Product monograph brand safety updates
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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 |
September 2024
Product Monograph Brand Safety Updates - September 2024
(PDF, 78 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Advagraf | 286250 | Tacrolimus | Astellas Pharma Canada Inc | No | No | No | No | Yes | No | No | Yes |
Balversa | 280318 | Erdafitinib | Janssen Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Benvyon | 287270 | Bendamustine Hydrochloride | Pfizer Canada ULC | No | No | No | Yes | No | No | No | Yes |
Brilinta | 286653 | Ticagrelor | AstraZeneca Canada Inc | No | No | No | No | Yes | No | No | Yes |
Cabometyx | 280615 | Cabozantinib Malate | Ipsen Biopharmaceuticals Canada Inc | No | No | No | No | No | No | No | Yes |
Concerta | 286261 | Methylphenidate Hcl | Janssen Inc | No | No | No | Yes | No | No | No | Yes |
Constella | 279169 | Linaclotide | Abbvie Corporation | Yes | Yes | Yes | Yes | No | Yes | No | Yes |
Depo-Provera | 286411 | Medroxyprogesterone Acetate | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Docetaxel Injection USP | 280749 | Docetaxel | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Estradot 25, Estradot 37.5, Estradot 50, Estradot 75, Estradot 100 | 286712 | Estradiol | Sandoz Canada Incorporated | No | No | No | No | Yes | No | No | Yes |
Hydrea | 286140 | Hydroxyurea | Cheplapharm Arzneimittel GmbH | No | Yes | No | No | Yes | No | No | Yes |
Ibrance | 287136 | Palbociclib | Pfizer Canada ULC | No | No | No | Yes | No | No | No | Yes |
Imovane | 286391 | Zopiclone | Sanofi-Aventis Canada Inc | No | Yes | No | No | No | No | No | Yes |
Lynparza | 281651 | Olaparib | AstraZeneca Canada Inc | No | No | No | No | No | No | No | Yes |
Metoject Subcutaneous | 285868 | Methotrexate Sodium | Medexus Pharmaceuticals Inc | No | Yes | No | No | No | No | No | Yes |
Mounjaro Kwikpen | 283968 | Tirzepatide | Eli Lilly Canada Inc | Yes | Yes | No | No | No | Yes | No | Yes |
Ofev | 286263 | Nintedanib Esilate | Boehringer Ingelheim (Canada) Ltd Ltee | No | Yes | No | Yes | No | No | No | Yes |
Ondansetron ODT | 285751 | Ondansetron | Sandoz Canada Incorporated | Yes | Yes | No | Yes | Yes | Yes | No | Yes |
Prograf | 286251 | Tacrolimus | Astellas Pharma Canada Inc | No | No | No | No | Yes | No | No | Yes |
Tegsedi | 284567 | Inotersen Sodium | Akcea Therapeutics Inc | No | Yes | Yes | Yes | No | Yes | No | Yes |
Teva-Domperidone | 283070 | Domperidone | Teva Canada Limited | No | Yes | No | No | No | No | No | Yes |
Trileptal | 278353 | Oxcarbazepine | Novartis Pharmaceuticals Canada Inc | No | Yes | No | No | No | No | No | Yes |
Vitrakvi | 279970 | Larotrectinib Sulfate | Bayer Inc | No | Yes | No | Yes | No | No | No | Yes |
Xalatan | 286293 | Latanoprost | BGP Pharma ULC | No | No | No | Yes | No | No | No | No |
August 2024
Product Monograph Brand Safety Updates - August 2024
(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 |
---|---|---|---|---|---|---|---|---|---|---|---|
AA-Atenidone | 283834 | Chlorthalidone, Atenolol | AA Pharma Inc | No | No | Yes | Yes | Yes | No | Yes | Yes |
Carbaglu | 279202 | Carglumic Acid | Recordati Rare Diseases | No | Yes | No | No | No | Yes | No | Yes |
Doptelet | 285407 | Avatrombopag Maleate | Swedish Orphan Biovitrum AB (Publ) | No | Yes | No | No | Yes | No | No | Yes |
Erleada | 285552 | Apalutamide | Janssen Inc | No | Yes | No | Yes | No | No | No | Yes |
Jorveza | 275976 | Budesonide | Avir Pharma Inc | No | Yes | No | Yes | No | No | No | Yes |
Kinevac | 285254 | Sincalide | Bracco Imaging Canada | No | Yes | No | No | No | No | No | No |
Leqvio | 283980 | Inclisiran Sodium | Novartis Pharmaceuticals Canada Inc | No | No | No | No | No | No | No | Yes |
Loperacap | 284276 | Loperamide Hcl | Bausch Health, Canada Inc. | Yes | Yes | No | Yes | No | Yes | Yes | Yes |
Lumakras | 276755 | Sotorasib | Amgen Canada Inc | No | Yes | No | Yes | No | No | No | No |
Mavenclad | 283635 | Cladribine | EMD Serono A Division of EMD Inc Canada | No | Yes | No | Yes | No | No | Yes | Yes |
Mezera | 284935 | Mesalazine | Avir Pharma Inc | No | Yes | No | Yes | No | No | No | Yes |
MS Contin | 285408 | Morphine Sulfate | Purdue Pharma | No | Yes | No | Yes | No | Yes | No | Yes |
Nexavar | 285359 | Sorafenib Tosylate | Bayer Inc | No | Yes | No | Yes | No | No | No | Yes |
Paxlovid | 285210 | Ritonavir, Nirmatrelvir | Pfizer Canada ULC | No | Yes | No | No | Yes | No | No | No |
Piqray | 278954 | Alpelisib | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
PMS-Fluoxetine | 284860 | Fluoxetine Hydrochloride | Pharmascience Inc | No | Yes | Yes | No | No | Yes | Yes | Yes |
Precedex | 279381 | Dexmedetomidine Hydrochloride | Pfizer Canada ULC | No | Yes | Yes | No | Yes | Yes | No | Yes |
Pylera | 285298 | Metronidazole, Tetracycline Hcl, Bismuth Subcitrate Potassium | Laboratoires Juvise Pharmaceuticals | Yes | Yes | No | Yes | Yes | No | No | Yes |
Sandoz-Carbamazepine CR | 285830 | Carbamazepine | Sandoz Canada Incorporated | No | Yes | No | No | Yes | No | No | No |
Spravato | 285417 | Esketamine Hydrochloride | Janssen Inc | No | Yes | No | Yes | Yes | Yes | Yes | Yes |
Toradol | 283292 | Ketorolac Tromethamine | AA Pharma Inc | No | Yes | No | No | No | No | No | Yes |
Vermox | 285206 | Mebendazole | Janssen Inc | No | Yes | No | Yes | No | No | Yes | Yes |
Zeposia | 285356 | Ozanimod | Bristol-Myers Squibb Canada | No | Yes | No | Yes | No | No | Yes | Yes |
July 2024
Product Monograph Brand Safety Updates – July 2024(PDF, 109 KB, 2 page)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Aleve Caplets | 264895 | Naproxen Sodium | Bayer Inc | No | No | No | Yes | No | No | No | Yes |
Alkeran | 285163 | Melphalan Hcl, Buffer Solution, Melphalan | Aspen Pharmacare Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Aspirin 81 mg, Aspirin 81 mg Quick Chews, Aspirin Regular Strength, Aspirin Extra Strength | 280158 | Acetylsalicylic Acid | Bayer Inc | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
Bosulif | 275812 | Bosutinib Monohydrate | Pfizer Canada ULC | No | Yes | Yes | Yes | No | No | No | Yes |
Cabometyx | 279079 | Cabozantinib Malate | Ipsen Biopharmaceuticals Canada Inc | No | Yes | No | No | No | No | No | No |
Duratocin | 284214 | Carbetocin | Ferring Inc | No | Yes | No | Yes | No | Yes | No | No |
Flonase Allergy Relief | 282043 | Fluticasone Propionate | Haleon Canada ULC | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes |
Inrebic | 276471 | Fedratinib Hydrochloride | Bristol-Myers Squibb Canada | No | No | No | No | Yes | Yes | No | Yes |
Mounjaro | 283593 | Tirzepatide | Eli Lilly Canada Inc | No | Yes | No | Yes | No | No | No | Yes |
Pepcid Complete | 284021 | Famotidine, Magnesium Hydroxide, Calcium Carbonate | McNeil Consumer Healthcare Division of Johnson & Johnson Inc | No | No | No | No | Yes | No | No | Yes |
Provera | 284720 | Medroxyprogesterone Acetate | Pfizer Canada ULC | No | Yes | No | No | No | No | No | Yes |
Qinlock | 278324 | Ripretinib | Deciphera Pharmaceuticals. LLC | No | Yes | No | Yes | No | Yes | No | Yes |
Reyataz | 283745 | Atazanavir Sulfate | Bristol-Myers Squibb Canada | Yes | No | No | No | Yes | No | No | No |
Rinvoq | 278797 | Upadacitinib | Abbvie Corporation | No | Yes | No | No | No | No | No | No |
Scemblix | 283889 | Asciminib Hydrochloride | Novartis Pharmaceuticals Canada Inc | No | Yes | No | Yes | Yes | No | No | Yes |
Tagrisso | 279138 | Osimertinib Mesylate | AstraZeneca Canada Inc | No | Yes | No | Yes | No | Yes | No | Yes |
Tagrisso | 282907 | Osimertinib Mesylate | AstraZeneca Canada Inc | No | No | No | Yes | No | No | No | Yes |
Tasigna | 286412 | Nilotinib Hydrochloride Monohydrate | Novartis Pharmaceuticals Canada Inc | No | No | No | No | No | Yes | No | Yes |
Tracleer | 283862 | Bosentan Monohydrate | Janssen Inc | No | Yes | No | No | Yes | Yes | No | Yes |
Trikafta | 282009 | Elexacaftor, Ivacaftor, Tezacaftor | Vertex Pharmaceuticals (Canada) Incorporated | No | No | No | No | No | No | No | Yes |
Vepesid | 284682 | Etoposide | Cheplapharm Arzneimittel GmbH | No | Yes | Yes | Yes | No | No | No | Yes |
Xydalba | 278103 | Dalbavancin | Endo Ventures Ltd | No | Yes | No | Yes | No | Yes | No | Yes |
Xywav | 285449 | Magnesium Oxybate, Sodium Oxybate, Potassium Oxybate, Calcium Oxybate | Jazz Pharmaceuticals Ireland Limited | No | No | No | No | No | Yes | No | No |
Zaditor | 279943 | Ketotifen Fumarate | Laboratoires Thea | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes |
June 2024
Product Monograph Brand Safety Updates – June 2024(PDF, 97 KB, 1 page)
Brand Name | Submission Number | Ingredient(s) | Manufacturer | Contraindications | Warnings & Precautions | Serious Warnings & Precautions | Adverse Reactions | Drug Interactions | Dosage & Administration | Overdosage | Consumer Information |
---|---|---|---|---|---|---|---|---|---|---|---|
Alecensaro | 282375 | Alectinib Hydrochloride | Hoffmann-La Roche Limited | No | Yes | No | Yes | No | Yes | No | Yes |
Argatroban | 282415 | Argatroban | Sandoz Canada Incorporated | No | No | No | No | No | Yes | No | Yes |
Ceftin | 279940 | Cefuroxime Axetil | Sandoz Canada Incorporated | No | Yes | No | Yes | No | No | No | Yes |
Clavulin | 283115 | Amoxicillin Trihydrate, Clavulanate Potassium | GlaxoSmithKline Inc | No | No | No | Yes | No | No | No | Yes |
Depakene | 283332 | Sodium Valproate | BGP Pharma ULC | Yes | Yes | Yes | No | No | Yes | No | Yes |
Epival | 283322 | Divalproex Sodium | BGP Pharma ULC | Yes | Yes | Yes | No | No | Yes | No | Yes |
Eyezirgan | 281912 | Ganciclovir | Laboratoires Thea | No | Yes | No | No | No | Yes | No | Yes |
Ferinject | 287221 | Ferric Carboxymaltose | Vifor (International) Inc | No | No | No | No | No | No | No | Yes |
Gadovist 1.0 | 280292 | Gadobutrol | Bayer Inc | No | Yes | No | No | No | No | No | Yes |
Gadovist 1.0 | 282773 | Gadobutrol | Bayer Inc | No | No | No | Yes | No | No | No | Yes |
Magnevist | 280423 | Gadopentetate Dimeglumine | Bayer Inc | No | Yes | No | No | No | No | No | Yes |
Pentasa | 281523 | Mesalazine | Ferring Inc | No | Yes | No | Yes | No | No | No | Yes |
Primovist | 275119 | Gadoxetate Disodium | Bayer Inc | No | Yes | No | No | No | No | No | Yes |
Retevmo | 283771 | Selpercatinib | Loxo Oncology Inc | No | Yes | No | Yes | No | No | No | Yes |
Rezurock | 280993 | Belumosudil Mesylate | Sanofi-Aventis Canada Inc | No | Yes | No | No | Yes | No | No | Yes |
Sunosi | 281424 | Solriamfetol Hydrochloride | Axsome Malta Ltd | No | Yes | No | No | No | No | No | Yes |
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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