Open Government Portal

Open Data Portal Catalogue Dataset
Found 20880 records
Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs: …
Federal

This section of the guidance provides criteria and examples to help you classify a safety or efficacy related change. Examples …

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: post-notice of compliance-changes safety and efficacy veterinary drugs reporting categories
Rozlytrek - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Rozlytrek notice of compliance NOC with Conditions qualifying notice
Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, …
Federal

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new …

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: summary guidance document post-notice-of-compliance-changes NOC framework document Pharmaceutical biologic radiopharmaceutical drugs for human-use-only framework Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs
Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy
Federal

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new …

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: summary guidance document post-notice of-compliance-changes safety-and-efficacy framework safety-and-efficacy quality guidance documents post-approval changes to-new-drugs
Vitrakvi - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Vitrakvi notice of compliance NOC with Conditions qualifying notice
Arzerra - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Arzerra notice of compliance NOC with Conditions qualifying notice
Balversa - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Balversa notice of compliance NOC with Conditions qualifying notice
Blincyto - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Blincyto notice of compliance NOC with Conditions qualifying notice
Notice: Prescription Drug List (PDL): Avilamycin
Federal

The purpose of this Notice of Amendment is to notify the addition of avilamycin to both the Human and Veterinary …

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL Avilamycin human-and-veterinary PDL
Notice: Prescription Drug List (PDL): Casirivimab and Imdevimab (COVID-19)
Federal

The purpose of this Notice of Amendment is to notify about the addition of casirivimab and imdevimab to the Prescription …

Last Updated: Sep 30, 2023
Date Published: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL casirivimab imdevimab human-and-veterinary PDL