Spravato™ is indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults [see Clinical Studies (14.1)].Limitations of Use:Spravato is not approved as an anesthetic agent. Product Monograph Page 9 of 28 Do not inject the vaccine intravascularly, subcutaneously or … For more information on SPRAVATO ® clinical trials, benefits, risks and side effects, please see the SPRAVATO ® Product Monograph. You are about to review information on the Janssen COVID-19 Vaccine. Janssen Inc. You agree that Janssen Inc., and companies working with Janssen Inc., … 12. Janssen, a division of Johnson & Johnson (NYSE: JNJ), received U.S. Food and Drug Administration approval for SPRAVATO ® for use with an oral antidepressant in adults with treatment-resistant depressive disorder (TRD), followed by the drug being made available in Canada … The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. Click the Return button to return to www.janssenmedicalinformation.ca or Continue to continue. * SPRAVATO® (esketamine) nasal spray uses the first new mechanism of action in decades to treat treatment resistant depression disorder * Aleafia Health medical clinics along with … The goal of the Janssen Journey™ … See footnote 4, Active ingredient group (AIG) number:See footnote 5. For more information on SPRAVATO ® clinical trials, benefits, risks and side effects, please see the SPRAVATO ® Product Monograph. Product Monograph (PDF) December 17, 2020; Patient Medication Information (PDF) December 17, 2020; Public Communication (PDF) February 18, 2015; Dear Doctor Letter (PDF) February 18, 2015; Dear … See footnote 3, 28:16.04.92 The information provided to you by Janssen Inc. is not medical advice/recommendations and that the information provided to you is in response to your specific unsolicited request for information. 19 Green Belt Drive Toronto Mepolizumab for Injection . Version date: May 19, 2020. Drugs are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutical properties. The DPD is updated nightly and includes: availability of the drug in Canada ; product monograph (PM) for human drugs ; labels for animal drugs; Generic drug manufacturers must update their PM to ensure it aligns with the Canadian Reference Product. 12 SPRAVATO™ Product Monograph. You agree that Janssen Inc., and companies working with Janssen Inc., may passively collect personally identifiable browsing information to customize the site based on your preferences, compile and analyze statistics and trends, and otherwise administer and improve the site for your use. Please select the following that would apply to you: I am a Healthcare Professional in Canada I am a consumer or caregiver in Canada I am a US Healthcare Professional I am a US consumer or caregiver. Please refer to the SPRAVATO ® Product Monograph … Pursuant to the Canadian product monograph, SPRAVATO® is only available through a controlled distribution program called the Janssen Journey™ Program. The AIG number is a 10 digit number that identifies products that have the same active ingredient(s) and ingredient strength(s). Psychiatrists may prescribe SPRAVATO® to patients who meet the appropriate criteria in a community setting, as long as they have appropriate training and knowledge and are doing so in accordance with requirements set out by Health Canada and the SPRAVATO® Canadian product monograph… As indicated in the Spravato® product monograph, … For Investor & Media Relations. You are a healthcare professional in Canada and that you will only use the information provided on this website as an informational aid for your use only and that you will not disseminate to gain profit from this information. Help on accessing alternative formats, such as Portable Document Format (, Product monograph/Veterinary Labelling (PDF version ~ 175K), Licensed natural health products database. Janssen Inc. only recommends the use of these products in a manner as described in the Health Canada approved product monograph. The AIG is comprised of three portions: Refer to the Health Canada Guidance Documents - "Submission of Risk Management Plans and Follow-up Commitments" as well as "Submission of targeted Risk Management Plans Follow-up Commitments for Prescription Opioid-containing Products" for additional details. We encourage you to read the Legal Notice and Privacy Policy of every website you visit. See footnote 1, Date: 1 Spravato® (esketamine) is a drug product initially approved in Canada on May 19, 2020 that includes a nasal spray formulation of esketamine for treatment of depression. MISCELLANEOUS ANTIDEPRESSANTS, Anatomical Therapeutic Chemical (ATC): Canada Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer … We encourage you to read the Legal Notice and Privacy Policy of every website you visit. Drug Product Database online query From Health Canada 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 … Nicholas Bergamini VP Investor …  M3C 1L9, American Hospital Formulary Service (AHFS): The earliest marketed date recorded in the Drug Product Database. For Investor & Media Relations. 2020-05-19 The purpose of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system is to be used as a tool for drug utilization research in order to improve quality of drug use. Anti-allergy Agent Novartis Pharmaceuticals Canada … In the September/October 2020 College Connector, registrants were advised that ketamine for the treatment of a major depressive disorder administered by any route in the community setting must be … Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. the second portion (5 digits) identifies the unique groups of active ingredients(s). This site is intended for Healthcare Professionals from Canada only and is published by Janssen Inc., which is solely responsible for its contents. PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrOCREVUSTM Ocrelizumab for injection Concentrate for intravenous infusion 300 mg/10 mL (30 mg/mL) Selective … The American Hospital Formulary Service permits an easy review of information on a group of drugs with similar activities and uses and allows the reader to determine quickly the similarities and differences among drugs within a group. Esketamine is used as a nasal spray or by injection … Esketamine, sold under the brand name Spravato among others, is a medication used as a general anesthetic and for treatment-resistant depression. PRODUCT MONOGRAPH . Rapidly absorbed following intranasal administration; peak concentrations attained in 20–40 minutes following the last nasal … You agree that Janssen Inc., and companies working … Adults with treatment-resistant depression (TRD) Depressive symptoms in adults with major … For Investor & Media Relations. For Investor & Media Relations. the last portion (3 digits) identifies the active ingredient group strength. For Investor & Media Relations Nicholas Bergamini For more information on SPRAVATO ® clinical trials, benefits, risks and side effects, please see the SPRAVATO ® Product Monograph. This site was last modified on: March 8, 2021, I have read and agree to the Legal Notice and Privacy Policy of this Web site.*. Janssen Inc. only recommends the use of these products in a manner as described in the Health Canada approved product monograph. PrNUCALA . PRODUCT MONOGRAPH PrPATADAY® Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v olopatadine (as olopatadine hydrochloride) Mfr. Std. Ontario Nicholas Bergamini VP Investor … NUCALA – Product Monograph Page 1 of 69. Product Monograph (PDF) May 8, 2020; Consumer Information (PDF) May 8, 2020; Dear Doctor Letter (PDF) December 17, 2012; Dear Doctor Letter (PDF) January 12, 2004; Dear Doctor Letter (PDF) July … SPRAVATO ® is self-administered as a nasal spray, under the supervision of a healthcare professional and is absorbed through the lining of the nasal passages. For more information on SPRAVATO ® clinical trials, benefits, risks and side effects, please see the SPRAVATO ® Product Monograph. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate. Your use of this information on this site is subject to our Legal Notice. 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For more information on SPRAVATO ® clinical trials, benefits, risks and side effects, please see the SPRAVATO ® Product Monograph. Janssen 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. Version date: May 19, 2020. PROLIA Product Monograph Page 1 of 74 PRODUCT MONOGRAPH PrProlia (denosumab) 60 mg/mL solution for injection Prefilled Syringe Professed Standard RANK Ligand Inhibitor (Bone Metabolism Regulator) Physicians should become fully familiarized with the efficacy/safety profile of PROLIA and the full content of the Product Monograph … Janssen Inc. only recommends the use of these products in a manner as described in the Health Canada approved product monograph.   The Canadian cost of esketamine is unavailable, as this product is not marketed in the country. Product monograph/Veterinary Labelling (PDF version ~ 175K), JANSSEN INC Aleafia Health Inc. (TSX: AH, OTC: ALEAF) today announced that Janssen Pharmaceuticals, Inc., has approved its wholly owned subsidiary, Canabo Medical Inc. as an administrator and prescriber of antidepressant SPRAVATO … INCLUDING PATIENT MEDICATION INFORMATION . This link will take you to another website that is unrelated to the Janssen Inc. Medical Information website and to which the Legal Notice and Privacy Policy of the Janssen Inc. Medical Information website do not apply. For the US market, the manufacturer has announced that SPRAVATO will be priced at $590 for a 56 mg dose … 100 mg/mL lyophilized powder … A Risk Management Plan (RMP) for this product was submitted. Original market date: The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. Esketamine Pharmacokinetics Absorption Bioavailability. The strength group has a tolerance of ‑2% to +10%. The safety and effectiveness of Spravato as an anesthetic agent have not been established. Clicking on a product monograph link will direct you away from the Janssen Medical Information website to documents stored on https://www.janssen.com/canada/products. The veterinary labelling is … Please see our Privacy Policy. SPRAVATO ® is a prescription medicine, used along with an antidepressant taken by mouth to treat: . the first portion (2 digits) identifies the number of active ingredients. Nicholas Bergamini … VELCADE® is a trademark of Millennium Pharmaceuticals, Inc. SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson