Product Monograph Brand Safety Updates

October 2018

Product Monograph Brand Safety Updates October 2018
(PDF, 133 KB, 2 pages)

Brand Name List	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions	Dosage & Administration	Overdosage	Consumer Information
Advair, Advair Diskus	218142	Fluticasone Propionate, Salmeterol Xinafoate	Glaxosmithkline Inc	No	Yes	No	No	No	No	No	Yes
Aerius	218962	Desloratadine	Bayer Inc	No	No	No	No	No	No	No	Yes
Apo-Cefprozil	218218	Cefprozil	Apotex Inc	No	Yes	No	No	No	No	No	Yes
Apo-Sulfatrim Tab, Apo Sulfatrim DS, Apo Sulfatrim Pediatric, Apo-Sulfatrim Oral Suspension	210871	Sulfamethoxazole, Trimethoprim	Apotex Inc	No	Yes	No	No	No	No	No	Yes
Arnuity Ellipta	217172	Fluticasone Furoate	Glaxosmithkline Inc	No	Yes	No	No	Yes	No	No	Yes
Avamys	218351	Fluticasone Furoate	Glaxosmithkline Inc	No	Yes	No	No	No	No	No	Yes
Bevespi Aerosphere	217809	Formoterol Fumarate, Glycopyrronium Bromide	AstraZeneca Canada Inc	No	No	No	Yes	No	No	No	Yes
Biaxin, Biaxin Bid, Biaxin XL	218738	Clarithromycin	BGP Pharma ULC	Yes	Yes	No	No	Yes	No	No	Yes
Breo Ellipta	218271	Fluticasone Furoate, Vilanterol Trifenatate	Glaxosmithkline Inc	No	Yes	No	Yes	No	No	No	Yes
Brilinta	217905	Ticagrelor	AstraZeneca Canada Inc	No	Yes	No	No	No	Yes	No	Yes
Canesoral, Canesoral Combi	218335	Clotrimazole, Fluconazole	Bayer Inc	No	Yes	No	Yes	Yes	No	No	Yes
Coversyl Plus HD	214373	Perindopril Erbumine, Indapamide	Servier Canada Inc	No	No	No	No	No	No	No	Yes
Depakene	217988	Valproic Acid	BGP Pharma ULC	No	No	No	Yes	Yes	No	No	Yes
Eliquis	198842	Apixaban	Bristol-Myers Squibb Canada	No	Yes	No	No	No	Yes	No	No
Emend IV	218162	Fosaprepitant Dimeglumine	Merck Canada Inc	No	Yes	No	No	No	No	No	Yes
Epival	218169	Divalproex Sodium	BGP Pharma ULC	No	Yes	No	Yes	No	No	No	Yes
Flovent HFA, Flovent Diskus	218581	Fluticasone Propionate	Glaxosmithkline Inc	No	Yes	No	No	No	No	No	Yes
GD-Varenicline	219175	Varenicline Tartrate	Genmed a Division of Pfizer Canada Inc	No	Yes	No	Yes	No	No	No	No
Gemcitabine Injection	219022	Gemcitabine HCl	Pfizer Canada Inc	No	Yes	No	Yes	No	No	No	No
Gilenya	218286	Fingolimod Hydrochloride	Novartis Pharmaceuticals Canada Inc	Yes	Yes	No	Yes	No	No	No	Yes
Imovane	217812	Zopiclone	Sanofi-Aventis Canada Inc	No	Yes	Yes	Yes	Yes	Yes	No	Yes
Invokamet	210969	Metformin HCl, Canagliflozin	Janssen Inc	No	No	No	Yes	No	No	No	Yes
Invokana	210676	Canagliflozin	Janssen Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Jakavi	216617	Ruxolitinib Phosphate	Novartis Pharmaceuticals Canada Inc	No	No	No	Yes	No	No	No	No
Janumet, Janumet XR	218949	Metformin HCl, Sitagliptin Phosphate Monohydrate	Merck Canada Inc	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Kazano	217455	Metformin HCl, Alogliptin Benzoate	Takeda Canada Inc	No	No	No	Yes	No	No	No	Yes
Kyprolis	218596	Carfilzomib	Amgen Canada Inc	No	Yes	No	No	No	No	No	Yes
Lederle Leucovorin	217726	Leucovorin Calcium	Pfizer Canada Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Levofloxacin in 5% Dextrose Injection	219020	Levofloxacin	Pfizer Canada Inc	No	Yes	No	No	Yes	No	No	Yes
Mitoxantrone Injection USP	220187	Mitoxantrone Hydrochloride	Pfizer Canada Inc	No	Yes	No	Yes	No	No	No	No
Nesina	217457	Alogliptin Benzoate	Takeda Canada Inc	No	No	No	Yes	No	No	No	Yes
Nexium 24 Hr	217405	Esomeprazole Magnesium Trihydrate	Pfizer Consumer Healthcare a Division of Pfizer Canada Inc	Yes	Yes	No	No	Yes	No	No	Yes
Ocaliva	218565	Obeticholic Acid	Intercept Pharmaceuticals Inc	No	No	No	No	No	Yes	No	Yes
Orfadin	215784	Nitisinone	Swedish Orphan Biovitrum AB (Publ)	No	Yes	No	No	Yes	Yes	No	Yes
Picato	218185	Ingenol Mebutate	Leo Pharma Inc	No	Yes	No	No	No	No	No	Yes
Propecia	218806	Finasteride	Merck Canada Inc	No	No	No	Yes	No	No	No	Yes
Proscar	218801	Finasteride	Merck Canada Inc	No	No	No	Yes	No	No	No	Yes
Reactine, Reactine Allergy Liquid Gels, Reactine Fast Melt Junior, Reactine Rapid Dissolve	217641	Cetirizine Hydrochloride	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	Yes	No	No	No	Yes
Reyataz	218585	Atazanavir Sulfate	Bristol-Myers Squibb Canada	Yes	No	No	No	Yes	No	No	Yes
Rifadin	217986	Rifampin	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Rydapt	210496	Midostaurin	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Sensorcaine, Sensorcaine with Epinephrine	204198	Bupivacaine HCl, Epinephrine	Aspen Pharmacare Canada Inc.	No	Yes	No	No	No	Yes	No	No
Sutent	218940	Sunitinib Malate	Pfizer Canada Inc	No	No	Yes	Yes	No	No	No	Yes
Symtuza	217492	Emtricitabine, Darunavir Ethanolate, Cobicistat, Tenofovir Alafenamide Hemifumarate	Janssen Inc	Yes	Yes	No	No	Yes	No	No	Yes
Tasigna	211052	Nilotinib	Novartis Pharmaceuticals Canada Inc	No	Yes	Yes	Yes	No	Yes	No	Yes
Trajenta	194075	Linagliptin	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	Yes	No	No	No	Yes
Trelegy Ellipta	218191	Fluticasone Furoate, Umeclidinium Bromide, Vilanterol Trifenatate	Glaxosmithkline Inc	No	Yes	No	No	No	No	No	Yes
Viacoram	218438	Amlodipine Besylate, Perindopril Arginine	Servier Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Vimpat	218312	Lacosamide	UCB Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Xeljanz	209643	Tofacitinib	Pfizer Canada Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Zeldox	217496	Ziprasidone HCl	Pfizer Canada Inc	No	Yes	No	Yes	No	No	No	Yes

September 2018

Product Monograph Brand Safety Updates September 2018
(PDF, 135 KB, 2 pages)

Brand Name List	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions	Dosage & Administration	Overdosage	Consumer Information
Acuvail	216960	ketorolac tromethamine	Allergan Inc	No	Yes	No	Yes	No	Yes	No	Yes
Alecensaro	211291	alectinib	Hoffmann La Roche Limited	No	Yes	No	No	Yes	Yes	No	Yes
Aptiom	209753	eslicarbazepine acetate	Sunovion Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Buscopan	216733	hyoscine butylbromide	Sanofi-Aventis Canada Inc	Yes	No	No	No	No	No	No	Yes
Chloromycetin Succinate Injection	212536	chloramphenicol	Erfa Canada 2012 Inc	No	Yes	No	No	No	No	No	Yes
Clavulin	217568	clavulanate potassium, amoxicillin trihydrate	GlaxoSmithKline Inc	No	Yes	No	No	No	Yes	No	Yes
Codeine Contin	216666	codeine	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Cozaar	215619	losartan potassium	Merck Canada Inc	No	Yes	No	No	Yes	No	No	Yes
Cyklokapron	216111	tranexamic acid	Pfizer Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Duavive	210469	conjugated estrogens, bazedoxifene acetate	Pfizer Canada Inc	No	Yes	No	No	No	No	No	Yes
Flolan, Ph 12 Sterile Diluent for Flolan	216701	glycine, sodium chloride, water, epoprostenol sodium	GlaxoSmithKline Inc	No	No	No	Yes	No	No	No	Yes
Genvoya	217448	emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide hemifumarate	Gilead Sciences Canada Inc	No	Yes	No	No	Yes	No	No	No
Giotrif	209785	afatinib dimaleate	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	No	No	No	No	Yes
Invega	217288	paliperidone	Janssen Inc	No	Yes	No	Yes	Yes	No	No	Yes
Invega Sustenna	217289	paliperidone palmitate	Janssen Inc	No	Yes	No	Yes	Yes	No	No	Yes
Invega Trinza	217315	paliperidone palmitate	Janssen Inc	No	Yes	No	Yes	Yes	No	No	Yes
Isentress, Isentress HD	210317	raltegravir potassium	Merck Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Januvia	218647	sitagliptin phosphate monohydrate	Merck Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Kaletra	217633	ritonavir, lopinavir	Abbvie Corporation	Yes	No	No	Yes	No	No	No	Yes
Kayexalate	217331	sodium polystyrene sulfonate	Sanofi-Aventis Canada Inc	No	Yes	No	No	Yes	Yes	No	Yes
Keppra	217699	levetiracetam	Ucb Canada Inc	No	No	No	Yes	No	No	No	No
Lanvis	217284	thioguanine	Aspen Pharmacare Canada Inc.	No	Yes	No	No	No	Yes	No	Yes
Lectopam	216862	bromazepam	Hoffmann La Roche Limited	Yes	Yes	No	Yes	Yes	No	No	Yes
Lenvima	217205	lenvatinib mesylate	Eisai Limited	No	Yes	No	Yes	No	No	No	Yes
Lotensin	216946	benazepril hcl	Novartis Pharmaceuticals Canada Inc	Yes	Yes	No	No	Yes	No	No	Yes
Mekinist	213580	trametinib	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Nasacort Allergy 24hr	216913	triamcinolone acetonide	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Neupro	216298	rotigotine	UCB Canada Inc	Yes	Yes	Yes	Yes	No	Yes	No	Yes
Norvir	217630	ritonavir	Abbvie Corporation	Yes	No	No	No	Yes	No	No	Yes
Nuvaring	217697	ethinyl estradiol, etonogestrel	Merck Canada Inc	No	No	No	No	Yes	No	No	Yes
Prevacid, Prevacid Fastab	209755	lansoprazole	Takeda Pharmaceuticals America Inc	No	No	No	No	No	Yes	No	No
Prevymis	216537	letermovir	Merck Canada Inc	Yes	No	No	No	Yes	No	No	Yes
Prezcobix	212389	darunavir ethanolate, cobicistat	Janssen Inc	No	Yes	No	No	No	Yes	No	No
Reactine Complete	215138	cetirizine hydrochloride, pseudoephedrine HCl	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	Yes	Yes	No	Yes	No	No	No	Yes
Resonium Calcium	217338	calcium polystyrene sulphonate	Sanofi-Aventis Canada Inc	No	Yes	No	No	Yes	Yes	No	Yes
Risperdal	217309	risperidone	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes
Risperdal Consta	217311	risperidone	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes
Sectral	217282	acebutolol HCl	Sanofi-Aventis Canada Inc	No	No	No	Yes	Yes	No	Yes	Yes
Somatuline Autogel	217659	lanreotide	Ipsen Biopharm Limited	No	No	No	Yes	No	No	No	Yes
Stribild	217409	emtricitabine, tenofovir disoproxil fumarate, elvitegravir, cobicistat	Gilead Sciences Canada Inc	No	Yes	No	No	Yes	No	No	No
Tafinlar	213581	dabrafenib	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Tarceva	216181	erlotinib	Hoffmann La Roche Limited	No	Yes	No	No	No	Yes	No	Yes
Teveten	216410	eprosartan mesylate	BGP Pharma ULC	No	No	No	Yes	No	No	No	Yes
Teveten Plus	216411	hydrochlorothiazide, eprosartan mesylate	BGP Pharma ULC	No	No	No	Yes	No	No	No	Yes
Tybost	217447	cobicistat	Gilead Sciences Canada Inc	No	Yes	No	No	Yes	No	No	No
Venclexta	214078	venetoclax	Abbvie Corporation	No	Yes	No	Yes	No	No	No	Yes
Viagra	218856	sildenafil citrate	Pfizer Canada Inc	No	Yes	No	No	No	No	No	Yes
Volibris	215342	ambrisentan	GlaxoSmithKline Inc	No	No	No	No	No	No	No	Yes
Voltaren Emulgel Back & Muscle Pain	217849	diclofenac diethylamine	GlaxoSmithKline Consumer Healthcare Inc	No	Yes	No	No	No	No	No	Yes
Xalkori	209925	crizotinib	Pfizer Canada Inc	No	Yes	Yes	No	Yes	No	No	Yes
Xarelto	211611	rivaroxaban	Bayer Inc	Yes	Yes	No	Yes	Yes	Yes	No	Yes
Xeljanz	209522	tofacitinib	Pfizer Canada Inc	Yes	Yes	No	Yes	Yes	Yes	No	Yes
Xiidra	218601	lifitegrast	Shire Pharma Canada ULC	No	Yes	No	No	No	No	No	Yes
Zithromax	218645	azithromycin	Pfizer Canada Inc	No	Yes	No	No	Yes	No	No	Yes

August 2018

Product Monograph Brand Safety Updates August 2018
(PDF, 135 KB, 2 pages)

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

Product Monograph Brand Safety Updates July 2018
(PDF, 135 KB, 2 pages)

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

Yes

No

Yes

Aerius Dual Action 12 Hour

215390

Pseudoephedrine Sulfate, Desloratadine

Bayer Inc

No

Yes

No

Yes

Aerius Kids

215388

Desloratadine

Bayer Inc

No

Yes

No

Yes

Apo-Fluconazole-150

215312

Fluconazole

Apotex Inc

No

Yes

No

Yes

Blexten

214883

Bilastine

Aralez Pharmaceuticals Trading DAC

No

Yes

No

Yes

Canesoral

214931

Fluconazole

Bayer Inc

No

Yes

No

Yes

Canesoral Combi-Pak

214932

Clotrimazole, Fluconazole

Bayer Inc

No

Yes

No

Yes

Cefazolin for Injection

212089

Cefazolin Sodium

Teva Canada Limited

No

Yes

No

Yes

Cefoxitin for Injection

212534

Cefoxitin Sodium

Teva Canada Limited

No

Yes

No

Yes

Cubicin, Cubicin RF

215429

Daptomycin

Cubist Pharmaceuticals LLC

No

Yes

No

Dilantin

215484

Phenytoin Sodium

Pfizer Canada Inc

Yes

No

Yes

No

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

215486

Phenytoin

Pfizer Canada Inc

Yes

No

Yes

No

Durezol

215431

Difluprednate

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

Yes

Erivedge

215754

Vismodegib

Hoffmann La Roche Limited

No

Yes

No

Yes

No

Yes

No

Erythrocin I.V.

215232

Erythromycin Lactobionate

Amdipharm Limited

No

Yes

No

Yes

Etibi

210593

Ethambutol HCl

Valeant Canada LP Valeant Canada S.E.C.

No

Yes

No

Yes

Flagyl

214986

Metronidazole

Sanofi-Aventis Canada Inc

No

Yes

No

Yes

Idamycin PFS

216520

Idarubicin HCl

Pfizer Canada Inc

No

Yes

No

Yes

No

Imbruvica

212632

Ibrutinib

Janssen Inc

No

Yes

No

Yes

No

Yes

Inhibace

214793

Cilazapril Monohydrate

Hoffmann La Roche Limited

No

Yes

No

Yes

No

Yes

Inhibace Plus

214825

Hydrochlorothiazide, Cilazapril Monohydrate

Hoffmann La Roche Limited

No

Yes

No

Yes

No

Yes

Jinarc

214553

Tolvaptan

Otsuka Pharmaceutical Co Ltd

No

Yes

No

Yes

No

Yes

Nuvaring

215183

Ethinyl Estradiol, Etonogestrel

Merck Canada Inc

No

Yes

No

Yes

No

Yes

Prinivil

215717

Lisinopril

Merck Canada Inc

No

Yes

No

Yes

No

Yes

Relenza

215337

Zanamivir

Glaxosmithkline Inc

No

Yes

No

Yes

No

Yes

Relistor

208302

Methylnaltrexone Bromide

Salix Pharmaceuticals Inc

No

Yes

No

Yes

No

Yes

Retrovir

215352

Zidovudine

ViiV Healthcare Ulc

No

Yes

No

Yes

Rofact

210961

Rifampin

Valeant Canada LP Valeant Canada S.E.C.

No

Yes

No

Yes

Samsca

214552

Tolvaptan

Otsuka Pharmaceutical Co Ltd

Yes

No

Yes

No

Yes

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

215228

Ethinyl Estradiol, Norethindrone

Pfizer Canada Inc

No

Yes

No

Stribild

215298

Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat

Gilead Sciences Canada Inc

No

Yes

No

Yes

No

Yes

Synphasic

215187

Ethinyl Estradiol, Norethindrone

Pfizer Canada Inc

No

Yes

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

No

Yes

No

Yes

Teva-Cefadroxil

211316

Cefadroxil

Teva Canada Limited

No

Yes

No

Yes

Truvada

215258

Emtricitabine, Tenofovir Disoproxil Fumarate

Gilead Sciences Canada Inc

No

Yes

No

Yes

No

Yes

Venclexta

214135

Venetoclax

Abbvie Corporation

No

Yes

No

Yes

Viaderm KC Cream, Viaderm KC Ointment

214456

Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide

Taro Pharmaceuticals Inc

No

Yes

No

Yes

Voltaren Rapide

215252

Diclofenac Potassium

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

Yes

Voltaren, Voltaren SR

215251

Diclofenac Sodium

Novartis Pharmaceuticals Canada Inc

No

Yes

No

Yes

No

Yes

Zymar

211845

Gatifloxacin

Allergan Inc

No

Yes

No

Yes

June 2018

Product Monograph Brand Safety Updates June 2018
(PDF, 150KB, 4 pages)

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
(PDF, 139KB, 3 pages)

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
(PDF, 137KB, 3 pages)

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
(PDF, 66KB, 3 pages)

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 2016
(PDF, 81 KB, 2 pages)

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

Non-Prescription Submissions Cleared in 2014

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

Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014
Brand Name	Submission Number	Ingredient	Manufacturer	Contra-indications	Warning and Precautions	Serious Warnings and Precautions Box	Adverse Reactions	Drug Interactions	Dosage and Administration	Overdosage
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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Non-Prescription Submissions Cleared in 2014

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