Product Monograph Brand Safety Updates

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Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014

May 2017

(PDF Version - 84K)

Table - Product Monograph Brand Safety Updates May 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
3TC 202946 Lamivudine ViiV Healthcare ULC   N/A N/A N/A   N/A N/A  
Actonel, Actonel DR 200428 Risedronate Sodium Warner Chilcott Canada Co N/A   N/A N/A N/A N/A N/A  
Advil Tablets, Advil Caplets, Advil Gel Caplets, Advil Extra Strength  Caplets, Advil Muscle and Joint, Advil 12 Hour 203345 Ibuprofen Pfizer Consumer Healthcare A Division of Pfizer Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Afinitor, Afinitor Disperz 202080 Everolimus Novartis Pharmaceuticals Canada Inc N/A   N/A N/A N/A   N/A  
Aleve, Aleve Liquid Gels, Aleve Back And Body Pain 203003 Naproxen Sodium Bayer Inc Consumer Care N/A   N/A N/A   N/A N/A  
Antizol 203100 Fomepizole Paladin Labs Inc N/A   N/A   N/A N/A N/A N/A
Apo-Norflox 202159 Norfloxacin Apotex Inc N/A     N/A N/A N/A N/A  
Arthrotec 50, Arthrotec 75 202618 Diclofenac Sodium, Misoprostol Pfizer Canada Inc N/A       N/A N/A N/A N/A
Avalide 203641 Hydrochlorothiazide, Irbesartan Sanofi-Aventis Canada Inc N/A   N/A   N/A N/A N/A N/A
Avelox, Avelox I.V. 202157 Moxifloxacin Bayer Inc N/A     N/A N/A N/A N/A  
Biltricide 201666 Praziquantel Bayer Inc N/A N/A N/A N/A   N/A N/A  
Buscopan 202547 Hyoscine Butylbromide Boehringer Ingelheim (Canada) Ltd Ltee N/A   N/A N/A N/A N/A N/A N/A
Bydureon 204999 Exenatide AstraZeneca Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Caduet 203042 Amlodipine Besylate, Atorvastatin Calcium Pfizer Canada Inc     N/A N/A N/A N/A N/A N/A
Cancidas 202368 Caspofungin Acetate Merck Canada Inc N/A   N/A N/A N/A N/A N/A  
Caprelsa 201914 Vandetanib Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc N/A N/A N/A   N/A N/A N/A  
Celebrex 202594 Celecoxib Pfizer Canada Inc N/A       N/A N/A N/A  
Cipro XL 202154 Ciprofloxacin Bayer Inc N/A     N/A N/A N/A N/A  
Cipro XL 202739 Ciprofloxacin Hydrochloride Bayer Inc     N/A N/A     N/A  
Cipro, Cipro Oral Suspension 202151 Ciprofloxacin Bayer Inc N/A     N/A N/A N/A N/A  
Cipro, Cipro Oral Suspension 202735 Ciprofloxacin Hydrochloride Bayer Inc     N/A N/A     N/A  
Coated Daily Low Dose ASA 81 mg 203112 Acetylsalicylic Acid Apotex Inc N/A N/A N/A N/A N/A N/A N/A  
Combivir 202851 Zidovudine, Lamivudine ViiV Healthcare ULC   N/A N/A N/A   N/A N/A  
Cytovene 201511 Ganciclovir Hoffmann-La Roche Limited N/A   N/A     N/A    
Daklinza 202374 Daclatasvir Bristol-Myers Squibb Canada N/A     N/A N/A N/A N/A  
Dalacin C 202619 Clindamycin HCl Pfizer Canada Inc N/A N/A N/A N/A     N/A  
Dalacin C Flavoured Granules 202622 Clindamycin 2-Palmitate HCl Pfizer Canada Inc N/A N/A N/A N/A     N/A  
Dalacin C Phosphate 202620 Clindamycin Phosphate Pfizer Canada Inc N/A N/A N/A N/A     N/A  
Descovy 197995 Emtricitabine, Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc N/A   N/A       N/A  
Diflucan One 201295 Fluconazole Pfizer Consumer Healthcare A Division of Pfizer Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Duaklir Genuair 202738 Formoterol Fumarate Dihydrate, Aclidinium Bromide AstraZeneca Canada Inc N/A N/A N/A   N/A N/A N/A  
Dymista 202447 Fluticasone Propionate, Azelastine Hydrochloride Meda Pharmaceuticals Ltd N/A   N/A N/A N/A   N/A  
Epclusa 202377 Sofosbuvir, Velpatasvir Gilead Sciences Canada Inc N/A     N/A N/A N/A N/A  
Epuris 201026 Isotretinoin Cipher Pharmaceuticals Inc N/A N/A N/A   N/A N/A N/A  
Evotaz 203191 Atazanavir Sulfate, Cobicistat Bristol-Myers Squibb Canada     N/A     N/A N/A  
Faslodex 200400 Fulvestrant Astrazeneca Canada Inc N/A N/A N/A N/A N/A   N/A  
Fosamax 200426 Alendronate Sodium Merck Canada Inc N/A   N/A N/A N/A N/A N/A  
Fosavance 200427 Vitamin D3, Alendronic Acid Merck Canada Inc N/A   N/A N/A N/A N/A N/A  
Gadovist 1.0 202823 Gadobutrol Bayer Inc N/A   N/A N/A N/A   N/A  
Genvoya 195789 Emtricitabine, Elvitegravir, Cobicistat, Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc     N/A          
Glyxambi 202749 Linagliptin, Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A   N/A   N/A N/A N/A  
Harvoni 199607 Ledipasvir, Sofosbuvir Gilead Sciences Canada Inc N/A   N/A   N/A   N/A  
Harvoni 202334 Ledipasvir, Sofosbuvir Gilead Sciences Canada Inc N/A     N/A N/A N/A N/A  
Heptovir 203510 Lamivudine Glaxosmithkline Inc   N/A N/A N/A   N/A N/A  
Ibrance 195948 Palbociclib Pfizer Canada Inc N/A   N/A       N/A  
Imovane 202617 Zopiclone Sanofi-Aventis Canada Inc N/A         N/A N/A  
Intelence 196519 Etravirine Janssen Inc N/A   N/A N/A     N/A  
Intralipid 10%, Intralipid 20%, Intralipid 30% 203141 Soybean Oil Fresenius Kabi Canada Ltd N/A N/A N/A N/A N/A N/A N/A  
Jurnista 203425 Hydromorphone HCl Janssen Inc N/A   N/A N/A   N/A N/A  
Kalydeco 195308 Ivacaftor Vertex Pharmaceuticals (Canada) Incorporated N/A   N/A N/A N/A   N/A  
Kivexa 202845 Lamivudine, Abacavir Sulfate ViiV Healthcare ULC   N/A N/A N/A   N/A N/A  
Magnevist 202873 Gadopentetate Dimeglumine Bayer Inc N/A   N/A N/A N/A   N/A  
Mekinist 199382 Trametinib Novartis Pharmaceuticals Canada Inc N/A       N/A      
Men's Rogaine Foam 5% 194149 Minoxidil Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A N/A  
Metronidazole 5 mg/mL Injection 202113 Metronidazole Baxter Corporation N/A   N/A          
MS Contin 202457 Morphine Sulfate Purdue Pharma     N/A   N/A N/A   N/A
Multihance 202826 Gadobenate Dimeglumine Bracco Imaging Canada N/A   N/A N/A N/A   N/A  
Norvasc 202935 Amlodipine Besylate Pfizer Canada Inc     N/A N/A N/A N/A N/A  
Nuvaring 204315 Ethinyl Estradiol, Etonogestrel Merck Canada Inc N/A   N/A N/A     N/A  
Oxyneo 195400 Oxycodone HCl Purdue Pharma N/A   N/A N/A N/A N/A N/A N/A
Plaquenil 202211 Hydroxychloroquine Sulfate Sanofi-Aventis Canada Inc N/A   N/A N/A     N/A  
Precedex 202530 Dexmedetomidine HCl Hospira Healthcare Corporation N/A N/A N/A N/A N/A   N/A N/A
Primovist 202821 Gadoxetate Disodium Bayer Inc N/A   N/A N/A N/A   N/A  
Prohance 202827 Gadoteridol Bracco Imaging Canada N/A   N/A N/A N/A   N/A  
Revolade 192586 Eltrombopag Olamine Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A N/A
Revolade 195798 Eltrombopag Olamine Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A  
Revolade 202335 Eltrombopag Olamine Novartis Pharmaceuticals Canada Inc N/A N/A N/A   N/A N/A N/A  
Reyataz 203194 Atazanavir Bristol-Myers Squibb Canada     N/A     N/A N/A  
Sovaldi 202358 Sofosbuvir Gilead Sciences Canada Inc N/A     N/A N/A N/A N/A  
Suboxone 203547 Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate Indivior UK Limited N/A     N/A N/A   N/A  
Sustiva 202776 Efavirenz Bristol-Myers Squibb Canada N/A   N/A     N/A N/A  
Tafinlar 199381 Dabrafenib Novartis Pharmaceuticals Canada Inc N/A       N/A      
Targin 202525 Naloxone HCl, Oxycodone HCl Purdue Pharma     N/A     N/A N/A  
Technivie 195504 Ritonavir, Paritaprevir, Ombitasvir Abbvie Corporation N/A   N/A   N/A   N/A  
Teva-Levofloxacin 202153 Levofloxacin Teva Canada Limited N/A     N/A N/A N/A N/A  
Triquilar 28 202824 Ethinyl Estradiol, Levonorgestrel Bayer Inc N/A N/A N/A N/A N/A N/A N/A  
Triumeq 202867 Lamivudine, Abacavir Sulfate, Dolutegravir Sodium ViiV Healthcare ULC   N/A N/A N/A   N/A N/A  
Trizivir 202849 Zidovudine, Lamivudine, Abacavir Sulfate ViiV Healthcare ULC   N/A N/A N/A   N/A N/A  
Truvada 201806 Emtricitabine, Tenofovir Disoproxil Fumarate Gilead Sciences Canada Inc N/A   N/A       N/A  
Tudorza Genuair 202742 Aclidinium Bromide AstraZeneca Canada Inc N/A N/A N/A   N/A N/A N/A  
Uniphyl 203028 Theophylline Purdue Pharma     N/A     N/A    
Viread 201858 Tenofovir Disoproxil Fumarate Gilead Sciences Canada Inc N/A   N/A N/A     N/A  
Zepatier 202393 Grazoprevir, Elbasvir Merck Canada Inc N/A     N/A N/A N/A N/A  
Zestoretic 202913 Hydrochlorothiazide, Lisinopril Dihydrate AstraZeneca Canada Inc     N/A     N/A N/A  
Zestril 202914 Lisinopril Dihydrate AstraZeneca Canada Inc     N/A     N/A N/A  
Zytram XL 202562 Tramadol HCl Purdue Pharma N/A N/A N/A   N/A N/A N/A N/A
Table - Product Monograph Brand Safety Updates April 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Aclasta 200432 zoledronic acid Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A  
Act Etidrocal 201597 calcium carbonate, etidronate disodium Actavis Pharma Company N/A   N/A N/A N/A N/A N/A  
Act Etidronate 201916 etidronate disodium Actavis Pharma Company N/A   N/A N/A N/A N/A N/A  
Aspirin 81 mg, Aspirin 81 mg Quick Chews, Aspirin Regular Strength 202259 acetylsalicylic acid Bayer Inc Consumer Care N/A   N/A N/A   N/A N/A  
Banzel 194343 rufinamide Eisai Limited N/A   N/A   N/A N/A N/A  
Biphentin 201555 methylphenidate HCl Purdue Pharma N/A   N/A          
Caduet 201169 amlodipine besylate, atorvastatin calcium Pfizer Canada Inc N/A   N/A   N/A N/A N/A N/A
Cardura 201486 doxazosin mesylate Pfizer Canada Inc N/A   N/A N/A N/A N/A N/A N/A
Depo-Medrol, Depo-Medrol (with preservative) 202516 methylprednisolone acetate Pfizer Canada Inc N/A N/A N/A N/A N/A   N/A N/A
Duodopa 201985 levodopa, carbidopa monohydrate Abbvie Corporation N/A N/A N/A   N/A N/A N/A N/A
Duragesic 202716 fentanyl Janssen Inc N/A   N/A N/A   N/A N/A  
Eltroxin 201136 levothyroxine sodium Aspen Pharma Trading Limited                
Emend IV 201642 fosaprepitant dimeglumine Merck Canada Inc N/A   N/A   N/A N/A N/A  
Erivedge 194933 vismodegib Hoffmann La Roche Limited N/A   N/A N/A N/A N/A N/A  
Galexos 201947 simeprevir Janssen Inc N/A     N/A N/A N/A N/A  
Inspiolto Respimat 196472 tiotropium, olodaterol hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A N/A  
Invokana 194762 canagliflozin Janssen Inc N/A N/A N/A   N/A N/A N/A  
Jevtana 202244 cabazitaxel Sanofi-Aventis Canada Inc N/A   N/A   N/A N/A N/A  
Metvix 180975 methyl aminolevulinate hydrochloride Galderma Canada Inc N/A       N/A   N/A  
Mezavant 201889 mesalazine Shire Pharma Canada Ulc N/A N/A N/A   N/A N/A N/A  
Multihance 188279 gadobenate dimeglumine Bracco Imaging Canada N/A   N/A   N/A   N/A  
Norvir 201368 ritonavir Abbvie Corporation     N/A     N/A N/A  
Ofev 194900 nintedanib Boehringer Ingelheim (Canada) Ltd Ltee N/A   N/A       N/A  
Orkambi 198036 ivacaftor, lumacaftor Vertex Pharmaceuticals (Canada) Incorporated N/A   N/A       N/A  
Pentasa 201731 mesalazine Ferring Inc     N/A     N/A N/A  
Pomalyst 194902 pomalidomide Celgene Inc N/A   N/A N/A     N/A  
Precedex 199357 dexmedetomidine HCl Hospira Healthcare Corporation N/A   N/A   N/A N/A N/A N/A
Prezcobix 201611 darunavir ethanolate, cobicistat Janssen Inc   N/A N/A N/A   N/A N/A  
Prezista 201621 darunavir ethanolate Janssen Inc   N/A N/A N/A   N/A N/A  
Requip 202058 ropinirole hydrochloride Glaxosmithkline Inc N/A   N/A N/A N/A N/A N/A N/A
Solu-Medrol, Solu-Medrol Act-O-Vials 202492 methylprednisolone sodium succinate Pfizer Canada Inc N/A N/A N/A N/A   N/A N/A  
Tobramycin Injection, Tobramycin for Injection 203072 tobramycin Fresenius Kabi Canada Ltd N/A N/A N/A N/A N/A N/A N/A  
Tramacet 201748 acetaminophen, tramadol HCl Janssen Inc N/A   N/A     N/A    
Uptravi 201926 selexipag Actelion Pharmaceuticals Ltd N/A   N/A N/A   N/A N/A N/A
Valcyte 201550 valganciclovir hydrochloride Hoffmann La Roche Limited     N/A     N/A    
Viacoram 201871 perindopril arginine, amlodipine Servier Canada Inc     N/A     N/A N/A  
Yondelis 202008 trabectedin Janssen Inc N/A   N/A   N/A N/A N/A N/A
Zevtera 201602 ceftobiprole medocaril Basilea Pharmaceutica International Ag N/A   N/A N/A N/A N/A N/A  
Zoloft 201862 sertraline HCl Pfizer Canada Inc N/A N/A N/A   N/A N/A N/A N/A
Zometa 200447 zoledronic acid Novartis Pharmaceuticals Canada Inc N/A   N/A N/A N/A N/A N/A  
Table - Product Monograph Brand Safety Updates March 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Accupril 200979 quinapril HCl Pfizer Canada Inc N/A N/A N/A N/A
Accuretic 201238 hydrochlorothiazide, quinapril HCl Pfizer Canada Inc N/A N/A N/A N/A
Aclasta 201491 zoledronic acid Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Agrylin 200919 anagrelide hydrochloride monohydrate Shire Pharma Canada Ulc N/A N/A N/A N/A
Airomir 200916 salbutamol sulfate Valeant Canada Lp Valeant Canada S.E.C. N/A N/A N/A N/A
Aptiom 201472 eslicarbazepine acetate Sunovion Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Bonefos 200438 clodronate disodium Bayer Inc N/A N/A N/A N/A N/A N/A
Busulfex 200963 busulfan Otsuka Pharmaceutical Co Ltd N/A N/A N/A N/A N/A N/A N/A
Champix 193081 varenicline tartrate Pfizer Canada Inc N/A N/A
Clasteon 200437 clodronate disodium Sunovion Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Coumadin 200502 warfarin sodium Bristol-Myers Squibb Canada N/A N/A N/A
Coversyl 201008 perindopril erbumine Servier Canada Inc N/A N/A N/A
Coversyl Plus Ld, Coversyl Plus, Coversyl Plus Hd 201004 perindopril erbumine, indapamide Servier Canada Inc N/A N/A N/A
Crestor 200016 rosuvastatin calcium Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A N/A
Cyclen 201124 ethinyl estradiol, norgestimate Janssen Inc N/A N/A N/A
Diane-35 201157 ethinyl estradiol, cyproterone acetate Bayer Inc N/A N/A N/A N/A
Diflucan 200992 fluconazole Pfizer Canada Inc N/A N/A N/A N/A N/A
Faslodex 200701 fulvestrant Astrazeneca Canada Inc N/A N/A N/A N/A N/A
Gelnique 198933 oxybutynin chloride Allergan Pharma Co. N/A N/A N/A
Holkira Pak 201441 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie Corporation N/A N/A
Incruse Ellipta 200693 umeclidinium bromide Glaxosmithkline Inc N/A N/A N/A N/A N/A N/A
Jakavi 198757 ruxolitinib phosphate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A
Janumet, Janumet Xr 201792 metformin HCl, sitagliptin phosphate monohydrate Merck Canada Inc N/A N/A N/A N/A N/A
Januvia 201760 sitagliptin phosphate monohydrate Merck Canada Inc N/A N/A N/A N/A N/A
Kaletra 201359 ritonavir, lopinavir Abbvie Corporation N/A N/A N/A N/A
Narcan Nasal Spray 202248 naloxone HCl Adapt Pharma Operations Limited N/A N/A N/A N/A N/A N/A N/A
Nidagel 200861 metronidazole Valeant Canada Lp Valeant Canada S.E.C. N/A N/A N/A N/A
Nozinan 200878 methotrimeprazine HCl Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Nuvaring 200891 ethinyl estradiol, etonogestrel Merck Canada Inc N/A N/A N/A N/A N/A
Ortho 0.5/35 201106 ethinyl estradiol, norethindrone Janssen Inc N/A N/A N/A N/A
Ortho 1/35 201117 ethinyl estradiol, norethindrone Janssen Inc N/A N/A N/A N/A
Ortho 7/7/7 201105 ethinyl estradiol, norethindrone Janssen Inc N/A N/A N/A N/A
Pentamidine Isetionate for Injection, Bp 200751 pentamidine isetionate Hospira Healthcare Corporation N/A N/A N/A N/A N/A N/A N/A
Pravachol 200020 pravastatin sodium Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A N/A
Prezista 201394 darunavir ethanolate Janssen Inc N/A N/A N/A N/A N/A N/A N/A
Primaquine 196046 primaquine phosphate Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Renagel 200994 sevelamer hydrochloride Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Renvela 200973 sevelamer carbonate Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Revolade 188969 eltrombopag olamine Novartis Pharmaceuticals Canada Inc N/A N/A
Rifadin 200835 rifampin Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A
Seroquel, Seroquel Xr 200543 quetiapine fumarate Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Signifor 193942 pasireotide Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Stribild 200747 emtricitabine, tenofovir disoproxil fumarate, elvitegravir, cobicistat Gilead Sciences Canada Inc N/A N/A N/A N/A N/A N/A
Tarceva 194018 erlotinib hydrochloride Hoffmann La Roche Limited N/A N/A N/A N/A N/A
Technivie 201487 ritonavir, paritaprevir, ombitasvir Abbvie Corporation N/A N/A
Tiazac 201438 diltiazem HCl Valeant Canada Lp Valeant Canada S.E.C. N/A N/A
Tiazac Xc 202119 diltiazem HCl Valeant Canada Lp Valeant Canada S.E.C. N/A N/A
Tri-Cyclen 201126 ethinyl estradiol, norgestimate Janssen Inc N/A N/A N/A
Tri-Cyclen Lo 201134 ethinyl estradiol, norgestimate Janssen Inc N/A N/A N/A
Wellbutrin Sr 200957 bupropion HCl Valeant Canada Lp Valeant Canada S.E.C. N/A N/A N/A N/A N/A
Wellbutrin Xl 200959 bupropion HCl Valeant Canada Lp Valeant Canada S.E.C. N/A N/A N/A N/A N/A
Xatral 200961 alfuzosin HCl Sanofi-Aventis Canada Inc N/A N/A N/A N/A
Yasmin 21, Yasmin 28 200941 ethinyl estradiol, drospirenone Bayer Inc N/A N/A N/A
Yasmin Plus 200982 ethinyl estradiol, drospirenone, levomefolate calcium Bayer Inc N/A N/A N/A
Yaz 200938 ethinyl estradiol, drospirenone Bayer Inc N/A N/A N/A
Yaz Plus 201007 ethinyl estradiol, drospirenone, levomefolate calcium Bayer Inc N/A N/A N/A
Zepatier 201181 grazoprevir, elbasvir Merck Canada Inc N/A N/A N/A N/A
Zeulide Depot 180093 leuprolide acetate Pendopharm Division of Pharmascience Inc N/A N/A N/A N/A
Zocor 200021 simvastatin Merck Canada Inc N/A N/A N/A N/A N/A N/A
Zyban 200951 bupropion HCl Valeant Canada Lp Valeant Canada S.E.C. N/A N/A N/A N/A N/A

February 2017

(PDF Version - 72 K)

Table - Product Monograph Brand Safety Updates February 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Abilify 199169 Aripiprazole Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A
Anoro Ellipta 198790 Umeclidinium Bromide, Vilanterol Trifenatate Glaxosmithkline Inc N/A N/A N/A N/A N/A N/A
Apo-ASA LD 200347 Acetylsalicylic Acid Apotex Inc N/A N/A N/A
Aubagio 200227 Teriflunomide Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A
Bosulif 200815 Bosutinib Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Clavulin 196916 Amoxicillin, Clavulanic Acid Glaxosmithkline Inc N/A N/A N/A N/A
Complera 199560 Emtricitabine, Tenofovir Disoproxil Fumarate, Rilpivirine Hydrochloride Gilead Sciences Canada Inc N/A N/A N/A N/A N/A N/A
Copaxone 200357 Glatiramer Acetate Teva Canada Limited N/A N/A N/A N/A N/A N/A N/A
Cotellic 199785 Cobimetinib Hoffmann-La Roche Limited N/A N/A N/A N/A
Evra 200474 Ethinyl Estradiol, Norelgestromin Janssen Inc N/A N/A N/A N/A
Flagyl 200299 Metronidazole Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A
Flagystatin 200324 Metronidazole, Nystatin Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A
Harvoni 193140 Ledipasvir, Sofosbuvir Gilead Sciences Canada Inc N/A N/A N/A
Heptovir 200536 Lamivudine Glaxosmithkline Inc N/A N/A N/A N/A N/A N/A
Holkira Pak 192833 Ritonavir, Paritaprevir, Ombitasvir, Dasabuvir AbbVie Corporation N/A N/A N/A N/A
Iclusig 199527 Ponatinib Hydrochloride Ariad Pharmaceuticals Inc N/A N/A N/A N/A N/A
Imbruvica 192718 Ibrutinib Janssen Inc N/A N/A N/A N/A
Invokamet 199731 Metformin HCl, Canagliflozin Janssen Inc N/A N/A N/A N/A
Jevtana 194950 Cabazitaxel Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Levothyroxine Sodium for Injection 197889 Levothyroxine Sodium Fresenius Kabi Canada Ltd N/A
Lupron Depot 193372 Leuprolide Acetate AbbVie Corporation N/A N/A N/A N/A N/A N/A N/A
Lysodren 200001 Mitotane Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A
Micardis Plus 200158 Hydrochlorothiazide, Telmisartan Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A
Oesclim 199389 Estradiol Searchlight Pharma Inc N/A N/A N/A N/A N/A N/A N/A
Oxytrol 198930 Oxybutynin Allergan Pharma Co. N/A N/A N/A N/A
Prefesta 199390 Estradiol, Norgestimate Searchlight Pharma Inc N/A N/A N/A N/A N/A N/A N/A
Pristiq 200419 Desvenlafaxine Succinate Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Rapamune 200932 Sirolimus Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Reminyl ER 200217 Galantamine Hydrobromide Janssen Inc N/A N/A N/A N/A N/A N/A
Revlimid 200591 Lenalidomide Celgene Inc N/A N/A N/A N/A
Tamiflu 199480 Oseltamivir Phosphate Hoffmann-La Roche Limited N/A N/A N/A N/A N/A N/A N/A
Tecfidera 198810 Dimethyl Fumarate Biogen Canada Inc N/A N/A N/A N/A N/A N/A
Technivie 192844 Ritonavir, Paritaprevir, Ombitasvir AbbVie Corporation N/A N/A N/A N/A
Tivicay 192462 Dolutegravir Sodium ViiV Healthcare ULC N/A N/A N/A
Treanda 199858 Bendamustine Hydrochloride Lundbeck Canada Inc N/A N/A N/A N/A
Triquilar 21, Triquilar 28 200226 Ethinyl Estradiol, Levonorgestrel Bayer Inc N/A N/A N/A
Tybost 200692 Cobicistat Gilead Sciences Canada Inc N/A N/A N/A N/A N/A N/A
Tykerb 199954 Lapatinib Ditosylate Monohydrate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Videx EC 197051 Didanosine Bristol-Myers Squibb Canada
Vimpat 193732 Lacosamide UCB Canada Inc N/A

January 2017

(PDF Version - 77 K)

Table - Product Monograph Brand Safety Updates January 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Advair, Advair Diskus 199754 fluticasone propionate, salmeterol xinafoate GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A N/A
Allegra-D 200316 pseudoephedrine HCl, fexofenadine HCl Sanofi-Aventis Canada Inc N/A N/A N/A
Allopurinol 198729 allopurinol Apotex Inc N/A N/A N/A N/A N/A
Apo-Bisoprolol 197881 bisoprolol fumarate Apotex Inc N/A N/A N/A N/A N/A N/A N/A
Butorphanol Nasal Spray 196224 butorphanol tartrate Aa Pharma Inc
Depakene 200975 valproic acid BGP Pharma Ulc N/A N/A N/A N/A N/A
Docetaxel Injection Usp 199491 docetaxel Hospira Healthcare Corporation N/A N/A N/A
Epival 201016 divalproex sodium BGP Pharma Ulc N/A N/A N/A N/A N/A
Esbriet 199306 pirfenidone Hoffmann La Roche Limited N/A N/A N/A N/A N/A
Gleevec 199774 imatinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Imbruvica 199713 ibrutinib Janssen Inc N/A N/A N/A N/A N/A N/A
Invokamet 198711 metformin HCl, canagliflozin Janssen Inc N/A N/A N/A N/A N/A
Invokana 198712 canagliflozin Janssen Inc N/A N/A N/A N/A N/A
Jadenu 194474 deferasirox Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Jardiance 198914 empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A N/A
Lipidil Ez 198956 fenofibrate BGP Pharma Ulc N/A N/A N/A
Lipidil Supra 198973 fenofibrate BGP Pharma Ulc N/A N/A N/A
Marvelon 21, Marvelon 28 199319 desogestrel, ethinyl estradiol Merck Canada Inc N/A N/A N/A N/A
Nersione 200095 diflucortolone valerate GlaxoSmithKline Inc N/A N/A
Nuvaring 199249 ethinyl estradiol, etonogestrel Merck Canada Inc N/A N/A N/A N/A
Prevacid, Prevacid Fastab 200287 lansoprazole Takeda Pharmaceuticals America Inc N/A N/A N/A N/A
Rupall 199706 rupatadine fumarate Pediapharm Inc
Sunvepra 199423 asunaprevir Bristol-Myers Squibb Canada N/A N/A N/A
Synjardy 199955 metformin HCl, empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A
Telzir 198633 fosamprenavir Viiv Healthcare Ulc N/A N/A N/A N/A N/A
Tramacet 196229 acetaminophen, tramadol HCl Janssen Inc
Ultram 196230 tramadol HCl Janssen Inc
Zelboraf 192354 vemurafenib Hoffmann La Roche Limited N/A N/A N/A N/A N/A N/A N/A
Zyloprim 198730 allopurinol Aa Pharma Inc N/A N/A N/A N/A N/A

December 2016

(PDF Version - 85 KB)

Product Monograph Brand Safety Updates December 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
3TC 197792 lamivudine Viiv Healthcare Ulc N/A N/A N/A N/A
Abilify Maintena 198294 aripiprazole Otsuka Pharmaceutical Co Ltd N/A N/A N/A N/A N/A
Adempas 198385 riociguat Bayer Inc N/A N/A N/A N/A N/A
Amaryl 198596 glimepiride Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Amiodarone Hydrochloride For Injection, Amiodarone Syringe 198348 amiodarone HCl Sandoz Canada Incorporated N/A N/A N/A N/A N/A N/A N/A
Arcosyl Plus, Arcosyl Plus Ld 197114 indapamide, perindopril arginine Servier Canada Inc N/A N/A N/A N/A N/A N/A
Atripla 198437 efavirenz, emtricitabine, tenofovir disoproxil fumarate Bristol-Myers Squibb And Gilead Sciences Llc N/A N/A N/A N/A N/A N/A
Burinex 199138 bumetanide Leo Pharma Inc N/A N/A N/A N/A N/A N/A N/A
Caprelsa 198802 vandetanib Sanofi Genzyme, A Division Of Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A N/A
Caripul 197550 epoprostenol sodium Actelion Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A
Clindamycin IV Infusion 197403 clindamycin phosphate Sandoz Canada Incorporated N/A N/A N/A
Combivir 197907 zidovudine, lamivudine Viiv Healthcare Ulc N/A N/A N/A N/A
Depo-Provera 198801 medroxyprogesterone acetate Pfizer Canada Inc N/A
Dexilant 197719 dexlansoprazole Takeda Canada Inc N/A N/A N/A N/A
Duratocin 190823 carbetocin Ferring Inc N/A N/A
Durela 196227 tramadol HCl Cipher Pharmaceuticals Inc
Exjade 191351 deferasirox Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Ferrlecit 195781 sodium ferric gluconate complex in sucrose injection Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A N/A
Forxiga 198838 dapagliflozin Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Fycompa 194525 perampanel Eisai Limited N/A N/A N/A N/A
Genvoya 198272 emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc N/A N/A N/A N/A N/A
Gilenya 198247 fingolimod hydrochloride Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A
Hp-Pac 197727 amoxicillin, clarithromycin, lansoprazole Takeda Pharmaceuticals America Inc N/A N/A N/A N/A
Imodium Calming Liquid, Imodium Caplets, Imodium Liqui-Gels, Imodium Quick Dissolve 198609 loperamide HCl Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc N/A N/A N/A N/A
Imodium Complete Caplets, Imodium Complete Chewable Tablets 198510 loperamide HCl, simethicone Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc N/A N/A N/A N/A
Istodax 199398 romidepsin Celgene Inc N/A N/A N/A N/A N/A N/A
Jentadueto 198478 metformin HCl, linagliptin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A
Kivexa 197786 lamivudine, abacavir sulfate Viiv Healthcare Ulc N/A N/A N/A
Kyprolis 194999 carfilzomib Amgen Canada Inc N/A N/A N/A N/A N/A N/A
Lotensin 197116 benazepril HCl Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Lyrica 198215 pregabalin Pfizer Canada Inc N/A N/A N/A N/A N/A N/A N/A
Mekinist 197849 trametinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A
Methotrexate 198792 methotrexate sodium Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Movantik 198089 naloxegol oxalate Astrazeneca Canada Inc N/A N/A N/A
Neurontin 198809 gabapentin Pfizer Canada Inc N/A N/A N/A N/A N/A
Olmetec 198091 olmesartan  medoxomil Merck Canada Inc N/A N/A N/A N/A N/A N/A
Olmetec Plus 198164 hydrochlorothiazide, olmesartan  medoxomil Merck Canada Inc N/A N/A N/A N/A N/A N/A
Panto IV 197721 pantoprazole sodium sesquihydrate Takeda Canada Inc N/A N/A N/A N/A
Pantoloc 197723 pantoprazole Takeda Canada Inc N/A N/A N/A N/A
Pariet 197710 rabeprazole Janssen Inc N/A N/A N/A N/A
Plavix 199386 clopidogrel bisulfate Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Ralivia 196236 tramadol HCl Valeant Canada Lp Valeant Canada S.E.C.
Remeron 197879 mirtazapine Merck Canada Inc N/A N/A N/A N/A N/A N/A
Remeron Rd 197936 mirtazapine Merck Canada Inc N/A N/A N/A N/A N/A N/A
Retrovir (Azt) 197908 zidovudine Viiv Healthcare Ulc N/A N/A N/A N/A N/A
Revlimid 190743 lenalidomide Celgene Inc N/A N/A N/A
Serophene 189606 clomiphene citrate Emd Serono Z Division Of Emd Inc Canada N/A N/A N/A N/A
Sonovue 189455 sulfur hexafluoride Bracco Imaging Canada N/A N/A N/A
Suboxone 195433 buprenorphine hydrochloride, naloxone hydrochloride dihydrate Indivior Uk Limited
Tafinlar 197867 dabrafenib Novartis Pharmaceuticals Canada Inc N/A N/A N/A
Tecta 197724 pantoprazole magnesium Takeda Canada Inc N/A N/A N/A N/A
Topamax 198204 topiramate Janssen Inc N/A N/A N/A N/A
Torisel 199380 temsirolimus Pfizer Canada Inc N/A N/A N/A N/A N/A
Trajenta 198479 linagliptin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A
Tridural 196232 tramadol HCl Paladin Labs Inc
Triumeq 197843 lamivudine, abacavir sulfate, dolutegravir sodium Viiv Healthcare Ulc N/A N/A N/A N/A
Trizivir 197841 zidovudine, lamivudine, abacavir sulfate Viiv Healthcare Ulc N/A N/A N/A N/A
Ultibro Breezhaler 198299 glycopyrronium bromide, indacaterol maleate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A
Viacoram 198962 perindopril arginine, amlodipine Servier Canada Inc N/A N/A N/A N/A
Vimpat 198678 lacosamide Ucb Canada Inc N/A N/A N/A N/A
Votrient 198325 pazopanib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Xalkori 198487 crizotinib Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Xigduo 198902 metformin HCl, dapagliflozin Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Ziagen 197787 abacavir sulfate Viiv Healthcare Ulc N/A N/A N/A N/A
Zocor 197663 simvastatin Merck Canada Inc N/A N/A N/A N/A
Zocor 199039 simvastatin Merck Canada Inc N/A N/A N/A N/A N/A
Zyprexa, Zyprexa Zydis, Zyprexa Intramuscular 198327 olanzapine, olanzapine tartrate Eli Lilly Canada Inc N/A N/A N/A N/A N/A
Zytram XL 196235 tramadol HCl Purdue Pharma

November 2016

(PDF Version - 119K)

Product Monograph Brand Safety Updates November 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Accutane Roche 198170 isotretinoin Hoffmann La Roche Limited N/A N/A N/A N/A N/A N/A N/A
Adcirca 197483 tadalafil Eli Lilly Canada Inc N/A N/A N/A N/A N/A N/A
Amerge 195190 naratriptan HCl GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A N/A
Apo-Doxy, Apo-Doxy-Tabs 194708 doxycycline hyclate Apotex Inc N/A N/A
Arcosyl 197113 perindopril arginine Servier Canada Inc N/A N/A N/A N/A N/A N/A
Casodex 198469 bicalutamide Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Cialis 197461 tadalafil Eli Lilly Canada Inc N/A N/A N/A N/A N/A N/A
Codeine Contin 196233 codeine sulfate Purdue Pharma
Cubicin 197629 daptomycin Cubist Pharmaceuticals LLC N/A N/A N/A N/A N/A N/A
Cysview 193861 hexaminolevulinate hydrochloride Biosyent Pharma Inc N/A N/A N/A N/A N/A
Daklinza 189820 daclatasvir Bristol-Myers Squibb Canada N/A N/A
Dexilant 194184 dexlansoprazole Takeda Canada Inc N/A N/A N/A N/A N/A N/A
Diabeta 197357 glyburide Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A
Dilaudid HP 195097 hydromorphone HCl Purdue Pharma
Erivedge 196987 vismodegib Hoffmann La Roche Limited N/A N/A N/A
Faslodex 197757 fulvestrant Astrazeneca Canada Inc N/A N/A N/A N/A
Fibristal 190760 ulipristal acetate Actavis Specialty Pharmaceuticals Co N/A N/A N/A
Flagyl 197442 metronidazole Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A
Flagystatin 197434 metronidazole, nystatin Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Galexos 190665 simeprevir Janssen Inc N/A N/A N/A
Holkira Pak 190518 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie Corporation N/A N/A N/A N/A N/A
Intralipid 10%, Intralipid 20%, Intralipid 30% 196682 soybean oil Fresenius Kabi Canada Ltd N/A N/A N/A
Iopidine 197019 apraclonidine HCl Alcon Canada Inc N/A N/A
Losec 197703 omeprazole, omeprazole magnesium Astrazeneca Canada Inc N/A N/A N/A N/A
Marvelon 197331 desogestrel, ethinyl estradiol Merck Canada Inc N/A N/A N/A N/A N/A
Mavik 197753 trandolapril BGP Pharma ULC N/A N/A N/A N/A N/A
Movantik 193483 naloxegol Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Nexium 197707 esomeprazole Astrazeneca Canada Inc N/A N/A N/A N/A
Nuvaring 197333 ethinyl estradiol, etonogestrel Merck Canada Inc N/A N/A N/A N/A
Ofev 196957 nintedanib Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A
Paxil 195493 paroxetine HCl GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A
Paxil CR 195495 paroxetine HCl GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A
Picato 198249 ingenol mebutate Leo Pharma Inc N/A N/A N/A N/A N/A
Plan B 190655 levonorgestrel Teva Branded Pharmaceutical Products R&D Inc N/A N/A N/A N/A N/A N/A
Revolade 198151 eltrombopag olamine Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Saphris 190584 asenapine Merck Canada Inc N/A N/A N/A N/A N/A N/A
Signifor Lar 189699 pasireotide Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Talwin 195187 pentazocine HCl Sanofi-Aventis Canada Inc
Technivie 197870 ritonavir, paritaprevir, ombitasvir Abbvie Corporation N/A N/A N/A N/A N/A N/A
Thalomid 198336 thalidomide Celgene Inc N/A N/A N/A N/A N/A
Tobramycin Injection 197545 tobramycin Fresenius Kabi Canada Ltd N/A N/A N/A N/A
Toloxin 196770 digoxin Pendopharm Division of Pharmascience Inc N/A N/A N/A N/A N/A N/A
Treanda 188195 bendamustine hydrochloride Lundbeck Canada Inc N/A N/A N/A N/A N/A
Vidaza 197742 azacitidine Celgene Corporation N/A N/A N/A N/A N/A N/A
Vimovo 197709 naproxen, esomeprazole magnesium trihydrate Astrazeneca Canada Inc N/A N/A N/A N/A

October 2016

(PDF Version - 77K)

Product Monograph Brand Safety Updates October 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Abilify Maintena 188748 aripiprazole Otsuka Pharmaceutical Co Ltd N/A N/A N/A N/A
Abstral 194811 fentanyl citrate Paladin Labs Inc
Cardizem CD 196868 diltiazem HCl Valeant Canada LP Valeant Canada S.E.C. N/A N/A N/A
Champix 188898 varenicline tartrate Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Clindets 192195 clindamycin GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A
Clozaril 196471 clozapine HLS Therapeutics Inc N/A N/A N/A N/A N/A N/A
Depakene 197328 valproic acid BGP Pharma ULC N/A N/A
Diamicron 197558 gliclazide Servier Canada Inc N/A N/A N/A N/A N/A N/A
Diamicron MR 197557 gliclazide Servier Canada Inc N/A N/A N/A N/A N/A
Digoxin Injection C.S.D., Pediatric Digoxin Injection C.S.D. 196778 digoxin Sandoz Canada Incorporated N/A N/A N/A N/A N/A N/A
Dilaudid 195096 hydromorphone HCl Purdue Pharma
Eligard 196408 leuprolide acetate Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Epival 196507 divalproex sodium BGP Pharma ULC N/A N/A
Fentanyl Citrate Injection USP 194813 fentanyl citrate Hospira Healthcare Corporation
Fentora 194812 fentanyl citrate Teva Canada Limited
Forane 194452 isoflurane Baxter Corporation N/A N/A N/A N/A
Holkira PAK 197939 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie Corporation N/A N/A N/A
Invokamet 196792 metformin HCl, canagliflozin Janssen Inc N/A N/A N/A N/A N/A
Invokana 196794 canagliflozin Janssen Inc N/A N/A N/A N/A N/A N/A
Janumet, Janumet XR 189405 metformin HCl, sitagliptin phosphate monohydrate Merck Canada Inc N/A N/A N/A N/A N/A
Januvia 189383 sitagliptin phosphate monohydrate Merck Canada Inc N/A N/A N/A N/A N/A
Juxtapid 194945 lomitapide mesylate Aegerion Pharmaceuticals Canada Ltd N/A N/A N/A N/A
Kuvan 186959 sapropterin dihydrochloride Biomarin Pharmaceutical Inc N/A N/A N/A N/A
Lamictal 194353 lamotrigine GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A N/A
Megace OS 195954 megestrol acetate Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A N/A
Naproxen Liquid Gel Capsules 197381 naproxen, naproxen sodium Mcneil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A N/A
Natesto 195395 testosterone Acerus Pharmaceuticals SRL N/A N/A N/A N/A N/A N/A N/A
Nucynta IR 195181 tapentadol hydrochloride Janssen Inc
Oxy.IR 194806 oxycodone HCl Purdue Pharma
Remeron 193516 mirtazapine Merck Canada Inc N/A N/A N/A N/A N/A N/A N/A
Remeron RD 193523 mirtazapine Merck Canada Inc N/A N/A N/A N/A N/A N/A N/A
Rythmodan 196675 disopyramide Sanofi-Aventis Canada Inc N/A N/A N/A
Stribild 196911 emtricitabine, tenofovir disoproxil fumarate, elvitegravir, cobicistat Gilead Sciences Canada Inc N/A N/A N/A N/A N/A N/A
Truvada 196830 emtricitabine, tenofovir disoproxil fumarate Gilead Sciences Canada Inc N/A N/A N/A N/A N/A
Viracept 197422 nelfinavir mesylate Pfizer Canada Inc N/A N/A
Viread 196890 tenofovir disoproxil fumarate Gilead Sciences Canada Inc N/A N/A N/A N/A N/A N/A
Voltaren Emulgel Joint Pain 196570 diclofenac diethylamine GlaxoSmithKline Consumer Healthcare Inc N/A N/A N/A
Voltaren Emulgel, Voltaren Emulgel Extra Strength 196568 diclofenac diethylamine GlaxoSmithKline Consumer Healthcare Inc N/A N/A N/A
Xeljanz 197115 tofacitinib Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Xyrem 196511 sodium oxybate Valeant Canada LP Valeant Canada S.E.C. N/A N/A N/A N/A

September 2016

(PDF Version - 117K)

Product Monograph Brand Safety Updates September 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Afinitor 188334 everolimus Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A
Bosulif 195997 bosutinib Pfizer Canada Inc N/A N/A N/A N/A N/A
Canesten Comfortab 3 188128 clotrimazole Bayer Inc Consumer Care N/A N/A N/A N/A N/A
Clasteon 195971 clodronate disodium Sunovion Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Clolar 195475 clofarabine Sanofi-Aventis Canada Inc N/A N/A N/A
Depo-Medrol (with preservative), Depo-Medrol 193764 methylprednisolone acetate Pfizer Canada Inc N/A
Depo-Medrol with Lidocaine 193798 lidocaine HCl, methylprednisolone acetate Pfizer Canada Inc N/A
Dilantin 196056 phenytoin sodium Pfizer Canada Inc N/A N/A N/A N/A N/A
Dilantin - 30 Suspension, Dilantin - 125 Suspension, Dilantin Infatabs 196033 phenytoin Pfizer Canada Inc N/A N/A N/A N/A N/A
Edarbyclor 195494 chlorthalidone, azilsartan medoxomil Valeant Canada LP Valeant Canada S.E.C. N/A N/A
Entrophen, Entrophen Chewable, Entrophen 325 mg Tablets, Entrophen 325 mg Caplets 191533 acetylsalicylic acid Pendopharm Division of Pharmascience Inc N/A N/A N/A N/A N/A N/A
Extraneal 195522 calcium chloride, magnesium chloride, sodium chloride, sodium lactate, icodextrin Baxter Corporation N/A N/A N/A N/A N/A
Famvir 196268 famciclovir Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Faslodex 195194 fulvestrant Astrazeneca Canada Inc N/A N/A N/A N/A N/A
Imbruvica 194722 ibrutinib Janssen Inc N/A N/A N/A N/A N/A
Jardiance 196523 empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A
Keppra 195211 levetiracetam UCB Canada Inc N/A N/A N/A N/A N/A
Komboglyze 195708 metformin HCl, saxagliptin Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Lasix Oral Solution 196514 furosemide Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Lasix Special 196515 furosemide Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Metvix 193502 methyl aminolevulinate hydrochloride Galderma Canada Inc N/A N/A N/A N/A N/A
Nighttime Cold, Cough And Flu 192563 diphenhydramine HCl, ibuprofen Apotex Inc N/A N/A N/A N/A N/A N/A N/A
Novo-Salbutamol HFA 189999 salbutamol sulfate Teva Canada Limited N/A N/A
Onglyza 195704 saxagliptin Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Pomalyst 195645 pomalidomide Celgene Inc N/A N/A N/A N/A N/A
Prefesta 194575 estradiol, norgestimate Searchlight Pharma Inc N/A N/A N/A N/A N/A
Reyataz 196912 atazanavir sulfate Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A N/A
Sandostatin LAR 196642 octreotide acetate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Seebri Breezhaler 196095 glycopyrronium bromide Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Solu-Medrol 194272 methylprednisolone hemisuccinate Pfizer Canada Inc N/A
Tecfidera 196304 dimethyl fumarate Biogen Canada Inc N/A N/A N/A N/A
Thalomid 180988 thalidomide Celgene Inc N/A N/A N/A N/A N/A
Travatan Z 196444 travoprost Alcon Canada Inc N/A N/A N/A
Vfend 196793 voriconazole Pfizer Canada Inc N/A N/A N/A N/A N/A N/A N/A
Voltaren Ophtha 193966 diclofenac sodium Alcon Canada Inc N/A N/A N/A N/A
Vyvanse 181720 lisdexamfetamine dimesylate Shire Pharma Canada ULC N/A N/A N/A N/A
Xtandi 188577 enzalutamide Astellas Pharma Canada Inc N/A N/A N/A N/A
Yondelis 194563 trabectedin Janssen Inc N/A N/A N/A N/A N/A N/A
Zydelig 194004 idelalisib Gilead Sciences Canada Inc N/A N/A
Zykadia 194492 ceritinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A

August 2016

(PDF Version -75K)

Product Monograph Brand Safety Updates August 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Avelox, Avelox IV 194225 Moxifloxacin Hydrochloride Bayer Inc N/A N/A N/A N/A N/A N/A
Azopt 195439 Brinzolamide Alcon Canada Inc N/A N/A N/A N/A N/A N/A N/A
Butrans 194686 Buprenorphine Purdue Pharma N/A N/A N/A N/A N/A N/A N/A
Cardura 195152 Doxazosin Mesylate Pfizer Canada Inc N/A N/A N/A N/A
Ciprodex 195747 Dexamethasone, Ciprofloxacin Alcon Canada Inc N/A N/A N/A N/A N/A N/A
Copaxone 186047 Glatiramer Acetate Teva Canada Limited N/A N/A N/A
Coversyl Plus 187041 Perindopril Erbumine, Indapamide Servier Canada Inc N/A N/A N/A N/A N/A N/A
Cytosar 194840 Cytarabine Pfizer Canada Inc N/A N/A N/A N/A N/A N/A N/A
Entresto 195332 Valsartan, Sacubitril Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Estragyn Vaginal Cream 195579 Estrone Searchlight Pharma Inc N/A N/A N/A N/A N/A N/A N/A
Evotaz 195706 Atazanavir Sulfate, Cobicistat Bristol-Myers Squibb Canada N/A N/A N/A N/A
Ferrlecit 195206 Sodium Ferric Gluconate Complex in Sucrose Injection Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Flonase 194417 Fluticasone Propionate Glaxosmithkline Inc N/A N/A N/A N/A
Forxiga 194091 Dapagliflozin AstraZeneca Canada Inc N/A N/A N/A N/A
Giotrif 187656 Afatinib Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A
Gleevec 195215 Imatinib Mesylate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Inomax 195633 Nitric Oxide INO Therapeutics N/A N/A N/A N/A N/A
Invokana 194078 Canagliflozin Janssen Inc N/A N/A N/A N/A
Jardiance 194090 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A
Lenvima 194919 Lenvatinib Mesylate Eisai Limited N/A N/A N/A N/A N/A
Lescol, Lescol XL 195234 Fluvastatin Sodium Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Medrol 193759 Methylprednisolone Pfizer Canada Inc N/A N/A N/A
Mefloquine 192237 Mefloquine HCl AA Pharma Inc N/A N/A
Monurol 193809 Fosfomycin Tromethamine Paladin Labs Inc N/A N/A N/A N/A N/A N/A N/A
Norvasc 195429 Amlodipine Besylate Pfizer Canada Inc N/A N/A N/A N/A N/A N/A N/A
Pradaxa 194941 Dabigatran Etexilate Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A
Prezista 188263 Darunavir Ethanolate Janssen Inc N/A N/A N/A
Prinivil 194510 Lisinopril Merck Canada Inc N/A N/A N/A N/A N/A N/A N/A
Pristiq 194783 Desvenlafaxine Succinate Pfizer Canada Inc N/A N/A N/A N/A N/A
Prometrium 194573 Progesterone Merck Canada Inc N/A N/A N/A N/A N/A
Sensipar 194491 Cinacalcet Hydrochloride Amgen Canada Inc N/A N/A N/A N/A N/A N/A
Signifor LAR 194062 Pasireotide Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Singulair 195377 Montelukast Sodium Merck Canada Inc N/A N/A N/A N/A N/A N/A
Solu-Medrol, Solu-Medrol Act-O-Vials 195651 Methylprednisolone Sodium Succinate Pfizer Canada Inc N/A N/A N/A N/A
Sprycel 195287 Dasatinib Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A
Symbicort Turbuhaler 194760 Budesonide, Formoterol Fumarate Dihydrate AstraZeneca Canada Inc N/A N/A N/A N/A N/A N/A
Tasigna 195243 Nilotinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Xalatan 195072 Latanoprost Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Xeloda 194861 Capecitabine Hoffmann-La Roche Limited N/A N/A N/A N/A N/A N/A
Xigduo 194093 Metformin HCl, Dapagliflozin AstraZeneca Canada Inc N/A N/A N/A N/A
Zerbaxa 195705 Tazobactam Sodium, Ceftolozane Sulfate Merck Canada Inc N/A N/A N/A N/A N/A N/A
Zoladex, Zoladex LA 194119 Goserelin Acetate AstraZeneca Canada Inc N/A N/A N/A N/A N/A
Zometa Concentrate 194820 Zoledronic Acid Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Zyban 194844 Bupropion HCl Valeant Canada LP Valeant Canada S.E.C. N/A N/A N/A N/A
Zytiga 191178 Abiraterone Acetate Janssen Inc N/A N/A N/A N/A N/A N/A

July 2016

(PDF Version -79K)

Product Monograph Brand Safety Updates July 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Adalat XL 194331 Nifedipine Bayer Inc N/A N/A N/A N/A
Allegra-D 194147 Pseudoephedrine HCl, Fexofenadine HCl Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A N/A
Bactroban 194465 Mupirocin GlaxoSmithKline Consumer Healthcare Inc N/A N/A N/A N/A
Bactroban Cream 194464 Mupirocin GlaxoSmithKline Consumer Healthcare Inc N/A N/A N/A N/A
Caelyx 194526 Doxorubicin HCl Janssen Inc N/A N/A N/A N/A N/A N/A
Caprelsa 194111 Vandetanib Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Celebrex 187485 Celecoxib Pfizer Canada Inc N/A N/A N/A
Cisplatin Injection 194668 Cisplatin Hospira Healthcare Corporation N/A N/A N/A N/A
Claritin Kids 190569 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A N/A
Complera 194358 Emtricitabine, Tenofovir Disoproxil Fumarate, Rilpivirine Hydrochloride Gilead Sciences Canada Inc N/A N/A N/A N/A N/A N/A
Conray 30, Conray 43, Conray 60 195030 Iothalamate Meglumine Leiner Health Products Inc, Liebel-Flarsheim Canada Inc N/A N/A N/A N/A N/A N/A
Cymbalta 192853 Duloxetine HCl Eli Lilly Canada Inc N/A N/A N/A N/A N/A N/A
Diamicron 193245 Gliclazide Servier Canada Inc N/A N/A N/A N/A
Diamicron MR 193244 Gliclazide Servier Canada Inc N/A N/A N/A N/A
Effexor XR 192644 Venlafaxine HCl Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Exelon 194254 Rivastigmine Hydrogen Tartrate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A
Exelon Patch 194302 Rivastigmine Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Flarex 193208 Fluorometholone Acetate Alcon Canada Inc N/A N/A N/A N/A N/A N/A
Heptovir 196237 Lamivudine GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A N/A
HP-Pac 194123 Amoxicillin, Clarithromycin, Lansoprazole Takeda Pharmaceuticals America Inc N/A N/A N/A N/A N/A
Imbruvica 190730 Ibrutinib Janssen Inc N/A N/A N/A N/A
Jadenu 194378 Deferasirox Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Janumet, Janumet XR 195266 Metformin HCl, Sitagliptin Merck Canada Inc N/A N/A N/A N/A N/A N/A
Januvia 195337 Sitagliptin Phosphate Monohydrate Merck Canada Inc N/A N/A N/A N/A N/A N/A
Jardiance 190736 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A
Kaletra 187436 Ritonavir, Lopinavir Abbvie Corporation N/A N/A
Lasix Oral Solution 193797 Furosemide Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Lasix Special 193757 Furosemide Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Losec 194504 Omeprazole, Omeprazole Magnesium AstraZeneca Canada Inc N/A N/A N/A N/A N/A
Luvox 192638 Fluvoxamine Maleate BGP Pharma ULC N/A N/A N/A N/A N/A N/A
Mepron 188021 Atovaquone GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A N/A
Methotrexate 186635 Methotrexate Sodium Pfizer Canada Inc N/A N/A
Nitroglycerin in 5% Dextrose Injection 192761 Nitroglycerin, Dextrose Anhydrous Baxter Corporation N/A N/A
Norvir 187473 Ritonavir Abbvie Corporation N/A N/A
Pediapred 194274 Prednisolone Phosphate Sodium Sanofi-Aventis Canada Inc N/A N/A N/A N/A
Pediapred 194862 Prednisolone Sodium Phosphate Sanofi-Aventis Canada Inc N/A N/A N/A
Pepcid Complete 194117 Calcium Carbonate, Famotidine, Magnesium Hydroxide McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A
Pristiq 192643 Desvenlafaxine Succinate Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Prozac 192639 Fluoxetine HCl Eli Lilly Canada Inc N/A N/A N/A N/A N/A N/A
Reactine Complete 192151 Cetirizine Hydrochloride, Pseudoephedrine HCl McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A
Revolade 194226 Eltrombopag Olamine Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A
Saphris 186897 Asenapine Merck Canada Inc N/A N/A N/A N/A
Selexid 178013 Pivmecillinam HCl Leo Pharma Inc N/A
Sovaldi 192837 Sofosbuvir Gilead Sciences Canada Inc N/A N/A N/A N/A N/A N/A
Staxyn 195312 Vardenafil Hydrochloride Bayer Inc N/A N/A N/A
Striverdi Respimat 191601 Olodaterol Hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A N/A
Tarceva 194541 Erlotinib Hydrochloride Hoffmann-La Roche Limited N/A N/A N/A N/A N/A N/A
Tenoretic 190685 Atenolol, Chlorthalidone AstraZeneca Canada Inc N/A N/A N/A N/A N/A N/A
Tenormin 190682 Atenolol AstraZeneca Canada Inc N/A N/A N/A N/A N/A N/A
Tobradex 194015 Dexamethasone, Tobramycin Alcon Canada Inc N/A N/A N/A N/A N/A
Trelstar 189866 Triptorelin Pamoate Allergan Pharma Co. N/A N/A N/A N/A N/A N/A
Trosec 193424 Trospium Chloride Sunovion Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Yondelis 193606 Trabectedin Janssen Inc N/A N/A N/A N/A
Zantac Tab 75 mg, Zantac Maximum Strength Non-Prescription Tablets 194126 Ranitidine HCl McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A
Zepatier 193658 Grazoprevir, Elbasvir Merck Canada Inc N/A N/A N/A N/A
Zithromax 192780 Azithromycin Dihydrate Pfizer Canada Inc N/A N/A N/A N/A N/A
Zoloft 192642 Sertraline HCl Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Zyban 192854 Bupropion HCl Valeant Canada LP Valeant Canada S.E.C. N/A N/A N/A N/A N/A N/A

June 2016

(PDF Version -82K)

Product Monograph Brand Safety Updates July 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Activelle 193378 norethindrone acetate, estradiol hemihydrate Novo Nordisk Canada Inc N/A N/A N/A N/A
Activelle LD 193505 norethindrone acetate, estradiol hemihydrate Novo Nordisk Canada Inc N/A N/A N/A N/A N/A
Advair, Advair Diskus 185411 fluticasone propionate, salmeterol xinafoate GlaxoSmithKline Inc N/A N/A N/A N/A N/A
Alomide 192491 lodoxamide tromethamine Alcon Canada Inc N/A
Anandron 193850 nilutamide Sanofi-Aventis Canada Inc N/A N/A N/A N/A
Apo-Bisoprolol 190664 bisoprolol fumarate Apotex Inc N/A N/A N/A N/A N/A N/A
Busulfex 190897 busulfan Otsuka Pharmaceutical Co Ltd N/A N/A N/A N/A
Caverject 193414 alprostadil Pfizer Canada Inc N/A N/A N/A N/A N/A
Celexa 192636 citalopram hydrobromide Lundbeck Canada Inc N/A N/A N/A N/A N/A N/A
Cipralex 192637 escitalopram oxalate, escitalopram Lundbeck Canada Inc N/A N/A N/A N/A N/A N/A
Combivent Respimat 192183 ipratropium bromide, salbutamol Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A
Concerta 195814 methylphenidate HCl Janssen Inc N/A N/A N/A N/A
Dalacin C 192185 clindamycin HCl Pfizer Canada Inc N/A N/A N/A N/A N/A
Dalacin C Phosphate 192190 clindamycin phosphate Pfizer Canada Inc N/A N/A N/A N/A N/A
Dalacin T 192193 clindamycin phosphate Pfizer Canada Inc N/A N/A N/A N/A N/A
Dalacin Vaginal Cream 192194 clindamycin phosphate Pfizer Canada Inc N/A N/A N/A N/A N/A
Depo-Provera, Depo-Provera - SC 191629 medroxyprogesterone acetate Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Duodopa 193087 levodopa, carbidopa monohydrate Abbvie Corporation N/A N/A N/A N/A N/A
Eliquis 184464 apixaban Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A
Flovent Diskus, Flovent HFA 185395 fluticasone propionate GlaxoSmithKline Inc N/A N/A N/A N/A N/A
Harvoni 190246 ledipasvir, sofosbuvir Gilead Sciences Canada Inc N/A N/A N/A
Holkira Pak 192923 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie Corporation N/A N/A N/A N/A N/A N/A
Inspiolto Respimat 191398 tiotropium bromide monohydrate, olodaterol hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A
Intuniv XR 193758 guanfacine HCl Shire Pharma Canada ULC N/A N/A N/A N/A
Invega Trinza 185929 paliperidone palmitate Janssen Inc
Invokana 193242 canagliflozin Janssen Inc N/A N/A N/A N/A N/A
Jardiance 192785 empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A
Jevtana 193235 cabazitaxel Sanofi-Aventis Canada Inc N/A N/A N/A
Latisse 193534 bimatoprost Allergan Inc N/A N/A N/A N/A N/A N/A
Myrbetriq 192447 mirabegron Astellas Pharma Canada Inc N/A N/A N/A N/A N/A N/A
Nadolol 190672 nadolol Aa Pharma Inc N/A N/A N/A N/A N/A N/A
Oxeze Turbuhaler 185400 formoterol fumarate dihydrate Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A
Periolimel 2.5% E, Olimel 3.3%E, Olimel 4.4%, Olimel 4.4% E, Olimel 5.7%, Olimel 5.7% E 193319 alanine, l-aspartic acid, dextrose, calcium chloride, glutamic acid, glycine, histidine, l-arginine, l-isoleucine, l-leucine, l-phenylalanine, l-proline, l-threonine, l-valine, lysine acetate, magnesium chloride,  l-methionine, olive oil, potassium chloride, serine, sodium glycerophosphate, soybean oil, tryptophan, l-tyrosine, sodium acetate trihydrate Baxter Corporation N/A N/A N/A N/A
Picato 191625 ingenol mebutate Leo Pharma Inc N/A N/A N/A N/A N/A N/A
Precedex 192779 dexmedetomidine HCl Hospira Healthcare Corporation N/A N/A N/A N/A N/A N/A
Rasilez 192713 aliskiren fumarate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Rasilez HCT 192711 hydrochlorothiazide, aliskiren fumarate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A
Revolade 192244 eltrombopag olamine Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Rhinocort Aqua 192246 budesonide Astrazeneca Canada Inc N/A N/A
Spiriva Respimat 191395 tiotropium bromide monohydrate Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A N/A
Technivie 192731 ritonavir, paritaprevir, ombitasvir Abbvie Corporation N/A N/A N/A N/A N/A N/A
Tivicay 195180 dolutegravir sodium Viiv Healthcare ULC N/A N/A N/A N/A N/A N/A N/A
Trandate 190689 labetalol HCl Paladin Labs Inc N/A N/A N/A N/A N/A N/A
Uptravi 193755 selexipag Actelion Pharmaceuticals Ltd N/A N/A
Vancocin 182113 vancomycin Merus Labs International Inc N/A N/A
Voltaren Rapide 193384 diclofenac potassium Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A
Voltaren, Voltaren SR 193614 diclofenac sodium Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A
Vyvanse 194040 lisdexamfetamine dimesylate Shire Pharma Canada ULC N/A N/A N/A
Yaz 189056 ethinyl estradiol, drospirenone Bayer Inc N/A N/A N/A N/A N/A N/A N/A
Zytiga 192721 abiraterone acetate Janssen Inc N/A N/A N/A
Table - Product Monograph Brand Safety Updates May 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Afinitor 188629 everolimus Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Apo-Zidovudine-Lamivudine-Nevirapine 193373 zidovudine, lamivudine, nevirapine Apotex Inc
Atarax Syrup 183332 hydroxyzine HCl Erfa Canada 2012 Inc N/A
Biaxin, Biaxin XL, Biaxin Bid 191336 clarithromycin BGP Pharma ULC N/A N/A N/A N/A
Brevibloc Injection, Brevibloc Premixed Injection 190667 esmolol HCl Baxter Corporation N/A N/A N/A N/A N/A N/A
Brilinta 184666 ticagrelor AstraZeneca Canada Inc N/A N/A
Bystolic 190670 nebivolol HCl Forest Laboratories Canada Inc N/A N/A N/A N/A N/A N/A
Cancidas 192019 caspofungin acetate Merck Canada Inc N/A N/A N/A N/A N/A N/A N/A
Colchicine 190129 colchicine Odan Laboratories Ltd N/A N/A N/A N/A
Concerta 185399 methylphenidate HCl Janssen Inc N/A N/A N/A N/A N/A
Coumadin 191315 warfarin sodium Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A
Cyclomen 191891 danazol Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Daklinza 189173 daclatasvir Bristol-Myers Squibb Canada N/A N/A N/A
Edurant 185031 rilpivirine hydrochloride Janssen Inc N/A N/A N/A N/A
Ella 188121 ulipristal acetate Laboratoire HRA Pharma N/A N/A N/A N/A N/A N/A N/A
Esbriet 184128 pirfenidone Hoffmann La Roche Limited N/A N/A N/A N/A N/A N/A
Extra Strength Tylenol Nighttime 192759 acetaminophen, diphenhydramine HCl McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A
Finacea 192498 azelaic acid Bayer Inc N/A N/A N/A N/A
Forxiga 191977 dapagliflozin AstraZeneca Canada Inc N/A N/A N/A N/A
Iclusig 191981 ponatinib hydrochloride Ariad Pharmaceuticals Inc N/A N/A N/A N/A
Inderal-La 190671 propranolol HCl Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Jalyn 190261 tamsulosin hydrochloride, dutasteride GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A
Lamisil 192408 terbinafine HCl Novartis Pharmaceuticals Canada Inc N/A N/A
Latuda 189779 lurasidone hydrochloride Sunovion Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Lincocin 192468 lincomycin HCl Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Lopresor 190663 metoprolol tartrate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Lumigan RC 193230 bimatoprost Allergan Inc N/A N/A N/A N/A N/A N/A
Lutrepulse 187199 gonadorelin acetate Ferring Inc N/A N/A N/A N/A N/A
Mekinist 185328 trametinib Novartis Pharmaceuticals Canada Inc N/A N/A
Motrimax 12 Hour Back & Body 192978 naproxen, naproxen sodium McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A N/A
Myfortic 190737 mycophenolate sodium Novartis Pharmaceuticals Canada Inc N/A N/A N/A
PMS-Carvedilol 190681 carvedilol Pharmascience Inc N/A N/A
Posanol 192829 posaconazole Merck Canada Inc N/A N/A N/A N/A N/A
Primaquine 192430 primaquine phosphate Sanofi-Aventis Canada Inc N/A N/A N/A N/A
Tafinlar 185149 dabrafenib Novartis Pharmaceuticals Canada Inc N/A N/A N/A
Taxotere 192429 docetaxel Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A
Temodal 192796 temozolomide Merck Canada Inc N/A N/A N/A N/A N/A
Tobradex 193340 dexamethasone, tobramycin Alcon Canada Inc N/A
Tobrex, Tobrexan 193426 tobramycin Alcon Canada Inc N/A N/A N/A
Tramacet 190825 acetaminophen, tramadol HCl Janssen Inc
Vagifem 10 192241 estradiol hemihydrate Novo Nordisk Canada Inc N/A N/A N/A N/A
Vigamox 192490 moxifloxacin hydrochloride Alcon Canada Inc N/A N/A N/A N/A N/A
Viracept 190648 nelfinavir mesylate Pfizer Canada Inc N/A N/A N/A N/A N/A
Viskazide 190706 hydrochlorothiazide, pindolol Tribute Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Visken 190690 pindolol Tribute Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A
Xigduo 191838 metformin HCl, dapagliflozin AstraZeneca Canada Inc N/A N/A N/A N/A
Zeldox 192415 ziprasidone hydrochloride monohydrate Pfizer Canada Inc N/A N/A N/A
Zovirax 191703 acyclovir GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A N/A
Zykadia 185683 ceritinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A
Table - Product Monograph Brand Safety Updates April 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
3TC 191518 Lamivudine ViiV Healthcare ULC N/A N/A N/A N/A N/A N/A
Abstral 191389 Fentanyl Citrate Paladin Labs Inc N/A N/A N/A
Afinitor, Afinitor Disperz 184759 Everolimus Novartis Pharmaceuticals Canada Inc N/A N/A N/A
Angiomax 191092 Bivalirudin Sunovion Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Axert 190856 Almotriptan Malate McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A
Carboplatin Injection BP 191679 Carboplatin Hospira Healthcare Corporation N/A N/A N/A N/A N/A
Dovobet 190820 Betamethasone Dipropionate, Calcipotriol Monohydrate Leo Pharma Inc N/A
Emla Cream, Emla Patch 184311 Lidocaine, Prilocaine AstraZeneca Canada Inc N/A N/A N/A N/A N/A
Erivedge 183952 Vismodegib Hoffmann-La Roche Limited N/A N/A N/A
Estragyn Vaginal Cream 190828 Estrone Searchlight Pharma Inc N/A N/A N/A N/A N/A N/A
Evotaz 190773 Atazanavir, Cobicistat Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A
Exjade 191352 Deferasirox Novartis Pharmaceuticals Canada Inc N/A N/A N/A
Genvoya 191108 Emtricitabine, Elvitegravir, Cobicistat, Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc N/A N/A N/A N/A N/A N/A
Holkira Pak 184061 Ritonavir, Paritaprevir, Ombitasvir, Dasabuvir Abbvie Corporation N/A N/A
Kazano 183705 Metformin HCl, Alogliptin Benzoate Takeda Canada Inc N/A N/A N/A N/A N/A N/A N/A
Kazano 183711 Metformin HCl, Alogliptin Benzoate Takeda Canada Inc N/A N/A N/A N/A N/A N/A
Manerix 187463 Moclobemide Valeant Canada LP Valeant Canada S.E.C. N/A N/A N/A N/A N/A N/A
Motrin Liquid Gels
200 mg, Super Strength Motrin IB Liquid Gels
190408 Ibuprofen McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A
Nerisone Cream, Nerisone Oily Cream 189976 Diflucortolone Valerate Glaxosmithkline Inc N/A N/A N/A N/A
Nesina 183700 Alogliptin Benzoate Takeda Canada Inc N/A N/A N/A N/A N/A N/A N/A
Nesina 183709 Alogliptin Benzoate Takeda Canada Inc N/A N/A N/A N/A N/A N/A
Neurontin 192127 Gabapentin Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Parnate 189894 Tranylcypromine Sulfate Glaxosmithkline Inc N/A N/A N/A N/A N/A N/A
Pomalyst 190764 Pomalidomide Celgene Inc N/A N/A N/A N/A N/A N/A
Reyataz 191501 Atazanavir Sulfate Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A
Tivicay 185725 Dolutegravir Sodium Glaxosmithkline Inc N/A N/A N/A N/A N/A N/A N/A
Toctino 183954 Alitretinoin Glaxosmithkline Inc N/A N/A
Tybost 191604 Cobicistat Gilead Sciences Canada Inc N/A N/A N/A N/A
Videx EC 190424 Didanosine Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A
Votrient 190148 Pazopanib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A
Wellbutrin SR 192254 Bupropion HCl, Valeant Canada LP Valeant Canada S.E.C. N/A N/A
Wellbutrin XL 192310 Bupropion HCl, Valeant Canada LP Valeant Canada S.E.C. N/A N/A
Xigduo 191680 Metformin HCl, Dapagliflozin AstraZeneca Canada Inc N/A
Zithromax, Zithromax for Intravenous Injection 190010 Azithromycin Pfizer Canada Inc N/A N/A N/A N/A N/A N/A N/A
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