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

Record Modified: Sep 30, 2023
Record Released: 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

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Vitrakvi notice of compliance NOC with Conditions qualifying notice

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Arzerra notice of compliance NOC with Conditions qualifying notice

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Balversa notice of compliance NOC with Conditions qualifying notice

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Blincyto notice of compliance NOC with Conditions qualifying notice

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

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL Avilamycin human-and-veterinary PDL

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

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL casirivimab imdevimab human-and-veterinary PDL

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for diclofenac on …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL Diclofenac only human PDL

The purpose of this Notice of Amendment is to notify that Health Canada will switch certain uses of Esomeprazole to …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL Esomeprazole only human PDL

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for omeprazole on …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL Omeprazole