Clinical information releases in progress

This page displays clinical information packages that are being prepared for release.

Proactive release refers to clinical information that Health Canada is processing for public release following its regulatory review of new products. On request releases refer to requests received on the clinical information portal.

Start date indicates when Health Canada initiated the process to prepare information for public release. Some on request releases may be listed as pending, for instance where a request requires clarification or where paper records need to be digitized.

Completed releases are available on Health Canada’s clinical information portal.

If you don’t see what you’re looking for, you can request clinical information for a drug or a medical device.

See Health Canada’s guidance document for more information.

View the lists of drugs and medical devices

Drugs

Brand name Manufacturer Process Status Start Date
Celexa Lundbeck Canada Inc On request Pending  
Cipralex Lundbeck Canada Inc On request  Active 2022-05-06
Zoloft Upjohn Canada ULC On request  Pending

 

Crestor Astrazeneca Canada Inc. On request Pending  
Enhertu AstraZeneca Canada Inc. Proactive Active 2021-04-19
Breztri Aerosphere AstraZeneca Canada Inc. Proactive Active 2021-07-15
Lyumjev  Eli Lilly Canada Inc. Proactive Active 2021-09-14
Rukobia ViiV Healthcare ULC Proactive Active 2021-10-01
Vaxzevria previously AstraZeneca COVID-19 Vaccine AstraZeneca Canada Inc.  Proactive Active 2021-11-19
Slynd Duchesnay Inc. Proactive Active 2021-11-30
Saphnelo AstraZeneca Canada Inc. Proactive Active 2021-12-01
Crestor AstraZeneca Canada Inc. On request Active 2022-01-05
Imfinzi AstraZeneca Canada Inc. Proactive Active 2022-02-08
Zynrelef Heron Therapeutics, Inc. Proactive Active 2022-03-16
Palynziq Biomarin International Limited Proactive Active 2022-03-30
Evusheld AstraZenaca Canada Inc. Proactive Active 2022-04-14
Vraylar Allergan Inc. Proactive Active 2022-04-22
Breyanzi Celgene Inc. Proactive Active 2022-05-06
Prevnar Pfizer Canada ULD Proactive Active 2022-05-09
Lumify Bausch Health, Canada Inc. Proactive Active 2022-05-19
Prohance Bracco Imaging Canada Proactive Active 2022-05-25
Tabrecta Novartis Pharmaceuticals Canada Inc. Proactive Active 2022-05-26
Xpovio Forus Therapeutics Inc. Proactive Active 2022-05-31
Poteligeo Kyowa Kirin Inc. Proactive Active 2022-06-02
Albrioza Amylyx Pharmaceuticals Inc. Proactive Active 2022-06-10
Letybo Croma Aesthetics Canada, Ltd Proactive Active 2022-06-14
Enhertu AstraZeneca Canada Inc. Proactive Active 2022-06-15
Propecia Organon Canada Inc. On request Active 2022-06-16
Scemblix Novartis Pharmaceuticals Canada Inc. Proactive Active 2022-06-23
Spravato Janssen Inc. Proactive Active 2022-06-28
Cibinqo Pfizer Canada ULC Proactive Active 2022-06-28
Vaxneuvance Merck Canada Inc. Proactive Active 2022-07-08
Rinvoq Abbvie Corporation Proactive Active 2022-07-13
Keytruda Merck Canada Proactive Active 2022-07-20
Opdivo Bristol-Myers Squibb Canada Proactive Active 2022-07-25
Lynparza AstraZeneca Canada Inc. Proactive Active 2022-07-27
Tezspire AstraZeneca Proactive Active 2022-07-28
Myxredlin Baxter Corporation Proactive Active 2022-08-03
Octasa Tillotts Pharma AG Proactive Active 2022-08-08
Korsuva Vifor Fresenius Medical Care Renal Pharma Ltd Proactive Active 2022-08-16
Vyndamax Pfizer Canada ULC Proactive Active 2022-08-17
Keytruda Merck Canada Inc Proactive Active 2022-08-18
Opdivo Bristol-Myers Squibb Canada Proactive Active 2022-08-18
Zejula GlaxoSmithKline Inc Proactive Active 2022-08-24
Pluvicto Advanced Accelerator Applications USA, Inc. Proactive Active 2022-08-25
Trulicity Eli Lilly Canada Inc Proactive Active 2022-08-26
Piqray Novartis Pharmaceuticals Canada Inc Proactive Active 2022-08-26
Eyezirgan Laboratoires Thea Proactive Active 2022-09-08
Koselugo AstraZeneca Canada Inc Proactive Active 2022-08-31
Rylaze Jazz Pharmaceuticals Ireland Limited Proactive Active 2022-09-02
Lutathera Advanced Accelerator Applications USA, Inc. Proactive Active 2022-09-09
Comirnaty BioNTech Manufacturing GMBH Proactive Active 2022-09-09
Darzalex SC, Darzalex Janssen Inc Proactive Active 2022-09-13
Tamiflu Hoffmann-La Roche Limited Proactive Active 2022-09-14
Imfinzi AstraZeneca Canada Inc Proactive Active 2022-09-15
Livtencity Takeda Canada Inc Proactive Active 2022-09-15
Cosentyx Novartis Pharmaceuticals Canada Inc. Proactive Active 2022-09-20
Pediacel

Sanofi Pasteur Limited

On request Active 2022-09-23
Sprycel Bristol-Myers Squibb Canada On request Active 2022-09-27
Imfinzi AstraZeneca Canada Inc Proactive Active 2022-09-28
Foquest Elvium Life Sciences Proactive Active 2022-09-28
Nubeqa Bayer Inc Proactive Active 2022-09-29
Iclusig Takeda Pharmaceuticals U.S.A., Inc. Proactive Active 2022-10-03
Auro-Levocarb Auro Pharma Inc Proactive Active 2022-10-11
Trumenba Pfizer Canada ULC Proactive Active 2022-10-11
Rebinyn Novo Nordisk Canada Inc Proactive Active 2022-10-12
Illuccix Telix Pharmaceuticals (US) Inc Proactive Active 2022-10-13
Ninlaro Takeda Canada Inc Proactive Active 2022-10-14
Vyndaqel Pfizer Canada ULC Proactive Active 2022-10-14
Kerendia Bayer Inc Proactive Active 2022-10-14
Evusheld AstraZeneca Proactive Active 2022-10-18
Ibrance Pfizer Canada ULC On request Active 2022-10-24
Effexor XR UpJohn Canada ULC On request Pending  
Keytruda Merck Canada Inc On request Active 2022-10-25
Skyrizi Abbvie Corporation Proactive Active 2022-10-19
Kineret Swedish Orphan Biovitrum AB (publ) Proactive Active 2022-10-26
Elonox, Elonox HP Fresenius Kabi Canada Ltd Proactive Active 2022-10-26
Tresiba (Flextouch), Tresiba (Penfil) Novo Nordisk Canada Inc Proactive Active 2022-10-27
Ultomiris Alexion Pharma GMBH Proactive Active 2022-11-01
Sunlenca Gilead Sciences Canada Inc Proactive Active 2022-11-02
Ultram Janssen Inc On request Active 2022-11-08
Tremfya, Tremfya One-Press Janssen Inc Proactive Active 2022-11-08
Radicava Mitsubishi Tanabe Pharma Corporation Proactive Active 2022-11-08
Ervebo Merck Canada Inc Proactive Active 2022-11-09
Camzyos Bristol-Myers Squibb Canada Proactive Active 2022-11-08
Keytruda Merck Canada Inc Proactive Active 2022-11-09
Evusheld AstraZeneca Canada Inc Proactive Active 2022-11-09
Dovato ViiV Healthcare ULC Proactive Active 2022-11-15
Ubrelvy Abbvie Corporation Proactive Active 2022-11-10
Polivy Hoffmann-La Roche Limited Proactive Active 2022-11-14
Lyrica Upjohn Canada ULC Proactive Active 2022-11-14
Tecartus Gilead Sciences Canada Inc Proactive Active 2022-11-16
Xyntha Pfizer Canada ULC Proactive Active 2022-11-17
Luvox BGP Pharma ULC On request Active 2022-11-21
Yervoy Bristol-Myers Squibb Canada Proactive Active 2022-11-24
Ravicti Horizon Therapeutics Ireland DAC Proactive Active 2022-11-24
Sotyktu Bristol-Myers Squibb Canada Proactive Active 2022-11-24
Opsumit Janssen Inc Proactive Active 2022-11-28
Beovu Novartis Pharmaceuticals Canada Inc Proactive Active 2022-11-30
Mounjaro Eli Lilly Canada Inc Proactive Active 2022-11-24
Ferriprox Chiesi Canada Corp. Proactive Active 2022-12-06
Nuvaxovid Novavax Inc. Proactive Active 2022-12-06
Prehevbrio VBI Vaccines Inc. Proactive Active 2022-12-06
Yescarta Gilead Sciences Canada Inc Proactive Active 2022-12-06
Evrysdi Hoffmann-La Roche Limited Proactive Active 2022-12-07
Paxlovid Pfizer Canada ULC Proactive Active 2022-12-08
Darzalex Janssen Inc Proactive Active 2022-12-08
Empaveli Swedish Orphan Biovitrum AB (publ) Proactive Active 2022-12-08
Cabenuva, Vocabria ViiV Healthcare ULC Proactive Active 2022-12-09
Tysabri Biogen Canada Inc On request Active 2022-12-12
Ultomiris Alexion Pharma GMBH Proactive Active 2022-12-13
Zimed PF Aequus Pharmaceuticals Inc Proactive Active 2022-12-14
Hadlima/Hadlima Pushtouch Samsung Bioepis Co., Ltd Proactive Active 2022-12-14
Kymriah Novartis Pharmaceuticals Canada Inc Proactive Active 2022-12-19
Opdivo Bristol-Myers Squibb Canada Proactive Active 2022-12-19
Kisqali Novartis Pharmaceuticals Canada Inc Proactive Active 2022-12-20
Tecentriq Hoffmann-La Roche Limited Proactive Active 2022-12-21
Qulipta Abbvie Corporation Proactive Active 2022-12-22
Hemlibra Hoffmann-La Roche Limited Proactive Active 2022-12-23
Jcovden Janssen Inc Proactive Active 2022-12-23
Keytruda Merck Canada Inc Proactive Active 2022-12-29
Acarizax Alk-Abello A/S Proactive Active 2022-12-29
Imbruvica Janssen Inc On request Pending  
Darzalex SC Janssen Inc On request Pending  
Vegzelma Celltrion Healthcare Co Ltd Proactive Active 2023-01-03
Enhertu AstraZeneca Canada Inc Proactive Active 2023-01-06
Ultomiris Alexion Pharma GMBH Proactive Active 2023-01-06
Effexor Upjohn Canada ULC On request Active 2023-01-10
Xtandi Astellas Pharma Canada Inc On request Active 2023-01-16
Spikevax Modernatx, Inc. Proactive Active 2023-01-12
Kengrexal Chiesi Farmceutici S.P.A. Proactive Active 2023-01-20
Polivy Hoffmann-La Roche Limited Proactive Active 2023-01-20
Trodelvy Gilead Sciences Canada Inc Proactive Active 2023-01-20
Keytruda Merck Canada Inc Proactive Active 2023-01-25
Pentacel Sanofi Pasteur Limited Proactive Active 2023-01-26
Quadracel Sanofi Pasteur Limited Proactive Active 2023-01-26
Fraxiparene Aspen Pharmacare Canada Inc. On request Active 2023-01-27
PRZ-Metformin Pharmaris Canada Inc Proactive Active 2023-01-24
Mylotarg Pfizer Canada ULC Proactive Active 2023-02-02
Lixiana Servier Canada Inc Proactive Active 2023-02-02
Adtralza Leo Pharma Inc Proactive Active 2023-02-03
Carvykti Janssen Inc Proactive Active 2023-02-09
Kisqali Novartis Pharmaceuticals Canada Inc Proactive Active 2023-02-10
Mekinist Novartis Pharmaceuticals Canada Inc On request Active 2023-02-15
Tafinlar Novartis Pharmaceuticals Canada Inc On request Active 2023-02-15
JCovden Janssen Inc Proactive Active 2023-02-16
Spikevax Bivalent Modernatx, Inc. Proactive Active 2023-02-17
Praluent Sanofi-Aventis Canada Inc Proactive Active 2023-02-17
Verity-BCG Verity Pharmaceuticals Inc. On request Active 2022-12-28
Fraxiparene Aspen Pharmacare Canada Inc. On request Pending  
Tagrisso AstraZeneca Canada Inc. On request Pending  
Lynparza AstraZeneca Canada Inc. On request Pending  
Arimidex AstraZeneca Canada Inc. On request Pending  
Keytruda Merck Canada Inc On request Pending  
Tasigna Novartis Pharmaceuticals Canada Inc On request Pending  
Femara Novartis Pharmaceuticals Canada Inc On request Pending  
Propecia Organon Canada Inc. On request Pending  
Xalkori Pfizer Canada Inc On request Pending  
Calquence AstraZeneca Canada Inc. Proactive Active 2023-02-27
Vyxeos Jazz Pharmaceuticals Ireland Limited Proactive Active 2023-03-01
Rexulti Otsuka Pharmaceutical Co LTD On request Active 2023-03-01
Rexulti Otsuka Pharmaceutical Co LTD On request Pending  

Medical devices

Device name Manufacturer Process Status Start Date
Neo Iris Immucor Inc. Proactive Active 2022-05-10
Ossmem Hard/Ossmem Soft Osstem Implant Co. Ltd. Proactive Active 2022-06-15
Mecta Sigma Mecta Corporation On request Active 2022-07-12
Architet "I" System Abbott GMBH & CO K.G Proactive Active 2022-07-08
Alinity I Syphilis TP Assay (Donor Screening and Cadaveric Testing) Abbott GMBH & CO K.G Proactive Active 2022-07-08
Alinity I Chagas Assay (Donor Screening/Cadaveric) Abbott GMBH & CO K.G Proactive Active 2022-07-08
Alinity I RHTLV-I/II Abbott GMBH & CO K.G Proactive Active 2022-07-08
Alinity I Anti-HBC II Assay Abbott GMBH & CO K.G Proactive Active 2022-07-08
Alinity I HIV AG/AB Combo Assay (Donor Screening and Cadaveric Testing) Abbott GMBH & CO K.G Proactive Active 2022-07-08
Neo Iris Immucor Inc. Proactive Active 2022-07-18
Zeus Infinity Empowered (Anesthesia workstation) Draegerwerk AG & CO. KGAA Proactive Active 2022-07-29
Accurate Neo2 Aortic Valve Boston Scientific Corporation Proactive Active 2022-07-29
Sprint Quattro Secure S Lead Medtronic Inc. Proactive Active 2022-08-02
Sprint Quattro Secure Lead Medtronic Inc. Proactive Active 2022-08-02
Sprint Quattro Secure 6947 Ventricular Lead with Defibrilation Coil Electrodes Medtronic Inc. Proactive Active 2022-08-02
Silk'N Tightra Home Skinovations Corp. On request Active 2022-08-16
Shockwave Coronary (IVL) System Shockwave Medical, Inc. Proactive Active 2022-09-16
Diamondtemp Ablation System Medtronic Inc. Proactive Active 2022-10-06
Lutonix 018 Drug Coated Balloon PTA Catheter Lutonix, Inc Proactive Active 2022-10-13
A-Oss Collagen Osstem Implant Co. Ltd Proactive Active 2022-10-25
Flowtriever Retrieval/Aspiration System Inari Medical, Inc Proactive Active 2022-10-17
HawkOne Directional Atherectomy System Medtronic Inc. Proactive Active 2022-11-10
Preset Thrombectomy Device Phenox LTD Proactive Active 2022-11-18
Minimed 780G System Medtronic Minimed Proactive Active 2022-10-27
Stimulan Biocomposites Ltd. On request Active 2022-12-02
Advance Serenity Hydrophilic PTA Balloon Catheter Creagh Medical Limited Proactive Active 2022-12-20
Rapid Response COVID-19 Antigen Rapid Test Device BTNX Inc. On request Active 2023-01-05
S.M.A.R.T. Radianz Vascular Stent System Cordis US Corp. Proactive Active 2023-01-30
Harmony Transcatheter Pulmonary Valve Medtronic Inc. Proactive Active 2023-02-17

 

Top of page

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: