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Notice: Prescription Drug List (PDL): Multiple Additions (2020-02-13)
Federal

The purpose of this Notice of Amendment is to notify about the additions of gemtuzumab ozogamacin, gilteritinib, icosapent ethyl, tafamidis, …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL human-and-veterinary use gemtuzumab ozogamacin gilteritinib icosapent ethyl tafamidis trifarotine and upadacitinib.
Notice: Prescription Drug List (PDL): Multiple additions (2020-07-15)
Federal

The purpose of this Notice of Amendment is to notify about the additions of Alpelisib, Baloxavir marboxil, Betula verrucosa (white …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL human-and-veterinary use Alpelisib Baloxavir marboxil Betula verrucosa white birch Brolucizumab Cabotegravir Caplacizumab Ciclesonide ...
Guidance Document : Post-Notice of Compliance (NOC) Changes: Quality Document
Federal

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to …

Record Modified: Sep 29, 2023
Record Released: Sep 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document NOC post-notice of compliance post-notice of compliance-changes quality document drug identification application biologics DIN-B drugs
Guidance Document: Notice of Compliance with Conditions (NOC/c)
Federal

This guidance document combines and supercedes the policy and guidance documents for Notices of Compliance with Conditions (NOC/c) dated June …

Record Modified: Sep 29, 2023
Record Released: Sep 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document notice of compliance NOC with Conditions NOC/c abbreviated new-drug submissions ANDSs supplement to SANDSs Canadian Reference Product CRP
Guidance Document: Patented Medicines (Notice of Compliance) Regulations
Federal

The Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) were introduced originally by Industry Canada under the Patent Act. The …

Record Modified: Sep 29, 2023
Record Released: Sep 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document patented-medicines regulations Notice of Compliance PM(NOC) Regulations Patent Act drug approval Food-and-Drugs Act Division 8 Food-and-Drug-Regulations
Imbruvica - Notice of Compliance with Conditions - Qualifying Notice - 2015 …
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 29, 2023
Record Released: Sep 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Imbruvica NOC with conditions qualifying notice
Keytruda - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice.

Record Modified: Sep 29, 2023
Record Released: Sep 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Keytruda NOC with Conditions qualifying notice
Libtayo - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice

Record Modified: Sep 29, 2023
Record Released: Sep 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Libtayo NOC with Conditions qualifying notice
Lynparza - Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice

Record Modified: Sep 29, 2023
Record Released: Sep 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Lynparza NOC with Conditions qualifying notice
Ocrevus – Notice of Compliance with Conditions - Qualifying Notice
Federal

Notice of Compliance with Conditions - Qualifying Notice

Record Modified: Sep 29, 2023
Record Released: Sep 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Ocrevus NOC with Conditions qualifying notice