Product monograph brand safety updates
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September 2025
Product Monograph Brand Safety Updates - September 2025
(PDF, 83 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Adderall XR | 296552 | Dextroamphetamine Sulfate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate | Takeda Canada Inc | No | No | No | No | Yes | No | No | Yes |
Advil Mini-Gels | 291312 | Ibuprofen | Haleon Canada ULC | Yes | Yes | Yes | No | No | No | No | Yes |
Aleve Back and Body Pain, Aleve Liquid Gels, Aleve Caplets | 291309 | Naproxen Sodium | Bayer Inc | Yes | Yes | Yes | No | No | No | No | Yes |
Aleve Nighttime | 291310 | Diphenhydramine Hcl, Naproxen Sodium | Bayer Inc | No | Yes | Yes | No | No | No | No | Yes |
Backup Plan Onestep | 296514 | Levonorgestrel | Apotex Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Calquence | 291668 | Acalabrutinib Maleate | AstraZeneca Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Contrave | 296775 | Bupropion Hcl, Naltrexone Hydrochloride | Bausch Health, Canada Inc | No | No | No | No | No | No | No | Yes |
Daybue | 296865 | Trofinetide | Acadia Pharmaceuticals Inc | No | No | No | No | Yes | No | No | Yes |
Delstrigo | 297704 | Doravirine, Tenofovir Disoproxil Fumarate, Lamivudine | Merck Canada Inc | No | No | No | Yes | No | No | No | Yes |
Elocom | 295432 | Mometasone Furoate | Organon Canada Inc. | No | No | No | No | No | No | No | Yes |
Etibi | 295216 | Ethambutol Hcl | Bausch Health, Canada Inc | No | Yes | Yes | Yes | Yes | No | No | Yes |
Flagyl | 297546 | Metronidazole | Sanofi-Aventis Canada Inc | No | Yes | Yes | Yes | No | No | No | Yes |
Flagystatin | 297536 | Metronidazole, Nystatin | Sanofi-Aventis Canada Inc | No | Yes | Yes | Yes | No | No | No | Yes |
Magnevist | 296001 | Gadopentetate Dimeglumine | Bayer Inc | No | Yes | Yes | No | No | No | No | Yes |
Methotrexate Tablets, USP | 294607 | Methotrexate | Pfizer Canada ULC | No | Yes | No | No | No | No | No | No |
Naropin | 295134 | Ropivacaine Hcl | Aspen Pharmacare Canada Inc | No | Yes | No | No | No | No | No | No |
Neuleptil | 297466 | Periciazine | Searchlight Pharma Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Opsumit | 282456 | Macitentan | Janssen Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Pifeltro | 297710 | Doravirine | Merck Canada Inc | No | No | No | Yes | No | No | No | Yes |
Spinraza | 291208 | Nusinersen Sodium | Biogen Canada Inc | No | No | No | Yes | No | No | No | No |
Tracleer | 297201 | Bosentan Monohydrate | Janssen Inc | No | Yes | No | Yes | No | No | No | Yes |
Ventolin Diskus | 296330 | Salbutamol Sulfate | GlaxoSmithKline Inc | No | Yes | No | No | No | No | No | Yes |
Vyvanse | 296290 | Lisdexamfetamine Dimesylate | Takeda Canada Inc | Yes | No | No | No | Yes | No | Yes | No |
Xarelto | 297542 | Rivaroxaban | Bayer Inc | No | Yes | No | Yes | Yes | No | No | Yes |
August 2025
Product Monograph Brand Safety Updates - August 2025
(PDF, 81.4 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Abilify Asimtufii | 294960 | Aripiprazole | Otsuka Pharmaceutical Co Ltd | No | Yes | Yes | No | No | No | No | Yes |
Abilify Maintena | 295837 | Aripiprazole | Otsuka Pharmaceutical Co Ltd | No | Yes | Yes | No | No | Yes | No | Yes |
Advil Plus Acetaminophen | 289055 | Acetaminophen, Ibuprofen | Haleon Canada ULC | Yes | Yes | Yes | No | No | No | Yes | Yes |
Androgel | 289983 | Testosterone | BGP Pharma ULC | No | Yes | No | Yes | Yes | Yes | No | Yes |
Brevicon 0.5/35 Tablets (21 Day Pack), Brevicon 1/35 Tablets (21 Day Pack), Brevicon 0.5/35 Tablets (28 Day Pack), Brevicon 1/35 Tablets (28 Day Pack) | 294278 | Ethinyl Estradiol, Norethindrone | Pfizer Canada ULC | No | No | No | No | No | No | No | Yes |
Evrysdi | 287978 | Risdiplam | Hoffmann-La Roche Limited | No | No | No | No | Yes | Yes | No | Yes |
Min-Ovral 21, Min-Ovral 28 | 294279 | Levonorgestrel, Ethinyl Estradiol | Pfizer Canada ULC | No | No | No | No | Yes | No | No | Yes |
Nubeqa | 291388 | Darolutamide | Bayer Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Optiray 300, Optiray 320, Optiray 350 | 293582 | Ioversol | Liebel-Flarsheim Company LLC | No | Yes | No | Yes | Yes | Yes | No | Yes |
Paxlovid | 289904 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Rinvoq | 290301 | Upadacitinib | Abbvie Corporation | No | No | No | Yes | No | Yes | No | Yes |
Select 1/35 (21-Day), Select 1/35 (28-Day) | 294280 | Ethinyl Estradiol, Norethindrone | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Stivarga | 294657 | Regorafenib | Bayer Inc | No | No | No | Yes | No | No | No | Yes |
Synphasic 21 Tablets, Synphasic 28 Tablets | 294281 | Ethinyl Estradiol, Norethindrone | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Tri-Cira 21, Tri-Cira 28 | 294283 | Norgestimate, Ethinyl Estradiol | Apotex Inc | No | No | No | No | Yes | No | No | Yes |
Tri-Cira Lo 21, Tri-Cira Lo 28 | 294285 | Norgestimate, Ethinyl Estradiol | Apotex Inc | No | No | No | No | Yes | No | No | Yes |
Tri-Jordyna 21, Tri-Jordyna 28 | 294286 | Norgestimate, Ethinyl Estradiol | Glenmark Pharmaceuticals Canada Inc | No | No | No | No | Yes | No | No | Yes |
Ubrelvy | 291488 | Ubrogepant | Abbvie Corporation | No | Yes | No | No | Yes | No | No | Yes |
Veklury | 290210 | Remdesivir | Gilead Sciences Canada Inc | No | No | No | No | Yes | No | Yes | Yes |
Ventolin HFA | 295222 | Salbutamol Sulfate | GlaxoSmithKline Inc | No | Yes | No | No | No | Yes | No | Yes |
Ventolin Respirator Solution | 295683 | Salbutamol Sulfate | GlaxoSmithKline Inc | No | Yes | No | No | No | No | No | Yes |
Wainua | 290319 | Eplontersen Sodium | AstraZeneca Canada Inc | No | No | No | Yes | No | No | No | No |
July 2025
Product Monograph Brand Safety Updates – July 2025(PDF, 91 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Apo-Pravastatin | 294008 | Pravastatin Sodium | Apotex Inc | No | Yes | No | Yes | No | No | No | No |
Auro-Levocarb | 295334 | Carbidopa, Levodopa | Auro Pharma Inc | No | No | No | Yes | No | No | No | Yes |
Avalide | 295055 | Hydrochlorothiazide, Irbesartan | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Avapro | 294898 | Irbesartan | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Braftovi | 292474 | Encorafenib | Pfizer Canada ULC | No | Yes | No | Yes | No | Yes | No | Yes |
Bridion | 289615 | Sugammadex | Merck Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Bylvay | 289602 | Odevixibat | Medison Pharma Canada Inc. | No | Yes | No | Yes | No | Yes | No | Yes |
Caduet | 294004 | Amlodipine Besylate, Atorvastatin Calcium | BGP Pharma ULC | No | Yes | No | Yes | No | No | No | No |
Celebrex | 295417 | Celecoxib | BGP Pharma ULC | No | Yes | No | Yes | No | No | No | No |
Clopixol, Clopixol Acuphase, Clopixol Depot | 294958 | Zuclopenthixol Acetate, Zuclopenthixol Decanoate, Zuclopenthixol Hydrochloride | Lundbeck Canada Inc | No | Yes | Yes | No | Yes | No | No | Yes |
Clotrimaderm Vaginal 3, Clotrimaderm Vaginal 6 | 294676 | Clotrimazole | Taro Pharmaceuticals Inc | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Clozaril | 293275 | Clozapine | HLS Therapeutics Inc | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Depo-Medrol With Lidocaine | 295207 | Lidocaine Hydrochloride, Methylprednisolone Acetate | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Diprivan 1% | 295642 | Propofol | Aspen Pharmacare Canada Inc. | No | No | No | Yes | Yes | No | No | Yes |
Eltroxin | 292656 | Levothyroxine Sodium | Aspen Pharmacare Canada Inc. | No | No | No | No | No | Yes | No | No |
Etoposide Injection | 293630 | Etoposide | Teva Canada Limited | No | Yes | No | Yes | Yes | No | No | Yes |
Ibrance | 293492 | Palbociclib | Pfizer Canada ULC | No | No | No | No | Yes | No | No | Yes |
Jardiance | 295840 | Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | No | No | No | Yes |
Kadian | 293099 | Morphine Sulfate | BGP Pharma ULC | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Lipitor | 294009 | Atorvastatin Calcium | BGP Pharma ULC | No | Yes | No | Yes | No | No | No | No |
Lovastatin | 294001 | Lovastatin | AA Pharma Inc | No | Yes | No | Yes | No | No | No | No |
Lupron Depot | 295706 | Leuprolide Acetate | Abbvie Corporation | No | Yes | No | Yes | No | No | No | Yes |
Maxidol Liquid Gels | 291311 | Naproxen Sodium | Bayer Inc | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
Onivyde | 294527 | Irinotecan Sucrose Octasulfate | Ipsen Biopharmaceuticals Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Pomalyst | 294588 | Pomalidomide | Bristol-Myers Squibb Canada | No | Yes | No | Yes | No | No | No | Yes |
Prometrium | 295264 | Progesterone | Organon Canada Inc. | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Retevmo | 289289 | Selpercatinib | Loxo Oncology Inc | No | Yes | No | Yes | No | No | No | No |
Scemblix | 290676 | Asciminib Hydrochloride | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Sunlenca | 295418 | Lenacapavir Sodium | Gilead Sciences Canada Inc | No | Yes | No | No | No | Yes | No | Yes |
Synjardy | 295892 | Metformin Hydrochloride, Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | No | No | No | Yes |
Teva-Fluvastatin | 294005 | Fluvastatin Sodium | Teva Canada Limited | No | Yes | No | Yes | No | No | No | No |
Thalomid | 294589 | Thalidomide | Bristol-Myers Squibb Canada | No | No | No | Yes | No | No | No | Yes |
Topamax | 289202 | Topiramate | Janssen Inc | No | Yes | No | No | No | No | No | No |
TPOXX | 289138 | Tecovirimat Monohydrate | Siga Technologies, Inc. | No | No | No | No | Yes | No | No | Yes |
Trileptal | 294648 | Oxcarbazepine | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | No | No | No | No |
Venclexta | 289982 | Venetoclax | Abbvie Corporation | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Verzenio | 293494 | Abemaciclib | Eli Lilly Canada Inc | No | No | No | No | Yes | No | No | Yes |
June 2025
Product Monograph Brand Safety Updates – June 2025(PDF, 113 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Allegra 12 Hour, Allegra 24 Hour, Allegra Hives |
293133 | Fexofenadine Hcl | Sanofi Consumer Health Inc | No | No | No | No | Yes | No | No | Yes |
Apretude | 288201 | Cabotegravir, Cabotegravir Sodium | ViiV Healthcare ULC | No | Yes | No | Yes | No | No | No | Yes |
Benazepril | 293832 | Benazepril Hcl | AA Pharma Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Biktarvy | 288709 | Emtricitabine, Tenofovir Alafenamide Hemifumarate, Bictegravir Sodium | Gilead Sciences Canada Inc | No | No | No | Yes | No | No | No | Yes |
Calquence | 289986 | Acalabrutinib Maleate | AstraZeneca Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Camcevi | 290136 | Leuprolide Mesylate | Accord Healthcare Inc | No | No | No | No | No | Yes | No | No |
Depo-Medrol (With Preservative), Depo-Medrol |
295247 | Methylprednisolone Acetate | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Firdapse | 288056 | Amifampridine Phosphate | Kye Pharmaceuticals Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Kisqali | 283993 | Ribociclib Succinate | Novartis Pharmaceuticals Canada Inc | No | Yes | Yes | Yes | Yes | Yes | No | Yes |
Lynparza | 294774 | Olaparib | AstraZeneca Canada Inc | No | Yes | No | No | No | No | No | Yes |
Mayzent | 294322 | Siponimod | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Medrol | 295241 | Methylprednisolone | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Mekinist | 289306 | Trametinib | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Midamor | 292158 | Amiloride Hydrochloride | AA Pharma Inc | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Nexavar | 292117 | Sorafenib Tosylate | Bayer Inc | No | No | No | Yes | No | No | No | Yes |
Oxlumo | 293368 | Lumasiran Sodium | Alnylam Netherlands B.V. | No | No | No | Yes | No | No | No | No |
Premarin | 294742 | Conjugated Estrogens | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Primaquine | 294983 | Primaquine Phosphate | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Qulipta | 293559 | Atogepant | Abbvie Corporation | No | Yes | No | No | No | No | No | Yes |
Seaford Nifedipine and Lidocaine Hydrochloride Cream |
293819 | Lidocaine Hydrochloride, Nifedipine | Seaford Pharmaceuticals Inc | No | No | No | No | No | Yes | No | Yes |
Solu-Medrol | 295242 | Methylprednisolone Sodium Succinate | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
Sporanox | 288116 | Itraconazole | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Sprycel | 292496 | Dasatinib | Bristol-Myers Squibb Canada | No | No | No | Yes | No | No | No | Yes |
Tafinlar | 289305 | Dabrafenib Mesylate | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Teva-Loperamide | 294203 | Loperamide Hcl | Teva Canada Limited | Yes | Yes | No | Yes | No | Yes | Yes | Yes |
Thalomid | 293383 | Thalidomide | Bristol-Myers Squibb Canada | No | Yes | No | No | No | No | No | Yes |
Wellbutrin SR | 294437 | Bupropion Hcl | Bausch Health, Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Zenhale | 293335 | Formoterol Fumarate Dihydrate, Mometasone Furoate | Organon Canada Inc | No | No | No | Yes | No | Yes | Yes | Yes |
May 2025
Product Monograph Brand Safety Updates – May 2025(PDF, 94 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Absorica LD | 290603 | Isotretinoin | Sun Pharmaceutical Industries Limited | No | Yes | No | No | No | No | No | Yes |
Accutane Roche | 290601 | Isotretinoin | Hoffmann-La Roche Limited | No | Yes | No | Yes | No | No | No | Yes |
Allegra-D | 293299 | Pseudoephedrine Hcl, Fexofenadine Hcl | Sanofi Consumer Health Inc | Yes | Yes | No | No | Yes | Yes | No | Yes |
Amiodarone Hydrochloride for Injection | 291661 | Amiodarone Hcl | Sandoz Canada Incorporated | No | Yes | Yes | Yes | No | No | No | Yes |
Apo-Hydralazine | 293554 | Hydralazine Hcl | Apotex Inc | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Belkyra | 293372 | Deoxycholic Acid | Abbvie Corporation | No | No | No | Yes | No | No | Yes | Yes |
Bicnu | 291447 | Carmustine | Marcan Pharmaceuticals Inc | Yes | No | No | No | No | Yes | No | Yes |
Caprelsa | 293185 | Vandetanib | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Cequa | 292888 | Cyclosporine | Sun Pharmaceutical Industries Limited | No | Yes | No | Yes | No | No | No | Yes |
Empaveli | 292934 | Pegcetacoplan | Swedish Orphan Biovitrum AB (Publ) | No | Yes | Yes | Yes | No | No | No | Yes |
Epuris | 290612 | Isotretinoin | Cipher Pharmaceuticals Inc | No | Yes | No | Yes | No | No | No | Yes |
Flagyl | 293271 | Metronidazole | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Flagystatin | 293279 | Metronidazole, Nystatin | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Fluorouracil Injection | 290778 | Fluorouracil | Sandoz Canada Incorporated | No | Yes | Yes | No | Yes | No | No | Yes |
ISDN | 293852 | Isosorbide Dinitrate | AA Pharma Inc | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Lenvima | 290940 | Lenvatinib Mesylate | Eisai Limited | No | No | No | Yes | No | Yes | No | No |
Leucovorin Calcium Injection | 294459 | Leucovorin Calcium | Teva Canada Limited | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Mefloquine | 292881 | Mefloquine Hcl | AA Pharma Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Neurontin | 293626 | Gabapentin | BGP Pharma ULC | No | Yes | No | No | No | No | No | Yes |
Nordimet | 293317 | Methotrexate Sodium | Nordic Group B.V. | No | Yes | No | Yes | No | No | No | Yes |
Norfloxacin | 293433 | Norfloxacin | AA Pharma Inc | No | Yes | Yes | Yes | Yes | No | No | Yes |
Novamoxin, Novamoxin (Sugar Reduced) | 288472 | Amoxicillin Trihydrate | Teva Canada Limited | No | Yes | No | Yes | No | No | Yes | Yes |
Orladeyo | 287743 | Berotralstat Hydrochloride | Biocryst Pharmaceuticals Inc | No | No | No | Yes | Yes | No | No | Yes |
Qulipta | 288095 | Atogepant | Abbvie Corporation | No | No | No | No | Yes | No | No | Yes |
Sandoz Amiodarone | 291660 | Amiodarone Hcl | Sandoz Canada Incorporated | No | Yes | Yes | Yes | No | No | No | Yes |
Signifor | 293622 | Pasireotide Diaspartate | Recordati Rare Diseases Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Signifor LAR | 293586 | Pasireotide Pamoate | Recordati Rare Diseases Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Spravato | 293518 | Esketamine Hydrochloride | Janssen Inc | No | Yes | No | Yes | No | No | No | Yes |
Timolol | 293856 | Timolol Maleate | AA Pharma Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Trikafta | 293416 | Elexacaftor, Ivacaftor, Tezacaftor | Vertex Pharmaceuticals (Canada) Incorporated | No | Yes | Yes | Yes | No | Yes | Yes | Yes |
VFEND | 293822 | Voriconazole | Pfizer Canada ULC | Yes | No | No | No | Yes | No | No | Yes |
Xofluza | 292965 | Baloxavir Marboxil | Hoffmann-La Roche Limited | No | No | No | No | No | No | No | Yes |
Zejula | 293823 | Niraparib Tosylate | GlaxoSmithKline Inc | No | No | No | No | Yes | No | No | Yes |
Zyban | 293583 | Bupropion Hcl | Bausch Health, Canada Inc. | No | Yes | No | Yes | Yes | No | No | Yes |
April 2025
Product Monograph Brand Safety Updates – April 2025(PDF, 86 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Advil Cold & Sinus Liqui-Gels, Advil Cold and Sinus, Advil Cold and Sinus Daytime, Children's Advil Cold, Advil Cold & Sinus Extra Strength Liqui-Gels | 282832 | Pseudoephedrine Hcl, Ibuprofen | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | No | No | No | Yes | Yes |
Advil Headache & Migraine Caplets, Advil Headache & Migraine Extra Strength, Advil Headache & Migraine Tablets | 289065 | Ibuprofen Sodium Dihydrate | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | No | No | No | No | Yes |
Advil Nighttime | 285289 | Diphenhydramine Hcl, Ibuprofen | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | No | No | No | No | Yes |
Camcevi | 292277 | Leuprolide Mesylate | Accord Healthcare Inc | No | Yes | No | Yes | No | No | No | Yes |
Copaxone | 292223 | Glatiramer Acetate | Teva Canada Limited | Yes | Yes | Yes | Yes | No | No | No | Yes |
Duavive | 293164 | Bazedoxifene Acetate, Conjugated Estrogens | Pfizer Canada ULC | No | No | No | No | No | No | No | Yes |
Eligard | 292718 | Leuprolide Acetate | Tolmar International Ltd | No | Yes | No | Yes | No | No | No | Yes |
Florinef | 293281 | Fludrocortisone 21-Acetate | Endo Operations Ltd | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Gadovist 1.0 | 292479 | Gadobutrol | Bayer Inc | No | Yes | Yes | No | No | No | No | Yes |
Gilenya | 291855 | Fingolimod Hydrochloride | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | No | Yes | No | Yes |
Ibsrela | 291930 | Tenapanor | Knight Therapeutics Inc | No | No | No | Yes | No | No | No | Yes |
Linessa 21, Linessa 28 | 290093 | Desogestrel, Ethinyl Estradiol | Aspen Pharmacare Canada Inc | No | No | No | No | No | No | No | Yes |
Lithmax | 291317 | Lithium Carbonate | AA Pharma Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Lynparza | 286243 | Olaparib | AstraZeneca Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Pantoprazole for Injection | 292119 | Pantoprazole Sodium Sesquihydrate | Fresenius Kabi Canada Ltd | No | Yes | No | Yes | No | No | No | Yes |
Pradaxa | 292587 | Dabigatran Etexilate Mesilate | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | No | No | No | Yes |
Primovist | 292476 | Gadoxetate Disodium | Bayer Inc | No | Yes | Yes | No | No | Yes | No | Yes |
Proglycem | 293995 | Diazoxide | Merck Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Rinvoq | 286973 | Upadacitinib | Abbvie Corporation | No | Yes | No | Yes | No | Yes | No | No |
Robax Platinum | 285287 | Methocarbamol, Ibuprofen | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | No | No | No | No | Yes |
Soriatane | 292616 | Acitretin | Allergan Inc | No | Yes | Yes | Yes | No | No | No | Yes |
Tagrisso | 288417 | Osimertinib Mesylate | AstraZeneca Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Tegretol, Tegretol CR, Tegretol Suspension | 292773 | Carbamazepine | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | No | No | No | No |
Veklury | 284988 | Remdesivir | Gilead Sciences Canada Inc | No | Yes | No | No | No | No | No | Yes |
Zeulide Depot | 293009 | Leuprolide Acetate | Verity Pharmaceuticals Inc | No | Yes | No | Yes | No | No | No | Yes |
March 2025
Product Monograph Brand Safety Updates – March 2025(PDF, 108 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Advil Pediatric Drops, Advil Pediatric Drops Fever from Colds or Flu, Children's Advil Chewable Tablets, Children's Advil, Children's Advil Fever from Colds or Flu, Junior Strength Advil, Junior Strength Advil Fever from Colds or Flu | 285281 | Ibuprofen | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | No | No | No | No | Yes |
Akeega | 285890 | Niraparib Tosylate, Abiraterone Acetate | Janssen Inc | No | Yes | No | Yes | No | No | No | Yes |
Alecensaro | 287835 | Alectinib Hydrochloride | Hoffmann-La Roche Limited | No | Yes | No | No | No | No | No | Yes |
Apo-Fluticasone | 290809 | Fluticasone Propionate | Apotex Inc | No | No | No | No | No | No | Yes | Yes |
Cardizem CD | 291522 | Diltiazem Hcl | Bausch Health, Canada Inc | No | No | No | No | Yes | No | No | Yes |
Coated Daily Low Dose ASA 81 Mg | 290777 | Acetylsalicylic Acid | Apotex Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Codeine Contin | 288909 | Codeine Sulfate, Codeine Monohydrate | Purdue Pharma | No | Yes | No | Yes | Yes | No | Yes | Yes |
Decapeptyl | 291110 | Triptorelin Acetate | Ferring Inc | No | Yes | No | Yes | No | No | No | Yes |
Ibrance | 292325 | Palbociclib | Pfizer Canada ULC | No | No | No | Yes | No | No | No | Yes |
Imbruvica | 291962 | Ibrutinib | Janssen Inc | No | Yes | No | Yes | No | No | No | Yes |
Kaletra | 291449 | Ritonavir, Lopinavir | Abbvie Corporation | No | No | No | No | Yes | No | No | Yes |
Koselugo | 285333 | Selumetinib Sulfate | Alexion Pharma GmbH | No | Yes | No | Yes | Yes | Yes | No | Yes |
Lamictal | 291590 | Lamotrigine | GlaxoSmithKline Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Naproxen Capsules 200 Mg | 290404 | Naproxen | Catalent Ontario Limited | Yes | No | No | Yes | No | Yes | Yes | Yes |
Norvir | 291456 | Ritonavir | Abbvie Corporation | No | No | No | No | Yes | No | No | Yes |
Opsynvi | 291515 | Macitentan, Tadalafil | Janssen Inc | No | Yes | No | Yes | No | No | No | No |
Pepcid AC, Maximum Strength Pepcid AC | 284010 | Famotidine | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Rinvoq | 292377 | Upadacitinib | Abbvie Corporation | No | Yes | No | No | No | No | No | Yes |
Tiazac XC | 291450 | Diltiazem Hcl | Bausch Health, Canada Inc | No | No | No | No | Yes | No | No | Yes |
Velsipity | 289505 | Etrasimod L-Arginine | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Zoryve | 285437 | Roflumilast | Arcutis Canada, Inc | No | No | No | Yes | No | No | No | Yes |
February 2025
Product Monograph Brand Safety Updates - February 2025
(PDF, 85 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Adderall XR | 284572 | Dextroamphetamine Sulfate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate | Takeda Canada Inc | Yes | Yes | No | Yes | No | Yes | Yes | Yes |
Apo-Cefuroxime | 290040 | Cefuroxime Axetil | Apotex Inc | No | Yes | No | Yes | No | No | No | Yes |
Apo-Levofloxacin | 289861 | Levofloxacin Hemihydrate | Apotex Inc | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Arava | 290800 | Leflunomide | Sanofi-Aventis Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Bicnu | 280995 | Carmustine | Marcan Pharmaceuticals Inc | Yes | No | No | No | No | Yes | No | Yes |
Biktarvy | 284007 | Emtricitabine, Tenofovir Alafenamide Hemifumarate, Bictegravir Sodium | Gilead Sciences Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Cefuroxime for Injection, USP | 289915 | Cefuroxime Sodium | Fresenius Kabi Canada Ltd | No | No | No | No | No | Yes | No | Yes |
Entrophen Chewable, Entrophen 325mg Caplets, Entrophen 325mg Tablets | 290249 | Acetylsalicylic Acid | Pendopharm Division of Pharmascience Inc | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
Iclusig | 290949 | Ponatinib Hydrochloride | Takeda Pharmaceuticals U.S.A., Inc | No | No | No | No | No | Yes | No | No |
Inrebic | 292227 | Fedratinib Hydrochloride | Bristol-Myers Squibb Canada | No | Yes | No | Yes | No | No | No | Yes |
Mifegymiso | 289927 | Mifepristone, Misoprostol | Linepharma International Limited | No | Yes | No | Yes | No | No | No | Yes |
Nexium 24Hr | 290208 | Esomeprazole Magnesium Trihydrate | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | No | No | Yes | Yes | No | Yes |
Oxy.IR | 290991 | Oxycodone Hydrochloride | Purdue Pharma | No | Yes | No | Yes | No | No | Yes | Yes |
Oxyneo | 290992 | Oxycodone Hydrochloride | Purdue Pharma | No | Yes | No | Yes | No | No | Yes | Yes |
Plaquenil | 287053 | Hydroxychloroquine Sulfate | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Provera | 290936 | Medroxyprogesterone Acetate | Pfizer Canada ULC | No | Yes | No | No | No | No | No | No |
Ralivia | 290350 | Tramadol Hcl | Bausch Health, Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Rinvoq | 290768 | Upadacitinib | Abbvie Corporation | No | No | No | Yes | No | No | No | No |
Silenor | 290257 | Doxepin Hcl | Endo Operations Ltd | No | No | No | Yes | Yes | Yes | Yes | Yes |
Tiazac | 290862 | Diltiazem Hcl | Bausch Health, Canada Inc | No | No | No | No | Yes | No | No | Yes |
Wakix | 284477 | Pitolisant Hydrochloride | Endo Ventures Ltd | No | Yes | No | Yes | No | Yes | No | Yes |
January 2025
Product Monograph Brand Safety Updates - January 2025
(PDF, 86 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Abilify Asimtufii, Abilify Maintena | 266917 | Aripiprazole | Otsuka Pharmaceutical Co Ltd | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Advil Cold and Sinus Nighttime, Advil Cold & Sinus Plus, Advil Cold, Sinus & Flu Extra Strength, Children's Advil Cold & Flu Multi-Symptom | 279937 | Pseudoephedrine Hcl, Chlorpheniramine Maleate, Ibuprofen | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
Advil Tablets, Advil Caplets, Advil Extra Strength Caplets, Advil Muscle and Joint, Advil 12 Hour | 282796 | Ibuprofen | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | No | No | Yes | No | Yes |
Dayvigo | 281784 | Lemborexant | Eisai Limited | No | Yes | No | Yes | No | Yes | Yes | Yes |
Depo-Medrol (with Preservative), Depo-Medrol | 290456 | Methylprednisolone Acetate | Pfizer Canada ULC | No | Yes | No | No | Yes | No | No | Yes |
Depo-Medrol with Lidocaine | 290493 | Methylprednisolone Acetate, Lidocaine Hcl | Pfizer Canada ULC | No | Yes | No | No | Yes | No | No | Yes |
Eliquis | 288960 | Apixaban | Bristol-Myers Squibb Canada | No | Yes | No | Yes | No | No | No | Yes |
Forxiga | 288938 | Dapagliflozin Propanediol Monohydrate | AstraZeneca Canada Inc | No | Yes | No | No | No | Yes | No | Yes |
Gen-Clozapine | 284195 | Clozapine | Mylan Pharmaceuticals ULC | No | Yes | No | No | No | Yes | No | Yes |
Lumakras | 274523 | Sotorasib | Amgen Canada Inc | No | Yes | No | No | No | Yes | No | Yes |
Medrol | 290421 | Methylprednisolone | Pfizer Canada ULC | No | Yes | No | No | Yes | No | No | Yes |
Monoferric | 276473 | Ferric Derisomaltose | Pharmacosmos A/S | No | Yes | No | Yes | No | Yes | No | Yes |
Myfortic | 289913 | Mycophenolate Sodium | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | Yes |
Orgalutran | 289424 | Ganirelix Acetate | Organon Canada Inc | Yes | Yes | No | No | No | Yes | No | Yes |
Oxlumo | 290990 | Lumasiran Sodium | Alnylam Netherlands B.V. | No | Yes | No | Yes | No | No | No | Yes |
Penthrox | 283985 | Methoxyflurane | Endo Operations Ltd | No | Yes | No | Yes | Yes | No | No | Yes |
PMS-Methotrexate | 285869 | Methotrexate Disodium | Pharmascience Inc | No | Yes | No | No | No | No | No | Yes |
Retevmo | 288545 | Selpercatinib | Loxo Oncology Inc | No | Yes | No | No | Yes | Yes | No | No |
Septanest N, Septanest SP | 288534 | Epinephrine Bitartrate, Articaine Hcl | Septodont | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Solu-Medrol | 290511 | Methylprednisolone Sodium Succinate | Pfizer Canada ULC | No | Yes | No | No | Yes | No | No | Yes |
Talzenna | 271537 | Talazoparib Tosylate | Pfizer Canada ULC | No | Yes | No | Yes | Yes | Yes | No | Yes |
Truqap | 289562 | Capivasertib | AstraZeneca Canada Inc | No | Yes | Yes | No | No | Yes | No | Yes |
Xigduo | 288937 | Dapagliflozin Propanediol Monohydrate, Metformin Hydrochloride | AstraZeneca Canada Inc | No | Yes | No | No | No | Yes | No | Yes |
Xyrem | 289933 | Sodium Oxybate | Jazz Pharmaceuticals Ireland Limited | No | Yes | No | No | No | Yes | No | Yes |
December 2024
Product Monograph Brand Safety Updates - December 2024
(PDF, 86 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Advil Liqui-Gels, Advil Extra Strength Liqui-Gels, Advil Arthritis Pain | 282804 | Ibuprofen | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | No | No | No | No | Yes |
Aricept | 288646 | Donepezil Hydrochloride | Pfizer Canada ULC | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Arimidex | 289564 | Anastrozole | AstraZeneca Canada Inc | No | No | No | No | No | No | No | Yes |
Biaxin BID, Biaxin | 288756 | Clarithromycin | BGP Pharma ULC | Yes | Yes | No | No | Yes | No | No | Yes |
Brukinsa | 286962 | Zanubrutinib | Beigene Switzerland GmbH | No | No | No | No | No | Yes | No | Yes |
Cerebyx | 288605 | Fosphenytoin Sodium | Searchlight Pharma Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Combogesic | 285323 | Acetaminophen, Ibuprofen | Biosyent Pharma Inc | No | Yes | Yes | No | No | No | No | Yes |
Delstrigo | 287870 | Doravirine, Tenofovir Disoproxil Fumarate, Lamivudine | Merck Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Evra | 286304 | Ethinyl Estradiol, Norelgestromin | Searchlight Pharma Inc | No | No | No | No | Yes | No | No | Yes |
Florinef | 286587 | Fludrocortisone 21-Acetate | Endo Operations Ltd | No | No | No | Yes | Yes | Yes | No | Yes |
Ibrance | 290029 | Palbociclib | Pfizer Canada ULC | No | No | No | No | Yes | Yes | No | Yes |
Lysodren | 289533 | Mitotane | HRA Pharma Rare Diseases | No | Yes | No | No | No | No | No | Yes |
Mekinist | 288807 | Trametinib Dimethyl Sulfoxide | Novartis Pharmaceuticals Canada Inc | No | No | No | Yes | No | No | No | Yes |
Nextstellis | 286306 | Drospirenone, Estetrol Monohydrate | Searchlight Pharma Inc | No | No | No | No | No | No | No | Yes |
Pifeltro | 287877 | Doravirine | Merck Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Ryaltris | 286560 | Olopatadine Hcl, Mometasone Furoate Monohydrate | Glenmark Specialty SA | No | No | No | No | No | Yes | No | Yes |
Tafinlar | 288803 | Dabrafenib Mesylate | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Trulance | 279583 | Plecanatide | Bausch Health, Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Vinblastine Sulfate Injection | 288620 | Vinblastine Sulfate | Pfizer Canada ULC | Yes | Yes | No | No | No | Yes | Yes | Yes |
Welireg | 282593 | Belzutifan | Merck Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Wellbutrin SR | 287465 | Bupropion Hcl | Bausch Health, Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Wellbutrin XL | 287467 | Bupropion Hcl | Bausch Health, Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Xtandi | 289427 | Enzalutamide | Astellas Pharma Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Xylocard | 288946 | Lidocaine Hcl | Aspen Pharmacare Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
November 2024
Product Monograph Brand Safety Updates - November 2024
(PDF, 90 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Advil Cold & Sinus Extra Strength Liqui-Gels, Advil Cold & Sinus Liqui-Gels, Advil Cold and Sinus, Advil Cold and Sinus Daytime, Children's Advil Cold | 274716 | Pseudoephedrine Hcl, Ibuprofn | GlaxoSmithKline Consumer Healthcare ULC | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Balversa | 282212 | Erdafitinib | Janssen Inc | No | No | No | Yes | Yes | No | No | Yes |
Bijuva | 286076 | Estradiol Hemihydrate, Progesterone | Knight Therapeutics Inc | No | Yes | No | No | No | No | No | Yes |
Cabazitaxel for Injection | 286854 | Cabazitaxel | Sandoz Canada Incorporated | No | No | No | Yes | No | No | No | Yes |
Cibinqo | 278770 | Abrocitinib | Pfizer Canada ULC | No | Yes | No | Yes | Yes | Yes | No | Yes |
Cresemba | 280928 | Isavuconazonium Sulfate | Avir Pharma Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Dovato | 281486 | Lamivudine, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | Yes | No | Yes |
Dymista | 287374 | Azelastine Hydrochloride, Fluticasone Propionate | BGP Pharma ULC | No | Yes | No | No | No | No | No | Yes |
Edurant | 288112 | Rilpivirine Hydrochloride | Janssen Inc | No | Yes | No | No | No | No | No | Yes |
Eltroxin | 287631 | Levothyroxine Sodium | Aspen Pharmacare Canada Inc | No | Yes | No | No | No | No | No | Yes |
Galafold | 281056 | Migalastat Hydrochloride | Amicus Therapeutics Canada Inc | No | No | No | Yes | No | Yes | No | Yes |
Gavreto | 284240 | Pralsetinib | Hoffmann-La Roche Limited | No | No | No | No | No | Yes | No | No |
Gemcitabine Injection | 287075 | Gemcitabine Hydrochloride | Pfizer Canada ULC | No | Yes | No | Yes | No | No | No | Yes |
IFEX | 286852 | Ifosfamide | Baxter Corporation | No | Yes | No | No | Yes | No | No | Yes |
Juluca | 281490 | Rilpivirine Hydrochloride, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | Yes | No | Yes |
Levothyroxine Sodium for Injection, Levothyroxine Sodium Injection | 287632 | Levothyroxine Sodium | Fresenius Kabi Canada Ltd | No | Yes | No | No | No | No | No | Yes |
Livtencity | 287353 | Maribavir | Takeda Canada Inc | No | Yes | No | No | Yes | Yes | No | No |
Marvelon 21, Marvelon 28 | 286308 | Desogestrel, Ethinyl Estradiol | Organon Canada Inc | No | No | No | No | Yes | No | No | Yes |
Maviret | 281371 | Glecaprevir, Pibrentasvir | Abbvie Corporation | Yes | No | No | No | Yes | No | No | No |
Micardis Plus | 287669 | Hydrochlorothiazide, Telmisartan | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | No | No | No | No |
Nolvadex - D | 288795 | Tamoxifen Citrate | AstraZeneca Canada Inc | No | Yes | No | No | No | No | No | Yes |
Nortriptyline | 287666 | Nortriptyline Hcl | Apotex Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Nuvaring | 286307 | Ethinyl Estradiol, Etonogestrel | Organon Canada Inc | No | No | No | No | No | No | No | Yes |
Plan B | 280947 | Levonorgestrel | Foundation Consumer Healthcare, LLC | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
Quviviq | 281384 | Daridorexant Hydrochloride | Idorsia Pharmaceuticals Ltd | No | Yes | No | No | Yes | No | No | Yes |
Sohonos | 288312 | Palovarotene | Ipsen Biopharmaceuticals Canada Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Tavneos | 287202 | Avacopan | Vifor Fresenius Medical Care Renal Pharma Ltd | No | Yes | No | Yes | Yes | No | No | Yes |
Tivicay | 281488 | Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | Yes | No | Yes |
Triumeq | 281500 | Abacavir Sulfate, Lamivudine, Dolutegravir Sodium | ViiV Healthcare ULC | No | Yes | No | No | No | Yes | No | Yes |
Twynsta | 287674 | Amlodipine Besylate, Telmisartan | Boehringer Ingelheim (Canada) Ltd Ltee | Yes | Yes | No | Yes | Yes | No | Yes | Yes |
October 2024
Product Monograph Brand Safety Updates - October 2024
(PDF, 86 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Amoxicillin Sodium and Potassium Clavulanate for Injection | 286649 | Amoxicillin Sodium, Clavulanate Potassium | Sandoz Canada Incorporated | No | Yes | No | Yes | Yes | Yes | No | Yes |
Apo-Amoxicillin | 286363 | Amoxicillin | Apotex Inc | No | Yes | No | Yes | No | No | No | Yes |
Arava | 287680 | Leflunomide | Sanofi-Aventis Canada Inc | No | No | No | No | No | Yes | No | Yes |
Crestor | 286971 | Rosuvastatin Calcium | AstraZeneca Canada Inc | No | No | No | No | Yes | No | No | Yes |
Duavive | 287357 | Bazedoxifene Acetate, Conjugated Estrogens | Pfizer Canada ULC | No | No | No | No | Yes | No | No | Yes |
Estalis 140/50 mcg, Estalis 250/50 mcg | 286803 | Norethindrone Acetate, Estradiol | Sandoz Canada Incorporated | No | No | No | No | Yes | No | No | Yes |
Euthyrox | 287630 | Levothyroxine Sodium | EMD Serono a Division of EMD Inc Canada | No | No | No | No | No | No | No | Yes |
Evrysdi | 284770 | Risdiplam | Hoffmann-La Roche Limited | No | Yes | No | Yes | No | Yes | No | Yes |
Extra Strength Tylenol Nighttime | 287258 | Diphenhydramine Hcl, Acetaminophen | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | No | Yes | Yes | No | No | Yes | No | Yes |
Imvexxy | 286037 | Estradiol Hemihydrate | Knight Therapeutics Inc | No | Yes | No | No | No | No | No | Yes |
Jardiance | 285974 | Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | No | No | Yes | No | Yes |
Lolo | 286305 | Norethindrone Acetate, Ethinyl Estradiol | Abbvie Corporation | No | No | No | No | Yes | No | No | No |
Lumakras | 276210 | Sotorasib | Amgen Canada Inc | No | No | No | No | No | Yes | No | Yes |
Metronidazole Injection, USP | 286761 | Metronidazole | Baxter Corporation | No | Yes | No | Yes | No | No | No | Yes |
Multaq | 286505 | Dronedarone (Dronedarone Hydrochloride) | Sanofi-Aventis Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Naropin | 283752 | Ropivacaine Hcl | Aspen Pharmacare Canada Inc | No | Yes | Yes | No | No | No | No | Yes |
Premarin | 287505 | Conjugated Estrogens | Pfizer Canada ULC | No | No | No | No | Yes | No | No | Yes |
Reactine 20 mg Tablet | 286899 | Cetirizine Hydrochloride | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | No | Yes | No | Yes | Yes | Yes | No | Yes |
Retevmo | 280820 | Selpercatinib | Loxo Oncology Inc | No | Yes | No | Yes | No | No | No | Yes |
Reyataz | 287317 | Atazanavir Sulfate | Bristol-Myers Squibb Canada | Yes | No | No | No | Yes | No | No | No |
Summit Ultra | 285337 | Methocarbamol, Ibuprofen | Pendopharm Division of Pharmascience Inc | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Synjardy | 285975 | Metformin Hydrochloride, Empagliflozin | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | No | No | Yes | No | Yes |
Synthroid | 287633 | Levothyroxine Sodium | BGP Pharma ULC | No | No | No | No | No | No | No | Yes |
Zevtera | 285584 | Ceftobiprole | Avir Pharma Inc | No | Yes | Yes | No | No | No | No | Yes |
Zoryve | 280534 | Roflumilast | Arcutis Canada, Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Non-Prescription Submissions Cleared in 2014
Brand Name | Submission number | Ingredient | Manufacturer | Contra- indications |
Warning and Precautions | Serious Warnings and Precautions Box | Adverse reactions | Drug interactions | Dosage and Administration | Overdosage | 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 |