Product monograph brand safety updates

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• December 2020
• November 2020
• October 2020
• September 2020
• August 2020
• July 2020
• June 2020
• May 2020
• April 2020
• March 2020
• February 2020
• January 2020
• Non-Prescription Submissions Cleared in 2014

December 2020

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

December 2020

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

November 2020

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

November 2020

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

October 2020

Product Monograph Brand Safety Updates October 2020
(PDF, 70KB, 1 page)

October 2020

Brand Name	Submission Number	Ingredient(S)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions	Dosage & Administration	Overdosage	Consumer Information
Aubagio	239626	Teriflunomide	Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Elmiron	239842	Pentosan Polysulfate Sodium	Janssen Inc	Yes	Yes	Yes	Yes	No	No	No	Yes
Ibuprofen Liquid Filled Capsules, Extra Strength Ibuprofen Liquid Filled Capsules	240415	Ibuprofen	Apotex Inc	Yes	Yes	No	No	Yes	No	No	Yes
Imovane	240565	Zopiclone	Sanofi-Aventis Canada Inc	Yes	Yes	Yes	Yes	Yes	No	No	Yes
Ketalar	238402	Ketamine Hydrochloride	ERFA Canada 2012 Inc	Yes	Yes	No	Yes	No	Yes	No	No
Kisqali	233623	Ribociclib Succinate	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	Yes	No	No
Maviret	234362	Pibrentasvir, Glecaprevir	Abbvie Corporation	No	No	No	No	No	Yes	No	No
Plavix	239831	Clopidogrel Bisulfate	Sanofi-Aventis Canada Inc	No	Yes	No	No	Yes	No	No	Yes
Prezcobix	240107	Darunavir Ethanolate, Cobicistat	Janssen Inc	No	No	No	No	Yes	No	No	Yes
Prezista	240039	Darunavir Ethanolate	Janssen Inc	No	No	No	No	Yes	No	No	Yes
Renagel	238457	Sevelamer Hydrochloride	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Renvela	238461	Sevelamer Carbonate	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Salazopyrin, Salazopyrin En-Tabs	239257	Sulfasalazine	Pfizer Canada ULC	No	No	No	Yes	No	No	No	No
Symtuza	240432	Darunavir Ethanolate, Emtricitabine, Cobicistat, Tenofovir Alafenamide Hemifumarate	Janssen Inc	No	No	No	No	Yes	No	No	Yes
Tagrisso	234607	Osimertinib Mesylate	AstraZeneca Canada Inc	No	Yes	No	Yes	No	Yes	No	No
Talzenna	234108	Talazoparib	Pfizer Canada ULC	No	Yes	No	Yes	Yes	Yes	No	No
Tenormin	239845	Atenolol	AstraZeneca Canada Inc	No	Yes	No	No	No	No	No	No
Teva-Mexiletine	238065	Mexiletine Hcl	Teva Canada Limited	No	Yes	No	No	No	No	No	No
Twynsta	239007	Telmisartan, Amlodipine Besylate	Boehringer Ingelheim (Canada) Ltd Ltee	Yes	Yes	No	Yes	Yes	No	Yes	Yes
Zejula	237670	Niraparib	GlaxoSmithKline Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Zerbaxa	238477	Ceftolozane Sulfate, Tazobactam Sodium	Merck Canada Inc	No	Yes	No	No	No	No	No	Yes
Zofran, Zofran ODT	240200	Ondansetron Hydrochloride Dihydrate	Novartis Pharmaceuticals Canada Inc	No	Yes	No	No	No	No	No	Yes

September 2020

Product Monograph Brand Safety Updates September 2020
(PDF, 72 KB, 1 page)

September 2020

Brand Name	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions	Dosage & Administration	Overdosage	Consumer Information
Aubagio	231739	Teriflunomide	Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Dovato	233469	Dolutegravir, Lamivudine	ViiV Healthcare ULC	No	No	No	Yes	No	No	No	No
Heartburn Control	238026	Omeprazole	Apotex Inc	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Imbruvica	233164	Ibrutinib	Janssen Inc	No	Yes	No	No	No	Yes	No	No
Incruse Ellipta	222505	Umeclidinium Bromide	GlaxoSmithKline Inc	No	No	No	No	No	No	No	Yes
Narcan Nasal Spray	234832	Naloxone Hcl	Adapt Pharma Operations Limited	No	No	No	No	No	No	No	Yes
Plaquenil	238801	Hydroxychloroquine Sulfate	Sanofi-Aventis Canada Inc	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Saphris	238694	Asenapine	Merck Canada Inc	No	Yes	No	No	No	No	No	No
Soliqua	232504	Lixisenatide, Insulin Glargine	Sanofi-Aventis Canada Inc	No	No	No	Yes	No	Yes	No	Yes
Synthroid	238350	Levothyroxine Sodium	BGP Pharma ULC	Yes	Yes	No	No	Yes	Yes	No	Yes
Targin	237753	Naloxone Hcl, Oxycodone Hcl	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Venclexta	234504	Venetoclax	Abbvie Corporation	No	No	No	Yes	No	Yes	No	No
Zytiga	236834	Abiraterone Acetate	Janssen Inc	No	No	No	Yes	No	No	No	No

August 2020

Product Monograph Brand Safety Updates August 2020
(PDF, 82 KB, 2 pages)

August 2020

Brand Name	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions		Dosage & Administration	Overdosage	Consumer Information
Brilinta	231818	Ticagrelor	AstraZeneca Canada Inc	No	Yes	No	Yes	No	Yes		No	Yes
Butrans	237701	Buprenorphine	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes		Yes	Yes
Clinimix E, Clinimix	239475	Nitrogen, Amino Acids, Dextrose	Baxter Corporation	No	Yes	No	No	No	Yes		No	No
Codeine Contin	237940	Codeine, Codeine Sulfate	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes		Yes	Yes
Epuris	238793	Isotretinoin	Cipher Pharmaceuticals Inc	No	Yes	No	Yes	No	No		No	No
Hepsera	236397	Adefovir Dipivoxil	Gilead Sciences Canada Inc	No	Yes	No	No	Yes	No		No	Yes
Invokamet	232307	Metformin Hcl, Canagliflozin	Janssen Inc	No	Yes	No	Yes	No	Yes		No	Yes
Lokelma	231794	Sodium Zirconium Cyclosilicate	AstraZeneca Canada Inc	No	Yes	No	Yes	No	Yes		No	Yes
Lotriderm	237862	Betamethasone Dipropionate, Clotrimazole	Merck Canada Inc	Yes	Yes	No	Yes	Yes	Yes		Yes	Yes
Lynparza	235698	Olaparib	AstraZeneca Canada Inc	No	Yes	No	Yes	Yes	No		No	Yes
Mezavant	238836	Mesalazine	Shire Pharma Canada ULC	No	No	No	Yes	No	No		Yes	Yes
Mirapex	234378	Pramipexole Dihydrochloride Monohydrate	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	Yes	No	Yes		No	Yes
MS Contin	237930	Morphine Sulfate	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes		Yes	Yes
MS IR	237978	Morphine Sulfate	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes		Yes	Yes
Otezla	233030	Apremilast	Amgen Canada Inc	No	Yes	No	Yes	No	Yes		No	Yes
Oxy.IR	237807	Oxycodone Hcl	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes		Yes	Yes
Oxyneo	237808	Oxycodone Hcl	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes		Yes	Yes
Sonovue	231944	Sulfur Hexafluoride	Bracco Imaging Canada	No	Yes	No	Yes	No	Yes		No	No
Sprycel	229858	Dasatinib	Bristol-Myers Squibb Canada	No	Yes	No	Yes	Yes	Yes		No	Yes
Sudafed Sinus Advance	237300	Ibuprofen, Pseudoephedrine Hcl	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	No	No	No		No	Yes
Symdeko	237289	Tezacaftor, Ivacaftor	Vertex Pharmaceuticals (Canada) Incorporated	No	Yes	No	No	No	No		No	No
Uniphyl	237977	Theophylline	Purdue Pharma	No	Yes	No	No	No	Yes		No	Yes
Zydelig	240413	Idelalisib	Gilead Sciences Canada Inc	No	Yes	Yes	Yes	No	No		No	Yes
Zytram XL	237703	Tramadol Hcl	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes		Yes	Yes

July 2020

Product Monograph Brand Safety Updates July 2020
(PDF, 77.9 KB, 2 pages)

July 2020

Brand Name	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings and Precautions	Serious Warnings and Precautions	Adverse Reactions	Drug Interactions	Dosage and Administration	Overdosage	Consumer Information
Diflucan	237806	Fluconazole	Pfizer Canada Inc	No	No	No	No	Yes	No	No	Yes
Dilaudid	237679	Hydromorphone Hcl	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Enstilar	237303	Betamethasone Dipropionate, Calcipotriol Monohydrate	Leo Pharma Inc	No	Yes	No	Yes	No	Yes	No	Yes
Hydromorph Contin	237700	Hydromorphone Hcl	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Ninlaro	236958	Ixazomib Citrate	Takeda Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Oxaliplatin	236783	Oxaliplatin	Pfizer Canada ULC	Yes	Yes	No	Yes	No	No	No	Yes
Precedex	237805	Dexmedetomidine	Pfizer Canada ULC	No	No	No	Yes	No	No	No	No
Protopic	237801	Tacrolimus	Leo Pharma Inc	No	Yes	No	No	No	Yes	No	Yes
Singulair	230733	Montelukast Sodium	Merck Canada Inc	No	Yes	Yes	Yes	No	Yes	No	Yes
Smofkabiven Electrolyte Free, Smofkabiven Extra Nitrogen Electrolyte Free	230307	Fish Oil, Phenylalanine, Valine, Methionamine, Tyrosine, Threonine, Nitrogen, Dextrose, Glycine, Histidine, Isoleucine, Proline, Arginine, Lysine, Alanine, Serine, Olive Oil, Tryptophan, Leucine, Soybean Oil, Taurine, Medium-Chain Triglycerides	Fresenius Kabi Canada Ltd	No	No	No	No	No	Yes	No	Yes
Smofkabiven, Smofkabiven Extra Nitrogen	230147	Fish Oil, Phenylalanine, Valine, Methionamine, Tyrosine, Threonine, Nitrogen, Dextrose, Glycine, Histidine, Isoleucine, Proline, Magnesium Sulfate, Potassium Chloride, Alanine, Arginine, Sodium Glycerophosphate, Lysine, Calcium Chloride Dihydrate, Serine, Olive Oil, Tryptophan, Sodium Acetate Trihydrate, Zinc Sulfate Heptahydrate, Leucine, Soybean Oil, Taurine, Medium-Chain Triglycerides	Fresenius Kabi Canada Ltd	No	No	No	No	No	Yes	No	Yes
Suboxone	229217	Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate	Indivior UK Limited	No	Yes	Yes	Yes	No	Yes	No	Yes
Teveten	237726	Eprosartan Mesylate	BGP Pharma ULC	No	Yes	No	No	Yes	No	No	Yes
Teveten Plus	237724	Hydrochlorothiazide, Eprosartan Mesylate	BGP Pharma ULC	No	Yes	No	No	Yes	No	No	Yes
Tiazac	237804	Diltiazem Hcl	Valeant Canada LP Valeant Canada S.E.C.	No	Yes	No	Yes	No	No	Yes	Yes
Vfend	237769	Voriconazole	Pfizer Canada ULC	Yes	Yes	Yes	Yes	Yes	No	No	Yes
Wellbutrin SR	237178	Bupropion Hcl	Valeant Canada LP Valeant Canada S.E.C.	No	Yes	No	Yes	No	No	Yes	Yes
Wellbutrin XL	237179	Bupropion Hcl	Valeant Canada LP Valeant Canada S.E.C.	No	Yes	No	Yes	No	No	Yes	Yes
Zyban	237455	Bupropion Hcl	Valeant Canada LP Valeant Canada S.E.C.	No	Yes	No	No	Yes	No	Yes	Yes

June 2020

Product Monograph Brand Safety Updates June 2020
(PDF, 109.68 KB, 3 pages)

Brand Name	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings and Precautions	Serious Warnings and Precautions	Adverse Reactions	Drug Interactions	Dosage and Administration	Overdosage	Consumer Information
Advair Diskus	237271	Fluticasone Propionate, Salmeterol Xinafoate	GlaxoSmithKline Inc	No	No	No	No	No	No	No	Yes
Aleve Tablets	237829	Naproxen Sodium	Bayer Inc	Yes	Yes	No	No	No	No	No	Yes
Apo-Cefprozil	235587	Cefprozil	Apotex Inc	No	Yes	No	No	No	No	No	Yes
	235590	Cefprozil	Apotex Inc	No	Yes	No	No	No	No	No	Yes
Caelyx	237448	Doxorubicin Hcl	Janssen Inc	No	Yes	No	Yes	No	Yes	No	Yes
Calcimar	230132	Calcitonin (Salmon Synthetic)	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	Yes	Yes	No
Children's MOTRIN, Infants' MOTRIN, Children's MOTRIN Chewable Tablets, Junior Strength MOTRIN Chewable Tablets	237473	Ibuprofen	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	Yes	No	No	No	Yes
Combogesic	237878	Ibuprofen, Acetaminophen	Biosyent Pharma Inc	No	No	No	No	No	Yes	No	Yes
Copaxone	236453	Glatiramer Acetate	Teva Canada Limited	No	Yes	No	Yes	No	No	No	Yes
Coversyl Plus, Coversyl Plus LD, Coversyl Plus HD	236978	Indapamide, Perindopril Erbumine	Servier Canada Inc	Yes	Yes	No	Yes	Yes	No	No	Yes
Envarsus PA	237246	Tacrolimus	Endo Ventures Ltd	No	Yes	No	Yes	Yes	Yes	No	Yes
Esbriet	237096	Pirfenidone	Hoffmann-La Roche Limited	No	Yes	No	Yes	No	Yes	No	No
Extra Strength Tylenol Nighttime	237375	Acetaminophen, Diphenhydramine Hcl	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	No	No	Yes	No	No	Yes	No
Flagystatin	236509	Metronidazole, Nystatin	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Forxiga	234304	Dapagliflozin Propanediol	AstraZeneca Canada Inc	Yes	Yes	Yes	Yes	No	Yes	No	Yes
Imuran	236597	Azathioprine Sodium, Azathioprine	Aspen Pharmacare Canada Inc.	No	Yes	No	Yes	Yes	Yes	No	Yes
Inhibace	235666	Cilazapril Monohydrate	Cheplapharm Arzneimittel GmbH	Yes	Yes	No	No	Yes	No	No	Yes
Inhibace Plus	235667	Hydrochlorothiazide, Cilazapril Monohydrate	Cheplapharm Arzneimittel GmbH	Yes	Yes	No	No	Yes	No	No	Yes
Jentadueto	229225	Metformin Hcl, Linagliptin	Boehringer Ingelheim (Canada) Ltd Ltee	Yes	Yes	No	Yes	Yes	Yes	No	Yes
Keppra	237080	Levetiracetam	UCB Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Levothyroxine Sodium Injection	223344	Levothyroxine Sodium	Fresenius Kabi Canada Ltd	No	No	No	No	No	No	No	Yes
Lozide	236979	Indapamide	Servier Canada Inc	Yes	Yes	No	Yes	Yes	No	No	Yes
Lynparza	229268	Olaparib	AstraZeneca Canada Inc	No	Yes	No	No	Yes	Yes	No	Yes
Maviret	229422	Pibrentasvir, Glecaprevir	AbbVie Corporation	No	Yes	No	No	Yes	No	No	Yes
Micatin Miconazole Nitrate Cream 2% USP	235783	Miconazole Nitrate	Wellspring Pharmaceutical Canada Corp	Yes	Yes	No	Yes	No	Yes	No	No
Micatin Powder Spray - Unscented 2%	235806	Miconazole Nitrate	Wellspring Pharmaceutical Canada Corp	Yes	Yes	No	Yes	No	Yes	No	No
Motrin 200 Mg, Motrin 300 Mg, Motrin 400 Mg	237424	Ibuprofen	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	Yes	No	No	No	Yes
Motrin Platinum Muscle and Body	237345	Methocarbamol, Ibuprofen	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	Yes	No	No	No	Yes
Multaq	237496	Dronedarone Hydrochloride	Sanofi-Aventis Canada Inc	No	Yes	No	No	Yes	Yes	No	Yes
Nitoman	236868	Tetrabenazine	Valeant Canada LP Valeant Canada S.E.C.	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Opsumit	236976	Macitentan	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes
Paxil	237146	Paroxetine Hcl	GlaxoSmithKline Inc	No	Yes	No	Yes	No	No	No	Yes
Paxil CR	237155	Paroxetine Hcl	GlaxoSmithKline Inc	No	Yes	No	Yes	No	No	No	Yes
Primaxin	229835	Cilastatin Sodium, Imipenem	Merck Canada Inc	No	No	No	No	No	Yes	No	Yes
Ritalin, Ritalin SR	237335	Methylphenidate Hcl	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Rythmol	236662	Propafenone Hcl	BGP Pharma ULC	Yes	Yes	No	No	No	No	Yes	Yes
Taxotere	237181	Docetaxel	Sanofi-Aventis Canada Inc	No	Yes	Yes	Yes	No	No	No	Yes
Tegsedi	234581	Inotersen Sodium	Akcea Therapeutics Inc	No	Yes	No	No	No	No	No	Yes
Trelegy Ellipta	236787	Umeclidinium Bromide, Fluticasone Furoate, Vilanterol Trifenatate	GlaxoSmithKline Inc	No	No	No	Yes	No	No	No	Yes
Tridural	237295	Tramadol Hcl	Paladin Labs Inc	No	Yes	No	No	No	No	No	Yes
Uptravi	229725	Selexipag	Janssen Inc	No	No	No	No	Yes	Yes	No	Yes
Xerese	236613	Acyclovir, Hydrocortisone	Valeant Canada LP Valeant Canada S.E.C.	Yes	Yes	No	No	Yes	No	No	Yes
Xtandi	233563	Enzalutamide	Astellas Pharma Canada Inc	No	Yes	No	Yes	No	No	No	Yes

May 2020

Product Monograph Brand Safety Updates May 2020
(PDF, 123 KB, 4 pages)

Brand Name	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions	Dosage & Administration	Overdosage	Consumer Information
Aczone	236260	Dapsone	Valeant Canada LP Valeant Canada S.E.C.	No	No	No	Yes	No	No	No	Yes
Advil Liqui-Gels, Advil Extra Strength Liqui-Gels, Advil Arthritis Pain	236129	Ibuprofen	Pfizer Consumer Healthcare A Division of Pfizer Canada ULC	No	Yes	No	No	No	No	No	No
Arthrotec 50, Arthrotec 75	235828	Misoprostol, Diclofenac Potassium	Pfizer Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Cabometyx	237444	Cabozantinib	Ipsen Biopharmaceuticals Canada Inc	No	Yes	No	No	No	No	No	Yes
Cayston	234938	Aztreonam	Gilead Sciences Canada Inc	No	Yes	No	No	No	No	No	Yes
Cefazolin for Injection	234941	Cefazolin Sodium	Teva Canada Limited	No	Yes	No	No	No	No	No	Yes
Ceftin	234485	Cefuroxime Axetil	GlaxoSmithKline Inc	No	Yes	No	No	No	No	No	Yes
Celebrex	236661	Celecoxib	Pfizer Canada ULC	No	Yes	No	No	No	No	No	Yes
Crestor	235939	Rosuvastatin Calcium	AstraZeneca Canada Inc	Yes	No	No	No	Yes	Yes	No	Yes
Cubicin, Cubicin RF	235553	Daptomycin	Cubist Pharmaceuticals LLC	No	Yes	No	Yes	No	No	No	Yes
Dermatop Ointment, Dermatop Emollient Cream	236612	Prednicarbate	Valeant Canada LP Valeant Canada S.E.C.	No	Yes	No	Yes	No	No	No	Yes
Diprosone	235123	Betamethasone Dipropionate	Merck Canada Inc	No	Yes	No	Yes	No	Yes	Yes	Yes
Envarsus PA	236672	Tacrolimus	Endo Ventures Ltd	No	No	No	No	Yes	No	No	Yes
Erivedge	236154	Vismodegib	Hoffmann La Roche Limited	No	Yes	Yes	Yes	No	No	No	Yes
Erleada	236573	Apalutamide	Janssen Inc	No	No	No	Yes	No	No	No	Yes
Fentora	236380	Fentanyl Citrate	Teva Canada Limited	No	Yes	No	Yes	Yes	No	No	Yes
Genvoya	236379	Emtricitabine, Cobicistat, Tenofovir Alafenamide Hemifumarate, Elvitegravir	Gilead Sciences Canada Inc	No	Yes	No	No	Yes	No	No	Yes
Hair Regrowth Treatment	235865	Minoxidil	Apotex Inc	No	No	No	Yes	No	No	Yes	Yes
Hp-PAC	235886	Lansoprazole, Amoxicillin, Clarithromycin	Takeda Pharmaceuticals America Inc	No	Yes	No	No	No	No	No	No
Invokamet	236214	Metformin Hcl, Canagliflozin	Janssen Inc	No	Yes	Yes	Yes	No	No	No	Yes
Invokamet XR	236251	Metformin Hcl, Canagliflozin	Janssen Inc	No	Yes	Yes	Yes	No	No	No	Yes
Invokana	236246	Canagliflozin	Janssen Inc	No	Yes	Yes	Yes	No	No	No	Yes
Isoptin SR	236383	Verapamil Hcl	BGP Pharma ULC	No	Yes	No	No	No	No	No	No
Lamictal	237004	Lamotrigine	GlaxoSmithKline Inc	No	No	No	Yes	Yes	No	No	Yes
Lioresal	235825	Baclofen	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Lioresal Intrathecal	235751	Baclofen	Novartis Pharmaceuticals Canada Inc	No	Yes	No	No	No	No	No	Yes
Lynparza	229261	Olaparib	AstraZeneca Canada Inc	No	Yes	No	No	Yes	Yes	No	Yes
Metadol	236670	Methadone Hydrochloride	Paladin Labs Inc	No	Yes	Yes	No	No	No	Yes	No
Nidagel	236355	Metronidazole	Valeant Canada LP Valeant Canada S.E.C.	No	No	No	Yes	No	No	No	No
Norvasc	236351	Amlodipine Besylate	Upjohn Canada ULC	Yes	Yes	No	No	Yes	No	Yes	Yes
Ofev	232923	Nintedanib	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	Yes	No	No	No	Yes
Olimel 4.4%, Olimel 5.7%, Olimel 7.6%, Periolimel 2.5% E, Olimel 3.3% E, Olimel 4.4% E, Olimel 5.7% E, Olimel 7.6% E	236356	Glutamic Acid, L-Lysine Acetate, L-Phenylalanine, L-Proline, Glucose, Magnesium Chloride Hexahydrate, Glycine, Potassium Chloride, L-Alanine, L-Isoleucine, L-Leucine, L-Methionine, L-Threonine, L-Tryptophan, L-Valine, Sodium Glycerophosphate, Calcium Chloride Dihydrate, L-Aspartic Acid, L-Histidine, L-Serine, Olive Oil, L-Arginine, Sodium Acetate Trihydrate, L-Tyrosine	Baxter Corporation	No	No	No	Yes	No	No	No	No
Paclitaxel for Injection	235717	Paclitaxel	Pfizer Canada ULC	No	No	No	No	Yes	No	No	Yes
Pediapred	235344	Prednisolone Sodium Phosphate	Sanofi-Aventis Canada Inc	Yes	Yes	No	Yes	Yes	No	No	Yes
Prevacid, Prevacid Fastab	235901	Lansoprazole	Takeda Pharmaceuticals America Inc	No	Yes	No	No	No	No	No	No
Prevymis	235148	Letermovir	Merck Canada Inc	No	No	No	No	Yes	No	No	No
Primaquine	226711	Primaquine Phosphate	Sanofi-Aventis Canada Inc	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Probuphine	236555	Buprenorphine Hydrochloride	Knight Therapeutics Inc.	No	Yes	No	No	Yes	No	No	Yes
Remeron	236043	Mirtazapine	Merck Canada Inc	Yes	Yes	No	Yes	Yes	No	No	Yes
Remeron RD	236098	Mirtazapine	Merck Canada Inc	Yes	Yes	No	Yes	Yes	No	No	Yes
Rosiver	235651	Ivermectin	Galderma Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Sofracort	236141	Dexamethasone Sodium Metasulphoben- zoate, Gramicidin, Framycetin Sulfate	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Stribild	236372	Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, Elvitegravir	Gilead Sciences Canada Inc	No	Yes	No	No	Yes	No	No	Yes
Symdeko	234531	Tezacaftor, Ivacaftor	Vertex Pharmaceuticals (Canada) Incorporated	No	No	No	No	Yes	No	No	Yes
Teva-Cefadroxil	234939	Cefadroxil Monohydrate	Teva Canada Limited	No	Yes	No	No	No	No	No	Yes
Topamax	236926	Topiramate	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes
Topicort, Topicort Mild, Topicort Gel, Topicort Ointment	236312	Desoximetasone	Bausch Health, Canada Inc.	No	Yes	No	Yes	No	No	No	No
Trajenta	229038	Linagliptin	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	No	No	No	Yes
Tybost	236347	Cobicistat	Gilead Sciences Canada Inc	Yes	Yes	No	No	Yes	No	No	Yes
Visudyne	235318	Verteporfin	Valeant Canada LP Valeant Canada S.E.C.	No	Yes	No	Yes	No	No	No	Yes
Zenhale	228615	Formoterol Fumarate Dihydrate, Mometasone Furoate	Merck Canada Inc	No	Yes	Yes	No	No	Yes	No	Yes

April 2020

Product Monograph Brand Safety Updates April 2020
(PDF, 105 KB, 5 pages)

Brand Name	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions	Dosage & Administration	Overdosage	Consumer Information
Abilify	234620	Aripiprazole	Otsuka Pharmaceutical Co Ltd	No	Yes	No	Yes	No	No	No	Yes
Abilify Maintena	234625	Aripiprazole	Otsuka Pharmaceutical Co Ltd	No	Yes	No	No	No	No	No	Yes
Asacol	235400	Mesalazine	Allergan Inc	No	Yes	No	Yes	No	No	No	Yes
Asacol 800	235403	Mesalazine	Allergan Inc	No	Yes	No	Yes	No	No	No	Yes
Bicillin L-A	234892	Penicillin G Benzathine	Pfizer Canada ULC	No	Yes	No	Yes	No	No	No	No
Caprelsa	237613	Vandetanib	Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Cefepime for Injection	234594	Cefepime Hcl	Apotex Inc	No	Yes	No	No	No	No	No	Yes
Cefoxitin for Injection	234942	Cefoxitin Sodium	Teva Canada Limited	No	Yes	No	No	No	No	No	Yes
Ceftriaxone Sodium for Injection	234479	Ceftriaxone Sodium	Teva Canada Limited	No	Yes	No	No	No	No	No	Yes
Cefuroxime for Injection, USP	233970	Cefuroxime Sodium	Fresenius Kabi Canada Ltd	No	Yes	No	No	No	No	No	Yes
Cetirizine Hydrochloride Capsules	233893	Cetirizine Hydrochloride	Catalent Ontario Limited	No	No	No	Yes	No	No	Yes	Yes
Cisplatin Injection BP	235278	Cisplatin	Pfizer Canada ULC	No	Yes	No	No	Yes	No	No	No
CLINIMIX E 8% Amino Acids (Blend D) with Electrolytes in 10% Dextrose with Calcium Injection, CLINIMIX E 8% Amino Acids (Blend D) with Electrolytes in 14% Dextrose with Calcium Injection, CLINIMIX 6% Amino Acids (Blend D) without Electrolytes in 5% Dextrose Injection, CLINIMIX 8% Amino Acids (Blend D) without Electrolytes in 10% Dextrose Injection, CLINIMIX 8% Amino Acids (Blend D) without Electrolytes in 14% Dextrose Injection	225011	L-Phenylalanine, L-Proline, Sodium Chloride, Magnesium Chloride Hexahydrate, Glycine, Histidine, L-Lysine Hcl, Dextrose, L-Alanine, L-Isoleucine, L-Leucine, L-Methionine, L-Threonine, L-Tryptophan, L-Valine, Calcium Chloride Dihydrate, Potassium Phosphate Dibasic, Serine, L-Arginine, L-Tyrosine	Baxter Corporation	No	Yes	No	No	No	Yes	No	Yes
Duratocin	236432	Carbetocin	Ferring Inc	Yes	Yes	No	No	Yes	Yes	Yes	Yes
Forxiga	227213	Dapagliflozin Propanediol	AstraZeneca Canada Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Glyxambi	235055	Linagliptin, Empagliflozin	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	Yes	Yes	No	No	No	Yes
Imbruvica	235078	Ibrutinib	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes
Jardiance	235061	Empagliflozin	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	Yes	Yes	No	No	No	Yes
Lopresor	235180	Metoprolol Tartrate	Novartis Pharmaceuticals Canada Inc	No	Yes	No	No	Yes	No	No	Yes
Lorbrena	235243	Lorlatinib	Pfizer Canada ULC	No	No	No	No	Yes	No	No	No
Lunesta	231283	Eszopiclone	Sunovion Pharmaceuticals Canada Inc	No	No	No	No	No	No	No	Yes
Mezera	235405	Mesalazine	Avir Pharma Inc	No	Yes	No	Yes	No	No	No	Yes
Moviprep	235769	Polyethylene Glycol 3350, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate, Sodium Sulfate Anhydrous	Aralez Pharmaceuticals Canada Inc	No	Yes	No	No	No	No	No	Yes
Olumiant	235025	Baricitinib	Eli Lilly Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Onstryv	235000	Safinamide	Valeo Pharma Inc	No	Yes	No	Yes	Yes	No	No	Yes
Perindopril Erbumine	235373	Perindopril Erbumine	Sanis Health Inc	No	No	No	Yes	No	No	No	Yes
Piperacillin for Injection	233968	Piperacillin Sodium	Fresenius Kabi Canada Ltd	No	Yes	No	No	No	No	No	Yes
Reactine	235677	Cetirizine Hydrochloride	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Reyataz	236039	Atazanavir Sulfate	Bristol-Myers Squibb Canada	Yes	No	No	No	Yes	No	No	Yes
Salofalk	235411	Mesalazine	Aptalis Pharma Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Salofalk Suppositories	235409	Mesalazine	Aptalis Pharma Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Salofalk Tablets	235406	Mesalazine	Aptalis Pharma Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Signifor	236660	Pasireotide	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Signifor LAR	236663	Pasireotide	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Spinraza	228080	Nusinersen	Biogen Canada Inc	No	No	No	Yes	No	No	No	Yes
Synjardy	235200	Metformin Hcl, Empagliflozin	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	Yes	Yes	No	No	No	Yes
Tapazole 5 mg Tablet, Tapazole	233764	Methimazole	Paladin Labs Inc	No	Yes	No	Yes	No	No	No	Yes
Teva-Modafinil	235652	Modafinil	Teva Canada Limited	Yes	Yes	No	No	No	No	No	Yes
Tygacil	235179	Tigecycline	Pfizer Canada ULC	No	Yes	No	Yes	Yes	No	No	Yes
Venclexta	228475	Venetoclax	Abbvie Corporation	No	Yes	No	Yes	No	Yes	No	Yes
Xigduo	228055	Metformin Hcl, Dapagliflozin	AstraZeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Zydelig	229315	Idelalisib	Gilead Sciences Canada Inc	No	No	No	No	No	No	No	Yes

March 2020

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

Brand Name	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions	Dosage & Administration	Overdosage	Consumer Information
20% Prosol	235340	L-Lysine Acetate, L-Phenylalanine, L-Proline, Glutamic Acid, Histidine, Glycine, L-Valine, L-Isoleucine, L-Leucine, L-Threonine, L-Methionine, L-Tryptophan, L-Alanine, L-Aspartic Acid, Serine, L-Arginine, L-Tyrosine	Baxter Corporation	No	Yes	No	No	No	Yes	No	No
Adempas	226431	Riociguat	Bayer Inc	No	Yes	No	No	Yes	Yes	No	Yes
Advil Tablets, Advil Caplets, Advil Extra Strength Caplets, Advil Muscle And Joint, Advil 12 Hour, Advil Gel Caplets	234297	Ibuprofen	Pfizer Consumer Healthcare a Division of Pfizer Canada ULC	No	Yes	No	No	No	No	Yes	No
Atriance	230597	Nelarabine	Novartis Pharmaceuticals Canada Inc	No	No	No	No	No	Yes	No	Yes
Biktarvy	226658	Emtricitabine, Bictegravir Sodium, Tenofovir Alafenamide Hemifumarate	Gilead Sciences Canada Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Brivlera	226734	Brivaracetam	UCB Canada Inc	No	Yes	No	Yes	No	Yes	No	No
Camptosar	235201	Irinotecan Hydrochloride	Pfizer Canada ULC	No	Yes	No	No	No	No	No	Yes
Cefotaxime Sodium for Injection, BP	233966	Cefotaxime Sodium	Sterimax Inc	No	Yes	No	No	No	No	No	Yes
Clotrimazole-Fluconazole Combi-Pack	234086	Fluconazole, Clotrimazole	Taro Pharmaceuticals Inc	No	Yes	No	Yes	No	No	No	Yes
Cyclen	235009	Ethinyl Estradiol, Norgestimate	Janssen Inc	No	No	No	Yes	Yes	No	No	Yes
Depakene	234417	Valproic Acid	BGP Pharma ULC	No	Yes	No	No	No	No	No	Yes
Efudex	235663	Fluorouracil	Valeant Canada LP Valeant Canada S.E.C.	Yes	Yes	No	No	No	No	No	No
Epival	234416	Divalproex Sodium	BGP Pharma ULC	No	Yes	No	No	Yes	No	No	Yes
Evra	235077	Norelgestromin, Ethinyl Estradiol	Janssen Inc	No	No	No	No	Yes	No	No	Yes
Fuzeon	235288	Enfuvirtide	Hoffmann La Roche Limited	No	Yes	No	No	No	No	No	No
Invirase	235283	Saquinavir Mesylate	Hoffmann La Roche Limited	No	Yes	No	No	No	No	No	No
Kazano	229340	Metformin Hcl, Alogliptin Benzoate	Takeda Canada Inc	Yes	Yes	No	Yes	Yes	Yes	No	Yes
Keflex	233620	Cephalexin	Pendopharm Division of Pharmascience Inc	No	Yes	No	No	No	No	No	Yes
Kisqali	234283	Ribociclib Succinate	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Latuda	234629	Lurasidone Hydrochloride	Sunovion Pharmaceuticals Canada Inc	No	Yes	No	No	No	No	No	Yes
Maviret	227240	Pibrentasvir, Glecaprevir	Abbvie Corporation	No	No	No	No	No	Yes	No	No
Nexavar	233760	Sorafenib Tosylate	Bayer Inc	No	Yes	No	Yes	No	No	No	Yes
Novamoxin	233622	Amoxicillin	Teva Canada Limited	No	Yes	No	No	No	No	No	Yes
Orilissa	233793	Elagolix	Abbvie Corporation	No	Yes	No	Yes	Yes	Yes	No	Yes
Perindopril Erbumine	233925	Perindopril Erbumine	Sivem Pharmaceuticals ULC	No	No	No	Yes	No	No	No	Yes
Piperacillin Sodium/Tazobactam Sodium Powder for Injection	233631	Piperacillin Sodium, Tazobactam Sodium	Sandoz Canada Incorporated	No	Yes	No	No	No	No	No	Yes
Pradaxa	234514	Dabigatran Etexilate Mesilate	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	Yes	No	No	Yes
Pravachol	234107	Pravastatin Sodium	Bristol-Myers Squibb Canada	No	Yes	No	Yes	No	No	No	Yes
Sandoz Fingolimod	235223	Fingolimod Hydrochloride	Sandoz Canada Incorporated	No	Yes	No	Yes	Yes	Yes	No	Yes
Septra Injection	224385	Trimethoprim, Sulfamethoxazole	Aspen Pharmacare Canada Inc.	Yes	Yes	Yes	Yes	Yes	No	No	Yes
Stivarga	233755	Regorafenib	Bayer Inc	No	Yes	No	Yes	No	No	No	Yes
Suprax	233967	Cefixime	Odan Laboratories Ltd	No	Yes	No	No	No	No	No	Yes
Tagrisso	234409	Osimertinib Mesylate	Astrazeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Tasigna	228181	Nilotinib Hydrochloride Monohydrate	Novartis Pharmaceuticals Canada Inc	No	Yes	Yes	Yes	No	Yes	No	Yes
Tri-Cyclen	235045	Ethinyl Estradiol, Norgestimate	Janssen Inc	No	No	No	Yes	Yes	No	No	Yes
Tri-Cyclen Lo	235080	Ethinyl Estradiol, Norgestimate	Janssen Inc	No	No	No	Yes	Yes	No	No	Yes
Votrient	234074	Pazopanib Hydrochloride	Novartis Pharmaceuticals Canada Inc	No	Yes	Yes	Yes	No	No	No	Yes

February 2020

Product Monograph Brand Safety Updates February 2020
(PDF, 79 KB, 2 pages)

Brand Name	Submission Number	Ingredient(s)	Manufacturer	Contraindications	Warnings & Precautions	Serious Warnings & Precautions	Adverse Reactions	Drug Interactions	Dosage & Administration	Overdosage	Consumer Information
Atripla	235076	Emtricitabine, Tenofovir Disoproxil Fumarate, Efavirenz	Gilead Sciences, LLC	No	No	No	No	Yes	No	No	Yes
Avelox I.V., Avelox	233350	Moxifloxacin Hydrochloride	Bayer Inc	No	Yes	No	Yes	No	Yes	No	Yes
Backup Plan Onestep	234289	Levonorgestrel	Apotex Inc	No	Yes	No	No	Yes	No	No	Yes
Cipro XL	233378	Ciprofloxacin Hydrochloride, Ciprofloxacin	Bayer Inc	No	Yes	No	Yes	No	Yes	No	Yes
Cipro, Cipro Oral Suspension	233351	Ciprofloxacin Hydrochloride	Bayer Inc	No	Yes	No	Yes	No	Yes	No	Yes
Clotrimaderm Vaginal 6, Clotrimaderm Vaginal 3	232921	Clotrimazole	Taro Pharmaceuticals Inc	Yes	Yes	No	No	No	No	No	Yes
Dovato	233231	Dolutegravir, Lamivudine	ViiV Healthcare ULC	Yes	Yes	No	No	Yes	Yes	No	Yes
Dovobet Gel	234060	Betamethasone Dipropionate, Calcipotriol Monohydrate	Leo Pharma Inc	No	No	No	No	No	Yes	No	Yes
Duodopa	233778	Levodopa, Carbidopa Monohydrate	Abbvie Corporation	No	Yes	No	Yes	No	No	No	Yes
Duratocin	225949	Carbetocin	Ferring Inc	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Effexor XR	226110	Venlafaxine Hcl	Pfizer Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Fycompa	225719	Perampanel	Eisai Limited	No	Yes	Yes	Yes	Yes	Yes	No	Yes
Harvoni	224930	Ledipasvir, Sofosbuvir	Gilead Sciences Canada Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Hemangiol	234158	Propranolol Hcl	Pierre Fabre Dermo-Cosmetique Canada Inc	Yes	Yes	No	Yes	Yes	Yes	No	No
Hydrea	226144	Hydroxyurea	Bristol-Myers Squibb Canada	No	Yes	No	Yes	No	No	No	Yes
Idhifa	233304	Enasidenib Mesylate	Celgene Inc	No	Yes	Yes	No	No	No	No	No
Juluca	233259	Dolutegravir, Rilpivirine	ViiV Healthcare ULC	Yes	Yes	No	No	Yes	Yes	Yes	Yes
Kisqali	225074	Ribociclib Succinate	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Kyprolis	233723	Carfilzomib	Amgen Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Levitra	234111	Vardenafil Hydrochloride	Bayer Inc	Yes	No	No	No	Yes	No	No	Yes
Lixiana	233505	Edoxaban Tosylate	Servier Canada Inc	No	No	No	Yes	No	No	No	Yes
Lupron, Lupron Depot	233585	Leuprolide Acetate	Abbvie Corporation	No	Yes	No	No	No	No	No	Yes
Lynparza	230309	Olaparib	Astrazeneca Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Maviret	234128	Pibrentasvir, Glecaprevir	Abbvie Corporation	No	No	No	Yes	No	No	No	Yes
Naproxen Capsules 200 mg	233389	Naproxen, Naproxen Sodium	Catalent Ontario Limited	No	Yes	Yes	No	Yes	No	No	Yes
Nozinan	233434	Methotrimeprazine Hcl	Sanofi-Aventis Canada Inc	Yes	Yes	No	Yes	Yes	Yes	No	Yes
Opsumit	233042	Macitentan	Janssen Inc	No	No	No	No	Yes	No	No	No
Picato	233545	Ingenol Mebutate	Leo Pharma Inc	No	No	No	Yes	No	No	No	Yes
Pristiq	225933	Desvenlafaxine Succinate	Pfizer Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Staxyn	234112	Vardenafil Hydrochloride	Bayer Inc	Yes	No	No	No	Yes	No	No	Yes
Tivicay	233258	Dolutegravir	ViiV Healthcare ULC	Yes	Yes	No	No	Yes	Yes	No	Yes
Tobradex	233347	Tobramycin, Dexamethasone	Novartis Pharmaceuticals Canada Inc	No	Yes	No	No	No	Yes	No	Yes
Tobrex	233358	Tobramycin	Novartis Pharmaceuticals Canada Inc	No	Yes	No	No	No	Yes	No	Yes
Triumeq	233245	Dolutegravir, Abacavir, Lamivudine	ViiV Healthcare ULC	Yes	Yes	No	No	Yes	Yes	No	Yes
Volulyte	223031	Hydroxyethyl Starch	Fresenius Kabi Canada Ltd	Yes	Yes	No	No	No	Yes	No	Yes
Voluven	222938	Hydroxyethyl Starch	Fresenius Kabi Canada Ltd	Yes	Yes	No	No	No	Yes	No	Yes
Xiidra	224297	Lifitegrast	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	No
Yondelis	233902	Trabectedin	Janssen Inc	No	No	No	Yes	No	No	No	No

January 2020

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

Brand name	Submission number	Ingredient(s)	Manufacturer	Contraindications	Warnings and precautions	Serious warnings and precautions	Adverse reactions	Drug interactions	Dosage and administration	Overdosage	Consumer information
Advil Mini-Gels	232267	Ibuprofen	Pfizer Consumer Healthcare a Division of Pfizer Canada ULC	No	Yes	No	No	No	No	Yes	No
Allegra-D	233901	Fexofenadine Hcl, Pseudoephedrine Hcl	Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc	No	No	No	No	No	No	No	Yes
Ambisome	232288	Amphotericin B	Astellas Pharma Canada Inc	No	No	No	No	No	Yes	No	No
Apo-Gain	232446	Minoxidil	Apotex Inc	No	No	No	Yes	No	No	Yes	Yes
Atriance	225174	Nelarabine	No vartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Avelox I.V.	230322	Moxifloxacin Hydrochloride	Bayer Inc	No	Yes	No	No	No	No	No	Yes
Belkyra	234220	Deoxycholic Acid	Kythera Biopharmaceuticals Inc	No	Yes	No	Yes	No	Yes	No	No
Biphentin	224342	Methylphenidate Hcl	Purdue Pharma	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Cipro XL	230325	Ciprofloxacin	Bayer Inc	No	Yes	No	No	No	No	No	Yes
Cipro, Cipro Oral Suspension	230323	Ciprofloxacin	Bayer Inc	No	Yes	No	No	No	No	No	Yes
Clavulin	232771	Clavulanic Acid, Amoxicillin Trihydrate	Glaxosmithkline Inc	No	No	No	Yes	No	No	No	Yes
Clozaril	232767	Clozapine	HLS Therapeutics Inc	No	Yes	No	Yes	No	No	No	No
Enstilar	232424	Betamethasone Dipropionate, Calcipotriol Monohydrate	Leo Pharma Inc	No	No	No	No	No	Yes	No	Yes
Epclusa	224935	Velpatasvir, Sofosbuvir	Gilead Sciences Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Ibrance	234582	Palbociclib	Pfizer Canada ULC	No	Yes	No	No	No	No	No	No
Intralipid 10%, Intralipid 20%, Intralipid 30%	233169	Soybean Oil	Fresenius Kabi Canada Ltd	No	Yes	No	No	No	Yes	No	Yes
Invega	231833	Paliperidone	Janssen Inc	No	Yes	Yes	Yes	Yes	Yes	No	Yes
Invega Sustenna	231845	Paliperidone Palmitate	Janssen Inc	No	Yes	Yes	Yes	Yes	Yes	No	Yes
Invega Trinza	231762	Paliperidone Palmitate	Janssen Inc	No	Yes	Yes	Yes	Yes	Yes	No	Yes
Invokana	229188	Canagliflozin	Janssen Inc	Yes	Yes	No	Yes	No	Yes	No	Yes
Lamictal	228920	Lamotrigine	Glaxosmithkline Inc	No	No	No	No	No	No	No	Yes
Lioresal	232773	Baclofen	Novartis Pharmaceuticals Canada Inc	No	Yes	Yes	No	No	No	No	Yes
Lorbrena	232764	Lorlatinib	Pfizer Canada ULC	Yes	Yes	No	Yes	Yes	No	Yes	Yes
Lyrica	232498	Pregabalin	Pfizer Canada ULC	No	Yes	Yes	No	Yes	No	No	Yes
Mezavant	232656	Mesalazine	Shire Pharma Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Neurontin	232770	Gabapentin	Pfizer Canada ULC	No	Yes	Yes	No	Yes	No	No	Yes
Ofev	232837	Nintedanib	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	No	No	No	Yes
Pentasa	232612	Mesalazine	Ferring Inc	No	Yes	No	Yes	No	No	No	Yes
PMS-Hydrochlorothiazide	232155	Hydrochlorothiazide	Pharmascience Inc	No	Yes	No	Yes	No	Yes	No	Yes
Precedex	232263	Dexmedetomidine Hcl	Pfizer Canada ULC	No	Yes	No	No	No	No	No	No
Risperdal Consta	232009	Risperidone	Janssen Inc	No	Yes	No	Yes	No	Yes	Yes	Yes
Sublocade	233256	Buprenorphine	Indivior UK Limited	No	No	No	No	No	Yes	No	Yes
Tramacet	232815	Acetaminophen, Tramadol Hcl	Janssen Inc	No	Yes	No	No	Yes	No	No	Yes
Ultram	232839	Tramadol Hcl	Janssen Inc	No	Yes	No	No	Yes	No	No	Yes
Ultravist 240, Ultravist 300, Ultravist 370	234206	Iopromide	Bayer Inc	No	No	No	No	No	Yes	No	Yes
Venclexta	224252	Venetoclax	Abbvie Corporation	No	Yes	No	Yes	No	No	No	Yes
Vosevi	224937	Voxilaprevir, Velpatasvir, Sofosbuvir	Gilead Sciences Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Zykadia	224168	Ceritinib	Novartis Pharmaceuticals Canada Inc	No	No	No	No	Yes	No	No	Yes
Zyprexa, Zyprexa Zydis, Zyprexa Intramuscular	232853	Olanzapine	Eli Lilly Canada Inc	No	No	No	Yes	No	No	No	Yes

Non-Prescription Submissions Cleared in 2014

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

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

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