Product Monograph Brand Safety Updates

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August 2018

Brand Name List Submission Number Ingredient(S) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
Acular, Acular LS 216595 Ketorolac Tromethamine Allergan Inc No No No Yes No No No Yes
Apo-Minocycline 210873 Minocycline Apotex Inc No Yes No No No No No Yes
Atripla 218063 Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine Gilead Sciences LLC Yes No No No Yes No No Yes
Baraclude 217518 Entecavir Bristol-Myers Squibb Canada No No No No No No No Yes
Belkyra 215414 Deoxycholic Acid Allergan Inc No Yes No Yes No No No Yes
Caduet 215359 Amlodipine Besylate, Atorvastatin Calcium Pfizer Canada Inc No No No No Yes No No No
Ceftriaxone Sodium for Injection 211848 Ceftriaxone Sodium Teva Canada Limited No Yes No No No No No Yes
Cefuroxime for Injection, USP 212082 Cefuroxime Sodium Fresenius Kabi Canada Ltd No Yes No No No No No Yes
Ditropan XL 216720 Oxybutynin Chloride Janssen Inc No No No Yes No No Yes No
Edurant 207249 Rilpivirine Hydrochloride Janssen Inc No Yes No Yes No Yes No Yes
Eloxatin 216163 Oxaliplatin Sanofi-Aventis Canada Inc No No No Yes No No No No
Flagyl 217063 Metronidazole Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Flagystatin 215051 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes No No No No No Yes
Flagystatin 217062 Metronidazole, Nystatin Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Flamazine 211660 Silver Sulfadiazine Smith & Nephew Inc No Yes No No No No No Yes
Flarex 215934 Fluorometholone Acetate Novartis Pharmaceuticals Canada Inc No Yes No Yes Yes No No Yes
Fortaz 213619 Ceftazidime Glaxosmithkline Inc No Yes No No No No No Yes
Fosrenol 216237 Lanthanum Carbonate Hydrate Shire Pharma Canada ULC No Yes No No No No No Yes
Intelence 216634 Etravirine Janssen Inc No Yes No No No No No No
Juluca 217811 Rilpivirine Hydrochloride, Dolutegravir Sodium ViiV Healthcare ULC No Yes No Yes No No No Yes
Lamictal 215774 Lamotrigine Glaxosmithkline Inc No Yes No No No No No Yes
Leucovorin Calcium Injection 217983 Leucovorin Calcium Teva Canada Limited No No No No No Yes No No
Lomotil 217009 Atropine Sulfate, Diphenoxylate Hcl Pfizer Canada Inc No Yes No Yes Yes No Yes No
Macrobid 211659 Nitrofurantoin Allergan Pharma Co No Yes No No No No No Yes
Metadol 211399 Methadone Hydrochloride Paladin Labs Inc Yes Yes Yes Yes Yes Yes Yes Yes
Metadol-D 211395 Methadone Hydrochloride Paladin Labs Inc Yes Yes Yes Yes Yes Yes Yes Yes
Ofev 216277 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee No Yes No Yes Yes No No Yes
Onreltea 215929 Brimonidine Tartrate Galderma Canada Inc No Yes No No No Yes No Yes
Orgalutran 216695 Ganirelix Acetate Merck Canada Inc Yes Yes No No No Yes No Yes
Pediapred 218110 Prednisolone Sodium Phosphate Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Pristiq 209469 Desvenlafaxine Succinate Pfizer Canada Inc No Yes No No No No No No
Pylera 211658 Metronidazole, Tetracycline Hcl, Bismuth Subcitrate Potassium Aptalis Pharma Canada ULC No Yes No No No No No Yes
Remifentanil Hydrochloride for Injection 215290 Remifentanil Hcl Sterimax Inc Yes Yes Yes Yes Yes Yes No Yes
Signifor Lar 209345 Pasireotide Novartis Pharmaceuticals Canada Inc Yes Yes Yes Yes Yes Yes No Yes
Spinraza 209005 Nusinersen Biogen Canada Inc No Yes No Yes No No No No
Sufentanil Citrate Injection USP 215292 Sufentanil Citrate Sandoz Canada Incorporated Yes Yes Yes Yes Yes Yes No Yes
Tivicay 217790 Dolutegravir, Dolutegravir Sodium ViiV Healthcare ULC No Yes No Yes No No No Yes
Triumeq 216512 Lamivudine, Dolutegravir, Abacavir ViiV Healthcare ULC No Yes No Yes No No No Yes
Triumeq 217833 Lamivudine, Abacavir Sulfate, Dolutegravir Sodium ViiV Healthcare ULC No Yes No Yes No No No Yes
Vemlidy 209483 Tenofovir Alafenamide Hemifumarate Gilead Sciences Canada Inc No Yes Yes Yes Yes No No Yes
Viberzi 216236 Eluxadoline Allergan Pharma Co No Yes Yes Yes Yes No No Yes
Volulyte 216462 Hydroxyethyl Starch Fresenius Kabi Canada Ltd Yes No No No No No No No
Zeulide Depot 217418 Leuprolide Acetate Pendopharm Division of Pharmascience Inc No No No No No Yes No Yes
Zocor 215663 Simvastatin Merck Canada Inc No No No Yes No No No Yes

July 2018

Brand Name List

Submission Number

Ingredient(S)

Manufacturer

Contraindications

Warnings & Precautions

Serious Warnings & Precautions

Adverse Reactions

Drug Interactions

Dosage & Administration

Overdosage

Consumer Information

Aerius

215387

Desloratadine

Bayer Inc

No

No

No

Yes

No

No

No

Yes

Aerius Dual Action 12 Hour

215390

Pseudoephedrine Sulfate, Desloratadine

Bayer Inc

No

No

No

Yes

No

No

No

Yes

Aerius Kids

215388

Desloratadine

Bayer Inc

No

No

No

Yes

No

No

No

Yes

Apo-Fluconazole-150

215312

Fluconazole

Apotex Inc

No

Yes

No

No

No

No

No

Yes

Blexten

214883

Bilastine

Aralez Pharmaceuticals Trading DAC

No

No

No

Yes

No

No

No

Yes

Canesoral

214931

Fluconazole

Bayer Inc

No

Yes

No

No

No

No

No

Yes

Canesoral Combi-Pak

214932

Clotrimazole, Fluconazole

Bayer Inc

No

Yes

Yes

No

No

No

No

Yes

Cefazolin for Injection

212089

Cefazolin Sodium

Teva Canada Limited

No

Yes

No

No

No

No

No

Yes

Cefoxitin for Injection

212534

Cefoxitin Sodium

Teva Canada Limited

No

Yes

No

No

No

No

No

Yes

Cubicin, Cubicin RF

215429

Daptomycin

Cubist Pharmaceuticals LLC

No

No

No

Yes

No

No

No

No

Dilantin

215484

Phenytoin Sodium

Pfizer Canada Inc

Yes

Yes

No

No

No

No

Yes

No

Dilantin - 30 Suspension, Dilantin - 125 Suspension, Dilantin Infatabs

215486

Phenytoin

Pfizer Canada Inc

Yes

Yes

No

No

No

No

Yes

No

Durezol

215431

Difluprednate

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

Yes

No

No

Yes

Erivedge

215754

Vismodegib

Hoffmann La Roche Limited

No

Yes

No

Yes

No

Yes

No

No

Erythrocin I.V.

215232

Erythromycin Lactobionate

Amdipharm Limited

No

No

No

Yes

No

No

No

Yes

Etibi

210593

Ethambutol HCl

Valeant Canada LP Valeant Canada S.E.C.

No

Yes

No

No

No

No

No

Yes

Flagyl

214986

Metronidazole

Sanofi-Aventis Canada Inc

No

Yes

No

No

No

No

No

Yes

Idamycin PFS

216520

Idarubicin HCl

Pfizer Canada Inc

No

Yes

No

No

No

Yes

Yes

No

Imbruvica

212632

Ibrutinib

Janssen Inc

No

Yes

No

Yes

No

No

No

Yes

Inhibace

214793

Cilazapril Monohydrate

Hoffmann La Roche Limited

No

Yes

No

No

Yes

No

No

Yes

Inhibace Plus

214825

Hydrochlorothiazide, Cilazapril Monohydrate

Hoffmann La Roche Limited

No

Yes

No

No

Yes

No

No

Yes

Jinarc

214553

Tolvaptan

Otsuka Pharmaceutical Co Ltd

No

Yes

Yes

No

No

Yes

No

Yes

Nuvaring

215183

Ethinyl Estradiol, Etonogestrel

Merck Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Prinivil

215717

Lisinopril

Merck Canada Inc

No

Yes

No

No

Yes

No

No

Yes

Relenza

215337

Zanamivir

Glaxosmithkline Inc

No

Yes

No

Yes

Yes

No

Yes

Yes

Relistor

208302

Methylnaltrexone Bromide

Salix Pharmaceuticals Inc

No

Yes

No

No

No

Yes

No

Yes

Retrovir

215352

Zidovudine

ViiV Healthcare Ulc

No

No

No

No

No

Yes

No

Yes

Rofact

210961

Rifampin

Valeant Canada LP Valeant Canada S.E.C.

No

Yes

No

No

No

No

No

Yes

Samsca

214552

Tolvaptan

Otsuka Pharmaceutical Co Ltd

Yes

Yes

Yes

No

Yes

No

No

Yes

Select 1/35 (21 Day), Select 1/35 (28 Day)

215228

Ethinyl Estradiol, Norethindrone

Pfizer Canada Inc

No

No

No

No

Yes

No

No

No

Stribild

215298

Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat

Gilead Sciences Canada Inc

No

Yes

No

No

Yes

No

No

Yes

Synphasic

215187

Ethinyl Estradiol, Norethindrone

Pfizer Canada Inc

No

No

No

No

Yes

No

No

No

Tagrisso

211762

Osimertinib Mesylate

AstraZeneca Canada Inc

No

Yes

No

Yes

No

Yes

No

Yes

Tasigna

208682

Nilotinib

Novartis Pharmaceuticals Canada Inc

No

Yes

Yes

Yes

No

Yes

No

Yes

Teva-Cefadroxil

211316

Cefadroxil

Teva Canada Limited

No

Yes

No

No

No

No

No

Yes

Truvada

215258

Emtricitabine, Tenofovir Disoproxil Fumarate

Gilead Sciences Canada Inc

No

Yes

No

No

Yes

No

No

Yes

Venclexta

214135

Venetoclax

Abbvie Corporation

No

No

No

No

Yes

No

No

Yes

Viaderm KC Cream, Viaderm KC Ointment

214456

Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide

Taro Pharmaceuticals Inc

No

Yes

No

No

No

No

No

Yes

Voltaren Rapide

215252

Diclofenac Potassium

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Voltaren, Voltaren SR

215251

Diclofenac Sodium

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

No

No

Yes

Zymar

211845

Gatifloxacin

Allergan Inc

No

Yes

No

No

No

No

No

Yes

June 2018

Brand Name List Submission Number Ingredient(s) Manufacturer Contraindications Warnings & Precautions Serious Warnings & Precautions Adverse Reactions Drug Interactions Dosage & Administration Overdosage Consumer Information
4% astracaine dental with epinephrine 1:200,000, 4% astracaine dental with epinephrine forte 1:100,000 207235 articaine hcl, epinephrine bitartrate Dentsply Canada Limited Yes Yes No Yes Yes Yes No Yes
Alecensaro 210816 alectinib Hoffmann La Roche Limited No Yes No Yes No Yes No Yes
Alesse 21, alesse 28 215227 ethinyl estradiol, levonorgestrel Pfizer Canada Inc No No No No Yes Yes No Yes
Alkeran 214596 buffer solution, melphalan, melphalan hcl Aspen Pharmacare Canada Inc. Yes Yes No Yes Yes No No Yes
Alkeran 215145 melphalan Aspen Pharmacare Canada Inc. No No No No No No No Yes
Apprilon 214275 doxycycline monohydrate Galderma Canada Inc No Yes No Yes Yes Yes Yes Yes
Aptiom 208086 eslicarbazepine acetate Sunovion Pharmaceuticals Canada Inc No Yes No Yes No Yes No Yes
Arcosyl 213430 perindopril arginine Servier Canada Inc Yes Yes No No Yes No No Yes
Arcosyl plus, arcosyl plus ld 213434 indapamide, perindopril arginine Servier Canada Inc Yes Yes No No Yes No No Yes
Avalide 214424 hydrochlorothiazide, irbesartan Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Avapro 214433 irbesartan Sanofi-Aventis Canada Inc No Yes No Yes No No No Yes
Brevicon 0.5/35, brevicon 1/35 215225 ethinyl estradiol, norethindrone Pfizer Canada Inc No No No No Yes No No No
Caelyx 214432 doxorubicin hcl Janssen Inc No No No Yes No No No Yes
Clozaril 214157 clozapine Hls Therapeutics Inc No Yes No Yes No No No No
Cyclen 214741 ethinyl estradiol, norgestimate Janssen Inc No No No No No No Yes Yes
Demulen 30 215221 ethynodiol diacetate, ethinyl estradiol Pfizer Canada Inc No No No No Yes No No No
Depakene 214828 valproic acid Bgp Pharma Ulc No Yes No Yes Yes No No Yes
Descovy 207964 emtricitabine, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc No Yes Yes Yes No No No Yes
Diflucan 207077 fluconazole Pfizer Canada Inc No Yes No No No No No No
Docetaxel injection usp 213007 docetaxel Pfizer Canada Inc No Yes Yes Yes No Yes No Yes
Elmiron 214593 pentosan polysulfate sodium Janssen Inc No Yes No Yes No No No Yes
Evra 214832 ethinyl estradiol, norelgestromin Janssen Inc No Yes No No Yes No No No
Fibristal 214324 ulipristal acetate Allergan Pharma Co. Yes Yes No No No No No Yes
Genvoya 207251 emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc No Yes Yes Yes Yes Yes No Yes
Hyzaar, hyzaar ds 214817 hydrochlorothiazide, losartan potassium Merck Canada Inc No Yes No No Yes No No Yes
Ibrance 207909 palbociclib Pfizer Canada Inc No Yes No No Yes Yes No No
Ifex 213560 ifosfamide Baxter Corporation No Yes Yes No No No No Yes
Imbruvica 214410 ibrutinib Janssen Inc No Yes No Yes Yes No No Yes
Imodium caplets, imodium quick dissolve, imodium calming liquid, imodium liqui-gels 213956 loperamide hcl Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc No No No No No No Yes No
Imodium complete caplets, imodium complete chewables 213957 loperamide hcl, simethicone Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc No No No No No No Yes No
Inspiolto respimat 213065 tiotropium bromide monohydrate, olodaterol hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee No No No Yes Yes No No No
Kyprolis 208296 carfilzomib Amgen Canada Inc No Yes No Yes No Yes No Yes
Lenvima 213705 lenvatinib mesylate Eisai Limited No Yes No Yes No No No Yes
Leucovorin calcium injection usp 215416 leucovorin calcium Pfizer Canada Inc No Yes Yes Yes Yes No No No
Lincocin 208095 lincomycin Pfizer Canada Inc No Yes No No Yes No No Yes
Lumigan 215827 bimatoprost Allergan Inc No Yes No Yes No No No Yes
Lumigan pf 216008 bimatoprost Allergan Inc No Yes No Yes No Yes Yes Yes
Mekinist 213866 trametinib Novartis Pharmaceuticals Canada Inc No Yes No No No No No No
Min-ovral 21, min-ovral 28 215223 ethinyl estradiol, levonorgestrel Pfizer Canada Inc No No No No Yes No No No
Naropin 215734 ropivacaine hcl Aspen Pharmacare Canada Inc. No Yes No No No No Yes No
Ocaliva 214061 obeticholic acid Intercept Pharmaceuticals Inc No Yes No Yes No Yes No Yes
Odefsey 207243 emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc No Yes Yes Yes Yes Yes Yes Yes
Pediapred 212653 prednisolone phosphate sodium Sanofi-Aventis Canada Inc No Yes No Yes No No No No
Periolimel 2.5% e, olimel 3.3 e, olimel 4.4%, olimel 4.4% e, olimel 5.7% e, olimel 7.6% e, olimel 5.7%, olimel 7.6% 211103 l-alanine, l-aspartic acid, glycine, l-arginine, l-glutamic acid, l-histidine, l-isoleucine, l-leucine, l-phenylalanine, l-proline, l-serine, l-threonine, l-tryptophan, l-valine, l-lysine acetate, l-methionine, olive oil, potassium chloride, sodium glycerophosphate, l-tyrosine, sodium acetate trihydrate, glucose, magnesium chloride hexahydrate, calcium chloride dihydrate Baxter Corporation No No No No No No No Yes
Rhinocort turbuhaler 215281 budesonide Astrazeneca Canada Inc No No No No Yes No No Yes
Sectral 214614 acebutolol hcl Sanofi-Aventis Canada Inc No Yes No No Yes No No Yes
Sofracort 214816 dexamethasone sodium metasulphobenzoate, framycetin sulfate, gramicidin Sanofi-Aventis Canada Inc No Yes No Yes No No No No
Sustiva 214820 efavirenz Bristol-Myers Squibb Canada Yes No No No Yes No No Yes
Tactupump, tactupump forte 215480 benzoyl peroxide, adapalene Galderma Canada Inc Yes Yes No Yes No No No Yes
Tasigna 215124 nilotinib hydrochloride monohydrate Novartis Pharmaceuticals Canada Inc No Yes No No No No No Yes
Tobradex 214254 dexamethasone, tobramycin Novartis Pharmaceuticals Canada Inc No Yes No No Yes No No Yes
Topamax 216637 topiramate Janssen Inc No Yes No No No No No Yes
Tracleer 213127 bosentan monohydrate Actelion Pharmaceuticals Ltd No No No No Yes No No No
Tri-cyclen 214757 ethinyl estradiol, norgestimate Janssen Inc No No No No No No Yes Yes
Tri-cyclen lo 214769 ethinyl estradiol, norgestimate Janssen Inc No No No No No No Yes Yes
Vaseretic 214771 hydrochlorothiazide, enalapril sodium Merck Canada Inc No Yes No No Yes No No Yes
Vasotec 214740 enalapril sodium Merck Canada Inc No Yes No No Yes No No Yes
Viacoram 213486 amlodipine besylate, perindopril arginine Servier Canada Inc Yes Yes No No Yes No No Yes
Viread 214437 tenofovir disoproxil fumarate Gilead Sciences Canada Inc No Yes No No Yes No No Yes
Visken 215735 pindolol Tribute Pharmaceuticals Canada Inc Yes Yes No No Yes No No Yes
Xyrem 214884 sodium oxybate Jazz Pharmaceuticals Ireland Limited No No No No No No No Yes
Zykadia 205116 ceritinib Novartis Pharmaceuticals Canada Inc No Yes No Yes No No No Yes

May 2018

Product Monograph Brand Safety Updates May 2018
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

Abraxane for Injectable Suspension

214316

paclitaxel

Celgene Inc

N/A checkmark N/A checkmark checkmark N/A N/A checkmark

Advagraf

214053

tacrolimus

Astellas Pharma Canada Inc

N/A checkmark N/A checkmark N/A N/A N/A checkmark

Aggrastat

209810

tirofiban HCl

Correvio (UK) Ltd

N/A N/A N/A N/A N/A checkmark N/A checkmark

Alecensaro

212795

alectinib

Hoffmann La Roche Limited

N/A checkmark checkmark checkmark N/A checkmark N/A checkmark

Atripla

214554

efavirenz, emtricitabine, tenofovir disoproxil fumarate

Gilead Sciences, LLC

N/A checkmark N/A N/A checkmark N/A N/A checkmark

Butorphanol Nasal Spray

212498

butorphanol tartrate

Aa Pharma Inc

checkmark checkmark checkmark N/A N/A checkmark N/A checkmark

Celsentri

213260

maraviroc

Viiv Healthcare ULC

N/A checkmark N/A N/A checkmark N/A N/A checkmark

Ciloxan

210590

ciprofloxacin, ciprofloxacin hydrochloride monohydrate

Novartis Pharmaceuticals Canada Inc

N/A checkmark N/A N/A N/A N/A N/A checkmark

Complera

214436

emtricitabine, tenofovir disoproxil fumarate, rilpivirine hydrochloride

Gilead Sciences Canada Inc

N/A N/A checkmark checkmark checkmark N/A N/A checkmark

Cortiment

213795

budesonide

Ferring Inc

checkmark checkmark N/A checkmark checkmark N/A checkmark checkmark

Depo-Medrol

213592

methylprednisolone acetate

Pfizer Canada Inc

N/A checkmark N/A N/A N/A N/A N/A checkmark

Depo-Medrol with Lidocaine

213588

lidocaine HCl, methylprednisolone acetate

Pfizer Canada Inc

N/A checkmark N/A N/A N/A N/A N/A checkmark

Derma-Smoothe/FS Topical Oil

214148

fluocinolone acetonide

Hill Dermaceuticals Inc

N/A N/A N/A N/A N/A checkmark N/A checkmark

Dymista

214083

fluticasone propionate, azelastine hydrochloride

BGP Pharma ULC

N/A checkmark N/A checkmark checkmark checkmark N/A checkmark

Flagystatin

214987

metronidazole, nystatin

Sanofi-Aventis Canada Inc

N/A N/A N/A N/A N/A N/A N/A checkmark

Flolan, PH 12 Sterile Diluent for Flolan

213177

glycine, sodium chloride, water, epoprostenol sodium

Glaxosmithkline Inc

N/A N/A N/A N/A N/A checkmark N/A checkmark

FML

214474

fluorometholone

Allergan Inc

N/A checkmark N/A N/A N/A N/A N/A N/A

Imovane

211924

zopiclone

Sanofi-Aventis Canada Inc

N/A checkmark checkmark N/A checkmark N/A N/A checkmark

Jaydess

213545

levonorgestrel

Bayer Inc

N/A checkmark N/A N/A N/A checkmark N/A checkmark

Keflex

210960

cephalexin

Pendopharm Division of Pharmascience Inc

N/A checkmark N/A N/A N/A checkmark checkmark checkmark

Kyleena

213546

levonorgestrel

Bayer Inc

N/A N/A N/A N/A N/A checkmark N/A checkmark

Lancora

213844

ivabradine hydrochloride

Servier Canada Inc

N/A checkmark N/A checkmark N/A N/A N/A checkmark

Linessa 21, Linessa 28

213700

desogestrel, ethinyl estradiol

Aspen Pharmacare Canada Inc.

checkmark checkmark N/A checkmark checkmark N/A N/A checkmark

Lorazepam Injection Usp

212410

lorazepam

Sandoz Canada Incorporated

N/A checkmark checkmark N/A checkmark N/A N/A checkmark

Lynparza

205873

olaparib

Astrazeneca Canada Inc

N/A checkmark checkmark checkmark N/A checkmark N/A checkmark

Lynparza

210204

olaparib

Astrazeneca Canada Inc

N/A checkmark N/A checkmark N/A N/A N/A checkmark

Medrol

213590

methylprednisolone

Pfizer Canada Inc

N/A checkmark N/A N/A N/A N/A N/A checkmark

Mekinist

210760

trametinib

Novartis Pharmaceuticals Canada Inc

N/A checkmark N/A checkmark N/A N/A N/A checkmark

Merrem

213873

meropenem trihydrate

Astrazeneca Canada Inc

N/A checkmark N/A checkmark N/A N/A N/A checkmark

Mirena

213675

levonorgestrel

Bayer Inc

N/A checkmark N/A N/A N/A checkmark N/A checkmark

Myfortic

214256

mycophenolate sodium

Novartis Pharmaceuticals Canada Inc

N/A N/A N/A N/A N/A N/A N/A checkmark

Nasacort Allergy 24hr

213350

triamcinolone acetonide

Sanofi-Aventis Canada Inc

N/A N/A N/A N/A N/A N/A N/A checkmark

Nix Dermal Cream

206334

permethrin

Glaxosmithkline Consumer Healthcare Inc

checkmark checkmark N/A checkmark checkmark checkmark checkmark checkmark

Nucynta IR

213119

tapentadol hydrochloride

Endo Ventures Ltd

checkmark checkmark checkmark N/A N/A checkmark N/A checkmark

Pentasa

213955

mesalazine

Ferring Inc

N/A N/A N/A checkmark N/A N/A checkmark checkmark

Prezcobix

214288

darunavir, cobicistat

Janssen Inc

checkmark checkmark N/A N/A checkmark N/A checkmark checkmark

Prezista

214286

darunavir

Janssen Inc

checkmark checkmark N/A N/A checkmark N/A checkmark checkmark

Prinivil

213296

lisinopril

Merck Canada Inc

checkmark checkmark N/A N/A checkmark N/A N/A checkmark

Prograf

214052

tacrolimus

Astellas Pharma Canada Inc

N/A checkmark N/A checkmark N/A N/A N/A checkmark

Risperdal Consta

213226

risperidone

Janssen Inc

N/A checkmark N/A N/A N/A N/A N/A checkmark

Risperdal, Risperdal M-Tab

214158

risperidone

Janssen Inc

N/A N/A N/A N/A N/A N/A N/A checkmark

Solu-Medrol, Solu-Medrol Act-O-Vial

213593

methylprednisolone sodium succinate

Pfizer Canada Inc

N/A checkmark N/A N/A N/A N/A N/A checkmark

Stivarga

212813

regorafenib

Bayer Inc

N/A N/A N/A checkmark N/A N/A N/A N/A

Tafinlar

210753

dabrafenib

Novartis Pharmaceuticals Canada Inc

N/A checkmark N/A checkmark N/A N/A N/A checkmark

Talwin

213122

pentazocine

Sanofi-Aventis Canada Inc

checkmark checkmark checkmark N/A N/A checkmark N/A checkmark

Tegretol

213356

carbamazepine

Novartis Pharmaceuticals Canada Inc

N/A checkmark N/A N/A N/A N/A N/A checkmark

Tivicay

207076

dolutegravir

Viiv Healthcare ULC

N/A checkmark N/A checkmark checkmark checkmark N/A checkmark

Tobramycin for Injection U.S.P.

213165

tobramycin

Sterimax Inc

N/A checkmark N/A N/A N/A N/A N/A checkmark

Topamax

213951

topiramate

Janssen Inc

N/A N/A N/A N/A checkmark N/A N/A checkmark

Tussionex

212502

phenyltoloxamine citrate, hydrocodone bitartrate

Sanofi-Aventis Canada Inc

checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark

Vaseretic

213382

enalapril sodium, hydrochlorothiazide

Merck Canada Inc

checkmark checkmark N/A N/A checkmark N/A N/A checkmark

Vasotec

213344

enalapril sodium

Merck Canada Inc

checkmark checkmark N/A N/A checkmark N/A N/A checkmark

Vimpat

213586

lacosamide

Ucb Canada Inc

N/A N/A N/A checkmark N/A N/A N/A N/A

Xarelto

206073

rivaroxaban

Bayer Inc

checkmark checkmark N/A checkmark N/A checkmark N/A checkmark

Zykadia

207972

ceritinib

Novartis Pharmaceuticals Canada Inc

N/A checkmark checkmark N/A N/A checkmark N/A checkmark

April 2018

Product Monograph Brand Safety Updates April 2018
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 199182 fluticasone propionate, salmeterol Glaxosmithkline Inc N/A checkmark checkmark checkmark checkmark checkmark N/A checkmark
Aleve Nighttime 212692 diphenhydramine HCl, naproxen sodium Bayer Inc N/A checkmark N/A N/A checkmark N/A N/A checkmark
Altace 212643 ramipril Valeant Canada LP Valeant Canada S.E.C. checkmark checkmark N/A N/A checkmark checkmark N/A checkmark
Altace HCT 212642 hydrochlorothiazide, ramipril Valeant Canada LP Valeant Canada S.E.C. checkmark N/A N/A N/A checkmark checkmark N/A checkmark
Aptiom 213953 eslicarbazepine acetate Sunovion Pharmaceuticals Canada Inc N/A N/A N/A checkmark N/A N/A N/A N/A
Azarga 212645 timolol maleate, brinzolamide Novartis Pharmaceuticals Canada Inc N/A checkmark N/A checkmark N/A checkmark N/A checkmark
Benzamycin 205922 benzoyl peroxide, erythromycin Valeant Canada LP Valeant Canada S.E.C. N/A checkmark N/A N/A N/A N/A N/A checkmark
Biaxin, Biaxin Bid, Biaxin XL 212657 clarithromycin BGP Pharma ULC N/A checkmark N/A N/A checkmark N/A checkmark checkmark
Cardizem CD 212348 diltiazem HCl Valeant Canada LP Valeant Canada S.E.C. checkmark checkmark N/A checkmark checkmark N/A checkmark checkmark
Contingency One 212674 levonorgestrel Mylan Pharmaceuticals ULC N/A checkmark N/A N/A checkmark checkmark N/A checkmark
Copaxone 205685 glatiramer acetate Teva Canada Limited N/A checkmark N/A checkmark checkmark N/A N/A N/A
Ddavp Injection 212376 desmopressin acetate Ferring Inc checkmark checkmark N/A checkmark checkmark N/A checkmark N/A
Ddvap Rhinyle, Ddvap Spray 212637 desmopressin acetate Ferring Inc checkmark checkmark N/A checkmark checkmark checkmark checkmark checkmark
Ditropan XL 212737 oxybutynin chloride Janssen Inc checkmark checkmark N/A checkmark N/A N/A N/A checkmark
Dotarem 205610 gadoterate meglumine Guerbet checkmark N/A N/A checkmark N/A checkmark N/A checkmark
Eliquis 213269 apixaban Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A N/A checkmark
Entocort 213259 budesonide Tillotts Pharma Gmbh N/A N/A N/A N/A N/A N/A N/A checkmark
Epclusa 212690 sofosbuvir, velpatasvir Gilead Sciences Canada Inc N/A checkmark N/A N/A checkmark N/A N/A checkmark
Fluorouracil Injection USP 211722 fluorouracil Pfizer Canada Inc N/A checkmark N/A checkmark checkmark N/A checkmark N/A
Genvoya 212599 emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc checkmark N/A N/A N/A checkmark N/A N/A checkmark
Gilenya 212711 fingolimod hydrochloride Novartis Pharmaceuticals Canada Inc N/A N/A N/A checkmark N/A N/A N/A checkmark
Harvoni 212676 ledipasvir, sofosbuvir Gilead Sciences Canada Inc N/A checkmark N/A N/A checkmark N/A N/A checkmark
Heptovir 212958 lamivudine Glaxosmithkline Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Imitrex DF, Imitrex Injection, Imitrex Nasal Spray 212914 sumatriptan succinate, sumatriptan Glaxosmithkline Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Invega Sustenna 213066 paliperidone palmitate Janssen Inc N/A N/A N/A checkmark N/A N/A N/A checkmark
Jardiance 193840 empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee checkmark checkmark N/A checkmark N/A checkmark N/A checkmark
Latuda 205325 lurasidone hydrochloride Sunovion Pharmaceuticals Canada Inc N/A checkmark N/A checkmark checkmark checkmark N/A checkmark
Lincocin 214155 lincomycin hydrochloride Pfizer Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Lupron, Lupron Depot 212565 leuprolide acetate Abbvie Corporation N/A checkmark N/A N/A N/A checkmark N/A checkmark
Magnevist 212849 gadopentetate dimeglumine Bayer Inc N/A checkmark N/A N/A N/A checkmark N/A N/A
Maxidol Liquid Gels 209010 naproxen sodium Bayer Inc N/A checkmark N/A N/A checkmark N/A checkmark checkmark
Mezavant 213141 mesalazine Shire Pharma Canada Ulc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Nesina 211126 alogliptin benzoate Takeda Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Neupro 212656 rotigotine UCB Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Noritate 209700 metronidazole Valeant Canada LP Valeant Canada S.E.C. N/A checkmark N/A N/A N/A N/A N/A checkmark
Nubain 213120 nalbuphine HCl Sandoz Canada Incorporated checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Nuvaring 212018 ethinyl estradiol, etonogestrel Merck Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Octostim Injection, Octostim Spray 212397 desmopressin acetate Ferring Inc checkmark checkmark N/A checkmark checkmark N/A checkmark checkmark
Otixal 209351 fluocinolone acetonide, ciprofloxacin Pediapharm Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Pataday 212582 olopatadine HCl Novartis Pharmaceuticals Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Resotran 212856 prucalopride succinate Janssen Inc N/A N/A N/A N/A N/A N/A N/A checkmark
Rovamycine 212446 spiramycin Odan Laboratories Ltd N/A checkmark N/A N/A N/A N/A N/A checkmark
Rydapt 213161 midostaurin Novartis Pharmaceuticals Canada Inc N/A checkmark N/A N/A checkmark N/A N/A checkmark
Sabril 214392 vigabatrin Lundbeck Pharmaceuticals Llc N/A N/A N/A checkmark N/A N/A N/A N/A
Sovaldi 212116 sofosbuvir Gilead Sciences Canada Inc N/A checkmark N/A N/A checkmark N/A N/A checkmark
Stribild 212054 emtricitabine, tenofovir disoproxil fumarate, elvitegravir, cobicistat Gilead Sciences Canada Inc checkmark N/A N/A N/A checkmark N/A N/A checkmark
Suprax 210595 cefixime Odan Laboratories Ltd N/A checkmark N/A N/A N/A N/A N/A checkmark
Thalomid 213100 thalidomide Celgene Inc N/A checkmark N/A N/A N/A N/A N/A N/A
Tramacet 210669 acetaminophen, tramadol HCl Janssen Inc checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Tridural 210667 tramadol HCl Paladin Labs Inc checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Triumeq 213710 lamivudine, abacavir sulfate, dolutegravir sodium Glaxosmithkline Inc N/A N/A N/A checkmark N/A N/A N/A checkmark
Twynsta 212948 amlodipine besylate, telmisartan Boehringer Ingelheim (Canada) Ltd Ltee checkmark checkmark N/A N/A N/A checkmark N/A checkmark
Tybost 212572 cobicistat Gilead Sciences Canada Inc checkmark N/A N/A N/A checkmark N/A N/A checkmark
Ultram 210670 tramadol HCl Janssen Inc checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Valium 212691 diazepam Hoffmann La Roche Limited checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark
Vimovo 213876 naproxen, esomeprazole magnesium trihydrate Astrazeneca Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Vosevi 212716 sofosbuvir, velpatasvir, voxilaprevir Gilead Sciences Canada Inc N/A N/A N/A N/A checkmark N/A N/A checkmark
Zyprexa, Zyprexa Zydis, Zyprexa Intramuscular 212793 olanzapine Eli Lilly Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Zytram XL 210668 tramadol HCl Purdue Pharma checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark

March 2018

Product Monograph Brand Safety Updates March 2018
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
Abstral 210630 Fentanyl Paladin Labs Inc checkmark N/A checkmark N/A N/A checkmark N/A checkmark
Aczone 209693 Dapsone Valeant Canada LP Valeant Canada S.E.C. N/A checkmark N/A N/A N/A N/A N/A checkmark
Aerius Dual Action 12 Hour 210334 Pseudoephedrine Sulfate, Desloratadine Bayer Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Atriance 212646 Nelarabine Novartis Pharmaceuticals Canada Inc N/A checkmark N/A N/A N/A checkmark N/A checkmark
Benzaclin Topical Gel 205918 Benzoyl Peroxide, Clindamycin Valeant Canada LP Valeant Canada S.E.C. N/A checkmark N/A N/A N/A N/A N/A checkmark
Biacna Topical Gel 205920 Tretinoin, Clindamycin Phosphate Valeant Canada LP Valeant Canada S.E.C. N/A checkmark N/A N/A N/A N/A N/A checkmark
Butrans 210014 Buprenorphine Purdue Pharma checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark
Champix, Champix (Starter Kit) 203774 Varenicline Tartrate Pfizer Canada Inc N/A checkmark N/A checkmark N/A N/A N/A N/A
Contingency One 212674 Levonorgestrel Mylan Pharmaceuticals ULC N/A checkmark N/A N/A checkmark checkmark N/A checkmark
Dilaudid 210661 Hydromorphone HCl Purdue Pharma checkmark checkmark checkmark N/A checkmark checkmark N/A checkmark
Dilaudid HP 210662 Hydromorphone HCl Purdue Pharma checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Dotarem 212858 Gadoterate Meglumine Guerbet N/A checkmark N/A N/A N/A checkmark N/A N/A
Durela 210666 Tramadol HCl Cipher Pharmaceuticals Inc checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Fentanyl Citrate Injection, USP 210633 Fentanyl Citrate Hospira Healthcare Corporation N/A checkmark checkmark N/A N/A checkmark N/A checkmark
Fentora 210634 Fentanyl Teva Canada Limited checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Fycompa 204327 Perampanel Eisai Limited N/A checkmark N/A checkmark N/A checkmark N/A checkmark
Gadovist 1.0 212848 Gadobutrol Bayer Inc N/A checkmark N/A N/A N/A checkmark N/A N/A
Glucophage 211582 Metformin HCl Sanofi-Aventis Canada Inc N/A checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Hydromorphone HP, Hydromorphone HP Forte Injection 210635 Hydromorphone HCl Sandoz Canada Incorporated checkmark checkmark checkmark N/A N/A checkmark N/A checkmark
Hydromorphone Hydrochloride Injection USP 210637 Hydromorphone HCl Sandoz Canada Incorporated checkmark checkmark checkmark checkmark N/A checkmark checkmark checkmark
Jaydess 204355 Levonorgestrel Bayer Inc N/A checkmark N/A checkmark N/A N/A N/A N/A
Jurnista 209997 Hydromorphone HCl Janssen Inc checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Kadian 209592 Morphine Sulfate BGP Pharma ULC checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Kazano 211124 Metformin HCl, Alogliptin Benzoate Takeda Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Komboglyze 211136 Metformin HCl, Saxagliptin AstraZeneca Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Lupron, Lupron Depot 212633 Leuprolide Acetate Abbvie Corporation N/A checkmark N/A N/A N/A checkmark N/A checkmark
M-Eslon 210000 Morphine Sulfate Ethypharm Inc checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark
Men's Rogaine Foam 5% 210435 Minoxidil Johnson & Johnson Inc checkmark N/A N/A N/A N/A N/A N/A checkmark
Metronidazole 5mg/Ml Injection 212619 Metronidazole Baxter Corporation N/A checkmark N/A N/A N/A N/A N/A checkmark
Micronor 210342 Norethindrone Janssen Inc N/A checkmark N/A N/A checkmark N/A checkmark checkmark
MS Contin 210003 Morphine Sulfate Purdue Pharma checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark
Nucynta Extended-Release 210010 Tapentadol Hydrochloride Endo Ventures Ltd checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark
Ofev 212069 Nintedanib Boehringer Ingelheim (Canada) Ltd Ltee N/A checkmark N/A N/A N/A checkmark N/A checkmark
Omniscan 212857 Gadodiamide GE Healthcare Canada Ine N/A checkmark N/A N/A N/A checkmark N/A N/A
Onglyza 211138 Saxagliptin AstraZeneca Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Orfadin 207481 Nitisinone Swedish Orphan Biovitrum AB (Publ) N/A N/A N/A N/A checkmark N/A N/A checkmark
Patanol 211652 Olopatadine HCl Novartis Pharmaceuticals Canada Inc N/A checkmark N/A checkmark checkmark N/A N/A checkmark
Paxil CR 211651 Paroxetine HCl Glaxosmithkline Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Piperacillin for Injection 203911 Piperacillin Sodium Hospira Healthcare Corporation N/A checkmark N/A N/A N/A N/A N/A checkmark
Plavix 211788 Clopidogrel Bisulfate Sanofi-Aventis Canada Inc N/A N/A N/A checkmark N/A N/A N/A checkmark
Qtern 211139 Dapagliflozin, Saxagliptin AstraZeneca Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Quinsair 210340 Levofloxacin Horizon Pharma Ireland Ltd N/A checkmark N/A N/A N/A N/A N/A checkmark
Ralivia 210665 Tramadol HCl Valeant Canada LP Valeant Canada S.E.C. checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Renagel 211980 Sevelamer Hydrochloride Sanofi-Aventis Canada Inc checkmark checkmark N/A checkmark N/A N/A N/A checkmark
Renvela 211979 Sevelamer Carbonate Sanofi-Aventis Canada Inc checkmark checkmark N/A checkmark N/A N/A N/A checkmark
Revlimid 212204 Lenalidomide Celgene Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Rogaine Minoxidil Topical 2% Solution 210434 Minoxidil Johnson & Johnson Inc checkmark N/A N/A N/A N/A N/A N/A checkmark
Saphris 211946 Asenapine Merck Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Triesence 213005 Triamcinolone Acetonide Novartis Pharmaceuticals Canada Inc N/A checkmark N/A checkmark N/A checkmark N/A checkmark
Vidaza 213133 Azacitidine Celgene Inc N/A N/A N/A N/A N/A checkmark N/A N/A
Women's Rogaine Foam 5% 210436 Minoxidil Johnson & Johnson Inc checkmark N/A N/A N/A N/A N/A N/A checkmark
Zykadia 204766 Ceritinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A checkmark N/A N/A N/A
Zytiga 212020 Abiraterone Acetate Janssen Inc N/A N/A N/A N/A N/A N/A N/A checkmark
Product Monograph Brand Safety Updates February 2018
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
Allegra 12 Hour, Allegra 24 Hour 211802 fexofenadine hcl Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A N/A checkmark
Aptiom 210683 eslicarbazepine acetate Sunovion Pharmaceuticals Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Avalide 211996 hydrochlorothiazide, irbesartan Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A checkmark N/A checkmark
Avapro 212012 irbesartan Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A N/A checkmark
Belbuca 210011 buprenorphine hydrochloride Purdue Pharma N/A checkmark N/A checkmark N/A N/A N/A checkmark
Besivance 209691 besifloxacin Bausch & Lomb Inc N/A N/A N/A N/A N/A checkmark N/A checkmark
Burinex 209292 bumetanide Leo Pharma Inc N/A N/A N/A N/A N/A N/A N/A checkmark
Cayston 209680 aztreonam Gilead Sciences Canada Inc checkmark checkmark N/A checkmark checkmark checkmark N/A checkmark
Cefepime for Injection 209347 cefepime hcl Apotex Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Cyanokit 211579 hydroxocobalamin Serb S.A. checkmark checkmark N/A checkmark checkmark checkmark checkmark checkmark
Depo-Provera 210121 medroxyprogesterone acetate Pfizer Canada Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Descovy 210394 emtricitabine, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Duragesic 210024 fentanyl Janssen Inc N/A N/A N/A N/A N/A N/A N/A checkmark
Effexor Xr 210424 venlafaxine hcl Pfizer Canada Inc N/A checkmark checkmark N/A N/A N/A N/A checkmark
Elavil 209567 amitriptyline hcl Aa Pharma Inc N/A N/A N/A N/A checkmark N/A N/A checkmark
Eliquis 211430 apixaban Bristol-Myers Squibb Canada N/A checkmark checkmark checkmark checkmark checkmark N/A checkmark
Eltroxin 209764 levothyroxine sodium Aspen Pharmacare Canada Inc. N/A checkmark N/A checkmark checkmark N/A N/A checkmark
Entocort 210828 budesonide Tillotts Pharma Gmbh checkmark checkmark N/A checkmark checkmark checkmark checkmark N/A
Entocort Enema 210898 budesonide Tillotts Pharma Gmbh N/A N/A N/A N/A checkmark checkmark N/A checkmark
Forane 207201 isoflurane Baxter Corporation checkmark checkmark checkmark checkmark checkmark checkmark checkmark checkmark
Fycompa 210784 perampanel Eisai Limited N/A checkmark N/A checkmark N/A N/A N/A checkmark
Hemangiol 209967 propranolol hcl Pierre Fabre Dermo-Cosmetique Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Holkira Pak 211536 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie Corporation N/A checkmark N/A N/A N/A N/A N/A N/A
Hydromorph Contin 209995 hydromorphone hcl Purdue Pharma N/A checkmark N/A N/A N/A N/A N/A N/A
Invega 203627 paliperidone Janssen Inc N/A N/A N/A checkmark N/A N/A N/A N/A
Iopidine 211991 apraclonidine hcl Novartis Pharmaceuticals Canada Inc checkmark N/A N/A checkmark checkmark N/A N/A checkmark
Isoflurane 210900 isoflurane Abbvie Corporation checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark
Jakavi 203442 ruxolitinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A checkmark N/A checkmark
Keppra 210426 levetiracetam Ucb Canada Inc N/A N/A N/A checkmark N/A N/A N/A checkmark
Lasix Oral Solution 211339 furosemide Sanofi-Aventis Canada Inc N/A checkmark N/A N/A N/A N/A N/A N/A
Lasix Special 211341 furosemide Sanofi-Aventis Canada Inc N/A N/A N/A checkmark N/A N/A N/A N/A
Levofloxacin in 5% Dextrose Injection 209358 levofloxacin Pfizer Canada Inc N/A N/A N/A checkmark N/A N/A N/A N/A
Lynparza 211221 olaparib Astrazeneca Canada Inc N/A N/A N/A checkmark N/A N/A N/A checkmark
Metrogel 209699 metronidazole Galderma Canada Inc N/A N/A N/A checkmark N/A N/A N/A checkmark
Mycobutin 209545 rifabutin Pfizer Canada Inc N/A checkmark N/A N/A N/A N/A N/A N/A
Neurontin 211678 gabapentin Pfizer Canada Inc N/A checkmark N/A checkmark N/A checkmark N/A checkmark
Ocuflox 210333 ofloxacin Allergan Inc N/A checkmark N/A N/A N/A N/A checkmark checkmark
Oxy.Ir 210629 oxycodone hcl Purdue Pharma N/A checkmark N/A N/A N/A N/A N/A checkmark
Oxyneo 209991 oxycodone hcl Purdue Pharma N/A checkmark N/A N/A N/A N/A N/A N/A
Plavix 211989 clopidogrel bisulfate Sanofi-Aventis Canada Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Pomalyst 210498 pomalidomide Celgene Inc checkmark checkmark checkmark N/A N/A checkmark N/A checkmark
Propecia 211612 finasteride Merck Canada Inc checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark
Proscar 211614 finasteride Merck Canada Inc N/A N/A N/A N/A N/A N/A N/A checkmark
Selexid 209543 pivmecillinam hcl Leo Pharma Inc N/A checkmark N/A checkmark N/A checkmark N/A checkmark
Sevorane Af 209018 sevoflurane Abbvie Corporation N/A N/A N/A checkmark N/A N/A N/A checkmark
Somatuline Autogel 203094 lanreotide acetate Ipsen Biopharm Limited N/A N/A N/A checkmark N/A N/A N/A checkmark
Spinraza 211749 nusinersen Biogen Canada Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Targin 210018 naloxone hcl, oxycodone hcl Purdue Pharma N/A checkmark N/A N/A N/A N/A N/A N/A
Tarka 211228 verapamil hcl, trandolapril Bgp Pharma Ulc N/A checkmark N/A checkmark checkmark checkmark N/A checkmark
Technivie 211480 ritonavir, paritaprevir, ombitasvir Abbvie Corporation N/A N/A N/A checkmark N/A N/A N/A checkmark
Teva-Trimel, Teva-Trimel Ds 205917 sulfamethoxazole, trimethoprim Teva Canada Limited checkmark checkmark checkmark checkmark checkmark checkmark N/A checkmark
Tobi Podhaler 201429 tobramycin Novartis Pharmaceuticals Canada Inc checkmark checkmark N/A N/A checkmark N/A N/A checkmark
Uloric 211533 febuxostat Takeda Canada Inc N/A checkmark N/A N/A checkmark N/A N/A checkmark
Vibativ 210338 telavancin hydrochloride Pendopharm Division of de Pharmascience Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Xarelto 203361 rivaroxaban Bayer Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Xtoro 209695 finafloxacin Alcon Canada Inc N/A N/A N/A checkmark N/A N/A N/A checkmark
Zaroxolyn 211229 metolazone Sanofi-Aventis Canada Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Zelboraf 210699 vemurafenib Hoffmann La Roche Limited N/A checkmark N/A N/A N/A checkmark N/A checkmark
Zenhale 210682 mometasone furoate, formoterol fumarate dihydrate Merck Canada Inc N/A checkmark N/A N/A N/A N/A N/A checkmark
Zerit 212105 stavudine Bristol-Myers Squibb Canada N/A checkmark N/A checkmark N/A N/A N/A N/A
Zydelig 210648 idelalisib Gilead Sciences Canada Inc N/A checkmark N/A checkmark N/A N/A N/A N/A
Zykadia 202746 ceritinib Novartis Pharmaceuticals Canada Inc N/A checkmark N/A checkmark N/A N/A N/A checkmark
Zytiga 207915 abiraterone acetate Janssen Inc N/A checkmark N/A N/A N/A checkmark N/A checkmark
Zyvoxam 211843 linezolid Pfizer Canada Inc N/A checkmark N/A N/A N/A N/A N/A N/A
Product Monograph Brand Safety Updates January 2018
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
Actos 203486 pioglitazone hydrochloride Takeda Canada Inc N/A   N/A N/A N/A N/A N/A N/A
Advil Cold, Sinus & Flu Extra Strength 202193 chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl Pfizer Consumer Healthcare a Division of Pfizer Canada Inc N/A N/A N/A N/A N/A   N/A  
Asmanex Twisthaler 210617 mometasone furoate Merck Canada Inc N/A   N/A   N/A N/A N/A  
Breo Ellipta 202721 fluticasone furoate, vilanterol trifenatate Glaxosmithkline Inc N/A           N/A  
Bricanyl Turbuhaler 211213 terbutaline sulfate Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Cotellic 209926 cobimetinib Hoffmann La Roche Limited N/A   N/A   N/A N/A N/A  
Cytovene 209988 ganciclovir Hoffmann La Roche Limited N/A   N/A   N/A N/A    
Dificid 209686 fidaxomicin Merck Canada Inc N/A   N/A N/A N/A N/A N/A  
Diflucan 209734 fluconazole Pfizer Canada Inc     N/A N/A   N/A N/A  
Diflucan One 210117 fluconazole Pfizer Consumer Healthcare a Division of Pfizer Canada Inc N/A   N/A     N/A N/A  
Eligard 209675 leuprolide acetate Sanofi-Aventis Canada Inc N/A N/A N/A   N/A   N/A N/A
Fibristal 209518 ulipristal acetate Allergan Pharma Co. N/A   N/A   N/A N/A N/A N/A
Flagyl 209684 metronidazole Odan Laboratories Ltd N/A   N/A N/A N/A N/A N/A  
Gleevec 210518 imatinib mesylate Novartis Pharmaceuticals Canada Inc N/A N/A N/A   N/A N/A N/A  
Ilevro 210275 nepafenac Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A  
Imbruvica 210084 ibrutinib Janssen Inc N/A   N/A   N/A N/A N/A  
Kivexa 210651 lamivudine, abacavir sulfate Viiv Healthcare Ulc N/A   N/A N/A N/A N/A N/A N/A
Lamictal 210561 lamotrigine Glaxosmithkline Inc N/A N/A N/A N/A   N/A N/A N/A
Levofloxacin in 5% Dextrose Injection 209966 levofloxacin Pfizer Canada Inc N/A   N/A   N/A N/A N/A  
Lioresal 208802 baclofen Novartis Pharmaceuticals Canada Inc N/A   N/A N/A N/A N/A    
Lotriderm 210423 betamethasone dipropionate, clotrimazole Merck Canada Inc N/A   N/A   N/A N/A N/A N/A
Lupron Depot 210906 leuprolide acetate Abbvie Corporation N/A N/A N/A   N/A   N/A N/A
Lupron, Lupron Depot 210907 leuprolide acetate Abbvie Corporation N/A N/A N/A N/A N/A   N/A N/A
Mictoryl, Mictoryl Pediatric 210208 propiverine hydrochloride Duchesnay Inc N/A N/A N/A N/A N/A   N/A  
Mirapex 210942 pramipexole dihydrochloride monohydrate Boehringer Ingelheim (Canada) Ltd Ltee N/A   N/A   N/A N/A N/A  
Nasonex 210572 mometasone furoate monohydrate Merck Canada Inc N/A   N/A   N/A N/A N/A  
Nevanac 210153 nepafenac Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A  
Novamoxin 209137 amoxicillin Teva Canada Limited N/A N/A N/A N/A N/A N/A N/A  
Odefsey 209596 emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc N/A N/A N/A N/A   N/A N/A  
Plaquenil 208371 hydroxychloroquine sulfate Sanofi-Aventis Canada Inc N/A   N/A     N/A N/A  
Pms-Levofloxacin 209359 levofloxacin Pharmascience Inc N/A   N/A N/A N/A N/A N/A  
Rivotril 208644 clonazepam Hoffmann La Roche Limited             N/A  
Sandostatin, Sandostatin Lar 210953 octreotide acetate Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A   N/A  
Septra Injection 204995 sulfamethoxazole, trimethoprim Aspen Pharmacare Canada Inc. N/A   N/A N/A N/A N/A N/A  
Suprane 207209 desflurane Baxter Corporation N/A   N/A N/A N/A N/A N/A N/A
Targin 195453 naloxone HCl, oxycodone HCl Purdue Pharma N/A   N/A N/A N/A N/A N/A N/A
Triumeq 210658 lamivudine, abacavir sulfate, dolutegravir sodium Viiv Healthcare Ulc N/A   N/A   N/A N/A N/A  
Trizivir 210649 zidovudine, lamivudine, abacavir sulfate Viiv Healthcare Ulc N/A   N/A N/A N/A N/A N/A N/A
Ultibro Breezhaler 210970 glycopyrronium bromide, indacaterol maleate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Vermox 208738 mebendazole Janssen Inc N/A   N/A   N/A N/A    
Visudyne 208530 verteporfin Valeant Canada Lp Valeant Canada S.E.C. N/A   N/A   N/A N/A N/A  
Votrient 209814 pazopanib hydrochloride Novartis Pharmaceuticals Canada Inc N/A N/A N/A   N/A N/A N/A  
Zoloft 208736 sertraline HCl Pfizer Canada Inc N/A   N/A   N/A N/A N/A  
Zydelig 209813 idelalisib Gilead Sciences Canada Inc N/A   N/A   N/A   N/A  
Product Monograph Brand Safety Updates December 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
Agrylin 210231 anagrelide hydrochloride Shire Pharma Canada Ulc N/A   N/A   N/A N/A N/A  
Apo-Norflox 208906 norfloxacin Apotex Inc   N/A N/A N/A N/A N/A N/A N/A
Avelox, Avelox I.V. 208903 moxifloxacin hydrochloride Bayer Inc   N/A N/A N/A N/A N/A N/A N/A
Buscopan 208936 hyoscine butylbromide Sanofi-Aventis Canada Inc     N/A     N/A N/A  
Carboplatin Injection Bp 209537 carboplatin Pfizer Canada Inc N/A     N/A N/A N/A N/A N/A
Celestone Soluspan 210219 betamethasone sodium phosphate, betamethasone acetate Merck Canada Inc N/A   N/A   N/A N/A N/A N/A
Cipro Xl 208893 ciprofloxacin Bayer Inc   N/A N/A N/A N/A N/A N/A N/A
Cipro, Cipro Oral Suspension 208894 ciprofloxacin Bayer Inc   N/A N/A N/A N/A N/A N/A N/A
Conray 30, Conray 43, Conray 60 205718 iothalamate meglumine Liebel-Flarsheim Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Cysto-Conray II 205720 iothalamate meglumine Liebel-Flarsheim Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Depo-Provera 202131 medroxyprogesterone acetate Pfizer Canada Inc N/A   N/A N/A N/A N/A N/A N/A
Dilantin 208646 phenytoin sodium Pfizer Canada Inc N/A   N/A N/A N/A   N/A  
Dilantin - 125 Suspension, Dilantin - 30 Suspension, Dilantin Infatabs 208647 phenytoin Pfizer Canada Inc N/A   N/A N/A N/A   N/A  
Diprosalic 210388 betamethasone dipropionate, salicylic acid Merck Canada Inc N/A   N/A   N/A N/A N/A N/A
Diprosone 210328 betamethasone dipropionate Merck Canada Inc N/A   N/A   N/A N/A N/A N/A
Duaklir Genuair 209387 formoterol fumarate dihydrate, aclidinium bromide Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Elocom 210612 mometasone furoate Merck Canada Inc N/A   N/A   N/A N/A N/A  
Extra Strength Tylenol Nighttime 209434 acetaminophen, diphenhydramine HCl Mcneil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A N/A  
Fluanxol Depot, Fluanxol Tablets 209135 flupentixol decanoate Lundbeck Canada Inc N/A   N/A N/A N/A   N/A N/A
Gastrografin 210489 diatrizoate sodium, diatrizoate meglumine Bracco Imaging Canada N/A N/A N/A N/A N/A N/A N/A  
Jaydess 209260 levonorgestrel Bayer Inc N/A   N/A   N/A N/A N/A  
Kyleena 209261 levonorgestrel Bayer Inc N/A   N/A   N/A N/A N/A  
Lumigan Rc 209572 bimatoprost Allergan Inc N/A N/A N/A   N/A N/A N/A N/A
Mifegymiso 211029 misoprostol, mifepristone Linepharma International Limited N/A N/A N/A N/A N/A N/A N/A  
Mirena 209259 levonorgestrel Bayer Inc N/A   N/A   N/A N/A N/A  
Pheburane 209765 sodium phenylbutyrate Medunik Canada N/A N/A N/A N/A N/A N/A N/A  
Primaxin 204987 imipenem, cilastatin sodium Merck Canada Inc N/A   N/A N/A N/A N/A N/A  
Pristiq 208616 desvenlafaxine succinate Pfizer Canada Inc N/A   N/A N/A     N/A  
Tecfidera 208072 dimethyl fumarate Biogen Canada Inc N/A   N/A N/A N/A N/A N/A N/A
Teva-Cefadroxil 209872 cefadroxil monohydrate Teva Canada Limited N/A   N/A N/A N/A   N/A N/A
Toviaz 202700 fesoterodine fumarate Pfizer Canada Inc N/A N/A N/A   N/A N/A N/A N/A
Valcyte 208920 valganciclovir hydrochloride Hoffmann La Roche Limited N/A              
Vancomycin Hydrochloride for Injection Usp 204448 vancomycin, vancomycin HCl Fresenius Kabi Canada Ltd N/A   N/A N/A N/A N/A N/A  
Vigamox 204458 moxifloxacin Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Xarelto 209485 rivaroxaban Bayer Inc N/A N/A N/A N/A   N/A N/A  
Xeljanz Xr 200033 tofacitinib Pfizer Canada Inc N/A   N/A N/A     N/A  

November 2017

Product Monograph Brand Safety Updates November 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 Maintena 200292 aripiprazole Otsuka Pharmaceutical Co Ltd N/A   N/A   N/A   N/A  
Aerius, Aerius Kids 208765 desloratadine Bayer Inc N/A   N/A N/A N/A N/A N/A  
Afinitor Disperz 200814 everolimus Novartis Pharmaceuticals Canada Inc     N/A       N/A  
Alesse 21, Alesse 28 208592 ethinyl estradiol, levonorgestrel Pfizer Canada Inc     N/A N/A   N/A N/A  
Andriol 207863 testosterone undecanoate Merck Canada Inc N/A   N/A   N/A N/A N/A  
Arestin Microspheres 208470 minocycline HCl Orapharma Inc N/A   N/A   N/A   N/A  
Biaxin, Biaxin Bid, Biaxin Xl 206790 clarithromycin Bgp Pharma Ulc N/A   N/A     N/A N/A  
Brevicon (21-Day Pack), Brevicon (28-Day Pack) 208580 ethinyl estradiol, norethindrone Pfizer Canada Inc     N/A N/A     N/A  
Clobex Shampoo 207206 clobetasol propionate Galderma Canada Inc     N/A   N/A      
Concerta 200397 methylphenidate HCl Janssen Inc     N/A       N/A  
Concerta 208669 methylphenidate HCl Janssen Inc N/A   N/A   N/A N/A N/A  
Constella 198867 linaclotide Forest Laboratories Canada Inc N/A   N/A   N/A   N/A  
Demulen 30 (21 Day Pack), Demulen 30 (28 Day Pack) 208606 ethynodiol diacetate, ethinyl estradiol Pfizer Canada Inc       N/A   N/A N/A  
Diprolene 210442 betamethasone dipropionate Merck Canada Inc N/A   N/A   N/A N/A N/A N/A
Duotrav Pq 209354 timolol maleate, travoprost Novartis Pharmaceuticals Canada Inc N/A N/A N/A   N/A N/A N/A  
Estring 208652 estradiol Pfizer Canada Inc N/A   N/A   N/A N/A N/A  
Faslodex 201150 fulvestrant Astrazeneca Canada Inc N/A   N/A   N/A N/A    
Gentamicin(E) 203910 gentamicin sulfate Baxter Corporation N/A   N/A N/A N/A N/A N/A  
Ibrance 200851 palbociclib Pfizer Canada Inc N/A   N/A   N/A N/A N/A  
Intelence 207931 etravirine Janssen Inc   N/A N/A N/A   N/A N/A  
Intuniv Xr 208582 guanfacine HCl Shire Pharma Canada Ulc N/A N/A N/A   N/A N/A N/A N/A
Invanz 203908 ertapenem sodium Merck Canada Inc N/A   N/A N/A N/A N/A N/A  
Invirase 208431 saquinavir mesylate Hoffmann La Roche Limited     N/A N/A     N/A  
Invokamet 209143 metformin HCl, canagliflozin Janssen Inc N/A       N/A N/A N/A  
Invokana 209087 canagliflozin Janssen Inc N/A       N/A N/A N/A  
Isovue 200 Injection, Isovue 300 Injection, Isovue Multipack 300, Isovue 370 Injection, Isovue Multipack 370 209195 iopamidol Bracco Imaging Canada N/A N/A N/A N/A N/A N/A N/A  
Kalydeco 208071 ivacaftor Vertex Pharmaceuticals (Canada) Incorporated N/A N/A N/A N/A N/A N/A N/A  
Lioresal Intrathecal 208539 baclofen Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A  
Losec 207632 omeprazole, omeprazole magnesium Astrazeneca Canada Inc N/A   N/A   N/A N/A N/A  
Mavik 207819 trandolapril Bgp Pharma Ulc     N/A N/A   N/A N/A  
Mifegymiso 200856 misoprostol, mifepristone Linepharma International Limited N/A       N/A   N/A  
Min-Ovral 21, Min-Ovral 28 208605 ethinyl estradiol, levonorgestrel Pfizer Canada Inc     N/A N/A   N/A N/A  
Nexium 207636 esomeprazole Astrazeneca Canada Inc N/A   N/A   N/A N/A N/A  
Norvir 209501 ritonavir Abbvie Corporation N/A N/A N/A N/A N/A N/A N/A  
Nozinan 208067 methotrimeprazine HCl Sanofi-Aventis Canada Inc N/A   N/A N/A N/A   N/A N/A
Optiray 240, Optiray 240 Ultraject, Optiray 300, Optiray 300 Ultraject, Optiray 320, Optiray 320 Ultraject, Optiray 350, Optiray 350 Ultraject 203281 ioversol Liebel-Flarsheim Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Orfadin 204557 nitisinone Swedish Orphan Biovitrum Ab (Publ) N/A   N/A N/A     N/A  
Otezla 208674 apremilast Celgene Inc N/A   N/A   N/A   N/A  
Pediapharm Naproxen Suspension 209180 naproxen Pediapharm Inc N/A N/A N/A N/A N/A   N/A  
Pulmicort Turbuhaler 207570 budesonide Astrazeneca Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Reyataz 209449 atazanavir sulfate Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A N/A  
Ritalin, Ritalin Sr 208313 methylphenidate HCl Novartis Pharmaceuticals Canada Inc N/A N/A N/A   N/A N/A    
Select 1/35 (21-Day), Select 1/35 (28-Day) 208576 ethinyl estradiol, norethindrone Pfizer Canada Inc       N/A     N/A  
Spiriva 208665 tiotropium bromide monohydrate Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A N/A  
Sporanox 206335 itraconazole Janssen Inc   N/A N/A N/A   N/A N/A  
Sporanox 206344 itraconazole Janssen Inc   N/A N/A N/A   N/A N/A  
Stribild 207605 emtricitabine, tenofovir disoproxil fumarate, elvitegravir, cobicistat Gilead Sciences Canada Inc     N/A N/A   N/A N/A  
Synphasic 208577 ethinyl estradiol, norethindrone Pfizer Canada Inc       N/A     N/A  
Taxotere 208062 docetaxel Sanofi-Aventis Canada Inc N/A       N/A   N/A  
Tegretol 208132 carbamazepine Novartis Pharmaceuticals Canada Inc N/A   N/A     N/A N/A  
Telzir 208687 fosamprenavir calcium Viiv Healthcare Ulc N/A   N/A N/A N/A N/A N/A  
Tybost 207583 cobicistat Gilead Sciences Canada Inc     N/A N/A   N/A N/A  
Ventolin Diskus 207155 salbutamol sulfate Glaxosmithkline Inc N/A   N/A N/A N/A   N/A  
Ventolin Hfa 207156 salbutamol sulfate Glaxosmithkline Inc N/A   N/A N/A N/A   N/A  
Ventolin Respirator Solution, Ventolin Nebules 207158 salbutamol sulfate Glaxosmithkline Inc N/A   N/A N/A N/A   N/A  
Vimovo 207638 naproxen, esomeprazole magnesium trihydrate Astrazeneca Canada Inc N/A   N/A   N/A N/A N/A  
Xyrem 209241 sodium oxybate Valeant Canada Lp Valeant Canada S.E.C. N/A N/A N/A   N/A N/A N/A N/A
Product Monograph Brand Safety Updates October 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
Accel-Sevelamer 205762 sevelamer carbonate Accel Pharma Inc N/A N/A N/A   N/A   N/A N/A
Airomir 206571 salbutamol sulfate Valeant Canada LP Valeant Canada S.E.C. N/A N/A N/A N/A N/A N/A N/A  
Antizol 207700 fomepizole Paladin Labs Inc N/A N/A N/A N/A N/A N/A N/A  
Asmanex Twisthaler 207491 mometasone furoate Merck Canada Inc N/A N/A N/A N/A   N/A N/A  
Ativan 207459 lorazepam Pfizer Canada Inc N/A     N/A   N/A N/A  
Avandia 189154 rosiglitazone maleate Glaxosmithkline Inc N/A   N/A   N/A   N/A  
Burinex 206137 bumetanide Leo Pharma Inc N/A N/A N/A N/A N/A N/A N/A  
Celestone Soluspan 207629 betamethasone sodium phosphate, betamethasone acetate Merck Canada Inc     N/A         N/A
Cetrotide 206074 cetrorelix acetate Emd Serono a Division of Emd Inc Canada N/A N/A N/A   N/A N/A N/A  
Coversyl 207286 perindopril erbumine Servier Canada Inc     N/A N/A   N/A N/A  
Coversyl Plus, Coversyl Plus LD, Coversyl Plus HD 207284 perindopril erbumine, indapamide Servier Canada Inc     N/A N/A   N/A N/A  
Cyanokit 206729 hydroxocobalamin Serb S.A. N/A   N/A   N/A N/A N/A  
Entresto 207731 valsartan, sacubitril Novartis Pharmaceuticals Canada Inc     N/A   N/A N/A N/A  
Exjade 207864 deferasirox Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A  
Fibristal 205771 ulipristal acetate Allergan Pharma Co. N/A N/A N/A   N/A N/A N/A N/A
Gilenya 207380 fingolimod hydrochloride Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A  
Hydromorph Contin 207027 hydromorphone HCl Purdue Pharma     N/A   N/A N/A    
Imbruvica 204436 ibrutinib Janssen Inc N/A           N/A  
Inomax 199061 nitric oxide Ino Therapeutics N/A   N/A   N/A N/A N/A  
Jadenu 207929 deferasirox Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A  
Jaydess 207337 levonorgestrel Bayer Inc N/A   N/A       N/A  
Kaletra 208279 ritonavir, lopinavir Abbvie Corporation N/A N/A N/A N/A N/A N/A N/A  
Mirena 207336 levonorgestrel Bayer Inc N/A   N/A       N/A  
Nasonex 207480 mometasone furoate Merck Canada Inc N/A N/A N/A N/A   N/A N/A  
Nitroglycerin in 5% Dextrose Injection 206985 nitroglycerin, dextrose anhydrous Baxter Corporation N/A N/A N/A   N/A N/A N/A N/A
Novo-Salbutamol HFA 206839 salbutamol sulfate Teva Canada Limited N/A   N/A N/A N/A   N/A  
Ofev 207762 nintedanib Boehringer Ingelheim (Canada) Ltd Ltee N/A   N/A   N/A N/A N/A  
Orkambi 207127 ivacaftor, lumacaftor Vertex Pharmaceuticals (Canada) Incorporated N/A   N/A   N/A N/A N/A  
Plan B 208163 levonorgestrel Teva Branded Pharmaceutical Products R&D Inc N/A N/A N/A N/A   N/A N/A  
Pravachol 208425 pravastatin sodium Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A N/A  
Prezista 206626 darunavir ethanolate Janssen Inc N/A   N/A N/A   N/A N/A  
Rapamune 208129 sirolimus Pfizer Canada Inc N/A N/A N/A   N/A N/A N/A N/A
Revatio 206732 sildenafil citrate Pfizer Canada Inc N/A   N/A N/A N/A N/A N/A N/A
Revlimid 207072 lenalidomide Celgene Inc N/A   N/A   N/A   N/A  
Reyataz 207645 atazanavir sulfate Bristol-Myers Squibb Canada   N/A N/A N/A   N/A N/A  
Rhovane 207199 zopiclone Sandoz Canada Incorporated N/A         N/A N/A  
Silkis 206311 calcitriol Galderma Canada Inc     N/A          
Sutent 206339 sunitinib malate Pfizer Canada Inc N/A   N/A   N/A N/A N/A N/A
Tafinlar 207771 dabrafenib Novartis Pharmaceuticals Canada Inc N/A N/A N/A   N/A N/A N/A  
Tobrex, Tobrexan 201433 tobramycin Alcon Canada Inc N/A   N/A N/A N/A N/A N/A  
Trileptal 208369 oxcarbazepine Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A N/A  
Triumeq 208070 lamivudine, abacavir sulfate, dolutegravir sodium Viiv Healthcare Ulc N/A   N/A       N/A  
Vancocin 203124 vancomycin Merus Labs International Inc N/A   N/A N/A N/A N/A N/A  
Xanax, Xanax TS 207447 alprazolam Pfizer Canada Inc N/A     N/A   N/A N/A  
Zenhale 207600 mometasone furoate, formoterol fumarate dihydrate Merck Canada Inc N/A N/A N/A N/A   N/A N/A  
Zykadia 201361 ceritinib Novartis Pharmaceuticals Canada Inc N/A   N/A   N/A N/A N/A N/A
Product Monograph Brand Safety Updates September 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
Aerius Dual Action 12 Hour 206592 pseudoephedrine sulfate, desloratadine Bayer Inc N/A N/A N/A N/A N/A N/A
Altace 206816 ramipril Valeant Canada Lp Valeant Canada S.E.C. N/A N/A N/A N/A
Altace Hct 206915 hydrochlorothiazide, ramipril Valeant Canada Lp Valeant Canada S.E.C. N/A N/A N/A N/A
Arcosyl 207395 perindopril arginine Servier Canada Inc N/A N/A
Arcosyl Plus, Arcosyl Plus Ld 207324 indapamide, perindopril arginine Servier Canada Inc N/A N/A
Blexten 206314 bilastine Aralez Pharmaceuticals Trading Dac N/A N/A N/A N/A N/A N/A N/A
Caduet 206425 amlodipine besylate, atorvastatin calcium Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Ciprodex 206140 dexamethasone, ciprofloxacin hydrochloride monohydrate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus 206590 pseudoephedrine sulfate, loratadine Bayer Inc N/A N/A N/A N/A N/A N/A
Claritin Allergy + Sinus Extra Strength 206591 pseudoephedrine sulfate, loratadine Bayer Inc N/A N/A N/A N/A N/A N/A
Clasteon 194371 clodronate disodium Sunovion Pharmaceuticals Canada Inc N/A
Clobex Spray 204859 clobetasol propionate Galderma Canada Inc N/A N/A N/A N/A N/A
Dexilant 206280 dexlansoprazole Takeda Canada Inc N/A N/A N/A N/A N/A
Dilaudid 206994 hydromorphone HCl Purdue Pharma N/A N/A
Epclusa 199753 sofosbuvir, velpatasvir Gilead Sciences Canada Inc N/A N/A
Erythrocin I.V. 204120 erythromycin lactobionate Amdipharm Limited N/A N/A
Evotaz 206829 atazanavir sulfate, cobicistat Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A
Fortaz 206545 ceftazidime Glaxosmithkline Inc N/A N/A N/A N/A N/A N/A N/A
Glyxambi 206650 linagliptin, empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A
Hydrea 206452 hydroxyurea Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A
Imbruvica 198803 ibrutinib Janssen Inc N/A N/A N/A
Jakavi 198974 ruxolitinib phosphate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A
Jevtana 198555 cabazitaxel Sanofi-Aventis Canada Inc N/A N/A N/A N/A
Kyleena 207339 levonorgestrel Bayer Inc N/A N/A N/A N/A
Lanvis 199259 thioguanine Aspen Pharmacare Canada Inc.
Lenvima 197794 lenvatinib mesylate Eisai Limited N/A N/A N/A N/A
Neurontin 206450 gabapentin Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Nexium 24hr 207640 esomeprazole magnesium trihydrate Pfizer Consumer Healthcare a Division of Pfizer Canada Inc N/A N/A N/A N/A N/A
Norvasc 206420 amlodipine besylate Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Pantoloc 206282 pantoprazole Takeda Canada Inc N/A N/A N/A N/A N/A
Pediapred 207618 prednisolone sodium phosphate Sanofi-Aventis Canada Inc N/A N/A N/A N/A
Quinsair 205688 levofloxacin Horizon Pharma Ireland Ltd N/A N/A N/A N/A N/A
Stivarga 203322 regorafenib Bayer Inc N/A N/A N/A N/A
Suboxone 200964 buprenorphine hydrochloride, naloxone hydrochloride dihydrate Indivior UK Limited N/A N/A N/A N/A
Synjardy 206979 metformin HCl, empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A
T-Lo, Timolol Maleate-Ex 207804 timolol maleate Sandoz Canada Incorporated N/A N/A N/A N/A N/A N/A N/A
Tecta 206283 pantoprazole Takeda Canada Inc N/A N/A N/A N/A N/A
Tobramycin For Injection, Tobramycin Injection 201434 tobramycin Fresenius Kabi Canada Ltd N/A N/A N/A N/A N/A N/A
Toviaz 206539 fesoterodine fumarate Pfizer Canada Inc N/A N/A N/A N/A N/A N/A N/A
Tygacil 203906 tigecycline Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Verelan 204929 verapamil HCl Recro Gainesville Llc N/A N/A N/A N/A N/A N/A
Xalacom 207642 timolol maleate, latanoprost Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Zantac, Zantac Maximum Strength Non-Prescription 206896 ranitidine HCl Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc N/A N/A N/A
Zerit 205498 stavudine Bristol-Myers Squibb Canada N/A
Zocor 206768 simvastatin Merck Canada Inc N/A N/A N/A N/A N/A
Zyvoxam 203907 linezolid Pfizer Canada Inc N/A N/A N/A N/A N/A N/A
Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014
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
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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