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47280 records

The purpose of this Notice of Amendment is to notify about the additions of:
- Strain Russian BCG-I to the …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL Strain Russian BCG-I Bacillus Calmette-Guérin human-and-veterinary use Bedinvetmab Binimetinib Brillant Blue G encorafenib eptinezumab mecasermin ...

The purpose of this Notice of Amendment is to notify about the additions of the following medicinal ingredients on the …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL medicinal ingredients human-and-veterinary use Brexucabtagene autoleucel Idecabtagene vicleucel Pitolisant Risdiplam Selpercatinib Solriamfetol Tepotinib ...

The purpose of this Notice of Amendment is to notify about the additions of: Elexacaftor, Inclisiran, Ospemifene, Pralsetinib and Tafasitamab …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL Elexacaftor Inclisiran Ospemifene Pralsetinib Tafasitamab PDL for human-and-veterinary use Frunevetmab PDL for veterinary-use

The purpose of this Notice of Amendment is to notify of the addition of the following medicinal ingredients on the …

Record Modified: Sep 30, 2023
Record Released: Sep 28, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment Prescription Drug List PDL medicinal ingredients human-and-veterinary use Infigratinib Lurbinectedin Pemigatinib Propylthiouracil Sacituzumab govitecan Sotorasib

The purpose of this Notice of Amendment is to notify about the additions of Dequalinium chloride, Enfortumab vedotin, Somatrogon, and …

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 Dequalinium chloride Enfortumab vedotin Somatrogon and Tralokinumab.

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.

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 ...

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

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

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