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.
2017
June
- 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]
- 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]
- Regulatory decision summary for TECENTRIQ (Control number 196843) [2017-06-14]
- Regulatory decision summary for REVOLADE (Control number 195798) [2017-06-14]
- Register of Innovative Drugs [2017-06-09]
- Product Monograph Brand Safety Updates [2017-06-16]
- 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]
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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