Product monograph brand safety updates

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

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

June 2019

Product Monograph Brand Safety Updates June 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	221275	Lamivudine	ViiV Healthcare ULC	No	Yes	Yes	No	No	Yes	No	Yes
AA-Amilzide	224577	Amiloride HCl, Hydrochlorothiazide	AA Pharma Inc	No	Yes	No	Yes	No	No	No	Yes
Alertec	225210	Modafinil	Teva Canada Limited	Yes	Yes	No	No	No	No	No	Yes
Apo-Triazide	224588	Hydrochlorothiazide, Triamterene	Apotex Inc	No	Yes	No	Yes	No	No	No	Yes
Atacand Plus	224589	Hydrochlorothiazide, Candesartan Cilexetil	AstraZeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Brilinta	225812	Ticagrelor	AstraZeneca Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Cetrotide	221823	Cetrorelix Acetate	EMD Serono a Division of EMD Inc Canada	No	No	No	No	No	No	No	Yes
Combivir	226229	Zidovudine, Lamivudine	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Cymbalta	225221	Duloxetine HCl	Eli Lilly Canada Inc	No	Yes	No	No	No	No	No	Yes
Diprivan 1%	224506	Propofol	Aspen Pharmacare Canada Inc.	No	Yes	No	Yes	Yes	No	No	Yes
Enalapril Maleate/HCTZ	224590	Enalapril Maleate, Hydrochlorothiazide	AA Pharma Inc	No	Yes	No	Yes	No	No	No	Yes
Epclusa	226107	Sofosbuvir, Velpatasvir	Gilead Sciences Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Firazyr	217805	Icatibant Acetate	Shire Orphan Therapies LLC	No	Yes	No	Yes	No	Yes	Yes	Yes
Giotrif	225731	Afatinib Dimaleate	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	Yes	Yes	No	No	No	Yes
Harvoni	226108	Ledipasvir, Sofosbuvir	Gilead Sciences Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Hyzaar, Hyzaar DS	224591	Hydrochlorothiazide, Losartan Potassium	Merck Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Inhibace Plus	224592	Hydrochlorothiazide, Cilazapril Monohydrate	Cheplapharm Arzneimittel GmbH Germany	No	Yes	No	Yes	No	No	No	Yes
Inspiolto Respimat	225755	Tiotropium Bromide Monohydrate, Olodaterol Hydrochloride	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	No	No	No	No	Yes
Intelence	225943	Etravirine	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes
Kivexa	226270	Lamivudine, Abacavir	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Kyleena	226318	Levonorgestrel	Bayer Inc	Yes	Yes	No	Yes	No	Yes	No	Yes
Lamictal	225948	Lamotrigine	Glaxosmithkline Inc	No	Yes	No	Yes	No	No	No	Yes
Lescol XL	226973	Fluvastatin Sodium	Novartis Pharmaceuticals Canada Inc	No	No	No	No	No	No	No	Yes
Levofloxacin in 5% Dextrose Injection	226599	Levofloxacin	Pfizer Canada ULC	No	Yes	No	No	No	No	No	Yes
Lipitor	215410	Atorvastatin Calcium	Pfizer Canada ULC	No	Yes	No	Yes	Yes	No	No	Yes
Lorazepam Injection USP	226066	Lorazepam	Sandoz Canada Incorporated	No	Yes	Yes	No	Yes	No	No	Yes
Losec	223402	Omeprazole	AstraZeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Lupron Depot	226992	Leuprolide Acetate	Abbvie Corporation	No	No	No	No	No	Yes	No	Yes
Lupron, Lupron Depot	226966	Leuprolide Acetate	Abbvie Corporation	No	No	No	No	No	Yes	No	Yes
Lupron, Lupron Depot	226995	Leuprolide Acetate	Abbvie Corporation	No	No	No	No	No	Yes	No	Yes
M-Eslon	226278	Morphine Sulfate	Ethypharm Inc	No	Yes	No	Yes	Yes	No	Yes	Yes
Maviret	222816	Glecaprevir, Pibrentasvir	Abbvie Corporation	No	Yes	No	No	No	No	No	Yes
Mezavant	225608	Mesalazine	Shire Pharma Canada ULC	Yes	Yes	No	Yes	Yes	No	No	Yes
Mirena	226328	Levonorgestrel	Bayer Inc	Yes	Yes	No	No	No	Yes	No	Yes
Nexium	223396	Esomeprazole Magnesium Trihydrate	AstraZeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Norfloxacin	226592	Norfloxacin	AA Pharma Inc	No	Yes	No	No	No	No	No	Yes
Ocuflox	223934	Ofloxacin	Allergan Inc	No	Yes	No	Yes	Yes	Yes	Yes	Yes
Precedex	224419	Dexmedetomidine HCl	Pfizer Canada ULC	No	Yes	No	No	No	No	No	No
Rifadin	225204	Rifampin	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Sabril	225756	Vigabatrin	Lundbeck Pharmaceuticals LLC	No	Yes	No	Yes	No	No	No	Yes
Samsca	224960	Tolvaptan	Otsuka Pharmaceutical Co Ltd	Yes	Yes	No	No	No	Yes	No	Yes
Sovaldi	226104	Sofosbuvir	Gilead Sciences Canada Inc	No	Yes	No	Yes	Yes	No	No	Yes
Tecfidera	205373	Dimethyl Fumarate	Biogen Canada Inc	No	Yes	No	No	No	No	No	Yes
Toctino	225922	Alitretinoin	Glaxosmithkline Inc	No	No	No	Yes	No	No	No	Yes
Trisenox	226370	Arsenic Trioxide	Teva Canada Limited	No	Yes	Yes	Yes	No	No	No	Yes
Vaseretic	224595	Hydrochlorothiazide, Enalapril Sodium	Merck Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Vimovo	223399	Naproxen, Esomeprazole	AstraZeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Viskazide	224596	Hydrochlorothiazide, Pindolol	Aralez Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Zestoretic	224598	Hydrochlorothiazide, Lisinopril	AstraZeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Zestoretic	225753	Hydrochlorothiazide, Lisinopril	AstraZeneca Canada Inc	No	No	No	No	No	Yes	No	Yes
Ziagen	226227	Abacavir	ViiV Healthcare ULC	No	Yes	No	No	No	No	No	Yes
Zymar	224198	Gatifloxacin	Allergan Inc	No	Yes	No	Yes	Yes	Yes	Yes	Yes

May 2019

Product Monograph Brand Safety Updates May 2019
(PDF, 139 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
Aerius Double Action 12 Hour	225003	pseudoephedrine sulfate, desloratadine	Bayer Inc	No	No	No	No	No	No	No	Yes
Aldactazide 25, Aldactazide 50	224433	hydrochlorothiazide, spironolactone	Pfizer Canada Ulc	No	Yes	No	Yes	No	No	No	Yes
Belkyra	225789	deoxycholic acid	Kythera Biopharmaceuticals Inc	No	No	No	Yes	No	No	No	No
Biktarvy	224191	emtricitabine, tenofovir alafenamide, bictegravir	Gilead Sciences Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Brivlera	224666	brivaracetam	UCB Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Bydureon	224768	exenatide	AstraZeneca Canada Inc	No	No	No	Yes	No	No	No	No
Caelyx	225464	doxorubicin hcl	Janssen Inc	No	No	No	Yes	No	No	No	No
Claritin Allergy	225773	loratadine	Bayer Inc	Yes	Yes	No	No	No	No	No	Yes
Claritin Allergy + Sinus	225712	pseudoephedrine sulfate, loratadine	Bayer Inc	Yes	Yes	No	No	No	No	No	Yes
Claritin Allergy + Sinus Extra Strength	225242	pseudoephedrine sulfate, loratadine	Bayer Inc	No	Yes	No	No	No	No	No	Yes
Claritin Kids	225774	loratadine	Bayer Inc	Yes	Yes	No	No	No	No	No	Yes
Claritin Liquid Capsules	225631	loratadine	Bayer Inc	Yes	Yes	Yes	No	No	Yes	No	Yes
Genvoya	224195	emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide	Gilead Sciences Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Gilenya	224273	fingolimod hydrochloride	Novartis Pharmaceuticals Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Glyxambi	224972	linagliptin, empagliflozin	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	No	No	No	Yes
Invokamet	225038	metformin hcl, canagliflozin	Janssen Inc	No	Yes	No	No	No	No	No	Yes
Invokamet Xr	225123	metformin hcl, canagliflozin	Janssen Inc	No	Yes	No	Yes	No	No	No	Yes
Jentadueto	224836	metformin hcl, linagliptin	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	No	No	No	Yes
Kaletra	225124	ritonavir, lopinavir	Abbvie Corporation	Yes	Yes	No	No	Yes	No	No	Yes
Lynparza	219799	olaparib	AstraZeneca Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Norvir	226180	ritonavir	Abbvie Corporation	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Odefsey	224194	emtricitabine, tenofovir alafenamide, rilpivirine	Gilead Sciences Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Olmetec Plus	224593	hydrochlorothiazide, olmesartan medoxomil	Merck Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Omniscan	225072	gadodiamide	GE Healthcare Canada Inc	No	Yes	No	Yes	No	Yes	No	No
Orgalutran	224718	ganirelix acetate	Merck Canada Inc	No	Yes	No	Yes	No	No	Yes	Yes
Parnate	222806	tranylcypromine sulfate	GlaxoSmithKline Inc	No	Yes	No	No	No	No	Yes	No
Pms-Methotrexate	224788	methotrexate sodium	Pharmascience Inc	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Quinsair	224015	levofloxacin	Horizon Pharma Ireland Ltd	No	Yes	No	No	No	No	No	Yes
Reactine Complete	224142	cetirizine hydrochloride, pseudoephedrine hcl	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	Yes	Yes	Yes	No	Yes	Yes
Reactine, Reactine Allergy Liquid Gels, Reactine Fast Melt Junior, Reactine Rapid Dissolve	224044	cetirizine hydrochloride	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Revolade	217802	eltrombopag olamine	Novartis Pharmaceuticals Canada Inc	No	No	No	Yes	No	Yes	No	Yes
Sensorcaine, Sensorcaine With Epinephrine	224469	bupivacaine hcl, epinephrine bitartrate	Aspen Pharmacare Canada Inc.	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Somatuline Autogel	225592	lanreotide	Ipsen Biopharm Limited	No	No	No	No	No	No	No	Yes
Spiriva Respimat	224205	tiotropium bromide monohydrate	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	No	Yes	No	No	Yes
Steglujan	224047	sitagliptin phosphate, ertugliflozin	Merck Canada Inc	No	Yes	No	No	No	Yes	No	Yes
Striverdi Respimat	224290	olodaterol hydrochloride	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	Yes	No	No	No	Yes
Sublocade	224875	buprenorphine	Indivior UK Limited	No	Yes	Yes	No	Yes	Yes	Yes	Yes
Trajenta	224835	linagliptin	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	No	No	No	Yes
Vemlidy	224496	tenofovir alafenamide	Gilead Sciences Canada Inc	No	Yes	No	Yes	No	Yes	Yes	Yes
Zocor	224707	simvastatin	Merck Canada Inc	No	Yes	No	No	Yes	No	No	Yes

April 2019

Product Monograph Brand Safety Updates April 2019
(PDF, 129 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
Adriamycin Pfs	224489	doxorubicin hcl	Pfizer Canada ULC	No	Yes	No	No	No	No	No	No
Aloxi	215829	palonosetron hydrochloride	Purdue Pharma	Yes	Yes	No	Yes	No	Yes	No	Yes
Anandron	224467	nilutamide	Sanofi-Aventis Canada Inc	No	No	No	No	No	No	No	Yes
Apo-Perindopril Arginine	223805	perindopril arginine	Apotex Inc	Yes	Yes	No	No	Yes	No	No	Yes
Apresoline	223367	hydralazine hcl	Sterimax Inc	No	Yes	No	No	No	Yes	No	No
Belsomra	224763	suvorexant	Merck Canada Inc	No	No	No	Yes	No	No	No	Yes
Brilinta	223019	ticagrelor	Astrazeneca Canada Inc	No	Yes	No	No	Yes	Yes	Yes	No
Carnitor	222342	levocarnitine	Leadiant Biosciences, Inc.	No	Yes	No	Yes	No	No	No	Yes
Celebrex	206954	celecoxib	Pfizer Canada Inc	No	Yes	Yes	No	No	No	No	No
Concerta	224296	methylphenidate hcl	Janssen Inc	No	No	No	No	Yes	No	No	Yes
Depakene	225434	valproic acid	Bgp Pharma ULC	No	No	No	No	No	Yes	No	Yes
Dexilant	215955	dexlansoprazole	Takeda Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Forxiga	217312	dapagliflozin	Astrazeneca Canada Inc	Yes	Yes	No	Yes	No	Yes	No	Yes
Idamycin Pfs	224473	idarubicin hcl	Pfizer Canada Ulc	No	Yes	No	No	No	No	No	No
Imodium Calming Liquid, Imodium Liqui-Gels, Imodium Quick Dissolve	222934	loperamide hcl	Mcneil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	No	No	No	Yes	Yes
Imodium Complete Caplets	222936	loperamide hcl, simethicone	Mcneil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	No	No	No	Yes	Yes
Invokana	225039	canagliflozin	Janssen Inc	No	Yes	No	No	No	No	No	Yes
Jardiance	221628	empagliflozin	Boehringer Ingelheim (Canada) Ltd Ltee	No	No	No	Yes	Yes	No	No	Yes
Lanvis	223270	thioguanine	Aspen Pharmacare Canada Inc.	No	No	No	No	No	Yes	No	Yes
Lomotil	222941	atropine sulfate, diphenoxylate hcl	Pfizer Canada ULC	No	No	No	No	No	No	No	Yes
Mekinist	223527	trametinib	Novartis Pharmaceuticals Canada Inc	No	No	No	Yes	No	No	No	Yes
Merrem	222507	meropenem trihydrate	Pfizer Canada ULC	No	No	No	Yes	No	No	No	Yes
Natesto	223106	testosterone	Acerus Biopharma Inc	No	No	No	No	No	Yes	No	Yes
Pepcid Ac, Maximum Strength Pepcid Ac	224006	famotidine	Mcneil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	Yes	Yes	Yes	No	Yes
Pepcid Complete	224012	calcium carbonate, famotidine, magnesium hydroxide	Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc	No	Yes	No	No	Yes	Yes	Yes	Yes
Prezcobix	223917	darunavir ethanolate, cobicistat	Janssen Inc	Yes	Yes	No	No	Yes	No	No	Yes
Prostin Vr Sterile Solution	222330	alprostadil	Pfizer Canada ULC	No	No	Yes	No	No	No	No	Yes
Remeron	224165	mirtazapine	Merck Canada Inc	No	No	No	Yes	No	No	No	Yes
Remeron Rd	224171	mirtazapine	Merck Canada Inc	No	No	No	Yes	No	No	No	Yes
Singulair	223908	montelukast sodium	Merck Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Sporanox	216151	itraconazole	Janssen Inc	No	Yes	No	No	Yes	Yes	No	Yes
Tafinlar	223526	dabrafenib	Novartis Pharmaceuticals Canada Inc	No	No	Yes	Yes	No	No	No	Yes
Trintellix	223451	vortioxetine hydrobromide	Lundbeck Canada Inc	No	No	No	Yes	No	No	No	Yes
Viibryd	222640	vilazodone hydrochloride	Allergan Inc	No	No	No	Yes	No	No	No	Yes
Vinblastine Sulfate Injection	223754	vinblastine sulfate	Pfizer Canada ULC	No	Yes	No	Yes	Yes	No	No	No
Xanax, Xanax Ts	223422	alprazolam	Pfizer Canada ULC	No	Yes	No	Yes	No	Yes	No	No
Zytiga	224003	abiraterone acetate	Janssen Inc	No	Yes	No	Yes	No	No	No	No

March 2019

Product Monograph Brand Safety Updates March 2019
(PDF, 135 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
Accuretic	224313	hydrochlorothiazide, quinapril hcl	Pfizer Canada Ulc	No	Yes	No	Yes	No	No	No	Yes
Advagraf	223040	tacrolimus	Astellas Pharma Canada Inc	No	No	Yes	Yes	Yes	No	No	Yes
Aleve Nighttime	219322	diphenhydramine hcl, naproxen sodium	Bayer Inc	Yes	No	Yes	No	No	No	No	Yes
Avalide	223037	hydrochlorothiazide, irbesartan	Sanofi-Aventis Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Corvert	222103	ibutilide fumarate	Pfizer Canada Ulc	No	No	Yes	No	No	No	No	Yes
Dificid	215516	fidaxomicin	Merck Canada Inc	No	Yes	No	No	No	No	No	Yes
Ditropan XL	223169	oxybutynin chloride	Janssen Inc	No	No	No	No	Yes	No	No	Yes
Dymista	223242	fluticasone propionate, azelastine hydrochloride	BGP Pharma Ulc	No	No	No	No	No	No	No	Yes
Edurant	223865	rilpivirine	Janssen Inc	No	Yes	No	No	No	No	Yes	Yes
Eliquis	222811	apixaban	Bristol-Myers Squibb Canada	No	Yes	No	No	Yes	Yes	No	Yes
Foquest	214860	methylphenidate hcl	Purdue Pharma	Yes	Yes	No	Yes	No	Yes	No	Yes
Galafold	215579	migalastat hydrochloride	Amicus Therapeutics UK Ltd	No	No	No	Yes	No	Yes	No	Yes
Imbruvica	214952	ibrutinib	Janssen Inc	No	No	No	Yes	No	Yes	No	Yes
Inlyta	207338	axitinib	Pfizer Canada Ulc	No	Yes	No	No	No	Yes	No	No
Intelence	223906	etravirine	Janssen Inc	No	Yes	No	No	No	No	No	Yes
Kinevac	223269	sincalide	Bracco Imaging Canada	No	No	No	No	No	No	No	Yes
Lupron, Lupron Depot	215907	leuprolide acetate	Abbvie Corporation	No	No	No	No	No	Yes	No	No
Lynparza	220476	olaparib	Astrazeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Lynparza	224063	olaparib	Astrazeneca Canada Inc	No	Yes	No	Yes	No	No	No	Yes
Metoject Subcutaneous	223139	methotrexate sodium	Medexus Inc	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Micardis Plus	222622	hydrochlorothiazide, telmisartan	Boehringer Ingelheim (Canada) Ltd Ltee	No	Yes	No	Yes	No	No	No	Yes
Naropin	222913	ropivacaine hcl	Aspen Pharmacare Canada Inc.	No	No	No	No	No	No	No	Yes
Nitro-Dur 0.2, Nitro-Dur 0.4, Nitro-Dur 0.6, Nitro-Dur 0.8	223266	nitroglycerin	Uspharma Ltd	No	No	No	No	No	No	No	Yes
Prezista	223905	darunavir	Janssen Inc	Yes	Yes	No	Yes	Yes	No	No	Yes
Prograf	223039	tacrolimus	Astellas Pharma Canada Inc	No	No	Yes	Yes	Yes	No	No	Yes
Segluromet	224031	metformin hcl, ertugliflozin	Merck Canada Inc	No	Yes	No	Yes	No	Yes	No	Yes
Sudafed Sinus Advance	223272	ibuprofen, pseudoephedrine hcl	McNeil Consumer Healthcare Division of Johnson & Johnson Inc	No	Yes	No	No	No	No	No	Yes
Symtuza	223719	emtricitabine, darunavir, cobicistat, tenofovir alafenamide	Janssen Inc	Yes	Yes	No	Yes	Yes	No	No	Yes
Teveten Plus	223468	hydrochlorothiazide, eprosartan mesylate	BGP Pharma Ulc	No	Yes	No	Yes	No	No	No	Yes
Thalomid	223254	thalidomide	Celgene Inc	No	Yes	No	Yes	No	No	No	Yes
Topamax	222972	topiramate	Janssen Inc	No	No	No	Yes	No	No	Yes	No
Trelegy Ellipta	215148	fluticasone furoate, umeclidinium bromide, vilanterol trifenatate	Glaxosmithkline Inc	No	Yes	No	Yes	No	No	No	Yes
Vermox	215898	mebendazole	Janssen Inc	No	No	No	Yes	No	Yes	No	No

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