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
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
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
Palynziq Biomarin International Limited Proactive Active 2022-03-30
Breyanzi Celgene Inc Proactive Active 2022-05-06
Letybo Croma Aesthetics Canada, Ltd Proactive Active 2022-06-14
Enhertu AstraZeneca Canada Inc Proactive Active 2022-06-15
Rinvoq Abbvie Corporation Proactive Active 2022-07-13
Lynparza AstraZeneca Canada Inc Proactive Active 2022-07-27
Tezspire AstraZeneca Canada Inc Proactive Active 2022-07-28
Myxredlin Baxter Corporation Proactive Active 2022-08-03
Opdivo Bristol-Myers Squibb Canada Proactive Active 2022-08-18
Koselugo AstraZeneca Canada Inc Proactive Active 2022-08-31
Imfinzi AstraZeneca Canada Inc Proactive Active 2022-09-15
Imfinzi AstraZeneca Canada Inc Proactive Active 2022-09-28
Nubeqa Bayer Inc Proactive Active 2022-09-29
Auro-Levocarb Auro Pharma Inc Proactive Active 2022-10-11
Kerendia Bayer Inc Proactive Active 2022-10-14
Ibrance Pfizer Canada ULC On request Active 2022-10-24
Effexor XR Upjohn Canada ULC On request Pending  
Sunlenca Gilead Sciences Canada Inc Proactive Active 2022-11-02
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
Dovato ViiV Healthcare ULC Proactive Active 2022-11-15
Ubrelvy Abbvie Corporation Proactive Active 2022-11-10
Ferriprox Chiesi Canada Corp. Proactive Active 2022-12-06
Evrysdi Hoffmann-La Roche Limited Proactive Active 2022-12-07
Empaveli Swedish Orphan Biovitrum AB (publ) Proactive Active 2022-12-08
Qulipta Abbvie Corporation Proactive Active 2022-12-22
Imbruvica Janssen Inc On request Pending  
Enhertu AstraZeneca Canada Inc Proactive Active 2023-01-06
Effexor Upjohn Canada ULC On request Active 2023-01-10
PRZ-Metformin Pharmaris Canada Inc Proactive Active 2023-01-24
Carvykti Janssen Inc Proactive Active 2023-02-09
Praluent Sanofi-Aventis Canada Inc Proactive Active 2023-02-17
Tagrisso AstraZeneca Canada Inc On request Pending  
Lynparza AstraZeneca Canada Inc On request Pending  
Arimidex AstraZeneca Canada Inc On request Pending  
Tasigna Novartis Pharmaceuticals Canada Inc On request Active 2023-08-22
Femara Novartis Pharmaceuticals Canada Inc On request Pending  
Xalkori Pfizer Canada ULC On request Pending  
Calquence AstraZeneca Canada Inc Proactive Active 2023-02-27
Rexulti Otsuka Pharmaceutical Co LTD On request Active 2023-03-01
Rexulti Otsuka Pharmaceutical Co LTD On request Active 2023-03-21
Tagrisso AstraZeneca Canada Inc Proactive Active 2023-03-09
Botox Abbvie Corporation On request Active 2023-03-31
Xtandi Astellas Pharma Canada Inc Proactive Active 2023-03-14
Spevigo Boehringer Ingelheim (Canada) Ltd Ltee Proactive Active 2023-03-22
Tecartus Gilead Sciences Canada Inc Proactive Active 2023-03-24
Ferriprox Chiesi Canada Corp. Proactive Active 2023-03-30
Fraxiparine Aspen Pharmacare Canada Inc. On request Active 2023-03-31
Locametz Advanced Accelerator Applications USA, Inc. Proactive Active 2023-04-05
Celexa Lundbeck Canada Inc On request Active 2023-04-06
Orkambi Vertex Pharmaceuticals (Canada) Incorporated Proactive Active 2023-04-06
Biktarvy Gilead Sciences Canada Inc Proactive Active 2023-04-14
Dupixent Sanofi-Aventis Canada Inc Proactive Active 2023-04-14
Immune VH Takeda Canada Inc Proactive Active 2023-04-18
Beyfortus AstraZeneca Canada Inc Proactive Active 2023-04-19
Keytruda Merck Canada Inc On request Active

2023-04-24

Lumigan AbbVie Corporation On request Pending  
Libtayo Sanofi-Aventis Canada Inc Proactive Active 2023-04-27
Verquvo Bayer Inc Proactive Active 2023-04-28
Zoryve Arcutis Biotherapeutics, Inc Proactive Active 2023-04-28
Quviviq Idorsia Pharmaceuticals Ltd Proactive Active 2023-04-28
Dupixent Sanofi-Aventis Canada Inc Proactive Active 2023-05-01
Rinvoq AbbVie Corporation Proactive Active 2023-05-02
Vyalev AbbVie Corporation Proactive Active 2023-05-04
Imcivree Rhythm Pharmaceuticals, Inc Proactive Active 2023-05-05
Eraxis Pfizer Canada ULC Proactive Active 2023-05-08
Darzalex SC Janssen Inc On request Active 2023-05-08
Xeljanz Pfizer Canada ULC Proactive Active 2023-05-12
Onakta Avir Pharma Inc Proactive Active 2023-05-12
Oxlumo Alnylam Netherlands B.V. Proactive Active 2023-05-12
Skyrizi AbbVie Corporation  Proactive Active 2023-05-15
Vaxchora Emergent Travel Heatlh Inc.  Proactive Active 2023-05-18
Tecfidera Biogen Canada Inc Proactive Active 2023-05-18
Spikevax Bivalent Original / Omicron BA.4/5 Modernatx, Inc. Proactive Active 2023-05-18
Brukinsa Beigene Swizerland GMBH Proactive Active 2023-05-25
Perseris HLS Therapeutics Inc Proactive Active 2023-05-25
Xywav Jazz Pharmaceuticals Ireland Limited Proactive Active 2023-05-25
Darzalex SC, Darzalex Janssen Inc Proactive Active 2023-05-29
Jardinace Boehringer Ingelheim (Canada) Ltd Ltee Proactive Active 2023-05-29
Pifeltro Merck Canada Inc Proactive Active 2023-05-30
PMS-Iron Sucrose Pharmascience Inc On request Active 2023-05-31
Silenor Paladin Labs Inc. On request Active 2023-06-02
Idhifa Celgene Inc Proactive Active 2023-06-09
Akeega Janssen Inc Proactive Active 2023-06-12
Xcopri Endo Ventures Ltd Proactive Active 2023-06-12
Olumiant Eli Lilly Canada Inc Proactive Active 2023-06-12
Onpattro Alnylam Netherlands B.V. Proactive Active 2023-06-13
Winlevi  Sun Pharmaceutical Industries Limited Proactive Active 2023-06-15
Ondexxya AstraZeneca Canada Inc Proactive Active 2023-06-16
Dayvigo Eisai Limited Proactive Active 2023-06-22
Absorica LD Sun Pharmaceutical Industries Limited Proactive Active 2023-06-22
Alfuria Tetra Seqirus PTY Proactive Active 2023-06-26
Tabrecta Novartis Pharmaceuticals Canada Inc Proactive  Active 2023-06-28
Wegovy Novo Nordisk Canada Inc Proactive Active 2023-06-29
Eylea Bayer Inc Proactive Active 2023-06-29
Delstrigo Merck Canada Inc Proactive Active 2023-07-06
Crinone EMD Serono, A Division of EMD Inc., Canada Proactive Active 2023-07-05
Vaxneuvance Merck Canada Inc Proactive Active 2023-07-07
Welireg Merck Canada Inc Proactive Active 2023-07-11
Rybrevant Janssen Inc Proactive Active 2023-07-11
Lynparza AstraZeneca Canada Inc Proactive Active 2023-07-11
Dupixent Sanofi-Aventis Canada Inc Proactive Active 2023-07-12
Fabrazyme Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc On request Pending  
Fraxiparine Aspen Pharmacare Canada Inc. On request Pending  
Trodelvy Gilead Sciences Canada Inc Proactive Active 2023-07-19
Scemblix Novartis Pharmaceuticals Canada Inc Proactive Active 2023-07-19
Keytruda Merck Canada Inc Proactive Active 2023-07-20
Omvoh Eli Lilly Canada Inc Proactive Active 2023-07-20
Livmarli Mirum Pharmaceuticals, Inc. Proactive Active 2023-07-21
Lenvima Eisai Limited Proactive Active 2023-07-21
Prevnar 20 Pfizer Canada ULC Proactive Active 2023-07-21
Rinvoq Abbvie Corporation Proactive Active 2023-07-21
Mekinist Novartis Pharmaceuticals Canada Inc Proactive Active 2023-07-24
Sogroya Novo Nordisk Canada Inc Proacive Active 2023-07-26
Alhemo Novo Nordisk Canada Inc Proactive Active 2023-07-26
Tafinlar Novartis Pharmaceuticals Canada Inc Proactive Active 2023-07-26
Tecvayli Janssen Inc Proactive Active 2023-07-26
Axberi Baxter Corporation Proactive Active 2023-07-27
Erleada Janssen Inc Proactive Active 2023-08-02
Jivi Bayer Inc Proactive Active 2023-08-03
Imbruvica Janssen Inc Proactive Active 2023-08-04
Arexvy GlaxoSmithKline Inc Proactive Active 2023-08-04
Adtralza Leo Pharma Inc Proactive Active 2023-08-04
Libtayo Sanofi-Aventis Canada Inc Proactive Active 2023-08-15
Tasigna Novartis Pharmaceuticals Canada Inc On request Pending  
Zejula GlaxoSmithKline Inc Proactive Active 2023-08-17
Narcan Nasal Spray Emergent Operations Ireland Limited On request Active 2023-08-22
Tepmetko EMD Serono, A Division of EMD Inc., Canada Proactive Active 2023-08-25
Blincyto Amgen Canada Inc Proactive Active 2023-08-29
Eucrisa Pfizer Canada ULC Proactive Active 2023-08-29
Paxlovid Pfizer Canada ULC Proactive Active 2023-08-30
Imjudo AstraZeneca Canada Inc Proactive Active 2023-08-31
Comirnaty Original & Omicron BA.4/BA.5 BioNTech Manufacturing GMBH Proactive Active 2023-08-31
Esperoct Novo Nordisk Canada Inc Proactive Active 2023-09-11
Spikevax XBB.1.5 Moderna Biopharma Canada Corporation Proactive Active 2023-09-12
Vabysmo Hoffman-La Roche Limited Proactive Active 2023-09-13
Opdualag Bristol-Myers Squibb Canada Proactive Active 2023-09-13
Vyepti Lundbeck Canada Inc Proactive Active 2023-09-19
Vyvgart Argenx BV  Proactive Active 2023-09-19
Quillivant ER Chewable Tablets/Quillivant ER Oral Suspension Kye Pharmaceuticals Inc Proactive Active 2023-09-21
Eligard Tolmar International Ltd. Proactive Active 2023-09-21
Prevymis Merck Canada Inc Proactive Active 2023-09-21

Medical devices

Device name Manufacturer Process Status Start Date
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
Shockwave Coronary (IVL) System Shockwave Medical, Inc. Proactive Active 2022-09-16
Lutonix 018 Drug Coated Balloon PTA Catheter Lutonix, Inc Proactive Active 2022-10-13
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
Natrelle 410 Truform Microcell Silicone-filled Breast Implants Allergan On request Active 2023-05-10
NxTag Respiratory Pathogen Panel v2 Luminex Molecular Diagnostics, Inc. Proactive Active 2023-08-24
Dermatological Treatment Systems Sharplight Technologies Ltd On request Active 2023-09-12
Heliostar Balloon Ablation Catheter Biosense Webster, Inc. Proactive Active 2023-09-13
Lassostar Nav Catheter Biosense Webster, Inc. Proactive Active 2023-09-21
Soprano Ice Alma Lasers Ltd. On request Active 2023-09-22

 

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