib | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | No |
MS Contin | 259272 | Morphine Sulfate | Purdue Pharma | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Nuvaring | 261329 | Ethinyl Estradiol, Etonogestrel | Organon Canada Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Ondansetron ODT | 260453 | Ondansetron | Sandoz Canada Incorporated | No | Yes | No | No | Yes | Yes | No | Yes |
Oxyneo | 259720 | Oxycodone Hcl | Purdue Pharma | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Plaquenil | 262105 | Hydroxychloroquine Sulfate | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
PMS-Diclofenac | 261768 | Diclofenac Sodium | Pharmascience Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Resonium Calcium | 261557 | Calcium Polystyrene Sulphonate | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Rinvoq | 247702 | Upadacitinib | Abbvie Corporation | No | Yes | No | Yes | No | Yes | No | Yes |
Sandoz Everolimus | 261603 | Everolimus | Sandoz Canada Incorporated | No | No | No | Yes | No | No | No | Yes |
Sublocade | 254890 | Buprenorphine | Indivior UK Limited | No | Yes | Yes | No | Yes | No | No | Yes |
Tafinlar | 256550 | Dabrafenib Mesylate | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | No |
Torisel | 262250 | Temsirolimus | Pfizer Canada ULC | No | Yes | No | No | Yes | Yes | No | Yes |
Wellbutrin SR | 261888 | Bupropion Hcl | Bausch Health, Canada Inc | No | No | No | Yes | No | No | No | Yes |
Wellbutrin XL | 261533 | Bupropion Hcl | Bausch Health, Canada Inc | No | No | No | Yes | No | No | No | Yes |
Zyban | 261453 | Bupropion Hcl | Bausch Health, Canada Inc | No | No | No | Yes | No | No | No | Yes |
June 2022
Product Monograph Brand Safety Updates June 2022
(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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Alphagan P | 260127 | Brimonidine Tartrate | Allergan Inc | No | No | No | No | No | No | No | Yes |
Atarax Syrup 2 mg/mL |
256970 | Hydroxyzine Hcl | ERFA Canada 2012 Inc | No | Yes | No | No | No | No | No | Yes |
Belkyra | 261056 | Deoxycholic Acid | Allergan Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Brevicon 1/35 Tablets (21-Day Pack), Brevicon 1/35 Tablets (28-Day Pack), Brevicon 0.5/35 Tablets (21-Day Pack), Brevicon 0.5/35 Tablets (28-Day Pack) |
258595 | Ethinyl Estradiol, Norethindrone | Pfizer Canada ULC | Yes | Yes | No | No | Yes | Yes | No | No |
Cabenuva, Vocabria | 254233 | Rilpivirine, Cabotegravir, Cabotegravir Sodium | ViiV Healthcare ULC | No | No | No | Yes | No | Yes | No | Yes |
Cardizem CD | 257201 | Diltiazem Hcl | Bausch Health, Canada Inc | Yes | No | No | No | Yes | No | No | Yes |
Cleviprex | 258197 | Clevidipine | Chiesi Farmaceutici S.P.A. | Yes | Yes | No | Yes | No | Yes | No | Yes |
Crestor | 260266 | Rosuvastatin Sodum | AstraZeneca Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Elavil | 259735 | Amitriptyline Hcl | AA Pharma Inc | No | Yes | No | No | No | No | No | Yes |
Hydrea | 259751 | Hydroxyurea | Bristol-Myers Squibb Canada | No | Yes | No | No | No | No | No | Yes |
Imbruvica | 261088 | Ibrutinib | Janssen Inc | No | Yes | Yes | No | No | Yes | No | Yes |
Invanz | 260091 | Ertapenem Sodium | Merck Canada Inc | No | No | No | Yes | No | No | No | Yes |
Isentress, Isentress HD | 260201 | Raltegravir Potassium | Merck Canada Inc | No | Yes | No | No | No | No | No | No |
Lithane | 261536 | Lithium Carbonate | ERFA Canada 2012 Inc | Yes | Yes | Yes | Yes | Yes | No | No | Yes |
Loratadine Soft Gelatin Capsules | 260270 | Loratadine | Catalent Ontario Limited | No | Yes | No | Yes | No | Yes | No | Yes |
Mifegymiso | 260648 | Mifepristone, Misoprostol | Linepharma International Limited | No | Yes | Yes | Yes | No | No | No | Yes |
Noritate | 260705 | Metronidazole | Bausch Health, Canada Inc | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Olumiant | 260967 | Baricitinib | Eli Lilly Canada Inc | No | Yes | Yes | No | No | Yes | No | Yes |
Paxlovid | 263843 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | No | No | Yes | No | No | Yes | No | No |
PDP-Amantadine Hydrochloride Capsules, PDP-Amantadine Hydrochloride Syrup | 261229 | Amantadine Hcl | Pendopharm Division of Pharmascience Inc | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Piqray | 261556 | Alpelisib | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | Yes | Yes | No | Yes |
Plaquenil | 256476 | Hydroxychloroquine Sulfate | Sanofi-Aventis Canada Inc | No | No | No | Yes | Yes | No | No | Yes |
Ritalin, Ritalin SR |
260742 | Methylphenidate Hcl | Novartis Pharmaceuticals Canada Inc | No | Yes | Yes | No | Yes | Yes | No | Yes |
Rydapt | 253178 | Midostaurin | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | Yes | Yes | No | Yes |
Sandoz Pazopanib | 261636 | Pazopanib Hydrochloride | Sandoz Canada Incorporated | No | Yes | No | Yes | No | No | No | Yes |
Spravato | 259588 | Esketamine Hydrochloride | Janssen Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Topamax | 260954 | Topiramate | Janssen Inc | No | Yes | No | Yes | No | No | No | Yes |
Topicort | 260348 | Desoximetasone | Bausch Health, Canada Inc | Yes | Yes | No | Yes | No | Yes | Yes | Yes |
Tramacet | 260176 | Tramadol Hcl, Acetaminophen | Janssen Inc | No | No | No | No | Yes | No | No | Yes |
Vidaza | 260852 | Azacitidine | Celgene Inc | No | Yes | Yes | Yes | No | Yes | No | Yes |
Voltaren, Voltaren SR | 260554 | Diclofenac Sodium | Novartis Pharmaceuticals Canada Inc | No | No | No | No | No | No | No | Yes |
Zejula | 260789 | Niraparib | GlaxoSmithKline Inc | No | Yes | No | Yes | No | No | No | Yes |
Zepzelca | 259506 | Lurbinectedin | Jazz Pharmaceuticals Ireland Limited | No | Yes | Yes | Yes | No | Yes | No | Yes |
May 2022
Product Monograph Brand Safety Updates May 2022
(PDF, 109 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Adriamycin PFS | 259714 | Doxorubicin Hcl | Pfizer Canada ULC | No | Yes | Yes | No | No | No | No | Yes |
Alecensaro | 260345 | Alectinib Hydrochloride | Hoffmann-La Roche Limited | No | Yes | No | No | No | Yes | No | No |
Apo-Verap | 258995 | Verapamil Hcl | Apotex Inc | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Celestone Soluspan | 259866 | Betamethasone Acetate, Betamethasone Sodium Phosphate | Organon Canada Inc. | Yes | Yes | No | Yes | No | No | No | Yes |
Clobex Shampoo, Clobex Spray | 259690 | Clobetasol Propionate | Galderma Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Clozaril | 259257 | Clozapine | HLS Therapeutics Inc | No | Yes | No | No | No | Yes | No | No |
Concerta | 257940 | Methylphenidate Hcl | Janssen Inc | No | Yes | No | Yes | Yes | No | Yes | Yes |
Depo-Medrol With Lidocaine | 259603 | Methylprednisolone Acetate, Lidocaine Hcl | Pfizer Canada ULC | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Dermatop Ointment, Dermatop Emollient Cream | 259325 | Prednicarbate | Bausch Health, Canada Inc. | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Dymista | 254371 | Azelastine Hydrochloride, Fluticasone Propionate | BGP Pharma ULC | No | No | No | No | No | No | No | Yes |
Enstilar | 259599 | Betamethasone Dipropionate, Calcipotriol Monohydrate | Leo Pharma Inc | No | No | No | Yes | No | No | No | No |
Flagyl | 259355 | Metronidazole | Sanofi-Aventis Canada Inc | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Flagystatin | 259350 | Metronidazole, Nystatin | Sanofi-Aventis Canada Inc | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Fluphenazine | 257193 | Fluphenazine Hcl | Aa Pharma Inc | Yes | Yes | Yes | No | Yes | Yes | No | No |
Gleevec | 259395 | Imatinib Mesylate | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Hydroxyzine | 256974 | Hydroxyzine Hcl | AA Pharma Inc | No | Yes | No | No | No | Yes | No | No |
Hydroxyzine Hydrochloride Injection USP | 256978 | Hydroxyzine Hcl | Sandoz Canada Incorporated | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Imodium Complete | 259265 | Loperamide Hcl, Simethicone | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | Yes | Yes | No | No | No | Yes | Yes | Yes |
Jakavi | 250022 | Ruxolitinib Phosphate | Novartis Pharmaceuticals Canada Inc | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Jorveza | 259435 | Budesonide | Avir Pharma Inc | No | No | No | Yes | No | No | No | Yes |
Ketoprofen, Ketoprofen-E, Ketoprofen SR | 258038 | Ketoprofen | AA Pharma Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Lenvima | 253057 | Lenvatinib Mesylate | Eisai Limited | No | Yes | No | Yes | Yes | Yes | No | Yes |
Lorbrena | 255326 | Lorlatinib | Pfizer Canada ULC | No | No | No | No | No | No | No | Yes |
Losec | 255605 | Omeprazole | Cheplapharm Arzneimittel Gmbh | No | No | No | Yes | No | No | No | Yes |
257614 | Esomeprazole Magnesium | Cheplapharm Arzneimittel Gmbh | No | No | No | Yes | No | No | No | Yes | |
Losec Mups | 255606 | Omeprazole Magnesium | Cheplapharm Arzneimittel Gmbh | No | No | No | Yes | No | No | No | Yes |
Mylan-Divalproex | 258987 | Valproic Acid | Mylan Pharmaceuticals ULC | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Nabumetone | 259319 | Nabumetone | Apotex Inc | Yes | Yes | No | No | Yes | Yes | No | Yes |
Nyda | 255325 | Dimethicone | G. Pohl-Boskamp Gmbh & Co Kg | No | Yes | No | No | No | Yes | Yes | Yes |
Oxpam | 248567 | Oxazepam | Biomed Pharma | No | Yes | Yes | No | Yes | Yes | No | Yes |
Paxlovid | 261884 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
PMS-Metoclopramide Tablets, PMS-Metoclopramide Oral Solution | 259250 | Metoclopramide Hcl | Pharmascience Inc | Yes | Yes | No | Yes | No | Yes | No | Yes |
Prohance | 252254 | Gadoteridol | Bracco Imaging Canada | No | Yes | No | Yes | No | Yes | No | Yes |
Qinlock | 252308 | Ripretinib | Deciphera Pharmaceuticals. LLC | No | No | No | No | No | Yes | No | Yes |
Septra Pediatric Suspension, Septra Injection | 259323 | Trimethoprim, Sulfamethoxazole | Aspen Pharmacare Canada Inc. | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Tibella | 259517 | Tibolone | Biosyent Pharma Inc | Yes | No | No | No | No | Yes | No | No |
Trispan | 259511 | Triamcinolone Hexacetonide | Medexus Inc | No | No | Yes | No | No | No | No | Yes |
Xeljanz, Xeljanz XR | 258173 | Tofacitinib Citrate | Pfizer Canada ULC | No | Yes | No | Yes | No | Yes | No | Yes |
Zocor | 259109 | Simvastatin | Organon Canada Inc. | No | Yes | No | Yes | Yes | No | No | Yes |
April 2022
Product Monograph Brand Safety Updates April 2022
(PDF, 88.2 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Bijuva | 257920 | Estradiol Hemihydrate, Progesterone | Knight Therapeutics Inc | No | No | No | Yes | No | No | No | Yes |
Braftovi | 258894 | Encorafenib | Pfizer Canada ULC | No | No | No | No | Yes | No | No | No |
Cabometyx | 257143 | Cabozantinib Malate | Ipsen Biopharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Caprelsa | 258988 | Vandetanib | Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Carboplatin Injection BP | 257501 | Carboplatin | Pfizer Canada ULC | No | Yes | No | Yes | No | Yes | No | Yes |
Cresemba | 256812 | Isavuconazonium Sulfate | Avir Pharma Inc | No | Yes | No | Yes | No | No | No | Yes |
Dilantin Infatabs, Dilantin-30 Suspension, Dilantin-125 Suspension | 256638 | Phenytoin | Upjohn Canada ULC | No | No | No | Yes | Yes | No | No | Yes |
Emla Cream, Emla Patch | 258891 | Lidocaine, Prilocaine | Aspen Pharmacare Canada Inc | No | Yes | No | No | No | No | Yes | Yes |
Enstilar | 251305 | Betamethasone Dipropionate, Calcipotriol Monohydrate | Leo Pharma Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Gleevec | 257566 | Imatinib Mesylate | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | Yes |
Imovane | 258560 | Zopiclone | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Imuran | 258189 | Azathioprine, Azathioprine Sodium | Aspen Pharmacare Canada Inc | No | No | No | Yes | No | No | No | Yes |
Jardiance | 256491 | Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | No | Yes | No | Yes |
Ketorolac Tromethamine Injection USP | 256941 | Ketorolac Tromethamine | Sandoz Canada Incorporated | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Maviret | 252251 | Glecaprevir, Pibrentasvir | Abbvie Corporation | No | No | No | Yes | No | No | No | No |
Micardis Plus | 258676 | Hydrochlorothiazide, Telmisartan | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | Yes | No | No | Yes |
Pantoloc | 255072 | Pantoprazole Sodium, Pantoprazole Sodium Sesquihydrate | Takeda Canada Inc | No | No | No | Yes | No | No | No | No |
Pediapred | 259452 | Prednisolone Sodium Phosphate | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Precedex | 257757 | Dexmedetomidine Hcl | Pfizer Canada ULC | No | No | No | No | No | Yes | No | No |
Retevmo | 257824 | Selpercatinib | Loxo Oncology Inc | No | Yes | No | No | No | No | No | No |
Sensorcaine, Sensorcaine with Epinephrine | 254303 | Bupivacaine Hcl | Aspen Pharmacare Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Spiriva | 258194 | Tiotropium Bromide Monohydrate | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | No | Yes | Yes | No | Yes |
Tecta | 257213 | Pantoprazole Magnesium | Takeda Canada Inc | No | No | No | Yes | No | No | No | No |
Toradol | 256959 | Ketorolac Tromethamine | AA Pharma Inc | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Toradol IM | 256960 | Ketorolac Tromethamine | Atnahs Pharma UK Limited | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Trikafta | 255136 | Elexacaftor, Ivacaftor, Tezacaftor | Vertex Pharmaceuticals (Canada) Incorporated | No | No | No | Yes | No | Yes | No | Yes |
Uptravi | 258347 | Selexipag | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Vascepa | 252460 | Icosapent Ethyl | HLS Therapeutics Inc | Yes | Yes | No | No | No | Yes | Yes | Yes |
Vimovo | 258409 | Naproxen, Esomeprazole | AstraZeneca Canada Inc | No | Yes | Yes | No | No | No | No | No |
Zeposia | 248992 | Ozanimod | Celgene Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
March 2022
Product Monograph Brand Safety Updates March 2022
(PDF, 95 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Bydureon BCise | 257624 | Exenatide | AstraZeneca Canada Inc | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Celebrex | 255827 | Celecoxib | Upjohn Canada ULC | Yes | Yes | Yes | No | Yes | No | No | Yes |
Combivir | 251298 | Lamivudine, Zidovudine | ViiV Healthcare ULC | No | Yes | No | No | No | Yes | Yes | Yes |
Contrave | 257357 | Bupropion Hcl, Naltrexone Hydrochloride | Bausch Health, Canada Inc. | No | Yes | Yes | Yes | No | No | No | Yes |
Desmopressin Spray | 258711 | Desmopressin Acetate | AA Pharma Inc | No | No | No | No | No | Yes | No | No |
Dilantin | 256632 | Phenytoin Sodium | Upjohn Canada ULC | No | No | No | Yes | Yes | No | No | Yes |
Duratocin | 257210 | Carbetocin | Ferring Inc | No | Yes | No | Yes | No | No | No | No |
Durela | 255293 | Tramadol Hcl | Cipher Pharmaceuticals Inc | No | Yes | No | Yes | No | No | Yes | Yes |
Effexor XR | 257418 | Venlafaxine Hcl | Upjohn Canada ULC | No | Yes | No | Yes | Yes | Yes | No | Yes |
Flurbiprofen | 257529 | Flurbiprofen | AA Pharma Inc | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
Flutamide | 257084 | Flutamide | AA Pharma Inc | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Fosrenol | 257792 | Lanthanum Carbonate Hydrate | Takeda Canada Inc | Yes | Yes | No | Yes | Yes | No | No | Yes |
Idamycin PFS | 258501 | Idarubicin Hcl | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Imovane | 254991 | Zopiclone | Sanofi-Aventis Canada Inc | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Inqovi | 258177 | Cedazuridine, Decitabine | Otsuka Pharmaceutical Co Ltd | No | Yes | No | Yes | No | Yes | No | Yes |
Jakavi | 252403 | Ruxolitinib Phosphate | Novartis Pharmaceuticals Canada Inc | No | No | No | No | No | Yes | No | No |
Juxtapid | 256310 | Lomitapide Mesylate | Aegerion Pharmaceuticals Canada Ltd | No | Yes | No | No | No | No | No | Yes |
Kalydeco | 255781 | Ivacaftor | Vertex Pharmaceuticals (Canada) Incorporated | No | Yes | No | No | No | Yes | No | Yes |
Kazano | 255701 | Metformin Hydrochloride, Alogliptin Benzoate | Takeda Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Kinevac | 256771 | Sincalide | Bracco Imaging Canada | No | Yes | No | No | Yes | No | No | No |
Levulan Kerastick | 257204 | Aminolevulinic Acid Hydrochloride | Dusa Pharmaceuticals Inc | No | Yes | No | Yes | No | No | No | Yes |
Nasonex | 256864 | Mometasone Furoate Monohydrate | Organon Canada Inc. | No | No | No | No | No | Yes | No | Yes |
Pentasa | 251582 | Mesalazine | Ferring Inc | No | Yes | No | Yes | No | No | No | Yes |
PMS-Fluoxetine | 256862 | Fluoxetine Hcl | Pharmascience Inc | No | Yes | No | No | No | Yes | No | Yes |
Ralivia | 256175 | Tramadol Hcl | Bausch Health, Canada Inc. | No | Yes | No | Yes | Yes | Yes | No | Yes |
Sublinox | 254996 | Zolpidem Tartrate | Bausch Health, Canada Inc. | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Tagrisso | 257918 | Osimertinib Mesylate | AstraZeneca Canada Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Tegsedi | 256844 | Inotersen Sodium | Akcea Therapeutics Inc | No | Yes | No | Yes | No | No | No | Yes |
Tramacet | 256180 | Tramadol Hcl, Acetaminophen | Janssen Inc | No | Yes | No | Yes | No | No | Yes | Yes |
Tridural | 256185 | Tramadol Hcl | Paladin Labs Inc | No | Yes | Yes | Yes | Yes | No | Yes | Yes |
Tykerb | 257841 | Lapatinib Ditosylate | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | Yes | No | No | Yes |
Ultram | 256187 | Tramadol Hcl | Janssen Inc | No | Yes | No | No | No | Yes | Yes | Yes |
Ultravist 300, Ultravist 370 | 257678 | Iopromide | Bayer Inc | Yes | Yes | No | Yes | No | No | No | No |
Zymar | 257117 | Gatifloxacin | Allergan Inc | Yes | Yes | No | Yes | No | Yes | No | Yes |
Zytram Xl | 256192 | Tramadol Hcl | Purdue Pharma | No | Yes | No | Yes | No | Yes | 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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