Product monograph brand safety updates

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• June 2020
• May 2020
• April 2020
• March 2020
• February 2020
• January 2020
• December 2019
• November 2019
• October 2019
• September 2019
• August 2019
• July 2019
• Non-Prescription Submissions Cleared in 2014

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

December 2019

Product Monograph Brand Safety Updates December 2019
(PDF, 98 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
Advil Liqui-Gels, Advil Extra Strength Liqui-Gels, Advil Arthritis Pain	232458	Ibuprofen	Pfizer Consumer Healthcare A Division of Pfizer Canada ULC	Yes	Yes		Yes	No		No		No	No	Yes
Bydureon	233114	Exenatide	Astrazeneca Canada Inc	No	Yes		No	Yes		No		No	No	Yes
Byetta	233128	Exenatide	Astrazeneca Canada Inc	No	Yes		No	Yes		No		No	No	Yes
Carboplatin Injection BP	231317	Carboplatin	Pfizer Canada ULC	No	Yes		No	Yes		Yes		No	No	No
Clobex Shampoo	233257	Clobetasol Propionate	Galderma Canada Inc	No	Yes		No	Yes		No		No	No	Yes
Duragesic	232433	Fentanyl	Janssen Inc	No	Yes		No	Yes		No		Yes	No	Yes
Effexor XR	231434	Venlafaxine Hcl	Pfizer Canada ULC	No	Yes		No	Yes		No		Yes	No	Yes
Erleada	228077	Apalutamide	Janssen Inc	No	Yes		No	Yes		Yes		Yes	No	Yes
Exjade	231555	Deferasirox	Novartis Pharmaceuticals Canada Inc	No	Yes		No	No		No		Yes	Yes	Yes
Ferrlecit	231584	Sodium Ferric Gluconate Complex in Sucrose Injection	Sanofi-Aventis Canada Inc	Yes	Yes		No	Yes		Yes		No	Yes	No
Gilenya	233920	Fingolimod Hydrochloride	Novartis Pharmaceuticals Canada Inc	No	Yes		No	No		No		Yes	No	Yes
Ibuprofen	229772	Ibuprofen	Jamp Pharma Corporation	Yes	Yes		Yes	Yes		Yes		Yes	Yes	Yes
Jadenu	231556	Deferasirox	Novartis Pharmaceuticals Canada Inc	No	Yes		No	No		No		Yes	Yes	Yes
Jurnista	232334	Hydromorphone Hcl	Janssen Inc	Yes	Yes		No	Yes		No		Yes	No	Yes
Loestrin 1.5/30	230515	Ethinyl Estradiol, Norethindrone Acetate	Allergan Inc	Yes	Yes		No	No		Yes		No	No	Yes
Lunesta	231401	Eszopiclone	Sunovion Pharmaceuticals Canada Inc	Yes	Yes		Yes	No		Yes		No	Yes	Yes
Mekinist	231497	Trametinib	Novartis Pharmaceuticals Canada Inc	No	Yes		No	Yes		No		No	No	Yes
Minestrin 1/20	230974	Ethinyl Estradiol, Norethindrone Acetate	Allergan Inc	Yes	Yes		No	No		Yes		No	No	Yes
Movantik	231693	Naloxegol Oxalate	Knight Therapeutics Inc.	No	Yes		No	Yes		No		No	No	Yes
Neupro	231666	Rotigotine	UCB Canada Inc	No	No		No	Yes		No		No	No	No
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	222961	Glucose, Magnesium Chloride Hexahydrate, Amino Acids, Potassium Chloride, Sodium Glycerophosphate, Calcium Chloride Dihydrate, Olive Oil, Sodium Acetate, Soybean Oil	Baxter Corporation	No	No		No	No		Yes		Yes	Yes	Yes
Pifeltro	223943	Doravirine	Merck Canada Inc	No	Yes		No	Yes		No		No	No	Yes
Primene 10%	232065	Glutamic Acid, L-Phenylalanine, L-Proline, Glycine, Histidine, L-Lysine, L-Alanine, L-Isoleucine, L-Leucine, L-Methionine, L-Threonine, L-Valine, L-Aspartic Acid, Serine, L-Cysteine, L-Arginine, L-Ornithine, Tryptophan, Taurine, L-Tyrosine	Baxter Corporation	No	Yes		No	No		No		Yes	No	No
Pristiq	222508	Desvenlafaxine Succinate	Pfizer Canada ULC	No	Yes		No	Yes		No		No	No	Yes
Pristiq	231425	Desvenlafaxine Succinate	Pfizer Canada ULC	No	No		Yes	No		No		Yes	No	Yes
Sativex	207694	Cannabidiol, Delta-9-Tetrahydrocannabinol	GW Pharma Limited	Yes	Yes		Yes	Yes		Yes		No	No	Yes
Seroquel, Seroquel XR	231524	Quetiapine Fumarate	Astrazeneca Canada Inc	No	No		No	No		No		No	Yes	Yes
Somatuline Autogel	230940	Lanreotide Acetate	Ipsen Biopharm Limited	Yes	Yes		No	Yes		No		Yes	No	Yes
Sustiva	230875	Efavirenz	Bristol-Myers Squibb Canada	No	Yes		No	No		Yes		No	No	Yes
Tafinlar	231496	Dabrafenib	Novartis Pharmaceuticals Canada Inc	No	Yes		No	Yes		No		No	No	Yes
Venclexta	224188	Venetoclax	Abbvie Corporation	No	Yes		No	No		No		Yes	No	No
Zantac, Zantac Maximum Strength Non-Prescription	231962	Ranitidine Hcl	Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc	No	No		No	No		Yes		No	No	Yes
Zelboraf	231572	Vemurafenib	Hoffmann La Roche Limited	No	Yes		No	No		No		No	No	Yes
Zoloft	231452	Sertraline Hcl	Pfizer Canada ULC	Yes	Yes		No	No		No		Yes	No	Yes
Zomig Nasal Spray, Zomig, Zomig Rapimelt	231420	Zolmitriptan	Astrazeneca Canada Inc	No	Yes		No	No		Yes		No	No	Yes

November 2019

Product Monograph Brand Safety Updates November 2019
(PDF, 95 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 Cold & Sinus Plus, Advil Cold, Sinus & Flu Extra Strength, Children's Advil Cold & Flu Multi-Symptom	231574	Ibuprofen, Pseudoephedrine Hcl, Chlorpheniramine Maleate	Pfizer Consumer Healthcare A Division of Pfizer Canada ULC	Yes	Yes	Yes	No	Yes	No	No	Yes
Advil Cold and Sinus Nighttime	231529	Ibuprofen, Pseudoephedrine Hcl, Chlorpheniramine Maleate	Pfizer Consumer Healthcare A Division of Pfizer Canada ULC	Yes	Yes	No	No	Yes	No	No	Yes
Advil Cold, Cough & Flu Nighttime	231648	Ibuprofen, Diphenhydramine Hcl	Pfizer Consumer Healthcare A Division of Pfizer Canada ULC	Yes	Yes	Yes	No	Yes	No	No	Yes
Advil Nighttime	231333	Ibuprofen, Diphenhydramine Hcl	Pfizer Consumer Healthcare A Division of Pfizer Canada ULC	Yes	Yes	Yes	No	Yes	No	No	Yes
Advil Tablets, Advil Caplets, Advil Extra Strength Caplets, Advil Muscle and Joint, Advil 12 Hour	231383	Ibuprofen	Pfizer Canada ULC, Pfizer Consumer Healthcare A Division of Pfizer Canada ULC	No	No	No	No	No	No	No	Yes
Atrovent HFA	230291	Ipratropium Bromide	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	No	No	No	No	Yes
Belsomra	232257	Suvorexant	Merck Canada Inc	No	No	No	No	No	No	No	Yes
Bicillin L-A	231017	Penicillin G Benzathine	Pfizer Canada ULC	No	Yes	No	No	No	No	No	Yes
Cabometyx	222733	Cabozantinib	Ipsen Biopharmaceuticals Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Calquence	231228	Acalabrutinib	AstraZeneca Canada Inc	No	Yes	Yes	Yes	Yes	Yes	No	Yes
Children's Advil, Children's Advil Fever from Colds or Flu, Advil Pediatric Drops, Advil Pediatric Drops Fever from Colds or Flu, Junior Strength Advil, Junior Strength Advil Fever from Colds or Flu	230868	Ibuprofen	Pfizer Consumer Healthcare A Division of Pfizer Canada ULC	Yes	Yes	Yes	No	Yes	Yes	No	Yes
Combivent Respimat	230157	Ipratropium Bromide Monohydrate, Salbutamol Sulfate	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	No	No	No	No	Yes
Depakene	231239	Valproic Acid	BGP Pharma ULC	No	Yes	No	No	No	No	No	Yes
Diprosalic	229611	Salicylic Acid, Betamethasone Dipropionate	Merck Canada Inc	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Epival	231240	Divalproex Sodium	BGP Pharma ULC	No	Yes	No	No	No	No	No	Yes
Faslodex	231097	Fulvestrant	AstraZeneca Canada Inc	No	Yes	No	No	No	No	No	Yes
Fetzima	222857	Levomilnacipran	Allergan Inc	No	Yes	No	Yes	No	Yes	No	No
Imbruvica	222804	Ibrutinib	Janssen Inc	No	Yes	No	Yes	No	Yes	No	Yes
Lonsurf	227070	Tipiracil Hydrochloride, Trifluridine	Taiho Pharma Canada, Inc.	No	Yes	No	Yes	Yes	Yes	No	Yes
Medrol	230711	Methylprednisolone	Pfizer Canada ULC	No	Yes	No	No	No	No	No	Yes
Metadol-D	230588	Methadone Hydrochloride	Paladin Labs Inc	No	Yes	No	No	No	No	Yes	No
Multihance	222736	Gadobenate Dimeglumine	Bracco Imaging Canada	No	No	No	Yes	No	Yes	No	No
Odefsey	229507	Emtricitabine, Tenofovir Alafenamide Hemifumarate, Rilpivirine Hydrochloride	Gilead Sciences Canada Inc	No	No	No	No	No	No	Yes	No
Ofev	227166	Nintedanib	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	Yes	Yes	Yes	No	Yes
Omeprazole	231179	Omeprazole Magnesium	Laboratoire Riva Inc	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Parnate	230098	Tranylcypromine Sulfate	Glaxosmithkline Inc	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Pharixia Alcohol Free	226851	Benzydamine Hcl	Pendopharm Division of Pharmascience Inc	No	No	No	No	No	No	No	Yes
Rapamune	231380	Sirolimus	Pfizer Canada ULC	No	No	No	No	No	Yes	No	Yes
Tapazole	229873	Methimazole	Paladin Labs Inc	Yes	Yes	No	Yes	No	No	No	Yes
Tecfidera	231004	Dimethyl Fumarate	Biogen Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Trajenta	222572	Linagliptin	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	Yes	No	No	No	Yes
Tridural	232435	Tramadol Hcl	Paladin Labs Inc	No	No	No	Yes	No	No	No	Yes
Zantac, Zantac Maximum Strength Non-Prescription	230576	Ranitidine Hcl	Sanofi Consumer Health Inc Sanofi Sante Grand Public Inc	No	No	No	No	No	No	No	Yes

October 2019

Product Monograph Brand Safety Updates October 2019
(PDF, 131.90 KB, 3 pages)

Brand name list	Submission number	Ingredient(s)	Manufacturer	Contraindications	Warnings and precautions	Serious warnings and precautions	Adverse reactions	Drug interactions	Dosage and administration	Overdosage	Consumer information
Addyi	229976	Flibanserin	Sprout Pharmaceuticals Canada, Ltd	No	No	No	Yes	No	No	No	Yes
Advil Cold and Flu	231035	Ibuprofen, Diphenhydramine Citrate	Pfizer Consumer Healthcare a Division of Pfizer Canada ULC	Yes	Yes	Yes	No	Yes	No	No	Yes
Advil Cold and Sinus, Advil Cold and Sinus Liqui-Gels, Children's Advil Cold	230574	Ibuprofen, Pseudoephedrine Hcl	Pfizer Consumer Healthcare a Division of Pfizer Canada ULC	Yes	Yes	Yes	No	No	No	No	Yes
Agrylin	230534	Anagrelide Hydrochloride	Shire Pharma Canada ULC	No	No	No	Yes	No	No	No	Yes
Cabometyx	221859	Cabozantinib	Ipsen Biopharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Children's Motrin, Infants' Motrin, Motrin Liquid Gels 400 Mg	226260	Ibuprofen	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Complera	229540	Emtricitabine, Tenofovir Disoproxil Fumarate, Rilpivirine Hydrochloride	Gilead Sciences Canada Inc	No	No	No	No	No	No	Yes	No
Dymista	221498	Fluticasone Propionate, Azelastine Hydrochloride	BGP Pharma ULC	No	No	No	Yes	No	No	No	Yes
Eliquis	229267	Apixaban	Bristol-Myers Squibb Canada	No	Yes	No	No	No	No	No	Yes
Gilenya	229509	Fingolimod Hydrochloride	Novartis Pharmaceuticals Canada Inc	Yes	Yes	No	Yes	No	No	No	Yes
Gleevec	230365	Imatinib Mesylate	Novartis Pharmaceuticals Canada Inc	No	Yes	No	No	No	No	No	Yes
Ibrance	226755	Palbociclib	Pfizer Canada ULC	No	No	No	No	Yes	Yes	No	Yes
Ibuprofen	230374	Ibuprofen	Jamp Pharma Corporation	Yes	Yes	No	Yes	No	Yes	Yes	Yes
Invanz	229790	Ertapenem Sodium	Merck Canada Inc	No	No	No	Yes	No	Yes	No	Yes
Isoptin SR	229449	Verapamil Hcl	BGP Pharma ULC	Yes	Yes	No	No	Yes	No	No	Yes
Jardiance	229872	Empagliflozin	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	No	No	No	No
Keppra	230494	Levetiracetam	UCB Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Kinevac	231066	Sincalide	Bracco Imaging Canada	No	Yes	No	No	Yes	Yes	No	Yes
Lixiana	229632	Edoxaban Tosylate	Servier Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Lolo	229630	Ethinyl Estradiol, Norethindrone Acetate	Allergan Inc	Yes	Yes	No	No	Yes	No	No	Yes
Men's Rogaine	230208	Minoxidil	Johnson & Johnson Inc	No	No	No	No	No	No	No	Yes
Nitisinone Tablets	224962	Nitisinone	Cycle Pharmaceuticals Ltd	No	No	No	No	No	Yes	No	Yes
Norvir	229482	Ritonavir	Abbvie Corporation	Yes	No	No	No	Yes	No	No	Yes
Odefsey	222137	Emtricitabine, Rilpivirine, Tenofovir Alafenamide	Gilead Sciences Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Plavix	229510	Clopidogrel Bisulfate	Sanofi-Aventis Canada Inc	No	No	No	No	Yes	No	No	Yes
Prevacid, Prevacid Fastab	230613	Lansoprazole	Takeda Pharmaceuticals America Inc	No	Yes	No	Yes	No	No	No	Yes
Sandoz Fingolimod	229537	Fingolimod Hydrochloride	Sandoz Canada Incorporated	No	Yes	No	Yes	No	Yes	No	Yes
Segluromet	224259	Ertugliflozin, Metformin Hcl	Merck Canada Inc	Yes	Yes	No	Yes	Yes	Yes	No	Yes
Sensipar	230496	Cinacalcet Hydrochloride	Amgen Canada Inc	No	No	No	Yes	No	No	No	Yes
Spectro Eczemacare Medicated Cream	221795	Clobetasone Butyrate	GlaxoSmithKline Consumer Healthcare Inc	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Tecta	230455	Pantoprazole Magnesium	Takeda Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Uloric	228535	Febuxostat	Takeda Canada Inc	No	Yes	Yes	Yes	No	No	No	Yes
Venclexta	230973	Venetoclax	Abbvie Corporation	No	Yes	Yes	No	No	No	No	Yes
Vimovo	230228	Naproxen, Esomeprazole Magnesium Trihydrate	AstraZeneca Canada Inc	No	No	No	No	Yes	No	No	No
Voltaren Rapide	229818	Diclofenac Potassium	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Voltaren, Voltaren SR	229809	Diclofenac Sodium	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Xeljanz, Xeljanz XR	230976	Tofacitinib	Pfizer Canada ULC	No	Yes	Yes	Yes	No	Yes	No	Yes
Xylocard	229232	Lidocaine Hcl	Aspen Pharmacare Canada Inc.	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Zytiga	230093	Abiraterone Acetate	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes

September 2019

Product Monograph Brand Safety Updates September 2019
(PDF, 130 KB, 2 pages)

Brand name list	Submission number	Ingredient(s)	Manufacturer	Contraindications	Warnings and precautions	Serious warnings and precautions	Adverse reactions	Drug interactions	Dosage and administration	Overdosage	Consumer information
Belsomra	229178	Suvorexant	Merck Canada Inc	No	Yes	No	No	Yes	Yes	No	Yes
Descovy	221256	Emtricitabine, Tenofovir Alafenamide	Gilead Sciences Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Dexilant	230454	Dexlansoprazole	Takeda Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Diamicron	229444	Gliclazide	Servier Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Diamicron MR	228875	Gliclazide	Servier Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Elidel	220947	Pimecrolimus	Valeant Canada LP Valeant Canada S.E.C.	No	Yes	No	Yes	No	No	No	Yes
Elmiron	229822	Pentosan Polysulfate Sodium	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes
Epclusa	230783	Velpatasvir, Sofosbuvir	Gilead Sciences Canada Inc	No	No	No	Yes	No	No	No	No
Invokana	222684	Canagliflozin	Janssen Inc	Yes	Yes	No	Yes	No	Yes	No	No
Kaletra	229483	Lopinavir, Ritonavir	Abbvie Corporation	Yes	No	No	No	Yes	No	No	Yes
Kyprolis	220590	Carfilzomib	Amgen Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Lenvima	228723	Lenvatinib Mesylate	Eisai Limited	No	Yes	No	Yes	No	Yes	No	Yes
Mavik	227932	Trandolapril	Bgp Pharma ULC	Yes	Yes	No	No	Yes	No	No	Yes
Methotrexate Tablets, USP	224778	Methotrexate	Pfizer Canada ULC	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Pantoloc	230453	Pantoprazole Sodium	Takeda Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Pradaxa	228664	Dabigatran Etexilate	Boehringer Ingelheim (Canada) Ltd Ltee	Yes	Yes	No	Yes	Yes	No	No	Yes
Propecia	229544	Finasteride	Merck Canada Inc	No	No	No	Yes	No	No	No	Yes
Proscar	229546	Finasteride	Merck Canada Inc	No	No	No	Yes	No	No	No	Yes
Robax Platinum	229825	Ibuprofen, Methocarbamol	Pfizer Consumer Healthcare a Division of Pfizer Canada ULC	Yes	Yes	Yes	No	No	No	No	Yes
Salazopyrin, Salazopyrin En-Tabs	229022	Sulfasalazine	Pfizer Canada ULC	No	Yes	No	No	Yes	No	No	Yes
Stalevo	229512	Entacapone, Levodopa, Carbidopa Monohydrate	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Symbicort 100 Turbuhaler, Symbicort 200 Turbuhaler, Symbicort Forte Turbuhaler	220998	Formoterol Fumarate Dihydrate, Budesonide	Astrazeneca Canada Inc	No	Yes	Yes	Yes	Yes	Yes	No	Yes
Tarka	228329	Verapamil HCl, Trandolapril	BGP Pharma ULC	Yes	Yes	No	No	Yes	No	No	Yes
Verzenio	229192	Abemaciclib	Eli Lilly Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Xarelto	228528	Rivaroxaban	Bayer Inc	No	Yes	No	Yes	No	No	No	Yes

August 2019

Product Monograph Brand Safety Updates August 2019
(PDF, 144 KB, 2 pages)

Brand name list	Submission number	Ingredient(s)	Manufacturer	Contraindications	Warnings and precautions	Serious warnings and precautions	Adverse reactions	Drug interactions	Dosage and administration	Overdosage	Consumer information
Accutane roche	226870	isotretinoin	Hoffmann La Roche Limited	No	Yes	No	No	No	No	No	Yes
Apo-methotrexate	227479	methotrexate	Apotex Inc	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Apresoline	227648	hydralazine hcl	Sterimax Inc	Yes	Yes	No	Yes	Yes	Yes	Yes	No
Bosulif	227624	bosutinib	Pfizer Canada Ulc	No	Yes	No	No	No	No	No	No
Caduet	228225	atorvastatin calcium, amlodipine besylate	Pfizer Canada Ulc	Yes	Yes	No	No	Yes	No	No	Yes
Dalacin C	220110	clindamycin hcl	Pfizer Canada Inc	No	Yes	No	No	No	No	No	Yes
Dalacin C flavoured granules	220071	clindamycin	Pfizer Canada Inc	No	Yes	No	No	No	No	No	Yes
Dalacin C phosphate	220534	clindamycin phosphate	Pfizer Canada Inc	No	Yes	No	No	No	No	No	Yes
Dalacin T	220678	clindamycin phosphate	Pfizer Canada Inc	No	Yes	No	No	No	No	No	Yes
Delstrigo	223138	doravirine, tenofovir disoproxil fumarate, lamivudine	Merck Canada Inc	No	Yes	No	Yes	Yes	No	No	No
Eltroxin	228921	levothyroxine sodium	Aspen Pharmacare Canada Inc.	No	No	No	Yes	Yes	No	No	Yes
Flomax CR	229213	tamsulosin hydrochloride	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	No	No	No	Yes
Flonase allergy relief	226709	fluticasone propionate	Glaxosmithkline Consumer Healthcare Inc	No	Yes	No	No	No	No	No	Yes
Fluorouracil injection usp	227813	fluorouracil	Pfizer Canada Ulc	Yes	Yes	No	Yes	Yes	Yes	No	No
Ibrance	219500	palbociclib	Pfizer Canada Ulc	No	Yes	No	Yes	No	No	No	Yes
Iclusig	226913	ponatinib hydrochloride	Ariad Pharmaceuticals Inc	No	Yes	Yes	Yes	No	No	No	Yes
Jinarc	228294	tolvaptan	Otsuka Pharmaceutical Co Ltd	No	No	No	No	No	No	No	Yes
Kuvan	226288	sapropterin dihydrochloride	Biomarin International Limited	No	Yes	No	Yes	Yes	No	No	Yes
Lenvima	226911	lenvatinib mesylate	Eisai Limited	No	Yes	Yes	Yes	No	No	No	Yes
Lipitor	228227	atorvastatin calcium	Pfizer Canada Ulc	Yes	Yes	No	No	Yes	No	No	Yes
Luvox	228735	fluvoxamine maleate	Bgp Pharma Ulc	No	No	No	Yes	No	No	No	No
Monistat derm cream	227967	miconazole nitrate 2 per/per	Insight Pharmaceuticals Llc	No	Yes	No	No	No	No	No	No
Plaquenil	221838	hydroxychloroquine sulfate	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	Yes	No	Yes	Yes
Posanol	228896	posaconazole	Merck Canada Inc	No	No	No	Yes	No	No	No	No
Prolopa	228354	benserazide hcl, levodopa	Hoffmann La Roche Limited	No	Yes	No	Yes	Yes	Yes	No	Yes
Rasilez hct	228128	aliskiren fumarate, hydrochlorothiazide	Noden Pharma Dac	Yes	Yes	No	No	No	No	No	Yes
Revlimid	229241	lenalidomide	Celgene Inc	No	Yes	Yes	Yes	No	Yes	No	Yes
Rexulti	228418	brexpiprazole	Otsuka Pharmaceutical Co Ltd	Yes	Yes	No	Yes	No	No	No	Yes
Rhinocort aqua	226546	budesonide	Mcneil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Rogaine minoxidil topical 2% solution, men's rogaine foam 5%, women's rogaine foam 5%	226115	minoxidil	Johnson & Johnson Inc	No	No	No	Yes	No	No	Yes	Yes
Rosiver	226496	ivermectin	Galderma Canada Inc	No	No	No	Yes	No	No	No	Yes
Tagrisso	219271	osimertinib mesylate	Astrazeneca Canada Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Tobrex	227811	tobramycin	Novartis Pharmaceuticals Canada Inc	No	Yes	No	No	No	No	No	Yes
Tussionex	226621	phenyltoloxamine, hydrocodone bitartrate	Sanofi-Aventis Canada Inc	Yes	Yes	No	No	No	Yes	No	Yes
Twynsta	225785	telmisartan, amlodipine besylate	Boehringer Ingelheim (Canada) Ltd Ltee	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Votrient	226907	pazopanib hydrochloride	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes

July 2019

Product Monograph Brand Safety Updates July 2019
(PDF, 114 KB, 3 pages)

Brand name list	Submission number	Ingredient(s)	Manufacturer	Contraindications	Warnings and precautions	Serious warnings and precautions	Adverse reactions	Drug interactions	Dosage and administration	Overdosage	Consumer information
3TC	226212	Lamivudine	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Apo-Nitrazepam	226498	Nitrazepam	Apotex Inc	Yes	Yes	Yes	No	Yes	No	No	Yes
Aptiom	226705	Eslicarbazepine Acetate	Sunovion Pharmaceuticals Canada Inc	No	Yes	No	No	No	No	No	No
Arixtra	225665	Fondaparinux Sodium	Aspen Pharmacare Canada Inc.	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Cardizem CD	226443	Diltiazem Hcl	Valeant Canada LP Valeant Canada S.E.C.	No	Yes	No	Yes	No	No	Yes	Yes
Celsentri	226222	Maraviroc	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Ciprofloxacin Intravenous Infusion, BP	226595	Ciprofloxacin	Apotex Inc	No	Yes	No	No	No	No	No	Yes
Clozaril	223099	Clozapine	HLS Therapeutics Inc	No	No	No	No	No	No	No	Yes
Coversyl	226990	Perindopril Erbumine	Servier Canada Inc	No	No	No	Yes	No	No	No	Yes
Coversyl Plus LD, Coversyl Plus, Coversyl Plus HD	226998	Indapamide, Perindopril Erbumine	Servier Canada Inc	No	No	No	Yes	No	No	No	Yes
Daklinza	226078	Daclatasvir	Bristol-Myers Squibb Canada	No	Yes	No	No	No	No	No	Yes
Dymista	226293	Fluticasone Propionate, Azelastine Hydrochloride	BGP Pharma ULC	No	No	No	No	No	Yes	No	Yes
Epuris	227256	Isotretinoin	Cipher Pharmaceuticals Inc	No	Yes	No	No	No	No	No	Yes
Ferriprox	223425	Deferiprone	Apopharma Inc	No	Yes	No	No	No	No	No	No
Fibristal	227397	Ulipristal Acetate	Allergan Inc	No	Yes	No	No	No	Yes	No	Yes
Genvoya	219784	Emtricitabine, Cobicistat, Tenofovir Alafenamide Hemifumarate, Elvitegravir	Gilead Sciences Canada Inc	No	Yes	Yes	Yes	No	Yes	No	Yes
Ibrance	227077	Palbociclib	Pfizer Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Iluvien	226424	Fluocinolone Acetonide	Knight Therapeutics Inc.	No	No	No	Yes	No	No	No	No
Inlyta	226912	Axitinib	Pfizer Canada ULC	No	Yes	No	Yes	No	No	No	No
Istodax	219411	Romidepsin	Celgene Inc	No	Yes	Yes	No	No	Yes	No	Yes
Jinarc	226267	Tolvaptan	Otsuka Pharmaceutical Co Ltd	Yes	Yes	Yes	No	Yes	Yes	No	Yes
Kyprolis	226135	Carfilzomib	Amgen Canada Inc	No	No	No	Yes	No	No	No	Yes
Lenvima	226188	Lenvatinib Mesylate	Eisai Limited	No	Yes	No	No	Yes	No	No	No
Lyrica	226385	Pregabalin	Pfizer Canada ULC	No	Yes	No	No	Yes	No	No	No
Methotrexate Injection USP	224776	Methotrexate Sodium	Pfizer Canada ULC	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Movantik	227872	Naloxegol Oxalate	Knight Therapeutics Inc.	No	No	No	No	Yes	No	No	Yes
Ozurdex	223933	Dexamethasone	Allergan Inc	No	No	No	Yes	No	Yes	No	Yes
Pomalyst	218459	Pomalidomide	Celgene Inc	No	Yes	Yes	Yes	No	Yes	No	Yes
Pomalyst	219719	Pomalidomide	Celgene Inc	No	No	No	No	No	Yes	No	No
Prevymis	227034	Letermovir	Merck Canada Inc	Yes	Yes	No	No	Yes	No	No	Yes
Rasilez HCT	224594	Aliskiren Fumarate, Hydrochlorothiazide	Noden Pharma DAC	No	Yes	No	Yes	No	No	No	Yes
Retrovir (AZT)	226223	Zidovudine	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Select 1/35	228390	Norethindrone, Ethinyl Estradiol	Pfizer Canada ULC	No	Yes	No	Yes	Yes	Yes	No	Yes
Sutent	226908	Sunitinib Malate	Pfizer Canada ULC	No	Yes	No	Yes	No	No	No	Yes
Synphasic	228383	Norethindrone, Ethinyl Estradiol	Pfizer Canada ULC	No	Yes	No	Yes	Yes	Yes	No	Yes
Telzir	226294	Fosamprenavir Calcium	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Teva-Levofloxacin	226600	Levofloxacin	Teva Canada Limited	No	Yes	No	No	No	No	No	Yes
Tivicay	226207	Dolutegravir	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Tramacet	226399	Acetaminophen, Tramadol Hcl	Janssen Inc	No	Yes	No	Yes	Yes	Yes	Yes	Yes
Triumeq	226210	Dolutegravir, Abacavir, Lamivudine	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Trizivir	226225	Zidovudine, Abacavir, Lamivudine	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Ultram	226400	Tramadol Hcl	Janssen Inc	No	Yes	No	Yes	Yes	Yes	Yes	Yes
Viacoram	226962	Perindopril Arginine, Amlodipine Besylate	Servier Canada Inc	No	No	No	Yes	No	No	No	Yes
Vosevi	226105	Voxilaprevir, Velpatasvir, Sofosbuvir	Gilead Sciences Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Vyvanse	220806	Lisdexamfetamine Dimesylate	Shire Pharma Canada ULC	No	No	No	No	No	Yes	No	Yes
Xeloda	227208	Capecitabine	Hoffmann La Roche Limited	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Xigduo	228253	Metformin Hcl, Dapagliflozin	AstraZeneca 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