Product monograph brand safety updates

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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
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