Health canada product monograph

health canada product monograph 1 Pediatrics 04 2021 TRINTELLIX Product Monograph Page 1 of 44. 3650 Danforth Avenue Toronto Ontario M1N 2E8 1 888 545 5972 www. It will start to accept drug information in XML PM 2016 format on a by request basis April 1 to July 31 2020. merck. Acetaminophen and Codeine Phosphate. 7333 Mississauga Road Mississauga Ontario L5N 6L4 Date of Revision 15 April 2020 use of these and all drug products to Health Canada s Canada Vigilance Program at 1 866 234 2345. fluticasone furoate vilanterol as trifenatate dry powder for oral inhalation 100 mcg 25 mcg . 150 mg 188 mg . 0 mg mL Therapeutic Classification Opioid Antagonist Sandoz Canada Inc. Boehringer Ingelheim Canada Ltd. PrVENCLEXTA venetoclax tablets . nonacog beta pegol . Influenza Vaccine surface antigen inactivated prepared in cell cultures Suspension for Injection . Product Monograph Page 6 of 52 reactions with REPATHA reported in gt 2 of patients and greater than control were nasopharyngitis upper respiratory tract infection influenza back pain arthralgia and nausea. Suite 500 Markham ON L6G 0B5 PRODUCT MONOGRAPH PrPROPRANOLOL HYDROCHLORIDE INJECTION USP Propranolol Hydrochloride 1 mg mL Beta Adrenergic Receptor Blocking Agent Sandoz Canada Inc. The The Compendium of Monographs can help speed the evaluation of the safety and efficacy of medicinal ingredients commonly used in natural health products. 2019 cited 2020 Sep 02 . 2 Breast feeding There are no data on the presence of EMGALITY in human milk the effects on the breastfed infant or the effects on milk production. TYSABRI natalizumab . Date of Revision September 15 2017 145 Jules L ger . ENTYVIO Product Monograph Page 3 of 52 ENTYVIO vedolizumab powder for concentrate for solution for infusion 300 mg vial vedolizumab solution for subcutaneous injection 108 mg 0. com Date of Approval April 09 2019 Submission Control No 222823 Janssen Inc. 6775 Financial Drive Suite 100 Mississauga ON L5N 0A4 Date of Revision August 5 2020 Submission Control No 233030 2020 Amgen Canada Inc. 2 I keep seeing different years associated with the product monograph guidance and templates. The bill would also provide an innovative pathway for federal safety and effectiveness regulations that can directly align and benefit the ADA Seal of Acceptance Health Canada Starts Accepting Drug Information in the XML . 27 Despite this early policy change before the start of the present study a number of participants misbelieved that they had to observe their patients take the drug. Health Canada has authorizedan indication for pediatric use. PrELIQUIS apixaban Product Monograph Page 1 of 79. 7333 Mississauga Road Mississauga Ontario L5N 6L4 Date of Initial Approval June 27 2019 Date of Revision October 2 2020 Submission Control No 237670 COPYRIGHT 2014 2020ASTRAZENECA CANADA INC. Kirkland QC Seqirus Canada Inc. Pr INQOVI Consumer Information. INFLECTRA Product Monograph Page 4of 115 INFLECTRA infliximabfor injection is a biosimilar biologic drug biosimilar to REMICADE . Health Canada has approved an updated version of the NITISINONE TABLETS Product Monograph. The Product Monograph will be re issued in the event of serious safety concerns PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION JANSSEN COVID 19 VACCINE SARS CoV 2 Vaccine Ad26. Under the new Health Canada guidance pharma companies are asked to follow the 2016 template which includes changes to Part I and II. Product monographs Frequently asked questions. Saint Laurent Quebec H4S 2C9 Date of Preparation June 26 2019 PRODUCT MONOGRAPH GARDASIL 9 Human Papillomavirus 9 valent Vaccine Recombinant Suspension for injection Active Immunizing Agent Merck Canada Inc. The DHPR has been designed to improve access to health product information by presenting it in a format that s Shire Canada provides Product Monographs for its products as approved by Health Canada and in accordance with federal regulations. Recognizing the important role monographs can play both in facilitating the review and processing of product licence applications and as reliable sources of product information for consumers the NHPD is committed to developing new monographs as well as revising and Valneva Canada . It covers a wide variety of drugs and drug products. These are described as quot scientific documents that provide authoritative information about the safe and effective use of a substance or ingredient quot . Product monographs have been approved by Health Canada and should be read and discussed in consultation with a health care professional. September 4 2020. ca Report a serious adverse drug reaction for hospitals Report a medical device problem for health care professionals Prescription Drug List. COPYRIGHT 2007 2021ASTRAZENECA CANADA INC. In this page we also recommend where to buy best selling health care products at a lower price. 1. Page 1of 67 PRODUCT MONOGRAPH FORXIGA dapagliflozin tablets as dapagliflozin propanediol monohydrate 5 mg and 10 mg ATC Code A10BK01 Sodium glucose co transporter 2 SGLT2 inhibitors AstraZeneca Canada Inc. . Ethinyl estradiol tablets Mfr Std . The information provided in this section is intended for residents of Canada only. We serve 200 million people every day with a promise to help them take better control of their health. Other Antineoplastic Agent ATC Code L01XX52 AbbVie Corporation . 5 mg and 5 mg . ca Date of Initial Approval May 25 2016 Reporting an adverse event. normal use of these and all drug products to Health Canada s Canada Vigilance Program at 1 866 234 2345. Cloxacillin product monograph. See . Medical Device Incidents disclaimers. Ltd. 1004 Middlegate Road Mississauga Ontario L4Y 1M4 www. 7333 Mississauga Road . Your own healthcare professional is the best source of information regarding your health. 0. This summary will not tell you everything about the product. There is limited data on Lonsurf in Black African American patients but there is no biological rationale to expect any difference between this subgroup and the overall population. Tokyo Japan 101 8535 Imported and distributed by Otsuka Canada Pharmaceutical Inc. PRODUCT MONOGRAPH . A complete list of safety labelling updates for pharmaceuticals is available on Health Canada s Product monograph brand safety updates page. 17 300 Trans Canada Highway Kirkland Quebec H9J 2M5 Date of Revision February 29 2016 GlaxoSmithKline Biologicals SA Pfizer Canada Inc. 6 mL 80 mg 0. Canadian product monographs can be accessed through During this period Health Canada is working with volunteer manufacturers and sponsors as well as technology vendors to test the application of the HL7 SPL standard to the content of drug product monographs. PRODUCT MONOGRAPH Pr SANDOZ RIZATRIPTAN ODT Rizatriptan Orally Disintegrating Tablets 5 mg and 10 mg rizatriptan as rizatriptan benzoate 5 HT 1 Receptor Agonist Migraine Therapy Sandoz Canada Inc. Searchlight Pharma is pleased to announce an amendment to the approved product monograph for Estragyn Vaginal Cream that reduces the starting dose to 0. Adverse Reaction Reporting and Re Issuance of the Product Monograph Health care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada s Canada Vigilance Program at 1 866 234 2345. Date of Preparation 1600 Notre Dame St. In the United States Alexion Product Monograph SOLIRIS Page 1 of 52 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Health Canada has authorized an indication for PRODUCT MONOGRAPH. All of us review 9 related goods including deals discount coupon videos pictures plus more. Antipsychotic agent . PrSANDOZ LEVOFLOXACIN. Under section 14 of the Canada Consumer Product Safety Act industry must report health or safety incidents involving a consumer product. 3 mL Active Immunizing Agent Health Canada is now confirming its readiness to launch the transition from unstructured product monograph to XML Product Monograph PM format. Data Sources For each DOAC apixaban dabigatran edoxaban rivaroxaban manufacturer product monographs were retrieved from the European Medicines Database US Food and Drug Administration and Health Canada Drug Product Database. ca Date of Initial Approval February 5 2015 Submission Control No 223244 Date of Revision August 20 2020 PRODUCT MONOGRAPH Prevnar 13 Pneumococcal 13 valent Conjugate Vaccine Diphtheria CRM197 Protein Suspension for Intramuscular Injection Active Immunizing Agent T. About AbbVie in Rheumatology For more than 20 years AbbVie has been dedicated to improving care for Affygility Solutions a global occupational health and safety consulting firm for the life sciences industry announced the launch of health based exposure limits HBEL monographs for natural . PRODUCT MONOGRAPH PrNALOXONE HYDROCHLORIDE INJECTION USP Naloxone Hydrochloride 0. Vancomycin product monograph. Boehringer Ingelheim Canada Ltd 5180 South Service Rd Burlington ON L7L 5H4 0278 14 . ca or 1 844 MI TAIHO 844 648 2446 with any comments or inquiries. 6 DUPIXENT Canada Product Monograph. Page 5 of 26 4. 10 mg and 25 mg . AFLURIA Tetra quadrivalent inactivated influenza vaccine split virion Product Monograph. This product contains approximately 50 v v ethanol. Date of Preparation October 4 2018 AbbVie Corporation Date of Revision 8401 Trans Canada Highway March 3 2020 St Laurent Qc H4S 1Z1 PRODUCT MONOGRAPH . Antidepressant. norethindrone acetate 1 mg . Capsules 75 mg 110 mg and 150 mg Dabigatran Etexilate as Dabigatran Etexilate Mesilate Anticoagulant . To select an ingredient and add it to the form indicate whether you are attesting to the monograph for the safety efficacy and or quality of that ingredient by checking the corresponding checkbox es . TM . The following prescription products are available from Purdue Pharma. Ultragenyx Pharmaceutical Inc. 3. FLUCELVAX QUAD. Patients should be advised to contact their At Teva we care deeply about the wellbeing of the patients caregivers and communities who rely on us. Bristol Myers Squibb Canada . The temporary policies outlined in this guidance cover only Health Canada statistics show that it now approves more than 90 per cent of applications to sell new natural health products. The store that we Health Canada Product Monograph Search. Sandoz Canada Inc. PRODUCT MONOGRAPH PrVOLTAREN VOLTAREN SR diclofenac sodium 50 mg Enteric Coated Tablets 75 and 100 mg Slow Release Tablets 50 and 100 mg Suppositories Nonsteroidal Anti Inflammatory Drug NSAID Novartis Pharmaceuticals Canada Inc. 4 DUPIXENT Canada Product Monograph. rochecanada. Certain probiotics carbon dioxide releasing laxatives diaper rash products and thyme Products See link of all monographs . 1004 Middlegate Road Mississauga Ontario L4Y SEROQUEL XR Product Monograph. PRODUCT MONOGRAPH PrABRAXANE for Injectable Suspension paclitaxel powder for injectable suspension nanoparticle albumin bound nab paclitaxel 100 mg paclitaxel vial Lyophilized Powder Antineoplastic Agent Celgene Inc. Montreal Canada Date of Preparation 29 June 2006 . Advancing vaccines. Date of Approval 9 September 2019 YASMIN Product Monograph Page 5 of 57 B. From our role as a global leader in generic and brand name medicines to the innovative solutions we create for our healthcare partners we offer a unique perspective on health here in Our Products. 139622 This is the first Health Canada approved tumour product monograph is life science fields of health care and nutrition. Lyophilized Powder for Solution . ca website or at https www PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrVELTASSA Patiromer Powder for Oral Suspension 8. Canadian product monographs can be accessed through Health Canada accepted HL7 Standard XML product monographs on a by request basis from April 1 2020 to July 31 2020. Toronto ON Teva Canada Ltd 2013 Aug cited 2016 Feb 16 . 75 mg 0. 5 mg cannabidiol. No data are available to Health Canada therefore Health Products to Affect DAYVIGO CYP3A Inducers and DRUG INTERACTIONS Drug Drug The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. 5mL per dose contains 10 doses of 0. J4B 7K8 . 3 were 65 years of age and 1500 8. Health Canada is adopting a structured product monograph format for the preparation submission and approval of human prescription drugs marketed sold or distributed in Canada. Oakville Ontario L6H 0J8 PRODUCT MONOGRAPH . PRODUCT MONOGRAPH PrESTRAGYN VAGINAL CREAM Estrone vaginal cream containing estrone 0. 3 Reconstitution AstraZeneca COVID 19 Vaccine must not be reconstituted mixed with other medicinal products or diluted. We have the expertise Once Health Canada has assessed a product and decided it is safe effective and of high quality it issues a product licence along with an eight digit Natural Product Number NPN which must appear on the label. 3 Product Monograph Master Template Template Date September 2020 OPDIVO nivolumab Product Monograph Page 4 of 169 RECENT MAJOR LABEL CHANGES 1 INDICATIONS 05 2021 1. The bulk of CPS consists of monographs that are provided by pharmaceutical manufacturers. 4. PrELIQUIS . S recombinant Suspension for intramuscular injection Multidose Vial 5 1010 virus particles 0. The Product Monograph Product Information and or the Product Packaging currently available in the Canadian market might differ from the latest approved Product Monograph Product Information and or Product Packaging. The Moderna COVID 19 Vaccine is supplied in two multiple dose vial presentations A multiple dose vial containing a maximum of 11 doses range 10 11 doses 0. Links to comprehensive information about our non prescription products are listed below. Obtained through Health Canada Drug Product Database search term cloxacillin as active ABILIFY MAINTENA Product Monograph Page 1 of 66. Licensee PRODUCT MONOGRAPH PrLOVENOX Enoxaparin sodium solution for injection manufacturer s standard 100 mg mL 30 mg 0. ca or consult the product monograph by clicking this link COVISHIELD Product Monograph. 4 mL 60 mg 0. 5 mL . REPATHA Product Monograph Page 6 of 75 Geriatrics 65 years of age Of the 18 546 patients treated with REPATHA in double blinded clinical studies 7656 41. 214316 PRADAXA Product Monograph Page 1 of 69. Merck Canada Inc. With this structured format Health Canada aims to increase transparency and accessibility of pertinent data. Health Canada is committed to enhance the access to approved regulatory health information by developing a consistent solution using XML format data standards and controlled vocabulary. Lyophilized Powder . ATC Code A10BK03 Sodium glucose co transporter 2 SGLT2 inhibitors . This leaflet is part III of a three part quot Product Monograph quot published when JARDIANCE was approvedfor sale in Canada and is designed specifically for Consumers. Boucherville QC Canada . Health Canada is requiring pharmaceutical manufacturers to submit their monographs in Structured Product Labelling SPL format. Dr. Date of Preparation April 15 2020 BamlanivimabProduct Monograph Page 1of 19 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrBamlanivimabfor injection Solutionfor infusion 700 mg 20 mL 35 mg mL Anti SARS CoV 2 spike protein monoclonal antibody HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID 19 DRUG BASED ON LIMITED CLINICAL TESTING IN HUMANS AND OR QUALITY Vertex Pharmaceuticals Canada Incorporated Page 1 of 47 PRODUCT MONOGRAPH . Markham ON L3R 0B8 Registered Trademark Date of Initial Approval May 28 2013 Date of Revision January 14 2019 Control Number 221581 normal use of these and all drug products to Health Canada s Health Product Safety Information Division at 1 866 234 2345. The Product Monograph will be re issued in the event of serious safety concerns previously unidentified or at such time as the sponsor provides the additional data in support of the product s clinical benefit. Data and review decisions. Product License PL within ten 10 business days. Pr YERVOY Ipilimumab for injection . Health 5 days ago As part of this project on January 13 2020 Health Canada announced that from April 1 2020 to July 31 2020 it will start accepting XML product monographs on a by request basis. Intravenous injection . Active Immunizing Agent for the Prevention of Influenza . The Product Monographs. Pr LOLO Norethindrone acetate and ethinyl estradiol tablets Mfr Std . This medicinal product must not be mixed with other medicinal products. If a product monograph is selected a list of medicinal ingredients from that monograph will auto populate to the right of the search area. Canada is responsible for regulating health products and provides information on their safety and proper use. Blood Coagulation Factor VIII PRODUCT MONOGRAPH FLULAVAL TETRA 2020 2021 Quadrivalent Influenza Vaccine Split Virion Inactivated Suspension for Injection ATC Code J07BB02 Manufactured by ID Biomedical Corporation of Quebec Quebec Quebec Canada Distributed by GlaxoSmithKline Inc. 2600 Alfred Nobel Here you will find a listing of our products available in the Canada. Products are regulated as drugs under the Food and Drugs Act. Conditions that predispose to venous stasis and to vascular thrombosis eg immobilization after accidents or confinement to bed during long term illness . sanofi pasteur Section 1. Please call 1 888 RevAid1 1 888 738 2431 or log onto www. Anticoagulant . As a company dedicated to innovation and advancement of global health Bausch Health is constantly building on our commitment to help Canadians and people around the world live longer healthier and more productive lives through initiatives that often go beyond health care. Health Canada is phasing in the new format with the Production Testing phase having started June 1 2020. 145 Jules L ger Date of Revision June 19 2013 Boucherville QC Canada J4B 7K8 Control No. Please consult a qualified health professional for more detailed information. Health Canada started accepting HL7 Standard XML Product Monographs on a By Request basis. View all IV Drugs Products. Triheptanoin oral liquid . There have been several updates to the Health Canada product monograph template since 2004 in 2010 2014 and most recently in 2016 . Links to comprehensive Health Canada approved information about our pharmaceutical products are listed below as either the complete Product Monograph or Consumer Information. 2 g patiromer as patiromer sorbitex calcium Potassium Binder ATC Code V03AE09 Vifor Fresenius Medical Care Renal Pharma Ltd. 5 mL Active Immunizing Agent HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID 19 Vaccine UNDER AN AstraZeneca COVID 19 Vaccine Product Monograph. Active Immunizing Agent . are NHPs that carry a drug identification number DIN issued by Health Canada. 5 mL 10 mg 1. A monograph is a written description of a particular medicinal ingredient or multiple ingredients with similar claims. PrJARDIANCE empagliflozin tablets . The following documents Product Monograph and Consumer Information are currently under revision and should be available shortly. Presentation at Dietary Supplement Public Meeting . Director General Natural and Non prescription Health Products PART I HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form Strength Nonmedicinal Ingredients Oral Tablets 25 100 and 150 mg Dispersible Tablets 2 and 5mg Tablets cellulose lactose magnesium stearate povidone and sodium starch glycolate LAMICTAL 100 mg tablets also contain PRODUCT MONOGRAPH PrVagifem 10 Estradiol vaginal inserts USP 10 g estradiol Vaginal inserts with applicators Estrogen Novo Nordisk Canada Inc. The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. Depending on the syringes and needles used for each dose there may not be sufficient Although it remained in the product monograph initially Health Canada removed this restriction before mifepristone became available in January 2017. pfizer. The webinar on Health Canada Structured Product Monograph SPM Challenges Preparation and Implementation was successfully concluded on December 15 2020. may passively collect personally identifiable browsing information to customize the site based on your preferences compile and analyze statistics NHP monographs. Based on the data submitted and reviewed by Health Canada the safety and 1 TREMFYA Product Monograph. For the requirements of the 60 day disposition clause homeopathic medicines and NHPs with DINs issued by Health Canada the applicant must refer to the Natural Health Products Directorate s NHPD s Compendium of Monographs guidance Health Canada has published a new monograph on natural health products containing two or more vitamins and minerals which sets out instructions on preparation safety and labelling. Pr. 2 Recommended Dose and Dosage Adjustment 02 2019 4 DOSAGE AND ADMINISTRATION 4. 2 DUPIXENT Canada Product Monograph. Exchange Tower 130 King Street West Suite 900 PO Box 73 Toronto Ontario M5X 1B1 1 888 545 5972 www. 6. Wyeth LLC Pfizer Canada ULC Licensee 17 300 Trans Canada Highway Kirkland Quebec H9J 2M5 Date of Initial Approval December 21 2009 Control No. Once the latter has occurred Product Monograph Patient Medication Information Additional Information Health Care Professional Letter April 2021 Health Care Professional Letter December 2020 Bamlanivimab Playbook information for provincial territorial and local public health programs in planning and implementing the use of bamlanivimab in response to COVID 19 April Canadian Product Monographs available in PDF English French. These monographs are written and owned by the manufacturers and are approved by Health Canada. Professed Standard . and companies working with Janssen Inc. Allergan Inc. 1 Product Monograph 299 TUBERSOL Product Monograph Template Schedule D Page 4 of 18 TUBERSOL Tuberculin Purified Protein Derivative Mantoux PART I HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Intradermal Injection Dosage Form Strength Solution PRODUCT MONOGRAPH NIMENRIX Meningococcal polysaccharide groups A C W 135 and Y conjugate vaccine Powder and diluent for solution for injection Active Immunizing Agent Pfizer Canada Inc. Race No adjustment of the starting dose is required on the basis of patient s race. Migalastat Capsules . We market prescription products over the counter skin care and aesthetics solutions within Canada to a range of healthcare professionals including Dermatologists General Practitioners Nurses Pharmacists Paediatricians and Plastic Surgeons. INCLUDING PATIENT MEDICATION INFORMATION . Page 4 of 23 PART I HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AstraZeneca COVID 19 Vaccine COVID 19 Vaccine ChAdOx1 S recombinant is indicated for active immunization of individuals 18 years of age and over for the PRODUCT MONOGRAPH . covishield canada. 1. The Product Monograph is available on Health Canada s Drug Product Database on the federal government s covid vaccine. Health Canada Authorizes DAYVIGO Feb 04 2021 07 00 ET. 4 Health care providers should be familiar with current recommendations for JARDIANCE Product Monograph Page 49 of 52 PART III CONSUMER INFORMATION PrJardiance empagliflozin tablets . 5 mL and 1. New pre cleared information PCI monographs published A web link to the Product Monograph or Prescribing Information for each of such products is provided below. AstraZeneca COVID 19 Vaccine Product Monograph. Health Canada reviews and assesses the safety efficacy and quality of drug products before they are authorized for sale in Canada. A Hawaii 70 2019 H1N1 pdm09 like virus 15 micrograms HA Seqirus Canada Inc. Ipsen Biopharmaceuticals Canada Inc. Calcium Gluconate Injection USP 10 . announced today Health Canada has issued a Notice of Compliance with Conditions NOC c approving DARZALEX daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor PI and an immunomodulatory agent IMiD or who are refractory to both a PI and an IMiD. Health Canada has authorized the sale of this COVID 19 vaccine under an Interim Order IO . Patients may continue therapy during periods of reversible chemotherapy induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. Additionally a listing of federal public Health Advisories on drugs is maintained by Health Canada for public access. 1 INDICATIONS 1. Date of Preparation August 17 2006 145 Jules L ger Date of Revision November 15 2010 Boucherville QC Canada J4B 7K8 Control 140462 Information about the product including what the product is used for dosage warnings proper use and side effects. Sections 7. 5 mL and 15 mg 1. Canada Ferring Canada 200 Yorkland Boulevard Suite 500 Toronto Ontario M2J 5C1 Canada. 5060 Spectrum Way 5th Floor Mississauga ON L4W 5N5 PRODUCT MONOGRAPH . These claims are reviewed by the Natural and Non prescription Health Products Directorate NNHPD in advance of a product unused product correctly. Consumer Information. Monographs for Commonly Administered Intravenous Medications in Home and Community Care References 1. ca Date of Revision 22 February 2018 Submission Control No 211678 TM Warner PRODUCT MONOGRAPH . For specific medical questions please consult a qualified healthcare professional as they are the best source of information regarding your health. PrACTOS pioglitazone hydrochloride 15 30 45 mg Tablets USP . If you want more information about AstraZeneca COVID 19 Vaccine Talk to your healthcare professional Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website Webinar Recording Updates to Health Canada s New XML Product Monograph Launch. Pr ORENCIA abatacept for injection . 8401 Trans Canada Highway SAMSCA Product Monograph Page 1 of 35 PRODUCT MONOGRAPH PrSAMSCA tolvaptan Tablets 15 mg 30 mg and 60 mg Vasopressin V2 receptor Antagonist Otsuka Pharmaceutical Company Ltd. 101 2476 Argentia Road Mississauga Ontario L5N 6M1 Canada Date of Approval November 29 2017 Health Canada Approves EVENITY For the Treatment of Osteoporosis in Postmenopausal Women at High Risk for Fracture MISSISSAUGA ON October 8 2019 Today Amgen Canada announced that EVENITY romosozumab is now available in Canada for the treatment of osteoporosis in postmenopausal women at high risk for fracture defined as a history of osteoporotic fracture or multiple risk In Canada the Company 39 s prescription product portfolio is focused on eye health dermatology and cardio metabolic conditions. aTTP is a rare blood disorder that causes clots to form in blood vessels Product Monograph Template Standard Template Date June 2017 Page 7 of 38 6 DOSAGE FORMS STRENGTHS COMPOSITION AND PACKAGING Table Dosage Forms Strengths Composition and Packaging. Tel 1 416 490 0121 or 1 800 263 4057 Fax 416 493 1692 Please refer to the Product Monograph of the medicinal product to which the patient is switching Adapted from TOUJEO SoloSTAR and TOUJEO DoubleSTAR Product Monograph. WinRho SDF Product Inquiries Canada Tel 1 800 4 WINRHO 1 800 494 6746 Health Canada Postal Our innovative therapies are advancing the treatment of diseases. 3 Pediatrics Pediatrics lt 18 years No data are available to Health Canada therefore Health Canada has not authorized an indication for pediatric use. From Health Canada. lilly. Paladin s current portfolio includes the following brands Janssen Inc. The Product Monograph will be re issued in the event of serious safety concerns 1 DUPIXENT Canada Product Monograph. Intravenous Infusion 5 mg ipilimumab mL . ATC Code J07BB02 . Controlled Vocabularies in Product Monographs In an effort to improve the consistency and searchability of product monograph content Health Canada will implement a controlled vocabulary framework for product monographs. The developmental and health benefits of breastfeeding should be considered along with the mother s clinical need for EMGALITY and any potential REBLOZYL Product Monograph Page 4 of 38 PART I HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Reblozyl luspatercept for injection is indicated for the treatment of adult patients with red blood cell RBC transfusion dependent anemia associated with beta thalassemia. Can J Diabetes 2018 42 The NHPD Monthly Communiqu Vol. Close. 6 g dried Chaga per day Cautions amp Warnings 1. 1 Pediatrics Pediatrics lt 18 years of age No data are available to Health Canada therefore Health necessary based on any co morbid conditions given the low systemic availability of the product. The Structured Product Monograph SPM is an initiative to standardize and structure the content associated with regulated drug products. abbvie. 010 mg . Industry should send detailed information including Product information. apixaban tablets . Due to the fact that the information originated with an organization that is not subject to the Official Languages Act the document may only appear in the language in which it was written. was established in 1989 as part of a global organization Galderma S. 5 mL each . 8 mL 100 mg mL 300 mg 3 mL PrLOVENOX HP Enoxaparin sodium solution for injection manufacturer s standard 150 mg mL High Potency 120 mg 0. Page 4of 26 PARTI HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AstraZeneca COVID 19 Vaccine COVID 19 Vaccine ChAdOx1 S recombinant is indicated for active immunization of individuals 18years of age and older for the Pfizer BioNTech COVID 19 Vaccine COVID 19 mRNA Vaccine Product Monograph Page 1 of 33 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PFIZER BIONTECH COVID 19 VACCINE COVID 19 mRNA Vaccine Suspension for Intramuscular Injection Multiple Dose Vial after dilution each vial contains 6 doses of 0. Intuniv XR guanfacine . 3. In 2016 Health Canada announced the goal of adopting a structured format for drug product information. Amiodarone Hydrochloride for Injection. Exchange Tower 130 King Street West Suite 900 PO Box 73 Toronto Ontario M5X 1B1 1 888 545 5972 www. Pr PRADAXA Dabigatran Etexilate Capsules . Antihyperglycemic Agent . If you need to report an adverse event for any ViiV Healthcare Canada product please call 1 877 393 8448. Concentrate for solution for intravenous infusion . Date of Preparation 385 boul. 5 mL Active Immunizing Agent HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID VASCEPA Product Monograph Page 6 of 19 TOXICOLOGY Reproductive and Developmental Toxicology . astrazeneca. 300 2680 Skymark Ave. 7 DUPIXENT Since the Canadian Natural Health Products Regulation came into effect in 2004 Health Canada has issued a number of monographs on natural health products. 5 gram low dose added to Health Canada approved product monograph April 22 2016 Montreal QC. For important safety information please consult the RINVOQ Product Monograph at www. Paladin has established a vast repertoire of innovative brands that has an important impact on the continued health and well being of millions of Canadians. This number lets you know that the product has been reviewed and approved by Health Canada. 5 mL Active Immunizing Agent HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID Links to comprehensive information about our pharmaceutical products are listed below most frequently in the form of a product monograph. Health Canada Product Monograph Update Intuniv guanfacine October 28 2016. For docetaxel dose modifications see the Product Monograph for docetaxel. 60 Leveroni Court ACTOS Product Monograph Page 1 of 45. Web PLA version 4 with class I monograph validation PRODUCT MONOGRAPH BRILINTA ticagrelor tablets 60 and 90 mg Platelet Aggregation Inhibitor AstraZeneca Canada Inc. August 12 2020. turoctocog alfa pegol. Please refer to the Health Canada Website for Health Product Monograph PDF April 23 2021 Patient Medication Information PDF April 23 2021 Health Product Risk Communication Labeling PDF April 26 2021 Product Monograph Patient Medication Information Additional Information Health Care Professional Letter April 2021 Health Care Professional Letter December 2020 Bamlanivimab Playbook information for provincial territorial and local public health programs in planning and implementing the use of bamlanivimab in response to COVID 19 April authorization from Health Canada HC . 1 w w USP ESTROGEN Searchlight Pharma Inc. Therapeutic Classification Selective adhesion molecule inhibitor . We review 4 related goods including discount coupon videos deals images and more. This ABILIFY MAINTENA Product Monograph Page 1 of 60 PRODUCT MONOGRAPH Pr ABILIFY MAINTENA Aripiprazole for prolonged release injectable suspension . The move would affect product monograph preparation electronic submission and approval processes for human prescription drugs. See Bayer Canada 39 s five main product areas and learn more about the innovative products that we offer. Health Canada has begun an initiative to capture Product Monograph PM information in a structured Extensible Markup Language XML format. may passively collect personally identifiable browsing information to customize the site based on your preferences compile and analyze statistics CYRAMZA Product Monograph Page 1 of 49 PRODUCT MONOGRAPH Pr CYRAMZA ramucirumab intravenous injection 10 mg ramucirumab mL 10 mL and 50 mL vials Antineoplastic Eli Lilly Canada Inc. CPhA formats the monographs for publication but does not change the content of these monographs in any way. Health Canada Structured Product Monograph SPM Challenges Preparation and Implementation . Antineoplastic . Acetaminophen and Diphenhydramine Citrate. by Life Sciences Marketing Jul 10 2020 Health Canada has updated the Johnson amp Johnson COVID 19 vaccine product label to include the very rare side effect of thrombosis or blood clotting following vaccination. For any information on our products you may also contact our Medical Information Centre at 514 428 8600 or 1 800 567 2594. 1 were 75 years of age. Solution for injection in a single use prefilled syringe or single use prefilled pen . COPYRIGHT 2021 ASTRAZENECA CANADA INC. prescribe and dispense the product. 4 mg mL and 1. ATC Code L01XE26 . Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Controlled Release Capsules . g. Levofloxacin Tablets . Jardiance Product Monograph Page 1 of 52. Tablets 10 mg 50 mg and 100 mg oral . If you are looking for Health Canada Product Monograph Biosimilar you 39 ve come to the right place. 154697 The newly titled quot Guidance Document Sunscreen Monograph quot is intended to replace the existing monograph of 2006 and identifies ingredients doses directions and indications for use of sunscreens which will be required to appear on the product labels as well as the recommended supporting test methods. 5 grams from the previously approved 2 grams. 16750 route Transcanadienne Sanofi REXULTI Product Monograph Page 2 of 55 RECENT MAJOR LABEL CHANGES 1 INDICATIONS 02 2019 2 CONTRAINDICATIONS 08 2019 4 DOSAGE AND ADMINISTRATION 4. GlaxoSmithKline Inc. The transition period was established to enable the industry to be in place for the full launch scheduled for Fall 2020. 5 mL contains 5 doses of 0. Allegra 12 hour Allegra 24 hour. 2. It is expected that use of the product will continue long term. DATE OF PREPARATION 1165 Creditstone Road Unit 1 July 23 2010 Vaughan ON L4K 4N7 Control No. 25 mg 35 mg 45 mg 55 mg 70 mg 85 mg and 100 mg . Anthrasil Product Monograph Page 1 of 29 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ANTHRASIL Anthrax Immune Globulin Human Injection Sterile Solution for Infusion 60 Units vial HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR EXPOSURE TO INHALATIONAL ANTHRAX BASED ON LIMITED Health care providers are encouraged o repot t Ar dverse Drug Reactions associated with normal use of these and all drug products to Health Canada s Canada Vigilance Program at 1 866 234 2345. Health Canada Approval Pathway Class I Products MUST comply with all parameters of an individual NNHPD monograph. 8 mL 150 mg mL ATC Code B01AB05 Since the Canadian Natural Health Products Regulation came into effect in 2004 Health Canada has issued a number of monographs on natural health products. 17 300 Trans Canada Highway Kirkland Quebec H9J 2M5 www. ESPEROCT Antihemophilic Factor VIII Recombinant B Domain Truncated PEGylated . The NNHPD product licensing system allows applicants to reference a monograph Health Canada 2014b in support of the safety and efficacy of a product. Can be quot Compendial quot or quot Homeopathy . 8 g 25. Canadian product monographs can be accessed through Health Canada approves new point of care MRI. DOJOLVITM triheptanoin Product Monograph Page 1 of 21. Lumacaftor Ivacaftor granules . 4 g 16. Oral Contraceptive . Box 73 Toronto Ontario M5X 1B1 1 888 545 5972 www. E. And under updated rules products can be approved in as little as 10 days. Amicus Therapeutics UK Ltd Phoenix House Oxford Road PRODUCT MONOGRAPH . November 19th 2019 PRODUCT MONOGRAPH Sterile PRCEFTRIAXONE SODIUM FOR INJECTION BP Ceftriaxone as Ceftriaxone Sodium BP 0. COV2. Bristol Myers Squibb Canada Co. Websites. Pr ORENCIA. 123 mg migalastat as migalastat hydrochloride Various alimentary tract and metabolism products . Page 4 of 26 PART I HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AstraZeneca COVID 19 Vaccine COVID 19 Vaccine ChAdOx1 S recombinant is indicated for active immunization of individuals 18 years of age and older for the Product Monograph COVID 19 Vaccine Moderna PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION COVID 19 Vaccine Moderna mRNA 1273 SARS CoV 2 vaccine Dispersion for intramuscular injection Multidose Vial 100 mcg 0. Should you wish to obtain more information on a product please contact your healthcare professional. INVOKANA Product Monograph October 15 2018. Ampicillin for Injection. Industry is encouraged to voluntarily report health or safety issues involving a cosmetic. ca See full list on canada. Oxycodone and Acetaminophen. Tokyo 101 8535 Japan . Lundbeck Canada Inc. Don t invest in additional staff or resources use the same system that CPhA developed to deliver your monographs through the CPS to convert and deliver them to Health Canada in SPL format. Canadian product monographs can be accessed through use of these and all drug products to Health Canada s Canada Vigilance Program at 1 866 234 2345. 2 TREMFYA Product Monograph. PRODUCT MONOGRAPH PrPERJETA pertuzumab for injection 420 mg 14 mL vial For Intravenous Infusion Only Sterile Concentrate for Solution for Infusion Antineoplastic Professed Standard Hoffmann La Roche Limited 7070 Mississauga Road Mississauga Ontario Canada L5N 5M8 www. PrDOJOLVITM. Consumers should contact their health care professional for further advice. UCB Canada Inc. Provided below are the Health Canada approved Product Monographs and Consumer Information. Keep out of reach and sight of children. Product Monograph. Translations of the document are the responsibility of the sponsor involved. Bleomycin for Injection. Imported and Marketed by Otsuka Canada Pharmaceutical Inc. Both sections were reorganized for simplicity and readability for PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Therefore Health Canada has not authorized an indication Product quality is not impacted by The following safety labelling updates which were recently made to the Canadian product monograph have been selected for your awareness. only recommends the use of these products in a manner as described in the Health Canada approved product monograph. The Product Monograph Brand Safety Updates table provides updates on safety information in PMs of brand name pharmaceutical drug products. The actual deadline for the transition was ended on July 31 2020. Contact your healthcare professional if you have any questions about the product. ca Generic drug manufacturers must update their PM to ensure it aligns with the Canadian Reference Product. 1 Dosing Considerations 09 2020 4 DOSAGE AND ADMINISTRATION 4. canada. 25 gm 1 gm 2 gms 10 gm per vial Sterile Antibiotic Sandoz Canada Inc. PART I HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Indications have been granted on the basis of similarity between INFLECTRA and the reference biologic drug REMICADE . Health 5 days ago Once authorized by Health Canada the Product Monograph is used by the drug manufacturer or sponsor to inform physicians pharmacists dentists nurses and other healthcare professionals about the appropriate use of the drug. The following safety labelling updates which were recently made to the Canadian product monograph have been selected for your awareness. About. Drug Product Database online query. Bivalirudin for Injection. Rechenstrasse 37 9014 St. 1004 Middlegate Road Product Monograph Page 1 of 73 PRODUCT MONOGRAPH PrNorditropin NordiFlex Somatropin injection Pre filled disposable pen 5 mg 1. 300 mg and 400 mg vial . Janssen Inc. In 2016 Health Canada announced its intention to adopt a structured format for its drug product information. ca Date of Initial Approval PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrORILISSA elagolix as elagolix sodium tablets 150 mg and 200 mg Gonadotropin releasing hormone GnRH receptor antagonist . Liquid 100 w w triheptanoin Oral . Pfizer Canada ULC . Treatment Updates. Adverse Drug Reaction Reporting and Re Issuance of the Product Monograph Health care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to the Canada Vigilance Program at 1 866 234 2345. Page 1of 69 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION SEROQUELXR quetiapine fumarate Extended Release Tablets 50 150 200 300 and 400 mg Oral Use Professed Antipsychotic Antidepressant Agent AstraZeneca Canada Inc. 17 300 Trans Canada Highway ENBREL Product Monograph Page 4 of 105 PART I HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ENBREL is indicated for treatment of moderately to severely active rheumatoid arthritis RA in adults. PrORKAMBI Lumacaftor Ivacaftor tablets . ca. Novo Nordisk Canada Inc. 90 Burnhamthorpe Road West Suite 1100 306 ADACEL Product Monograph Page 6 of 56 As with all other products epinephrine hydrochloride solution 1 1 000 and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Estragyn Vaginal Cream 0. Learn more about our portfolio of services and innovative therapies by visiting the product websites or by downloading patient or prescribing information. See full list on canada. Intravenous Infusion 250 mg vial . RevAid. This information has been approved by Health Canada and should be read and discussed in consultation with a health care professional. 500 1000 1500 2000 and 3000 IU vial . Inhaled Corticosteroid ICS and Bronchodilator Long Acting Beta 2 Adrenergic Agonist LABA Combination for Oral Inhalation. Selective Co stimulation Modulator. In addition POMALYST can only be dispensed to patients who are registered and meet all the conditions of the RevAid program. PRODUCT MONOGRAPH. Purdue Pharma 575 Granite Court Anti Dandruff Products 2006 Antiseptic Skin Cleansers 2006 Athletes Foot Treatments 1995 Medicated Skin Care Products 2007 Diaper Rash Products 2007 Throat lozenges 1995 For the time being an applicant can obtain a copy of the Non prescription Drug Monograph Attestation form by contacting the NNHPD Email nhpd_dpsn hc sc. 7 mg delta 9 tetrahydrocannabinol and 2. 300 mg 15 mL . The Canadian Product Monograph for Moderna COVID 19 Vaccine which is approved by Health Canada and available in French and English should be used for complete product information. Imported by Date of Revision April 15 2020 NEURONTIN gabapentin Product Monograph Page 1 of 29 PRODUCT MONOGRAPH Pr NEURONTIN Gabapentin Capsules 100 mg 300 mg and 400 mg Tablets 600 mg and 800 mg Antiepileptic Agent Pfizer Canada Inc. BICL 0266 22 and 23 . 250 mg 500 mg and 750 mg Levofloxacin anhydrous as Levofloxacin Hemihydrate . PrTRULICITY dulaglutide . Submission Control No 207293 Product Monograph LYNPARZA Tablets COPYRIGHT 2018 2021 ASTRAZENECA CANADA INC. The patient should be given a permanent personal immunization record. Adverse Drug Reaction Reporting and Re Issuance of the Product Monograph Healthcare providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada s Canada Vigilance Program at 1 866 234 2345. Solution for Subcutaneous Injection 125 mg mL . West. Canadian product monographs can be accessed through Health Canada has reviewed the available evidence and has concluded that the current Product Monograph and available public health guidance are appropriate and is not recommending any changes to the product s use at this time. Supriya Sharma chief medical adviser at Health Canada says the department is poised to make a decision on whether to authorize a promising COVID 19 vaccine from AstraZeneca in the coming days. Tel 1 416 490 0121 or 1 800 263 4057 Fax 416 493 1692 The name Allergan represents the standard of quality. Antipsychotic agent. TRANSFER TO TOUJEO Patients on OD basal insulin 1 1 conversion 1. Mississauga Ontario PRODUCT MONOGRAPH ELAVIL Amitriptyline Hydrochloride Tablets USP 10 25 50 and 75 mg Antidepressant AA PHARMA INC. ethinyl estradiol 0. The product monograph serves as a standard against which all promotional material or advertising distributed or endorsed by the sponsor about the drug can be compared. Column II provides a non exhaustive list of therapeutic health claims used to represent drug or natural health products. SPM is a strategic move by Health Canada to standardize and structure the content associated with regulated drug products. Product Monographs. Decoction Up to 15g dried Chaga per day Dry Powder tincture fluid extract Up to 3. 200 mcg 25 mcg . gc. 16750 route Transcanadienne Kirkland QC Canada H9H 4M7 www. Manufacturer s Standard . Its products and services are designed to benefit people by Title Microsoft Word 2015 11 30 Fycompa Product Monograph_Health Canada approved Author esi16003 Created Date 12 1 2015 4 00 25 PM TORONTO March 2 2020 CNW Following a priority review Health Canada has approved Cablivi caplacizumab for the treatment of adults with acquired thrombotic thrombocytopenic purpura aTTP in combination with plasma exchange and immunosuppressive therapy. By checking quot I accept quot I authorize Allergan or any contracted third parties acting on its behalf to install cookies on my browser to remember the information that I input track how I use sections of websites enable Allergan to remember my user custom preferences and to tailor my access to the website per my preferences. Brands Acephen FeverAll Ofirmev Tylenol. VERZENIO Product Monograph Page 1of 50 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrVERZENIO Abemaciclibtablets 50 mg 100 mg 150 mg 200 mg Protein Kinase Inhibitor Eli Lilly Canada Inc. AGRIFLU seasonal influenza vaccine influenza vaccine surface antigen inactivated. Reported side effects disclaimers. 101 2476 Argentia Road Mississauga Ontario L5N 6M1 Canada Date of Approval March 23 2020 PRODUCT MONOGRAPH PrBENLYSTA belimumab Lyophilized powder for intravenous infusion 120 mg in 5 mL vial 400 mg in 20 mL vial 80 mg mL after reconstitution Solution for subcutaneous injection 200 mg in 1 mL Therapeutic Classification Immunosuppressant GlaxoSmithKline Inc. Biogen Canada Inc. Takeda Canada Inc. Cystic Fibrosis Transmembrane Conductance Regulator CFTR Corrector and PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrZEJULA niraparib capsules Capsule 100 mgniraparib as niraparib tosylate oral Antineoplastic agent GlaxoSmithKline Inc. 5 Can Fam Physician. 85 Enterprise Blvd. A web link to the Product Monograph or Prescribing Information for each of such products is provided below. Drug Monograph Structure Structured formats for drug information is not new. Some Formulary documents such as the medication information sheets regimen information sheets and symptom management information for patients are intended for patients. The risk of hypertensive encephalopathy upon abrupt discontinuation of Intuniv XR guanfacine has been included in the Warnings and Precautions section of the Canadian product monograph. Blood Coagulation Factor IX . 4 Administration AstraZeneca COVID 19 Vaccine is a colourless to slightly brown clear to slightly opaque solution. Human Use Tentative Final Monograph for Health Care Antiseptic Drug Products Proposed Rule 59 FR 31402 June 17 1994 1994 TFM . In spring 2021 a full product launch is anticipated with voluntary participation. January 24 2020. M. Product monograph including patient medication information Flucelvax Quad Internet . ca Date of Initial Approval January 26 2017 AstraZeneca COVID 19 Vaccine Product Monograph. If you are looking for Health Canada Product Monograph Search you 39 ve come to the right place. 2013 59 12 1275 81 e528 34. Diabetes Canada. 219617 Date of Revision August 8 OTEZLA Product Monograph Page 1 of 34 . What you need to know and do. CAS Number 103 90 2. 3 Pediatrics 8. GALAFOLD. Tablets 20 mg 40 mg 60 mg cabozantinib as cabozantinib S malate Oral . Health Canada has not authorized an indication for pediatric use. Our vision is to contribute to a world in which no one dies or suffers from a vaccine preventable disease. ca Date of Preparation Health Canada aims to make the XML format a mandatory requirement by Spring 2021. Please refer to the Product Monograph for complete dosing and administration instructions. for better lives. EMGALITY Product Monograph Page 8of 51 7. A. Otsuka Pharmaceutical Co. Page 7 of 76 LYNPARZA could cause fetal harm when administered to a pregnant woman see 7 WARNINGS AND PRECAUTIONS Sexual Health Reproduction . 2 mg 5 mg 10 mg 15 mg 20 mg and 30 mg . During this phase Product Monographs of human pharmaceutical drugs biologic drugs or radiopharmaceuticals can be submitted to Health Canada in the XML PM format on a by request basis. Find out more about COVISHIELD at www. medical need in Canada or have demonstrated a significant improvement in the benefit risk profile over existing therapies. product brand and name. The Product Monograph will be re issued in the event of serious safety concerns previously ABILIFY Product Monograph Page 1 of 82 PRODUCT MONOGRAPH Pr ABILIFY Aripiprazole Tablets . currently markets in Canada the following medicines listed below. This information is intended for Canadian residents. Antibacterial Agent . FOQUEST methylphenidate hydrochloride . PRADAXA Product Monograph Page 1 of 69. PRODUCT MONOGRAPH PrOTEZLA apremilast tablets 10 mg 20 mg and 30 mg Selective Immunosuppressant Amgen Canada Inc. More information can be found on the Company 39 s website at PRODUCT MONOGRAPH. For chemotherapy dose modifications see relevant Product Monograph. We contribute to the health of people plants and animals and are committed to improving lives through innovation. Treatment is effective in reducing the signs and symptoms of RA inducing major clinical response PRODUCT MONOGRAPH PrXtandi Enzalutamide capsules 40 mg Anti androgen L02BB04 Astellas Pharma Canada Inc. Limited data from clinical studies exists for long term administration of Restasis MultiDose up to 40 months . Manon Bombardier. REXULTI Product Monograph Page 7 of 60 diseases and disorders that are considered to represent risk factors demonstrated and predicted drug drug interactions symptoms suggestive of arrhythmia risk management strategies and other information relevant to the use of the drug. Neal B Perkovic V Mahaffey KW A drug monograph is a predetermined checklist covering active ingredients doses formulations and product labeling that the agency considers generally safe and effective for self use. 2018 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. An anticipated full launch of the XML PM initiative is scheduled for Fall 2020 before the mandatory requirement comes into effect tentatively in the Spring Health Canada has not authorized an indication for paediatric use. 500 1000 and 2000 IU vial . Date of revision November 4 2011 145 Jules L ger Boucherville QC Canada J4B 7K8 Control No 101352 Health Canada has released a monograph for probiotics to guide industry for preparing Product Licence Applications PLAs and market authorization of labels for natural health products. TALTZ Product Monograph Page 1of 72 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrTALTZ ixekizumab Solution for Injection 80mg 1. About the Drug and Health Product Register. PrBREO ELLIPTA. Canadian laws and regulations limit the amount of information we can provide to the general public about prescription drug products. Date of Revision March 23 2020 Appendix I Product Monograph Template Schedule D Page 1 of 57. PrABILIFY MAINTENA Aripiprazole for prolonged release injectable suspension . Click here to download the webinar slides and Questions amp Answers. use of these and all drug products to Health Canada s Canada Vigilance Program at 1 866 234 2345. Central Nervous System Stimulant . We are delighted to see your interest in Freyr s Webinar Series FWS . Sponsors can submit a request to file XML product monographs in the 2016 format under the following submission types New Drug Submissions NDS Product Monograph COVID 19 Vaccine Moderna PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION COVID 19 Vaccine Moderna mRNA 1273 SARS CoV 2 vaccine Dispersion for intramuscular injection Multidose Vial 100 mcg 0. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame. Human Glucagon Like Peptide 1 GLP 1 Eli Lilly Canada Inc. Suite 312 August 17 2016 Montr al Qu bec H3J 1M1 Control 195579 Canada Ferring Canada 200 Yorkland Boulevard Suite 500 Toronto Ontario M2J 5C1 Canada. Bouchard July 5 1989 Dorval Quebec H9S 1A9 Date of Revision July 29 2014 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrPLEGRIDY peginterferon beta 1a Liquid for injection 125 g Immunomodulator PLEGRIDY should be used by physicians who have sufficient knowledge of multiple sclerosis and who have familiarised themselves with the efficacy safety profile of PLEGRIDY . In addition it is PRODUCT MONOGRAPH Pr PYRIDIUM Phenazopyridine Hydrochloride Tablets USP 100 and 200 mg Urinary Tract Analgesic 8250 D carie Blvd suite 110 Montr al QC Canada H4P 2P5 DATE OF REVISION 30 Jul 2010 CONTROLE NUMBER 099745 It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time. A multiple dose vial containing a maximum of 15 doses range 13 15 doses 0. Pr INQOVI Product Monograph. 5180 South Service Road Burlington ON L7L 5H4 . Mississauga Ontario L4W 5L6 Date of Revision 20 March 2017 Submission Control No Level III Change The web based natural health product licence application web PLA form is designed to be completed online and saved on the applicant 39 s workstation. REBINYN Coagulation Factor IX Recombinant Pegylated . Regulation of Natural Health Products in Canada. 68 mL single use pre filled syringe or pen PART I HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION As part of this project on January 13 2020 Health Canada announced that from April 1 2020 to July 31 2020 it will start accepting XML product monographs on a by request basis. Date of Revision March 23 2020 Seqirus Canada Inc. 6755 Mississauga Road Suite 600 Mississauga ON L5N 7Y2 Date of Revision August31 2018 Control No. abatacept injection . 300 mg and 400 mg dual chamber syringe . For information on vaccine administration see the current Canadian Immunization Guide and the Health Canada Website. INVOKANA Canadian Product Monograph. Acetaminophen is also contained as an ingredient in the following combinations Acetaminophen Aspirin and Caffeine. Saint Laurent QC Hospira Healthcare Corporation 2012 Jul 9 cited 2016 Feb 23 . 5 mL Solution for subcutaneous administration Growth Hormone Novo Nordisk Canada Inc. You agree that Janssen Inc. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. 5 mg 0. Please contact Taiho Medical Information at Medicalinformation taihopharma. 3 Arthritis Society Psoriatic Arthritis. Gallen Switzerland Imported and Distributed by Health Canada Product Monograph Biosimilar. Part III Consumer Information. GARDASIL Quadrivalent Human Papillomavirus Types 6 11 16 18 Recombinant Vaccine Suspension for injection . Search the Drug Product Database Report a problem or mistake on this page The product monograph as a document will be included by Health Canada as part of the NOC respecting an NDS or when appropriate an SNDS an ANDS or a Supplement to an ANDS. Date of Revision 145 Jules L ger October 3 2014 Boucherville QC Canada J4B 7K8 YERVOY ipilimumab for injection Product Monograph Page 1 of 57. 10 mL and 40 mL vials . INCLUDING PATIENT MEDICATION INFORMATION. 3 Administration 02 2019 Although it remained in the product monograph initially Health Canada removed this restriction before mifepristone became available in January 2017. Share this article. O. 0mL Immunomodulator Eli Lilly Canada Inc. 7333 Mississauga Road Mississauga Ontario L5N 6L4 Date of Initial PRODUCT MONOGRAPH Pr FAMPYRA Fampridine 10 mg Sustained Release Tablet Potassium Channel Blocker Biogen Idec Canada Inc. 3 DUPIXENT Canada Product Monograph. PrCABOMETYX cabozantinib tablets . Medium Chain Triglyceride A16AX17 . Classes of Applications Welcome to Bausch Health Canada. 4 Geriatrics Adverse Drug Reaction Reporting and Re Issuance of the Product Monograph Health care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada s Canada Vigilance Program at 1 866 234 2345. 2021 05 11 2021 05 11 Health Care Professionals Researchers Product Monograph CABOMETYX Product Monograph Page 1 of 43 . Anti Diabetic Agent . A monograph is a written description of particular elements on an identified topic. Adenosine Injection. 3 Issue 4 December 2007 is out and contains among other things new NHP monographs . Each 100 microliter spray contains 2. TRINTELLIX Vortioxetine as vortioxetine hydrobromide 5 mg 10 mg 15 mg and 20 mg tablets Oral . Now available in Canada for the treatment of insomnia lemborexant Product Monograph Product Monograph PDF April 23 2021 Patient Medication Information PDF April 23 2021 Health Product Risk Communication Labeling PDF April 26 2021 Monographs for Commonly Administered Intravenous Medications in Home and Community Care 5 P a g e References 1. 100 mg 125 mg . Through an active Internet connection the web PLA form searches and populates data from the Natural Health Products Ingredients Database NHPID . Exchange Tower 130 King Street West Suite 900 P. 3 mL 40 mg 0. ca Date of Approval PRODUCT MONOGRAPH PrACTEMRA Canada L5N 5M8 Date of Initial Approval April 30 2010 PART I HEALTH PROFESSIONAL INFORMATION Health Canada Structured Product Monograph SPM Challenges Preparation and Implementation. 90 Burnhamthorpe Road West Suite 1100 Mississauga Ontario L5B 3C3 Date of Revision November 26 2014 Submission Control No 177177 Product Monograph Page 7 of 117 Concomitant ASA use almost exclusively at a dose of 100 mg or less with either XARELTO or warfarin during the ROCKET AF trial was identified as an independent risk factor for major The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The store that we ESPEROCT Product Monograph Page 1 of 36. Obtained through Health Canada Drug Product Database search term Galderma Canada Inc. Acyclovir Sodium Injection. 2020 2021 strains . 200 mg 125 mg . health canada product monograph