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Product monograph brand safety updates

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February 2023

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

Product Monograph Brand Safety Updates January 2023
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)

Product Monograph Brand Safety Updates January 2023
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)

Product Monograph Brand Safety Updates December 2022
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)

Product Monograph Brand Safety Updates November 2022
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)

Product Monograph Brand Safety Updates October 2022
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)

Product Monograph Brand Safety Updates September 2022
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)

Product Monograph Brand Safety Updates August 2022
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)

Product Monograph Brand Safety Updates July 2022
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)

Product Monograph Brand Safety Updates June 2022
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)

Product Monograph Brand Safety Updates May 2022
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)

Product Monograph Brand Safety Updates April 2022
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)

Product Monograph Brand Safety Updates March 2022
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

Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014
(PDF format, 62 KB, 1 pages)

Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014
Brand Name Submission number Ingredient Manufacturer Contraindications Warning and Precautions Serious Warnings and Precautions Box Adverse reactions Drug interactions Dosage and Administration Overdosage Consumer information
Aerius, Aerius Kids 164302 Desloratadine Schering-Plough Canada Inc N/A N/A
Aspirin 81 Mg, Aspirin 81 MG Quick Chew, Aspirin Regular Strength 169398 Acetylsalicylic acid Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A N/A
Aspirin 81 MG, Aspirin 81 MG Quick Chews, Aspirin Regular Strength, Aspirin Extra Strength 172222 Acetylsalicylic acid Bayer Inc Consumer Care N/A N/A N/A N/A N/A
Bactroban 176769 Mupirocin GlaxoSmithKline Consumer Healthcare Inc N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus Extra Strength 167087 Pseudoephedrine sulfate, loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus, Claritin Allergy + Sinus Extra Strength 177692 Pseudoephedrine sulfate, loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus 168558 Pseudoephedrine sulfate, loratadine Schering-Plough Canada Inc N/A N/A N/A N/A N/A N/A N/A
Claritin, Claritin Kids 177690 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Liquid Capsules 177693 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Claritin Rapid Dissolve 177691 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A
Contingency 174868 Levonorgestrel Famy Care Ltd N/A N/A N/A N/A
Heartburn Control 178335 Omeprazole Apotex Incorporated N/A N/A N/A N/A
Next Choice 174352 Levonorgestrel Cobalt Pharmaceuticals Company N/A N/A N/A N/A
Plan B 174250 Levonorgestrel Teva Women's Health Inc N/A N/A N/A N/A
Reactine Fast Melt Junior 173699 Cetirizine hydrochloride McNeil Consumer Healthcare Division Of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A
Teva-Levonorgestrel 174883 Levonorgestrel Teva Canada Limited N/A N/A N/A N/A
Voltaren Emulgel Extra Strength 172960 Diclofenac diethylamine Novartis Consumer Health Canada Inc N/A N/A N/A N/A N/A N/A
Women's Rogaine Foam 5% 165769 Minoxidil Johnson & Johnson Inc N/A
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