What's New - Drug Products

Files added to the Web site are also posted here in the What's New section for three weeks. Once you have browsed through the entire site, all you need to do to keep current is make sure you visit this page more than once every three weeks.

Weekly Drug NOC updates

2017

September

How to Pay Fees to Health Products and Food Branch (HPFB) [2017-09-19]
Updated Patent Register - Frequently Asked Questions [2017-09-19]
Notice: Publication of the Guidance Document: Certificate of Supplementary Protection Regulations [2017-09-19]
Notice – Patented Medicines (Notice of Compliance) Regulations [2017-09-19]
Submissions Under Review [2017-09-12]
Register of Innovative Drugs [2017-09-12]
Regulatory Decision Summary for OCREVUS (Control number 198094) [2017-09-12]
Regulatory Decision Summary for FLEBOGAMMA 5% / FLEBOGAMMA 10% (Control number 194291) [2017-09-12]
Regulatory Decision Summary for FRAXIPARINE / FRAXIPARINE FORTE (Control number 195973) [2017-09-12]
SAP-OUC Record of Proceeding for 2017-03-24 [2017-09-08]
Summary of Expertise, Experience and Affiliations and Interests [2017-09-08]
SAP-OUC Updated Membership List and Biographies [2017-09-08]
DPD Extracts [2017-09-01]
Summary Basis of Decision (SBD) for PROCYSBI [2017-08-21]

August

Regulatory Decision Summary for DEFITELIO (Control number 200808) [2017-08-30]
Regulatory Decision Summary for ADCETRIS (Control number 185779) [2017-08-30]
Regulatory Decision Summary for ENTUZITY (Control number 189076) [2017-08-30]
Regulatory Decision Summary for LIPIODOL ULTRA FLUID (Control number 196107) [2017-08-30]
Regulatory Decision Summary for AGGRASTAT (Control number 186324) [2017-08-30]
Regulatory Decision Summary for LATUDA (Control number 197342) [2017-08-30]
Post-Authorization Activity Table (PAAT) for MEKINIST (Control number 157665) [2017-08-30]
Therapeutic Products Directorate (TPD), Biologics and Genetic Therapies Directorate (BGTD), Natural and Non-Prescription Health Products Directorate (NNHPD) Drug Submission Performance Quarterly Reports - April - June 2017 [2017-08-29]
Notice - Prescription Drug List (PDL): Hydroquinone [2017-08-29]
Notice: eCTD Pilot for Clinical Trial Regulatory Activities - Extension [2017-08-28]
Register of Innovative Drugs [2017-08-28]
Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation (ICH) [2017-08-25]
Notice - Publication of the Health Canada Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions [2017-08-21]
Regulatory Decision Summary for BELBUCA (Control number 196428) [2017-08-17]
Regulatory Decision Summary for EMEND IV (Control number 197185) [2017-08-17]
Regulatory Decision Summary for PROLASTIN-C (Control number 205855) [2017-08-17]
Product Monograph Brand Safety Updates July 2017 [2017-08-16]
Updated List of Drugs for an Urgent Public Health Need [2017-08-15]
Submissions Under Review [2017-08-15]
Notice - The Regulatory Enrolment Process (REP) Functional Pilot for eCTD Format - Stage III [2017-08-10]
Register of Innovative Drugs [2017-08-04]
Notice - Prescription Drug List (PDL): Multiple Additions [2017-08-04]
Post-Authorization Activity Table (PAAT) for Eylea [2017-08-02]
Post-Authorization Activity Table (PAAT) for Cosentyx [2017-08-02]
Post-Authorization Activity Table (PAAT) for Jublia [2017-08-02]
Regulatory Decision Summary for Keytruda (Control number 198839) [2017-08-02]
Register of Innovative Drugs [2017-08-01]

July

Notice: Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format [2017-07-28]
Consultation on Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products [2017-07-27]
Regulatory Decision Summary for VYVANSE (Control Number 181720) [2017-07-25]
Regulatory Decision Summary for LANCORA (Control Number 166949) [2017-07-25]
Regulatory Decision Summary for TAFINLAR (Control Number 199381) [2017-07-25]
Regulatory Decision Summary for MEKINIST (Control Number 199382) [2017-07-25]
Regulatory Decision Summary for SPINRAZA (Control Number 200070) [2017-07-25]
Regulatory Decision Summary for PROCYSBI (Control Number 191347) [2017-07-25]
Summary of Cancellation for JENTATUETO (Control Number 194067) [2017-07-25]
Post-Authorization Activity Table (PAAT) for RAVICTI [2017-07-25]
Therapeutic Products Directorate Statistical Report 2016/2017 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection [2017-07-14]
Register of Innovative Drugs [2017-07-14]
Regulatory Decision Summary for OPDIVO (Control number 99379) [2017-07-13]
Regulatory Decision Summary for TEPADINA (Control number 168816) [2017-07-13]
Regulatory Decision Summary for ADLYXINE (Control number 193862) [2017-07-13]
Regulatory Decision Summary for IBRANCE (Control number 195948) [2017-07-13]
Regulatory Decision Summary for VICTOZA (Control number 196457) [2017-07-13]
Regulatory Decision Summary for KINERET (Control number 195649) [2017-07-13]
Regulatory Decision Summary for EYLEA (Control number 186851) [2017-07-13]
Regulatory Decision Summary for BLINCYTO (Control number 197615) [2017-07-12]
Post-Authorization Activity Table for INVOKANA [2017-07-12]
Post-Authorization Activity Table for GARDASIL 9 [2017-07-12]
Summary Basis of Decision for OCALIVA [2017-07-12]
Summary Basis of Decision for OZANEX [2017-06-21]
Register of Innovative Drugs [2017-07-12]
Regulatory Decision Summary for ORKAMBI (Control number 198036) [2017-07-11]
Post-Authorization Activity Table for BEPREVE [2017-07-11]
Regulatory decision summary for BRINAVESS (Control number 190817) [2017-07-11]
Submissions Under Review [2017-07-11]
Summary Basis of Decision for CERDELGA [2017-07-10]
Post-Authorization Activity Table for BLEXTEN [2017-07-10]
Notice - Prescription Drug List (PDL): Veterinary Antimicrobials [2017-07-05]
Regulatory Decision Summary for PAZEO (Control number 189463) [2017-07-05]
Post-Authorization Activity Table for BOSULIF [2017-07-05]
Post-Authorization Activity Table for ENTRESTO [2017-07-05]
Post-Authorization Activity Table for AUBAGIO [2017-07-05]
Post-Authorization Activity Table for ADEMPAS [2017-07-05]
Post-Authorization Activity Table for XELJANZ [2017-07-05]
Post-Authorization Activity Table for ALCENSARO [2017-07-05]
Post-Authorization Activity Table for ALPROLIX [2017-07-05]

June

Access to naloxone in Canada (including NARCAN™ Nasal Spray): Frequently Asked Questions [2017-06-30]
Consultation on Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology [2017-06-30]
Updated: Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format [2017-06-29]
Access to Drugs in Exceptional Circumstances [2017-06-28]
Post-Authorization Activity Table for ALPROLIX [2017-06-26]
Regulatory Decision Summary for LIXIANA (Control number 187363) [2017-06-26]
Regulatory Decision Summary for GLATECT (Control number 191840) [2017-06-26]
Post-Authorization Activity Table for ISTODAX [2017-06-23]
Updated Prescription Drug List [2017-06-23]
Notice - Prescription Drug List (PDL): Multiple Additions [2017-06-23]
Submissions Under Review [2017-06-21]
Notice - Implementation of Regulated Product Submission (RPS) and Electronic Common Technical Document version 4 (eCTD v4) [2017-06-16]
Product Monograph Brand Safety Updates [2017-06-16]
Regulatory decision summary for TECENTRIQ (Control number 196843) [2017-06-14]
Regulatory decision summary for REVOLADE (Control number 195798) [2017-06-14]
Updated Changes in Manufacturer's Name and/or Product Name Policy [2017-06-13]
Regulatory Decision Summary Cancellation for ALVIMOPAN (*ENTEREG) (Control number 189825) [2017-06-13]
Regulatory Decision Summary for FIBRYNA (Control number 195870) [2017-06-13]
Register of Innovative Drugs [2017-06-09]
Regulatory decision summary for PRIMAQUINE (Control number 196046) [2017-06-06]
Regulatory decision summary for UTROGESTAN (Control number 180004) [2017-06-06]
Regulatory decision summary for XOLAIR (Control number 194542) [2017-06-06]
Post-Authorization Activity Table for PRAXBIND [2017-06-06]
Post-Authorization Activity Table for LENVIMA [2017-06-06]
Post-Authorization Activity Table for VIMIZIM [2017-06-06]
Regulatory decision summary for YERVOY (Control number 202533) [2017-06-06]
Post-Authorization Activity Table for OPDIVO [2017-06-06]
Regulatory decision summary for INVOKANA (Control number 194762) [2017-06-06]
Regulatory decision summary for KUVAN (Control number 186959) [2017-06-06]
Regulatory decision summary for ACARIZAX (Control number 195186) [2017-06-06]
Summary Basis of Decision for REXULTI [2017-06-06]
Post-Authorization Activity Table for XOFIGO [2017-06-06]
Post-Authorization Activity Table for ZERBAXA [2017-06-06]
Post-Authorization Activity Table for STRIVERDI RESPIMAT [2017-06-06]
Post-Authorization Activity Table for TIVICAY [2017-06-06]
Post-Authorization Activity Table for PLEGRIDY [2017-06-06]
Regulatory decision summary for PORTRAZZA (Control number 193689) [2017-06-06]
Post-Authorization Activity Table for PRALUENT [2017-06-06]
Regulatory decision summary for TARCEVA (Control number 194018) [2017-06-06]
Regulatory decision summary for CERDELGA (Control number 183050) [2017-06-06]
Post-Authorization Activity Table for DARZALEX [2017-06-06]
Post-Authorization Activity Table for GIOTRIF [2017-06-06]
Register of Innovative Drugs [2017-06-02]

May

Notice - Interim Implementation of International Council for Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) [2017-05-29]
Notice - Prescription Drug List (PDL): Multiple Additions [2017-05-19]
Register of Innovative Drugs [2017-05-19]
Updates to the Prescription Drug List [2017-05-19]
Summary Basis of Decision (SBD) for BRINAVESS [2017-05-17]
Notice: Publication of Update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations [2017-05-17]
Product Monograph Brand Safety Updates [2017-05-17]
Summary Basis of Decision for PORTRAZZA [2017-05-16]
Notice to Stakeholders: Release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug [2017-05-15]
Post-Authorization Activity Table for SOVALDI [2017-05-11]
Post-Authorization Activity Table for GENVOYA [2017-05-11]
Submissions Under Review [2017-05-09]
IGDRP/Health Canada/CAPRA Symposium [2017-05-09]
Regulatory decision summary for HARVONI (Control number 193140) [2017-05-08]
Regulatory decision summary for ODEFSEY (Control number 192454) [2017-05-08]
Post-Authorization Activity Table for ELELYSO [2017-05-08]
Register of Innovative Drugs [2017-05-05]
Post-Authorization Activity Table for NUWIQ [2017-05-03]
Post-Authorization Activity Table for ENTYVIO [2017-05-03]
Regulatory decision summary for ERELZI (Control number 193864) [2017-05-03]
Regulatory decision summary for BERINERT 500/ BERINERT 1500 (Control number 197440)[2017-05-03]
Regulatory decision summary for DARZALEX (Control number 198647) [2017-05-02]
Updated Master File (MF) Application Fee Form For Human Drugs [2017-05-01]
Post-Authorization Activity Table for ZEPATIER [2017-05-01]
Post-Authorization Activity Table for STRIBILD [2017-05-01]

April

Notice: Release of the Final Guidance Document: Master Files (MFs) Procedures and Administrative Requirements [2017-04-28]
Register of Innovative Drugs [2017-04-28]
Summary Basis of Decision for NEURACEQ [2017-04-18]
Post-Authorization Activity Table for MYRBETRIQ [2017-04-25]
Notice Mandatory use of the Electronic Common Technical Document (eCTD) format [2017-04-24]
Regulatory decision summary for REVOLADE (Control number 188969) [2017-04-24]
Summary Basis of Decision for MICTORYL/MICTORYL PEDIATRIC [2017-04-24]
Submissions Under Review [2017-04-21]
Updates to the Prescription Drug List [2017-04-21]
Notice - Prescription Drug List (PDL): Multiple Additions [2017-04-21]
Post-Authorization Activity Table for ICLUSIG [2017-04-20]
Post-Authorization Activity Table for UPTRAVI [2017-04-20]
Regulatory decision summary for REXULTI (Control number 192684) [2017-04-21]
Summary Basis of Decision for BAT [2017-04-12]
Regulatory decision summary for VIMPAT (Control number 193732) [2017-04-12]
Drug Product Database (DPD) Terminology [2017-04-12]
Product Monograph Brand Safety Updates [2017-04-10]
Submissions Under Review [2017-04-10]
Notice - Intellectual Property Hold for Notifiable Change Submissions [2017-04-07]
Regulatory decision summary for ENBREL (Control number 193787) [2017-04-07]
Post-Authorization Activity Table for PICATO [2017-04-06]
Regulatory decision summary for REPLAGAL (Control number 188407) [2017-04-06]

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March

Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use [2017-03-31]
Notice - Prescription Drug List (PDL): Multiple Additions [2017-03-29]
Notice: Availability of Summary Basis of Decision Documents and Regulatory Decision Summaries on the Drug and Health Products Register [2017-03-29]
Updates to the Prescription Drug List [2017-03-29]
Notice: Tablet Scoring of Subsequent-entry Pharmaceutical Products [2017-03-28]
Questions and Answers - Naloxone [2017-03-27]
Summary Basis of Decision for LANCORA [2017-03-27]
Regulatory Decision Summary for IMBRUVICA (Control number 192718) [2017-03-17]
Regulatory Decision Summary for LUPRON DEPOT (Control number 193372) [2017-03-16]
Product Monograph Brand Safety Updates [2017-03-15]
Health Canada New Drug Authorizations: 2016 Highlights [2017-03-15]
Notice: Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales [2017-03-14]
Notice - Upcoming Changes to the Annual Drug Notification Form [2017-03-14]
Notice: Guidance Document - Fees for the Right to Sell Drugs [2017-03-14]
Post-Authorization Activity for ZYKADIA [2017-03-14]
Post-Authorization Activity Table for TAFINLAR [2017-03-14]
Register of Innovative Drugs [2017-03-10]
Regulatory decision summary for ONCASPAR (Control number 189795) [2017-03-10]
Submissions Under Review [2017-03-10]
Summary Basis of Decison for RAPIVAB [2017-03-10]
Summary Basis of Decision for KEVZARA [2017-03-09]
Guidance Document - Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act [2017-03-09]
REPLAGAL Notice of Compliance with Conditions [2017-03-06]
Post-Authorization Activity Table for POMALYST [2017-03-06]
Summary Basis of Decision for VIBERZI [2017-03-06]
Register of Innovative Drugs [2017-03-03]

February

Regulatory Decision Summary for CUVITRU (Control number 190451) [2017-02-28]
Scientific Advisory Panel on Opioid Use and Contraindications [2017-02-24]
Summary Basis of Decision for NITISINONE TABLETS [2017-02-24]
Register of Innovative Drugs [2017-02-24]
Summary Basis of Decision for ORFADIN [2017-02-24]
Product Monograph Brand Safety Updates January 2017 [2017-02-21]
Scientific Advisory Panel Meeting on Opioids [2017-02-17]
Regulatory decision summary for EVICEL (Control number 178389) [2017-02-17]
Consultation on the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs [2017-02-17]
Regulatory Decision Summary for OBIZUR (Control number 177290) [2017-02-16]
Regulatory Decision Summary for ORFADIN (Control number 193226) [2017-02-15]
Regulatory Decision Summary for RAPIVAB (Control number 191280) [2017-02-15]
Regulatory decision summary for SYNJARDY (Control number 186812) [2017-02-15]
Updates to the Prescription Drug List [2017-02-10]
Notice - Prescription Drug List (PDL): Multiple Additions [2017-02-10]
Notice - Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) [2017-02-10]
Register of Innovative Drugs [2017-02-10]
Summary Basis of Decision for AFSTYLA [2017-02-10]
Summary Basis of Decision for ZINBRYTA [2017-02-09]
Regulatory decision summary for AFSTYLA (Control number 190891) [2017-02-02]
Notice - Prescription Drug List (PDL): Naloxone Qualifier Change [2017-02-02]
Updates to the Prescription Drug List [2017-02-02]
Consultation: Release of International Council on Harmonisation (ICH) Document: Good Clinical Practice (GCP) "Renovation" Reflection Paper [2017-02-02]
Consultation on the Prescription Drug List: Hydroquinone [2017-02-01]

January

Regulatory decision summary for MICTORYL, MICTORYL PEDIATRIC (Control number 188323) [2017-01-31]
Regulatory Decision Summary for DAKLINZA (Control number 189820) [2017-01-31]
Regulatory Decision Summary for DOTAREM (Control number 186333) [2017-01-31]
Regulatory Decision Summary for GALEXOS (Control number 190665) [2017-01-31]
Regulatory Decision Summary for HOLKIRA PAK (Control number 190518) [2017-01-31]
Post-Authorization Activity for STRENSIQ [2017-01-31]
Consultation on the Health Canada Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions [2017-01-31]
Post-Authorization Activity for EPERZAN [2017-01-31]
Submissions Under Review [2017-01-31]
Post-Authorization Activity for MOVANTIK [2017-01-30]
Summary Basis of Decision for DOTAREM [2017-01-27]
Regulatory Decision Summary for GAZYVA (Control number 191269) [2017-01-27]
Register of Innovative Drugs [2017-01-27]
Regulatory Decision Summary for ILARIS (Control number 195617) [2017-01-26]
Regulatory Decision Summary for FIASP (Control number 191494) [2017-01-25]
Regulatory decision summary for KEVZARA (Control number 191745) [2017-01-25]
Post-Authorization Activity for JETREA [2017-01-25]
Consultation on the Prescription Drug List: Naloxone [2017-01-24]
Terms of Reference for Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT) [2017-01-23]
Record of Proceedings for Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT) for 2016-10-06 Meeting [2017-01-23]
Register of Innovative Drugs [2017-01-20]
Updated ICH Q3D Notice: Health Canada recommendations for implementation of the ICH Harmonised Guideline for Elemental Impurities (Q3D) for new and marketed products [2017-01-19]
Regulatory Decision Summary for GLYXAMBI (Control number 188534) [2017-01-12]
Regulatory Decision Summary for KYLEENA (Control number 186786) [2017-01-18]
Updated Notice: eCTD Pilot for Clinical Trial Regulatory Activities [2017-01-18]
Product Monograph Brand Safety Updates December 2016 [2017-01-18]
Register of Innovative Drugs [2017-01-16]
Regulatory Decision Summary for STELARA (Control number 190732) [2017-01-16]
Post-Authorization Activity Table for MIFEGYMISO [2017-01-13]
Regulatory decision summary for KYPROLIS (Control number 190434) [2017-01-12]
Regulatory Decision Summary for DURATOCIN (Control number 190823) [2017-01-12]
Submissions Under Review [2017-01-11]
Register of Innovative Drugs [2017-01-06]
Summary Basis of Decision for ADYNOVATE [2017/01/06]
Regulatory Decision Summary for REVLIMID (Control number 190743) [2017-01-06]
Regulatory Decision Summary for HUMIRA (Control number 190514) [2017-01-04]
Notice - Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the "Non-eCTD Electronics-Only" Format [2017-01-03]

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Date modified:: 2017-09-20

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