Health Canada Package Insert
Listing Websites about Health Canada Package Insert
Guidance Document: Labelling of Pharmaceutical Drugs …
(6 days ago) Health Canada is seeking feedback on proposed revisions to this guidance. Please visit the Consultation on proposed agile regulations and guidance for licensing drugs and medical devices for more information and … See more
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Guidance Document: Questions and Answers: Plain …
(2 days ago) WEB(b) Package Inserts (Consumer Information or Patient Medication Information) Mock-Ups. Health Canada recommends the use of largest type size possible for package inserts. A point size of less than …
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Guidance Document - Labelling of In Vitro Diagnostic …
(6 days ago) WEBThe package insert must indicate the storage conditions necessary to ensure the stability of the product in the unopened state for both device and individual reagents. …
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Good label and package practices guide for prescription …
(5 days ago) WEBCanada. Health Canada. The Institute for Safe Medication Practices Canada. Title : Good label and package practices guide for prescription drugs. Publication type : Monograph : …
https://www.publications.gc.ca/site/eng/9.878403/publication.html
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PRODUCT MONOGRAPH INCLUDING PATIENT …
(4 days ago) WEBPfizer Canada ULC 17,300 Trans-Canada Highway Kirkland, Quebec, Canada H9J 2M5 Date of Initial Authorization: September 16, 2021 Date of Revision: March 21, 2023 …
https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBAdults: The range of blood concentrations measured in adult atopic dermatitis (AD) patients ( 18 years of age) was similar to that in pediatric patients. The highest blood level of …
https://pdf.hres.ca/dpd_pm/00053301.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBby Health Canada, the safety and efficacy of Alhemo in adolescent patients aged 12 to less than 18 years of age has been established; therefore, Health Canada has authorized an …
https://pdf.hres.ca/dpd_pm/00069890.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBHealth 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 …
https://pdf.hres.ca/dpd_pm/00049463.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBPfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of Initial Authorization: January 17, 2022 Date of Revision: January 2, 2024 Submission …
https://covid-vaccine.canada.ca/info/pdf/paxlovid-pm-en.pdf
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Health Canada consults on proposed guidelines for the use of …
(7 days ago) WEBA drug’s “label” can include its inner or outer labels, a package insert, or its product monograph (PM). The draft guidance is based on Health Canada’s existing legal …
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(6 days ago) WEBPediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (>65 …
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(2 days ago) WEBEli Lilly Canada Inc. Exchange Tower 130 King Street West, Suite 900 P.O. Box 73 Toronto, Ontario M5X 1B1 1-888-545-5972 www.lilly.ca Date of Initial Authorization: …
https://pi.lilly.com/ca/verzenio-ca-pm.pdf
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Health Canada drafts guidance on electronic media in labeling
(9 days ago) WEBHealth Canada last week launched a public consultation on its draft guidance for drugmakers on incorporating electronic media, such as websites or mobile …
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Good Label and Package Practices Guide for Prescription …
(Just Now) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and improve user-applied labels, product monographs, package inserts …
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBHealth 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. …
https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBPediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics: …
https://pdf.hres.ca/dpd_pm/00067467.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(7 days ago) WEBAstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca Date of Initial Authorization: MAY 30, 2011 Therefore, Health …
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(3 days ago) WEBPediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (≥65 …
https://www.gilead.ca/-/media/gilead-canada/pdfs/medicines/trodelvy-english-pm_-19jul2023.pdf
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