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Product monograph brand safety updates

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October 2021

Product Monograph Brand Safety Updates October 2021
(PDF, 101 KB, 2 pages)

Product Monograph Brand Safety Updates October 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Adderall XR 251964 Amphetamine Aspartate, Dextroamphetamine Saccharate, Amphetamine Sulfate, Dextroamphetamine Sulfate Takeda Canada Inc No No No Yes No No No Yes
Allegra Hives, Allegra 12 Hour, Allegra 24 Hour 252314 Fexofenadine Hcl Sanofi Consumer Health Inc Yes No No Yes No No Yes Yes
Biaxin Bid, Biaxin 253289 Clarithromycin BGP Pharma ULC Yes Yes No No Yes No No Yes
Bridion 234372 Sugammadex Merck Canada Inc Yes Yes Yes Yes Yes Yes No Yes
Buspirone 252361 Buspirone Hcl Apotex Inc No Yes Yes Yes Yes No No Yes
Cabometyx 245824 Cabozantinib Malate Ipsen Biopharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Cromolyn Eye Drops 252415 Cromolyn Sodium Pendopharm Division of Pharmascience Inc Yes Yes Yes Yes Yes Yes Yes Yes
Diflucan One 252521 Fluconazole Pfizer Canada ULC Yes No No No Yes No No Yes
Eltroxin 253114 Levothyroxine Sodium Aspen Pharmacare Canada Inc. Yes Yes No Yes Yes Yes No Yes
Enstilar 247673 Betamethasone Dipropionate, Calcipotriol Monohydrate Leo Pharma Inc No Yes No Yes No Yes No Yes
Epival 253012 Divalproex Sodium BGP Pharma ULC No Yes Yes Yes Yes No No Yes
Euthyrox 248518 Levothyroxine Sodium EMD Serono A Division of EMD Canada Inc No No No No No Yes No Yes
Ferriprox 244597 Deferiprone Chiesi Canada Corp. No Yes No Yes No No No Yes
Fluconazole 150 252705 Fluconazole Apotex Inc No Yes No Yes Yes No No Yes
Flurazepam 250741 Flurazepam Hcl AA Pharma Inc No Yes Yes Yes Yes Yes No Yes
Givlaari 253007 Givosiran Alnylam Netherlands B.V. No Yes No Yes No Yes No Yes
Inlyta 245813 Axitinib Pfizer Canada ULC No Yes No Yes No Yes No Yes
Intrarosa 253873 Prasterone Endoceutics Inc Yes No No Yes Yes Yes Yes Yes
Jardiance 246457 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee Yes Yes No Yes No Yes No Yes
Mavenclad 249245 Cladribine EMD Serono A Division of EMD Canada Inc No Yes No Yes No Yes No Yes
Mezera 251579 Mesalazine Avir Pharma Inc No Yes No No No No No Yes
Paxil 252405 Paroxetine Hcl GlaxoSmithKline Inc No Yes No No Yes No No Yes
Paxil CR 252407 Paroxetine Hcl GlaxoSmithKline Inc No Yes No No No No No Yes
Plaquenil 245822 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc No Yes No No Yes Yes No No
Rinvoq 245530 Upadacitinib Abbvie Corporation No Yes No Yes No Yes No Yes
Stromectol 253096 Ivermectin Merck Canada Inc No Yes No Yes No No Yes Yes
Suboxone 252770 Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate Indivior UK Limited No No No No No No Yes Yes
Synthroid 248519 Levothyroxine Sodium BGP Pharma ULC Yes Yes No Yes Yes Yes No Yes
Tecfidera 245515 Dimethyl Fumarate Biogen Canada Inc No Yes No Yes No No No Yes
Vfend 252675 Voriconazole Pfizer Canada ULC Yes Yes No No Yes No No Yes
Voltaren Rapide 253458 Diclofenac Potassium Novartis Pharmaceuticals Canada Inc Yes Yes Yes No No No No Yes
Voltaren, Voltaren SR 253534 Diclofenac Sodium Novartis Pharmaceuticals Canada Inc Yes Yes Yes No No No No Yes
Zeposia 253417 Ozanimod Celgene Inc No Yes No Yes No Yes No Yes

September 2021

Product Monograph Brand Safety Updates September 2021
(PDF, 96 KB, 2 pages)

September 2021
Brand Name Submission
Number		 Ingredient(s) Manufacturer Contraindications Warnings &
Precautions		 Serious Warnings &
Precautions		 Adverse
Reactions		 Drug
Interactions		 Dosage &
Administration		 Overdosage Consumer
Information
Accel-Sevelamer 249772 Sevelamer Carbonate Accel Pharma Inc No Yes No Yes No No No Yes
Biphentin 249146 Methylphenidate Hcl Elvium Life Sciences No Yes No Yes Yes No No Yes
Brilinta 252326 Ticagrelor AstraZeneca Canada Inc No Yes No Yes No No No Yes
Dexilant 251447 Dexlansoprazole Takeda Canada Inc No No No Yes No No No Yes
Differin, Differin XP 250710 Adapalene Galderma Canada Inc No No No Yes No No No Yes
Dovato 245212 Dolutegravir Sodium, Lamivudine ViiV Healthcare ULC No Yes No No No Yes No No
Entocort 251213 Budesonide Tillotts Pharma GmbH No Yes No No No No No Yes
Flagyl 251939 Metronidazole Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Flagystatin 251953 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Imitrex DF, Imitrex, Imitrex Nasal Spray 248682 Sumatriptan Succinate, Sumatriptan Hemisulfate GlaxoSmithKline Inc No Yes No No No Yes No No
Inrebic 253094 Fedratinib Hydrochloride Celgene Inc No No No No Yes No No Yes
Kivexa 243500 Abacavir, Lamivudine ViiV Healthcare ULC No Yes No No No Yes No No
Kyleena 251457 Levonorgestrel Bayer Inc No Yes No No No Yes No Yes
Mezavant 251581 Mesalazine Takeda Canada Inc No Yes No Yes No No No Yes
Mirena 251699 Levonorgestrel Bayer Inc No Yes No Yes Yes Yes No No
Monoferric 245637 Ferric Derisomaltose Pharmacosmos A/S Yes Yes Yes Yes Yes Yes No Yes
Nexium 251874 Esomeprazole Magnesium Trihydrate AstraZeneca Canada Inc No Yes No Yes No No No Yes
Prevacid, Prevacid Fastab 251460 Lansoprazole Takeda Pharmaceuticals America Inc No No No Yes No No No Yes
Spravato 244338 Esketamine Hydrochloride Janssen Inc No Yes No Yes No Yes No Yes
Treanda 251868 Bendamustine Hydrochloride Teva Canada Limited No Yes No Yes No No No Yes
Velphoro 244717 Sucroferric Oxyhydroxide Vifor Fresenius Medical Care Renal Pharma Ltd No No No Yes No No No Yes
Vimovo 252259 Naproxen, Esomeprazole AstraZeneca Canada Inc No Yes No Yes No No No Yes
Xofluza 253190 Baloxavir Marboxil Hoffmann-La Roche Limited No No No No Yes No No No
Zoloft 253527 Sertraline Hcl Upjohn Canada ULC No Yes No No Yes No No Yes
Zyloprim 248178 Allopurinol AA Pharma Inc No Yes Yes Yes No No No Yes

August 2021

Product Monograph Brand Safety Updates August 2021
(PDF, 88 KB, 2 pages)

August 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Atacand Plus 250812 Hydrochlorothiazide, Candesartan Cilexetil AstraZeneca Canada Inc No Yes No Yes No No No Yes
Atriance 248552 Nelarabine Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Blexten 241318 Bilastine Aralez Pharmaceuticals Canada Inc No No No Yes Yes Yes No Yes
Esbriet 249105 Pirfenidone Hoffmann-La Roche Limited No Yes No Yes No Yes No Yes
Forxiga 248367 Dapagliflozin Propanediol AstraZeneca Canada Inc Yes Yes No Yes No Yes No Yes
Genvoya 250387 Emtricitabine, Cobicistat, Tenofovir Alafenamide Hemifumarate, Elvitegravir Gilead Sciences Canada Inc No No No No Yes No No Yes
Hydrea 250623 Hydroxyurea Bristol-Myers Squibb Canada No Yes No Yes No No No Yes
Juluca 243354 Dolutegravir, Rilpivirine ViiV Healthcare ULC No Yes No Yes No No No No
Kalydeco 247481 Ivacaftor Vertex Pharmaceuticals (Canada) Incorporated No Yes No Yes Yes Yes No Yes
Kisqali 250667 Ribociclib Succinate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Levothyroxine Sodium for Injection, Levothyroxine Sodium Injection 246606 Levothyroxine Sodium Fresenius Kabi Canada Ltd Yes Yes No Yes Yes Yes No Yes
Mogadon 248565 Nitrazepam AA Pharma Inc No Yes Yes Yes Yes Yes No Yes
Moviprep 247990 Polyethylene Glycol 3350, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate, Sodium Sulfate Anhydrous Aralez Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Nucynta IR 247865 Tapentadol Hydrochloride Endo Ventures Ltd No Yes No Yes Yes Yes Yes Yes
Orilissa 250668 Elagolix Sodium Abbvie Corporation Yes Yes No No Yes No No Yes
Protopic 243249 Tacrolimus Leo Pharma Inc No Yes Yes No No No No Yes
Rythmol 251371 Propafenone Hcl BGP Pharma ULC No Yes No Yes No No No Yes
Trintellix 248464 Vortioxetine Hydrobromide Lundbeck Canada Inc No Yes No Yes Yes No No Yes
Tybost 250376 Cobicistat Gilead Sciences Canada Inc No No No No Yes No No Yes
Tygacil 251294 Tigecycline Pfizer Canada ULC No Yes No No No No No No
Uvadex 250515 Methoxsalen Therakos Inc No Yes No Yes No No Yes Yes
Veklury 250729 Remdesivir Gilead Sciences Canada Inc No No No Yes No Yes No Yes
Vimpat 251063 Lacosamide UCB Canada Inc No No No Yes No No No Yes
Votrient 251027 Pazopanib Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Zestoretic 250625 Hydrochlorothiazide, Lisinopril Searchlight Pharma Inc No Yes No Yes No No No Yes
Zeulide Depot 246754 Leuprolide Acetate Verity Pharmaceuticals Inc Yes Yes No No No Yes No Yes

July 2021

Product Monograph Brand Safety Updates July 2021
(PDF, 90 KB, 3 pages)

July 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Agrylin 245876 Anagrelide Hydrochloride Takeda Canada Inc No Yes Yes No No Yes No Yes
Alecensaro 250679 Alectinib Hydrochloride Hoffmann-La Roche Limited No No No Yes No No No Yes
Arimidex 250543 Anastrozole Astrazeneca Canada Inc No No No Yes No No No Yes
Axid 247715 Nizatidine Pendopharm Division of Pharmascience Inc No No No Yes No No No No
Brukinsa 242885 Zanubrutinib Beigene Switzerland Gmbh No No No Yes No No No Yes
Ceftin 249935 Cefuroxime Axetil GlaxoSmithKline Inc No Yes No No No Yes No Yes
Condyline 246341 Podophyllotoxin Sanofi-Aventis Canada Inc Yes Yes No Yes No No Yes No
Diacomit 248895 Stiripentol Biocodex SA No Yes No No No No No Yes
Edarbi 246524 Azilsartan Medoxomil Potassium Bausch Health, Canada Inc. No No No No No No No Yes
Edarbyclor 246568 Azilsartan Medoxomil Potassium, Chlorthalidone Bausch Health, Canada Inc. No Yes No No No No No Yes
Erleada 249685 Apalutamide Janssen Inc No Yes No No No No No No
Foradil 248892 Formoterol Fumarate Novartis Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Fosamax 247669 Alendronic Acid Organon Canada Inc. No Yes No No No Yes No Yes
Gilenya 249522 Fingolimod Hydrochloride Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes Yes No Yes
Janumet, Janumet XR 242894 Sitagliptin, Metformin Hcl Merck Canada Inc No Yes No Yes No Yes No Yes
Januvia 242950 Sitagliptin Merck Canada Inc No Yes No Yes No Yes No Yes
Kaletra 249555 Lopinavir, Ritonavir Abbvie Corporation Yes No No No Yes No No Yes
Komboglyze 249064 Metformin Hcl, Saxagliptin AstraZeneca Canada Inc No No No Yes No No No Yes
Lenvima 243615 Lenvatinib Mesylate Eisai Limited No Yes No No No No No No
Luvox 248243 Fluvoxamine Maleate BGP Pharma ULC No Yes No Yes Yes No No Yes
Monurol 250260 Fosfomycin Tromethamine Paladin Labs Inc Yes Yes No No No Yes Yes Yes
Nerlynx 249980 Neratinib Maleate Knight Therapeutics Inc. No Yes No Yes No Yes No Yes
Norvir 249539 Ritonavir Abbvie Corporation Yes No No No Yes No No Yes
Nubeqa 243046 Darolutamide Bayer Inc No Yes No Yes Yes No No Yes
Nucynta Extended-Release 247847 Tapentadol Hydrochloride Endo Ventures Ltd No Yes No Yes Yes Yes Yes Yes
Ofev 249336 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No No No No No Yes No Yes
Plaquenil 250901 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc No Yes No Yes No No Yes Yes
Prezcobix 249902 Darunavir Ethanolate, Cobicistat Janssen Inc No No No No Yes No No Yes
Prezista 249945 Darunavir Ethanolate Janssen Inc No No No No Yes No No Yes
Procysbi 240671 Cysteamine Bitartrate Horizon Therapeutics Ireland DAC No Yes No Yes Yes Yes No Yes
Prozac 249549 Fluoxetine Hcl Eli Lilly Canada Inc No Yes No No No No No Yes
Qtern 249090 Saxagliptin, Dapagliflozin AstraZeneca Canada Inc No No No Yes No No No Yes
Rinvoq 250262 Upadacitinib Abbvie Corporation No Yes No Yes No No No Yes
Sandoz Fingolimod 249277 Fingolimod Hydrochloride Sandoz Canada Incorporated No Yes No Yes Yes Yes No Yes
Stribild 250381 Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, Elvitegravir Gilead Sciences Canada Inc No No No No Yes No No Yes
Symtuza 249912 Emtricitabine, Darunavir Ethanolate, Cobicistat, Tenofovir Alafenamide Hemifumarate Janssen Inc No No No No Yes No No Yes
Teva-Bromazepam 248570 Bromazepam Teva Canada Limited No Yes Yes Yes Yes Yes No Yes
Vizimpro 243393 Dacomitinib Monohydrate Pfizer Canada ULC No No No No Yes Yes No Yes
Volibris 248077 Ambrisentan GlaxoSmithKline Inc No Yes No No No No No Yes

June 2021

Product Monograph Brand Safety Updates June 2021
(PDF, 101 KB, 4 pages)

June 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Altace HCT 246597 Hydrochlorothiazide, Ramipril Bausch Health, Canada Inc No Yes No Yes No No No Yes
Aspirin 81 mg, Aspirin 81 mg Quick Chews, Aspirin Regular Strength, Aspirin Extra Strength 248124 Acetylsalicylic Acid Bayer Inc No Yes No Yes Yes No No No
Bricanyl Turbuhaler 239089 Terbutaline Sulfate AstraZeneca Canada Inc Yes Yes No No No No No Yes
Cellcept, Cellcept I.V. 248429 Mycophenolate Mofetil Hoffmann-La Roche Limited No Yes No No No No No Yes
Cipro XL 248371 Ciprofloxacin Hydrochloride Bayer Inc Yes No No No No Yes No Yes
Cipro, Cipro Oral Suspension 248370 Ciprofloxacin Hydrochloride Bayer Inc Yes No No No No Yes No Yes
Clozaril 247538 Clozapine HLS Therapeutics Inc No Yes Yes No No Yes No Yes
Combogesic 248697 Ibuprofen, Acetaminophen Biosyent Pharma Inc No No No Yes No Yes No No
Efudex 246337 Fluorouracil Bausch Health, Canada Inc Yes Yes Yes Yes Yes Yes Yes Yes
Epclusa 247195 Velpatasvir, Sofosbuvir Gilead Sciences Canada Inc No No No Yes No No No Yes
Erleada 241210 Apalutamide Janssen Inc No Yes No Yes No Yes No Yes
Harvoni 247194 Ledipasvir, Sofosbuvir Gilead Sciences Canada Inc No No No Yes No No No Yes
Hemangiol 247151 Propranolol Hcl Pierre Fabre Dermo-Cosmetique Canada Inc No Yes No Yes No No No Yes
Idamycin PFS 249085 Idarubicin Hcl Pfizer Canada ULC No No No Yes No No No Yes
Imbruvica 248172 Ibrutinib Janssen Inc No Yes No Yes No No No Yes
Inderal-LA 248972 Propranolol Hcl Pfizer Canada ULC No No No Yes No No No Yes
Jakavi 247787 Ruxolitinib Phosphate Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Lorbrena 247174 Lorlatinib Pfizer Canada ULC No Yes No Yes No Yes No Yes
Lynparza 249369 Olaparib AstraZeneca Canada Inc No No No Yes No No No Yes
Manerix 246047 Moclobemide Bausch Health, Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Maxidol Liquid Gels 248432 Naproxen Sodium Bayer Inc No No No Yes No No No Yes
Nerlynx 242449 Neratinib Maleate Knight Therapeutics Inc No Yes No Yes Yes Yes No Yes
Ofev 241747 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No Yes No No Yes No No Yes
Orgalutran 248614 Ganirelix Acetate Organon Canada Inc Yes Yes No Yes No Yes No Yes
Pat-Galantamine ER 248978 Galantamine Hydrobromide Janssen Inc No Yes No Yes No Yes No Yes
Piqray 248616 Alpelisib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Ralivia 246159 Tramadol Hcl Bausch Health, Canada Inc No Yes No Yes No No Yes Yes
Retrovir (AZT) 249459 Zidovudine ViiV Healthcare ULC No Yes Yes No Yes Yes Yes Yes
Rinvoq 241253 Upadacitinib Abbvie Corporation No Yes No Yes No Yes No Yes
Rivotril 245341 Clonazepam Hoffmann-La Roche Limited No Yes Yes Yes Yes Yes No Yes
Rydapt 247829 Midostaurin Novartis Pharmaceuticals Canada Inc No No No Yes No No No Yes
Sandoz Zopiclone Tablet 247527 Zopiclone Sandoz Canada Incorporated No Yes Yes Yes No Yes No Yes
Sovaldi 247196 Sofosbuvir Gilead Sciences Canada Inc No No No Yes No No No Yes
Synalar 247002 Fluocinolone Acetonide Bausch Health, Canada Inc No Yes No Yes No No No Yes
Tapazole 246350 Methimazole Paladin Labs Inc No Yes No No No No Yes Yes
Toviaz 248542 Fesoterodine Fumarate Pfizer Canada ULC Yes Yes No Yes Yes Yes No No
Trileptal 247670 Oxcarbazepine Novartis Pharmaceuticals Canada Inc No Yes No No No Yes No Yes
Valium 245343 Diazepam Hoffmann-La Roche Limited No Yes Yes Yes Yes Yes No Yes
Vaseretic 247516 Enalapril Maleate, Hydrochlorothiazide Organon Canada Inc No Yes No No Yes No No Yes
Vasotec 247519 Enalapril Maleate Organon Canada Inc No Yes No No Yes No No Yes
Wellbutrin XL 247849 Bupropion Hcl Bausch Health, Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Zyban 247564 Bupropion Hcl Bausch Health, Canada Inc Yes Yes No Yes Yes Yes Yes Yes
Zyvoxam 248930 Linezolid Pfizer Canada ULC No Yes No Yes No Yes No Yes

May 2021

Product Monograph Brand Safety Updates May 2021
(PDF, 90 KB, 2 pages)

May 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Afinitor, Afinitor Disperz 247570 Everolimus Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Androcur, Androcur Depot 245903 Cyproterone Acetate Bayer Inc No Yes No Yes No No No Yes
Apo-Clobazam 245505 Clobazam Apotex Inc No Yes Yes Yes Yes Yes No Yes
Ativan 245317 Lorazepam Pfizer Canada ULC No Yes Yes Yes Yes Yes No Yes
Aubagio 247354 Teriflunomide Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No No No Yes No No No Yes
Biktarvy 240953 Emtricitabine, Bictegravir Sodium, Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc No Yes No Yes No Yes No Yes
Ceftriaxone Sodium for Injection 246728 Ceftriaxone Sodium Teva Canada Limited No No No Yes No No No Yes
Depakene 247699 Valproic Acid BGP Pharma ULC No Yes No Yes No No No Yes
Diastat 245322 Diazepam Valeant Pharmaceuticals North America Llc No Yes Yes Yes Yes Yes No Yes
Diazepam Injection USP 245324 Diazepam Sandoz Canada Incorporated Yes Yes Yes Yes Yes Yes No Yes
Epival 247581 Divalproex Sodium BGP Pharma ULC No Yes No Yes No No No Yes
Eucrisa 240171 Crisaborole Pfizer Canada ULC No No No No Yes No No Yes
Lorazepam Injection USP 245339 Lorazepam Sandoz Canada Incorporated No Yes Yes Yes Yes Yes No Yes
Mayzent 245078 Siponimod Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Ofev 247352 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes Yes Yes Yes Yes
Prinivil 247696 Lisinopril Merck Canada Inc No Yes No No Yes No No Yes
Sevorane AF 246821 Sevoflurane Abbvie Corporation No Yes No Yes No No No Yes
Soliqua 247226 Lixisenatide, Insulin Glargine Sanofi-Aventis Canada Inc No Yes No Yes No Yes No Yes
Tegretol 247229 Carbamazepine Novartis Pharmaceuticals Canada Inc Yes Yes Yes Yes Yes Yes Yes Yes
Toloxin 246803 Digoxin Pendopharm Division of Pharmascience Inc No No No No No Yes No Yes
Topamax 247698 Topiramate Janssen Inc Yes Yes No No Yes Yes Yes Yes
Trelegy Ellipta 240101 Umeclidinium Bromide, Fluticasone Furoate, Vilanterol Trifenatate GlaxoSmithKline Inc Yes Yes No Yes Yes Yes Yes Yes
Vitrakvi 241249 Larotrectinib Sulfate Bayer Inc No Yes No Yes Yes Yes No No
Vosevi 247191 Voxilaprevir, Velpatasvir, Sofosbuvir Gilead Sciences Canada Inc No No No Yes No No No Yes
Xanax,
Xanax TS		 245344 Alprazolam Upjohn Canada ULC No Yes Yes Yes Yes Yes No Yes
Xylocard 246218 Lidocaine Hcl Aspen Pharmacare Canada Inc. Yes Yes No No No Yes Yes Yes

April 2021

Product Monograph Brand Safety Updates April 2021
(PDF, 84.6 KB, 2 pages)

April 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Avalide 246609 Hydrochlorothiazide, Irbesartan Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Avapro 246866 Irbesartan Sanofi-Aventis Canada Inc No No No Yes No No No Yes
Docetaxel Injection USP 246984 Docetaxel Pfizer Canada ULC No Yes Yes Yes No No No Yes
Duodopa 245733 Levodopa, Carbidopa Monohydrate AbbVie Corporation No Yes No No No Yes No Yes
Hydromorphone Hydrochloride Injection USP 237401 Hydromorphone Hcl Sandoz Canada Incorporated No No No No No Yes Yes No
Iressa 246584 Gefitinib AstraZeneca Canada Inc No No No Yes No No No Yes
Kazano 243901 Metformin Hcl, Alogliptin Benzoate Takeda Canada Inc No No No Yes No No No Yes
Naproxen Capsules
200 Mg		 245549 Naproxen Catalent Ontario Limited No Yes No Yes Yes No No Yes
Nesina 243900 Alogliptin Benzoate Takeda Canada Inc No Yes No Yes No No No Yes
Nexplanon 247049 Etonogestrel Organon Canada Inc. No Yes No No No No No Yes
Opsumit 246750 Macitentan Janssen Inc No No No No Yes No No Yes
Reactine Fast Melt Junior 246339 Cetirizine Hydrochloride McNeil Consumer Healthcare Division of Johnson & Johnson Inc No No No No No No No Yes
Sandostatin, Sandostatin LAR 247160 Octreotide Novartis Pharmaceuticals Canada Inc No No No Yes No No Yes No
Seroquel, Seroquel XR >246849 Quetiapine Fumarate AstraZeneca Canada Inc No Yes Yes Yes Yes Yes No Yes
Sinemet 246915 Carbidopa Monohydrate, Levodopa Organon Canada Inc. No No No No No Yes No Yes
Vosevi 245142 Voxilaprevir, Velpatasvir, Sofosbuvir Gilead Sciences Canada Inc No Yes No Yes No No No Yes
Xeloda 247293 Capecitabine Hoffmann La Roche Limited No No No Yes No No No Yes
Zenhale 239493 Formoterol Fumarate Dihydrate, Mometasone Furoate Organon Canada Inc. No Yes No Yes No Yes No Yes

March 2021

Product Monograph Brand Safety Updates March 2021
(PDF, 108 KB, 3 pages)

March 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Abilify Maintena 237149 Aripiprazole Otsuka Pharmaceutical Co Ltd No Yes No No No Yes No Yes
Accuretic 244863 Hydrochlorothiazide, Quinapril Hcl Pfizer Canada ULC No Yes No Yes No No No Yes
Aldactazide 25, Aldactazide 50 244911 Hydrochlorothiazide, Spironolactone Pfizer Canada ULC No Yes No Yes No No No Yes
Alunbrig 237680 Brigatinib Takeda Canada Inc No Yes No Yes No No No Yes
Asacol 245536 Mesalazine Allergan Inc No Yes No Yes Yes No No Yes
Asacol 800 245722 Mesalazine Allergan Inc No Yes No Yes Yes No No Yes
Balversa 245919 Erdafitinib Janssen Inc No No No No Yes No No No
Belsomra 244781 Suvorexant Merck Canada Inc No Yes No Yes No No No Yes
Buscopan 245198 Hyoscine Butylbromide Sanofi Consumer Health Inc Yes Yes No No No No Yes Yes
Cellcept 245034 Mycophenolate Mofetil Hydrochloride, Mycophenolate Mofetil Hoffmann La Roche Limited No No No Yes No No No Yes
Children's Advil 244560 Ibuprofen GlaxoSmithkKine Consumer Healthcare ULC No Yes No No No Yes No Yes
Cymbalta 245810 Duloxetine Hcl Eli Lilly Canada Inc No Yes No No No No No Yes
Flovent HFA, Flovent Diskus 243742 Fluticasone Propionate GlaxoSmithkKine Inc No Yes No Yes No Yes Yes Yes
Gemcitabine Injection 245820 Gemcitabine Hcl Pfizer Canada ULC No Yes No Yes No No No No
Glatect 244549 Glatiramer Acetate Pharmascience Inc No Yes No Yes No No No Yes
Glyxambi 243907 Linagliptin, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Imbruvica 238064 Ibrutinib Janssen Inc No Yes No Yes Yes No No Yes
Invanz 245199 Ertapenem Sodium Merck Canada Inc No No No Yes No No No Yes
Jentadueto 243906 Metformin Hcl, Linagliptin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Jorveza 238101 Budesonide Avir Pharma Inc No No No Yes No Yes No Yes
Lynparza 246316 Olaparib AstraZeneca Canada Inc No Yes No Yes No No No Yes
Maviret 245141 Pibrentasvir, Glecaprevir Abbvie Corporation Yes Yes No Yes No No No Yes
Mekinist 245843 Trametinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Motrin Liquid Gels 200 Mg, Motrin Liquid Gels 400 Mg 244305 Ibuprofen McNeil Consumer Healthcare Division of Johnson & Johnson Inc No Yes No No No No No Yes
Neupro 245289 Rotigotine UCB Canada Inc No Yes No Yes No No No Yes
Nolvadex-D 243317 Tamoxifen Citrate AstraZeneca Canada Inc Yes Yes No Yes Yes No No No
Octostim 244562 Desmopressin Acetate Ferring Inc Yes Yes No Yes Yes Yes Yes Yes
Onbrez Breezhaler 245077 Indacaterol Maleate Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Onpattro 245256 Patisiran Sodium Alnylam Netherlands B.V. No Yes No Yes No No No Yes
PMS-Methadone 241778 Methadone Hydrochloride Paladin Labs Inc Yes Yes Yes Yes Yes Yes Yes Yes
Prevacid, Prevacid Fastab 241989 Lansoprazole Takeda Pharmaceuticals America Inc No Yes No Yes No No No No
Radicava 245593 Edaravone Mitsubishi Tanabe Pharma Corporation No No No No No Yes No No
Sandoz Methylphenidate SR 244991 Methylphenidate Hcl Sandoz Canada Incorporated No Yes No Yes No Yes No Yes
Sandoz Perindopril Erbumine/Indapamide LD, Sandoz Perindopril Erbumine/Indapamide, Sandoz Perindopril Erbumine/Indapamide HD 244537 Indapamide, Perindopril Erbumine Sandoz Canada Incorporated Yes Yes No Yes Yes No No Yes
Septra Injection 245929 Trimethoprim, Sulfamethoxazole Aspen Pharmacare Canada Inc. No Yes Yes Yes No No No Yes
Serevent Diskus 243734 Salmeterol Xinafoate GlaxoSmithKline Inc Yes Yes No Yes Yes Yes No Yes
Solu-Medrol, Solu-Medrol Act-O-Vials 245362 Methylprednisolone Pfizer Canada ULC No Yes No No No No No No
Somatuline Autogel 245315 Lanreotide Ipsen Biopharmaceuticals Canada Inc Yes Yes Yes Yes Yes Yes No Yes
Tafinlar 245834 Dabrafenib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes
Thalomid 244994 Thalidomide Celgene Inc No Yes No Yes No No No Yes
Trintellix 237793 Vortioxetine Hydrobromide Lundbeck Canada Inc No Yes No Yes No No No Yes
Viibryd 237588 Vilazodone Hydrochloride Allergan Inc No Yes No Yes No Yes No No
Vocabria, Cabenuva 238803 Rilpivirine, Cabotegravir ViiV Healthcare ULC Yes Yes No Yes Yes Yes No Yes
Zepatier 245140 Grazoprevir, Elbasvir Merck Canada Inc No Yes No Yes No No No Yes

February 2021

Product Monograph Brand Safety Updates February 2021
(PDF, 83 KB, 2 pages)

February 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Abilify 242200 Aripiprazole Otsuka Pharmaceutical Co Ltd No Yes No Yes No No No Yes
Aleve Caplets 243112 Naproxen Sodium Bayer Inc No No No No No Yes No Yes
Aubagio 243821 Teriflunomide Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Belkyra 242465 Deoxycholic Acid Kythera Biopharmaceuticals Inc No Yes No Yes No No No Yes
Biktarvy 237235 Emtricitabine, Bictegravir Sodium, Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc No No No Yes No No No Yes
Bridion 237151 Sugammadex Merck Canada Inc No Yes No Yes No No No No
Clobex Spray 244309 Clobetasol Propionate Galderma Canada Inc Yes Yes No Yes No Yes Yes Yes
Definity 242706 Perflutren Lantheus MI Canada Inc No Yes No No No No No No
Depo-Medrol 245381 Methylprednisolone Acetate Pfizer Canada ULC No No No No No Yes No No
Diflucan One 244031 Fluconazole Pfizer Canada ULC No No No No Yes No No Yes
Metadol 241772 Methadone Hydrochloride Paladin Labs Inc No Yes No Yes Yes Yes No Yes
Metadol-D 241773 Methadone Hydrochloride Paladin Labs Inc No Yes No Yes Yes Yes No Yes
Mycobutin 244143 Rifabutin Pfizer Canada ULC No Yes No Yes No No No Yes
Myleran 243043 Busulfan Aspen Pharmacare Canada Inc. No Yes No Yes No No No Yes
Ninlaro 244191 Ixazomib Citrate Takeda Canada Inc No No No No No No Yes Yes
Pomalyst 243491 Pomalidomide Celgene Inc No Yes Yes Yes Yes Yes Yes Yes
Revatio 237407 Sildenafil Citrate Upjohn Canada ULC No No No Yes No No No No
Sabril 244467 Vigabatrin Lundbeck Pharmaceuticals LLC No Yes No No No Yes No No
Salofalk 242059 Mesalazine Aptalis Pharma Canada ULC No Yes No Yes Yes Yes No Yes
Salofalk 242468 Mesalazine Aptalis Pharma Canada ULC No Yes No Yes Yes No No Yes
Salofalk 242774 Mesalazine Aptalis Pharma Canada ULC No Yes No Yes Yes No No Yes
Seasonale 245618 Levonorgestrel, Ethinyl Estradiol Teva Canada Limited Yes Yes Yes No No No No Yes
Seasonique 245619 Levonorgestrel, Ethinyl Estradiol Teva Canada Limited Yes Yes Yes No No No No Yes
Stieva-A 244142 Tretinoin GlaxoSmithKline Inc No Yes No No No Yes No Yes
Symbicort Turbuhaler 244507 Formoterol Fumarate Dihydrate, Budesonide AstraZeneca Canada Inc No Yes No Yes Yes Yes Yes Yes
Teveten Plus 244660 Hydrochlorothiazide, Eprosartan Mesylate BGP Pharma ULC No Yes No Yes No No No Yes
Trajenta 243905 Linagliptin Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes No No No Yes
Trintellix 243819 Vortioxetine Hydrobromide Lundbeck Canada Inc No Yes No Yes Yes No No Yes
Vfend 243931 Voriconazole Pfizer Canada ULC Yes No No No Yes No No Yes

January 2021

Product Monograph Brand Safety Updates January 2021
(PDF, 83 KB, 2 pages)

January 2021
Brand Name Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Addyi 229727 Flibanserin Searchlight Pharma Inc Yes Yes Yes Yes Yes Yes No Yes
Aptivus 242983 Tipranavir Boehringer Ingelheim (Canada) Ltd Ltee No No No No Yes Yes No Yes
Entocort Enema 242607 Budesonide Tillotts Pharma GmbH Yes Yes No No Yes Yes Yes Yes
Fycompa 235549 Perampanel Eisai Limited No Yes No No Yes No No No
Kyleena 243730 Levonorgestrel Bayer Inc No Yes No No No Yes No Yes
Kyprolis 237196 Carfilzomib Amgen Canada Inc No Yes No Yes No Yes No Yes
Micardis Plus 242123 Telmisartan, Hydrochlorothiazide Boehringer Ingelheim (Canada) Ltd Ltee Yes No No Yes Yes No No No
Monistat Derm Cream 242581 Miconazole Nitrate Insight Pharmaceuticals LLC No Yes Yes No No No Yes Yes
Omnipaque 180, Omnipaque 240, Omnipaque 300, Omnipaque 350 242219 Iohexol GE Healthcare Canada Inc No No No No No Yes No Yes
Retin-A 235656 Tretinoin Bausch Health, Canada Inc. Yes Yes No Yes No Yes No Yes
Rozlytrek 242028 Entrectinib Hoffmann La Roche Limited No No No Yes No Yes No Yes
Sinemet 240018 Carbidopa, Levodopa Merck Canada Inc No No No No No Yes No No
Tagrisso 243288 Osimertinib Mesylate AstraZeneca Canada Inc No Yes No Yes No Yes No Yes
Tivicay 235583 Dolutegravir Sodium ViiV Healthcare ULC No Yes No Yes Yes Yes No Yes
Trelstar 239594 Triptorelin Pamoate Knight Therapeutics Inc. No No No No No No No Yes
Venclexta 243474 Venetoclax Abbvie Corporation No Yes No No No Yes No Yes
Xarelto 234756 Rivaroxaban Bayer Inc Yes Yes No Yes Yes Yes Yes Yes
Xylac 243159 Loxapine Succinate Pendopharm Division of Pharmascience Inc No Yes Yes Yes Yes Yes No Yes
Ziagen 243476 Abacavir Sulfate ViiV Healthcare ULC No No No No Yes No No Yes
Zytiga 244273 Abiraterone Acetate Janssen Inc No Yes No Yes No No No Yes

December 2020

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

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

November 2020

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

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

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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