Product Monograph Brand Safety Updates June 2020

Brand Name Submission Ingredient(s) Manufacturer Contraindications Warnings & Serious Adverse Drug Dosage & Overdosage Consumer Number Precautions Warnings & Reactions Interactions Administration Information Precautions Advair Diskus 237271 Fluticasone Propionate, GlaxoSmithKline Inc No No No No No No No Yes Salmeterol Xinafoate

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 237473 Ibuprofen McNeil Consumer No Yes No Yes No No No Yes MOTRIN, Healthcare Division of Infants' MOTRIN, Johnson & Johnson Inc Children's MOTRIN Chewable Tablets, Junior Strength MOTRIN Chewable Tablets 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, 236978 Indapamide, Perindopril Servier Canada Inc Yes Yes No Yes Yes No No Yes Coversyl Plus LD, Erbumine Coversyl Plus HD 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

2020-07-10 Page 1 Brand Name Submission Ingredient(s) Manufacturer Contraindications Warnings & Serious Adverse Drug Dosage & Overdosage Consumer Number Precautions Warnings & Reactions Interactions Administration Information Precautions Extra Strength 237375 Acetaminophen, McNeil Consumer No No No Yes No No Yes No Tylenol Diphenhydramine Hcl Healthcare Division of Nighttime Johnson & Johnson Inc 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, Aspen Pharmacare Canada No Yes No Yes Yes Yes No Yes Azathioprine Inc. Inhibace 235666 Cilazapril Monohydrate Cheplapharm Arzneimittel Yes Yes No No Yes No No Yes GmbH Inhibace Plus 235667 Hydrochlorothiazide, Cilazapril Cheplapharm Arzneimittel Yes Yes No No Yes No No Yes Monohydrate GmbH Jentadueto 229225 Metformin Hcl, Linagliptin Boehringer Ingelheim Yes Yes No Yes Yes Yes No Yes (Canada) Ltd Ltee Keppra 237080 Levetiracetam UCB Canada Inc No Yes No Yes No No No Yes Levothyroxine 223344 Levothyroxine Sodium Fresenius Kabi Canada Ltd No No No No No No No Yes Sodium Injection 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 235783 Miconazole Nitrate Wellspring Pharmaceutical Yes Yes No Yes No Yes No No Miconazole Canada Corp Nitrate Cream 2% USP Micatin Powder 235806 Miconazole Nitrate Wellspring Pharmaceutical Yes Yes No Yes No Yes No No Spray - Canada Corp Unscented 2% Motrin 200 Mg, 237424 Ibuprofen McNeil Consumer No Yes No Yes No No No Yes Motrin 300 Mg, Healthcare Division of Motrin 400 Mg Johnson & Johnson Inc Motrin Platinum 237345 Methocarbamol, Ibuprofen McNeil Consumer No Yes No Yes No No No Yes Muscle and Body Healthcare Division of Johnson & Johnson Inc Multaq 237496 Dronedarone Hydrochloride Sanofi-Aventis Canada Inc No Yes No No Yes Yes No Yes

Nitoman 236868 Tetrabenazine Valeant Canada LP Valeant Yes Yes No Yes Yes Yes Yes Yes Canada S.E.C. Page 2 Brand Name Submission Ingredient(s) Manufacturer Contraindications Warnings & Serious Adverse Drug Dosage & Overdosage Consumer Number Precautions Warnings & Reactions Interactions Administration Information Precautions 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 No Yes No Yes No Yes No Yes Canada Inc 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, GlaxoSmithKline Inc No No No Yes No No No Yes Fluticasone Furoate, Vilanterol Trifenatate 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 Yes Yes No No Yes No No Yes Canada S.E.C. Xtandi 233563 Enzalutamide Astellas Pharma Canada Inc No Yes No Yes No No No Yes

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