Health Canada Product Monograph Template 2020

Health Canada reviews the product monograph as part of the drug review process as it forms an integral part of a new drug submission. Product Monograph master template PDF Version 332 Kb 31 pages Microsoft Word version Title Page Product Monograph.

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According to Health Canada guidelines the XML PM contents should include PM documents organization and product metadata.

Health canada product monograph template 2020. 2150 St-Elzear Blvd West October 29 2020 Laval Quebec H7L 4A8 Canada Submission Control No. Active Immunizing Agent for the Prevention of Influenza. BLES bovine lipid extract surfactant Product Monograph Page 1 of 19 PRODUCT MONOGRAPH BLES bovine lipid extract surfactant Suspension for Intratracheal Instillation 27 mg phospholipidmL THERAPEUTIC CLASSIFICATION Lung surfactant bovine BLES Biochemicals Inc.

Product Monograph Page 1 of 73 PRODUCT MONOGRAPH PrNorditropin NordiFlex Somatropin injection Pre-filled disposable pen 5 mg15 mL 10 mg15 mL and 15 mg15 mL Solution for subcutaneous administration Growth Hormone Novo Nordisk Canada Inc. 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 Canadas Canada Vigilance Program at 1-866-234-2345. March 23 2020 Submission Control No.

AHong Kong452019 H3N2-like virus. Product Monographs 2020-11-01 Notices. Product Monograph 2020 and Product Monograph PM Master Template came into effect.

The Product Monograph will be re-issued in the event of serious safety concerns previously unidentified or at such time as the. Influenza Vaccine surface antigen inactivated prepared in cell cultures Suspension for Injection. From April 1 2020 to July 31 2020 Health Canada will accept XML product monographs on a by request basis.

PRODUCT MONOGRAPH PrZYCLARA Imiquimod Cream 25 and 375 Immune response modifier Bausch Health Canada Inc. Health Canada is moving into the world of Structured Product Labeling SPL and has begun an initiative to capture Product Monograph PM information in a structured Extensible Markup Language XML format. The Product Monograph will be re-issued in the event of serious safety concerns previously unidentified or at such time as the sponsor.

Archived notices guidances and templates. Product Monograph 2020. Product Monograph Master Template Template Date.

Including Patient Medication Information Scheduling Symbol Brand name Proper name in final dosage form Dosage Forms Strengths and Routes of Administration Pharmaceutical Standard if applicable Therapeutic Classification For products that have been. September 2020 OPDIVOnivolumab Product Monograph Page 9 of 161 3 mgkg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks administered as an intravenous infusion over 30 minutes. As of November 1 2020 the full adoption of the Guidance Document.

101-2476 Argentia Road Mississauga Ontario L5N 6M1 Canada Date of Approval. In order to support the XML PM the previous six 2016 templates were amalgamated into one called the Master Template. In April 2019 Health Canada announced its intent to transition product monograph templates to a structured format based on XML Health Level 7s HL7 Structured Product Label SPL standard and controlled vocabularies.

60 Pacific Court Unit 8 London Ontario Canada N5V 3K4 Date of Authorization. INCLUDING PATIENT MEDICATION INFORMATION. AHawaii702019 H1N1pdm09-like virus 15 micrograms HA.

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 Canadas Canada Vigilance Program at 1-866-234-2345. A product monograph is intended to provide the necessary information for the safe and effective use of a new drug and also to serve as a standard against which all promotion and advertising of the drug can. Guidance Document 2020-11-01 Product Monograph Master Template 2020-11-01 Frequently Asked Questions.

Product Monograph Master Template Template Date. September 2020 Page 6 of 33 12 Geriatrics One of the following or similar statements may be used. No data are available to Health Canada.

The PM Guidance was also updated to align with the new Master Template. Phase II of the XML PM Project Product Monograph in the Extensible Markup Language Format 2021-05-28. In April 2019 Health Canada formally announced its intent to transition product monograph templates to a structured format based on Extensible Markup Language XML format Health Level 7 HL7s Structured Product Label SPL standard and controlled vocabularies.

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