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
Paxil GlaxoSmithKline Inc. On request Active 2022-02-28
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  
Luvox BGP Pharma ULC On request Active 2022-06-06
Elmiron Janssen Inc. On request Active 2022-05-30
Enhertu AstraZeneca Canada Inc. Proactive Active 2021-04-19
Lipitor Upjohn Canada ULC On request Active 2022-06-07
Suboxone Indivior UK Limited On request Active 2022-04-11
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
Hyqvia Amgen Canada Inc. Proactive Active 2022-01-14
Sohonos Ipsen Biopharmaceuticals Canada Inc. Proactive Active 2022-01-21
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
Dupixent Sanofi-Aventis Canada Inc. Proactive Active 2022-03-25
Zeposia Celgene Inc. Proactive Active 2022-04-08
Keytruda Merck Canada Inc. Proactive Active 2022-04-07
Jardiance Boehringer Ingelheim (Canada) Ltd Ltee Proactive Active 2022-04-06
Evusheld AstraZenaca Canada Inc. Proactive Active 2022-04-14
Keytruda Merck Canada Inc. Proactive Active 2022-04-12
Tavneos VIFOR Fresenius Medical Care Renal Pharma Ltd. Proactive Active 2022-04-14
Vraylar Allergan Inc. Proactive Active 2022-04-22
Trikafta Vertex Pharmaceuticals (Canada) Incorporation Proactive Active 2022-04-20
Breyanzi Celgene Inc. Proactive Active 2022-05-06
Keytruda Merck Canada Inc. Proactive Active 2022-05-04
Qinlock Deciphera Pharmaceuticals LLC Proactive Active 2022-05-10
Prevnar Pfizer Canada ULD Proactive Active 2022-05-09
Lumify Bausch Health, Canada Inc. Proactive Active 2022-05-19
Octagam Octapharma Phramazeutika Produktionges MBH 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
Orladeyo Biocryst Pharmaceuticals Inc. Proactive Active 2022-06-02
Poteligeo Kyowa Kirin Inc. Proactive Active 2022-06-02
Opdivo Bristol-Myers-Squibb Canada Proactive Active 2022-06-02
Kimmtrak Immunocore Ireland Limited Proactive Active 2022-06-02
Entyvio Takeda Canada Inc. Proactive Active 2022-06-08
Cutaquig Octapharma Pharmazeutika Produktionsges MBH Proactive Active 2022-06-09
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
Cabenuva, Vocabria VIIV Healthcare ULC 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
Opdivo Bristol-Myers Squibb Canada Proactive Active 2022-06-27
Spravato Janssen Inc. Proactive Active 2022-06-28
Cibinqo Pfizer Canada ULC Proactive Active 2022-06-28
Rydapt Novartis Pharmaceuticals Canada Inc. Proactive Active 2022-06-29
Piqray Novartis Pharmaceuticals Canada Inc. Proactive Active 2022-06-30
Octaplasma Octapharma Pharmazeutika Produktionsges M B H  Proactive Active 2022-06-30
Keytruda Merck Canada Inc. Proactive Active 2022-07-05
Sublocade Indivior UK Limited Proactive Active 2022-07-05
Entyvio Takeda Canada Inc. Proactive Active 2022-07-06
Opdivo Bristol-Myers Squibb Canada Proactive Active 2022-07-07
Vaxneuvance Merck Canada Inc. Proactive Active 2022-07-08
Welireg Merck Canada Inc. Proactive Active 2022-07-11
Rinvoq Abbvie Corporation Proactive Active 2022-07-13
Cymbalta Eli LIlly Canada Inc. On request Active 2022-07-11
Keytruda Merck Canada Proactive Active 2022-07-20
Alunbrig Takeda Canada Proactive Active 2022-07-20
Orencia Bristol-Myers Squibb Canada Proactive Active 2022-07-21
Opdivo Bristol-Myers Squibb Canada Proactive Active 2022-07-25
Gazyva Hoffman-La Roche Limited Proactive Active 2022-07-25
Constella Allergan Inc. Proactive Active 2022-07-26
Tafinlar Novartis Pharmaceutical Canada Inc. Proactive Active 2022-07-26
Mekinist Novartis Pharmaceutical Canada Inc. Proactive Active 2022-07-26
Lynparza AstraZeneca Canada Inc. Proactive Active 2022-07-27
Rozlytrek Hoffman-La Roche Limited Proactive Active 2022-07-28
Tezspire AstraZeneca Proactive Active 2022-07-28
Simponi I.V Jannsen Inc. Proactive Active 2022-07-29
Myxredlin Baxter Corporation Proactive Active 2022-08-03
Octasa Tillotts Pharma AG Proactive Active 2022-08-08
Cosentyx Novartis Pharmaceutical Canada Inc. Proactive Active

2022-08-10

Ocaliva Intercept Pharmaceuticals Inc. Proactive Active 2022-08-11
Epclusa Gilead Sciences Canada Inc. Proactive Active 2022-08-11
Korsuva Vifor Fresenius Medical Care Renal Pharma Ltd Proactive Active 2022-08-16
Bavencio EMD Serono A Division of EMD Inc Canada Proactive Active 2022-08-15
Vyndamax Pfizer Canada ULC Proactive Active 2022-08-17
Prezista Janssen Inc Proactive Active 2022-08-17
Symtuza Janssen Inc Proactive Active 2022-08-17
Prezcobix Janssen Inc 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
Spikevax Bivalent Modernatx, Inc. Proactive Active 2022-09-01
Rymti Lupin Pharma Canada Limited Proactive Active 2022-08-31
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
Sholyne Kye Pharmaceuticals Inc Proactive Active 2022-09-12
Darzalex SC, Darzalex Janssen Inc Proactive Active 2022-09-13
Susvimo Hoffman-La Roche Limited Proactive Active 2022-09-14
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
Ocaliva Intercept Pharmaceuticals Inc Proactive Active 2022-09-16
Cosentyx Novartis Pharmaceuticals Canada Inc. Proactive Active 2022-09-20
Ryaltris Glenmark Specialty SA Proactive Active 2022-09-21
Taltz Eli Lilly Canada Inc Proactive Active 2022-09-21
Xeomin Merz Pharmaceuticals GMBH Proactive Active 2022-09-22
Pediacel

Sanofi Pasteur Limited

On request Active 2022-09-23
Lariam Hoffmann-La Roche Limited On request Active 2022-09-27
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
Yescarta Gilead Sciences Canada Inc Proactive Active 2022-09-29
Iclusig Takeda Pharmaceuticals U.S.A., Inc. Proactive Active 2022-10-03
Comirnaty Original and Omicron BA.4/BA.5 BioNTech Manufacturing GMBH Proactive Active 2022-10-07
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
Actemra Hoffmann-La Roche Limited Proactive Active 2022-10-13
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
Gleevec Novartis Pharmaceuticals Canada Inc On request Active 2022-10-19
Comirnaty Original/ Omicron BA.1 BioNTech Manufacturing GMBH Proactive Active 2022-10-21
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

Medical devices

Device name Manufacturer Process Status Start Date
Micra Transcatheter Pacing System Medtronic Inc. Proactive Active

2021-02-12

Savvywire Opsens, Inc. Proactive Active 2022-04-19
Manta Vascular Closure Device Essential Medical, Inc. Proactive Active 2022-05-03
Neo Iris Immucor Inc. Proactive Active 2022-05-10
The Zenith Dissection Endovascular System William Cook Europe APS Proactive Active 2022-05-18
Penumbra System Penumbra Inc. Proactive Active 2022-05-26
Ossmem Hard/Ossmem Soft Osstem Implant Co. Ltd. Proactive Active 2022-06-15
Physio Flex Annuloplasty Ring Edwards Lifesciences LLC Proactive Active 2022-06-15
Multi-Spine High-Density Mapping Catheter Biosense Webster, Inc. Proactive Active 2022-06-16
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
Orsiro Mission Sirolimus Eluting Coronary Stent System BioTronik AG Proactive Active 2022-07-28
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
Venus Fiore Venus Concept Ltd 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
Sal6830 SARS-CoV-2 Saliva Test Microgem U.S., Inc. On request Active 2022-10-14

 

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: