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Found 2972 records

Animal-sourced insulins and biosynthetic (man-made) human insulins are used worldwide for managing diabetes. Recently, some concern has been expressed about …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Insulin Products animal-sourced insulins biosynthetic human insulins managing diabetes

An insulin pump is a medical device used by people with diabetes. It's an alternative to multiple daily injections of …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: insulin pumps insulin using-a-syringe medical device people with diabetes alternative to multiple-daily-injections

This labelling standard applies to ethylene oxide products labelled for use as gaseous sporicides in sterilizing medical instruments/devices. It does …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: labelling standard ethylene oxide gaseous products sterilization processes sterilizing medical devices

Overview of submission and regulatory requirements for licensing a medical device in Canada.

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: licensing medical device submission-and-regulatory requirements

The List of Drugs for an Urgent Public Health Need (the List) contains the following drug-related details: the brand name, …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: list of drugs urgent public health-need the List drug-related details brand name medicinal ingredient(s) route of administration strength dosage identifying code

List of Recognized Standards for Medical Devices

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: List recognized standards standards for medical-devices

This list represents substances and formulations which have been assessed by the Therapeutic Products Directorate on the basis of an …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: listing of drugs currently regulated new drugs the new-drugs list substances and formulations

Listing of therapeutic products with paediatric information available in their labelling

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: listing of therapeutic-products paediatric information labelling

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: M3(R2) Questions-and-Answers (R2) guidance nonclinical safety studies human clinical trials marketing authorization pharmaceuticals ICH Expert Working-Group regulatory parties

Responding to the Opioid Crisis and Other Emergency Situations.

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: urgently needed drugs making available emergency situations opioid crisis responding to opioid-crisis