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 |
|---|---|---|---|---|
| Tagrisso | AstraZeneca Canada Inc | On request | Pending | |
| Lynparza | AstraZeneca Canada Inc | On request | Pending | |
| Arimidex | AstraZeneca Canada Inc | On request | Pending | |
| Epkinly | AbbVie Corporation | Proactive | Active | 2023-10-13 |
| Sibboran | Trimedic Therapeutics Inc. | Proactive | Active | 2023-11-20 |
| Jorveza | Avir Pharma Inc. | Proactive | Active | 2024-08-21 |
| Miebo | Bausch & Lomb Inc | Proactive | Active | 2024-09-04 |
| Mezavant | Takeda Canada Inc | On request | Pending | |
| Truvada | Gilead Sciences Canada Inc | On request | Pending | |
| Ojjaara | GlaxoSmithKline Inc | Proactive | Active | 2024-11-08 |
| Cresemba | Avir Pharma Inc. | Proactive | Active | 2024-11-15 |
| Suboxone | Indivior UK Limited | On request | Active | 2024-12-05 |
| Welireg | Merck Canada Inc | Proactive | Active | 2024-12-17 |
| Ringza | Duchesnay Inc | Proactive | Active | 2024-12-18 |
| Vabomere | Xediton Pharmaceuticals Inc | Proactive | Active | 2024-12-20 |
| Trulance | Bausch Health, Canada Inc. | Proactive | Active | 2024-12-24 |
| Rybrevant | Janssen Inc | Proactive | Active | 2025-01-13 |
| Aripiprazole Oral Solution | Orimed Pharma Inc | Proactive | Active | 2025-01-15 |
| Baxdela | Xediton Pharmaceuticals Inc | Proactive | Active | 2025-01-17 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2025-01-17 |
| Penthrox | Endo Operations Inc. | Proactive | Active | 2025-01-31 |
| Movapo | Paladin Pharma Inc. | On request | Active | 2025-02-05 |
| Suboxone | Indivior UK Limited | On request | Pending | |
| Rybelsus | Novo Nordisk Canada Inc | On request | Pending | |
| Cardene | Hoffmann-La Roche Limited | On request | Pending | |
| Xfusor | Formative Pharma Inc. | Proactive | Active | 2025-03-20 |
| Wegovy | Novo Nordisk Canada Inc | Proactive | Active | 2025-03-24 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2025-04-08 |
| Elyxyb | Scilex Pharmaceuticals Inc. | Proactive | Active | 2025-04-09 |
| Opfolda | Amicus Therapeutics Canada Inc. | Proactive | Active | 2025-04-10 |
| Pombiliti | Amicus Therapeutics Canada Inc. | Proactive | Active | 2025-04-15 |
| Tagrisso | AstraZeneca Canada Inc | Proactive | Active | 2025-04-23 |
| Zepbound Kwikpen | Eli Lilly Canada Inc | Proactive | Active | 2025-05-13 |
| Apretude | ViiV HealthCare ULC | Proactive | Active | 2025-06-05 |
| Firdapse | Kye Pharmaceuticals Inc | Proactive | Active | 2025-06-10 |
| Kisqali | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2025-06-12 |
| Uplizna | Amgen Canada Inc | Proactive | Active | 2025-06-13 |
| Trajenta | Boehringer Ingelheim (Canada) Ltd Ltee | On request | Active | 2025-06-18 |
| Longavo | Teva Canada Limited | Proactive | Active | 2025-06-18 |
| Calquence | AstraZeneca Canada Inc | Proactive | Active | 2025-06-24 |
| Aflivu | Apotex Inc | Proactive | Active | 2025-06-26 |
| Yesafili | Biosimilar Collaborations Irelands Limited | Proactive | Active | 2025-06-26 |
| Cabenuva | ViiV HealthCare ULC | Proactive | Active | 2025-06-30 |
| Corzyna | Kye Pharmaceuticals Inc | Proactive | Active | 2025-06-30 |
| Amivas-Artesunate | Amivas Ireland Ltd. | Proactive | Active | 2025-07-04 |
| Omvoh | Eli Lilly Canada Inc | Proactive | Active | 2025-07-08 |
| Pavblu | Amgen Canada Inc | Proactive | Active | 2025-07-08 |
| Vyvanse | Takeda Canada Inc | On request | Pending | |
| Xipere | Bausch & Lamb Inc | Proactive | Active | 2025-07-14 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2025-07-16 |
| Zoloft | BGP Pharma ULC | On request | Active | 2025-07-17 |
| Buccolam | Neuraxpharm Pharmaceuticals, S.L. | Proactive | Active | 2025-07-22 |
| Depo-Provera | Pfizer Canada ULC | On request | Pending | |
| Dynavel XR Chewable tablets | Kye Pharmaceuticals Inc | Proactive | Active | 2025-07-28 |
| Bavencio | EMD Serono A Division of EMD Inc Canada | Proactive | Active | 2025-08-05 |
| Cyclophosphamide For Injection | Dr Reddys Laboratories LTD | Proactive | Active | 2025-08-05 |
| Tremfya | Janssen Inc | Proactive | Active | 2025-08-07 |
| Columvi | Hoffmann-La Roche Limited | Proactive | Active | 2025-08-13 |
| Brineura | Biomarin International Limited | Proactive | Active | 2025-08-18 |
| Odan-Pregabalin | Odan Laboratories Ltd | Proactive | Active | 2025-08-19 |
| Ubrelvy | AbbVie Corporation | Proactive | Active | 2025-08-26 |
| Calquence | AstraZeneca Canada Inc | Proactive | Active | 2025-09-11 |
| Opsumit | Janssen Inc | Proactive | Active | 2025-09-12 |
| Oritiniv | Xediton Pharmaceuticals Inc | Proactive | Active | 2025-09-12 |
| Columvi | Hoffmann-La Roche Limited | Proactive | Active | 2025-09-16 |
| Osenvelt | Celltrion Inc | Proactive | Active | 2025-09-17 |
| Stoboclo | Celltrion Inc | Proactive | Active | 2025-09-17 |
| Tyruko | Polpharma Biologics S.A. | Proactive | Active | 2025-09-24 |
| Femara | Novartis Pharmaceuticals Canada Inc | On request | Active | 2025-09-24 |
| Spinraza | Biogen Canada Inc | Proactive | Active | 2025-09-26 |
| Agamree | Kye Pharmaceuticals Inc | Proactive | Active | 2025-09-29 |
| Blexten | Aralez Pharmaceuticals Canada Inc | Proactive | Active | 2025-10-01 |
| Spevigo | Boehringer Ingelheim (Canada) Ltd Ltee | Proactive | Active | 2025-10-07 |
| Opuviz | Samsung Bioepis Co., Ltd | Proactive | Active | 2025-10-09 |
| Jaypirca | Eli Lilly Canada Inc | Proactive | Active | 2025-10-17 |
| Abrysvo | Pfizer Canada ULC | Proactive | Active | 2025-10-17 |
| Loqtorzi | Apotex Inc | Proactive | Active | 2025-10-17 |
| Jivi | Bayer Inc | Proactive | Active | 2025-10-20 |
| Dupixent | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-10-21 |
| Voydeya | Alexion Pharma GMBH | Proactive | Active | 2025-10-23 |
| Enhertu | AstraZeneca Canada Inc | Proactive | Active | 2025-10-27 |
| Dupixent | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-10-27 |
| Doxycycline for Injection USP | Sterimax Inc | Proactive | Active | 2025-10-28 |
| Enzeevu | Sandoz Canada Incorporated | Proactive | Active | 2025-10-30 |
| Vyvgart SC | Argenx BV | Proactive | Active | 2025-11-03 |
| Zoryve | Arcutis Canada, Inc. | Proactive | Active | 2025-11-12 |
| Lupron Depot | AbbVie Corporation | Poactive | Active | 2025-11-13 |
| Nilemdo | Esperion Therapeutics, Inc | Proactive | Active | 2025-11-14 |
| Darzalex SC | Janssen Inc | Proactive | Active | 2025-11-18 |
| Ahzantive | Valorum Biologics LLC | Proactive | Active | 2025-11-19 |
| Wynzora | Knight Therapeutics Inc. | Proactive | Active | 2025-11-21 |
| Menveo | GlaxoSmithKline Inc | Proactive | Active | 2025-11-21 |
| Eydenzelt | Celltrion Inc | Proactive | Active | 2025-11-24 |
| Rinvoq | AbbVie Corporation | On request | Active | 2025-11-27 |
| Tagrisso | AstraZeneca Canada Inc | On request | Active | 2025-12-02 |
| Lataneo PF | Orimed Pharma Inc | Proactive | Active | 2025-12-02 |
| Sublocade | Indivior UK Limited | Proactive | Active | 2025-12-02 |
| Winrevair | Merck Canada Inc | Proactive | Active | 2025-12-03 |
| Ultomiris | Alexion Pharma Gmbh | Proactive | Active | 2025-12-03 |
| Twyneo | Searchlight Pharma Inc | Proactive | Active | 2025-12-04 |
| Zurzuvae | Biogen Canada Inc | Proactive | Active | 2025-12-05 |
| Elfabrio | Chiesi Farmaceutici S.P.A. | Proactive | Active | 2025-12-09 |
| Wegovy | Novo Nordisk Canada Inc | Proactive | Active | 2025-12-10 |
| Zykadia | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2025-12-10 |
| Jatenzo (Testosterone Undecanoate) | Tolmar International Ltd. | Proactive | Active | 2025-12-12 |
| Amvuttra | Alnylam Netherlands B.V. | Proactive | Active | 2025-12-12 |
| Bimzelx | Ucb Canada Inc | Proactive | Active | 2025-12-12 |
| Tryngolza | Theratechnologies Inc | Proactive | Active | 2025-12-16 |
| Tevimbra | Beigene Switzerland Gmbh | Proactive | Active | 2025-12-18 |
| Nemluvio | Galderma Canada Inc | Proactive | Active | 2025-12-18 |
| Balversa | Janssen Inc | Proactive | Active | 2025-12-18 |
| Blincyto | Amgen Canada Inc | On request | Active | 2025-12-19 |
| Jeraygo | Idorsia Pharmaceuticals Ltd | Proactive | Active | 2025-12-23 |
| Benlysta | GlaxoSmithKline Inc | Proactive | Active | 2025-12-23 |
| Rybelsus | Novo Nordisk Canada Inc | Proactive | Active | 2025-12-31 |
| Soliris | Alexion Pharma International Sarl | On request | Active | 2026-01-05 |
| Daklinza | Bristol-Myers Squibb Canada | On request | Active | 2026-01-05 |
| Dyrupeg | Curateq Biologics Private Limited | Proactive | Active | 2026-01-06 |
| Isentress | Merck Canada Inc | On request | Active | 2026-01-09 |
| Taltz | Eli Lilly Canada Inc | On request | Active | 2026-01-09 |
| Ebglyss | Eli Lilly Canada Inc | Proactive | Active | 2026-01-12 |
| Depo-Provera | Pfizer Canada Inc | On request | Active | 2026-01-12 |
| Praxbind | Boehringer Ingelheim (Canada) Ltd Ltee | On request | Pending | |
| Mresvia | Moderna Biopharma Canada Corporation | Proactive | Active | 2026-01-14 |
| Siliq | Bausch Health, Canada Inc. | On request | Active | 2026-01-14 |
| Vectibix | Amgen Canada Inc | On request | Pending | |
| Opdivo | Bristol-Myers Squibb Canada | On request | Pending | |
| Sprycel | Bristol-Myers Squibb Canada | On request | Pending | |
| Orencia | Bristol-Myers Squibb Canada | On request | Pending | |
| Duratocin | Ferring Inc | On request | Pending | |
| Cayston | Gilead Sciences Canada Inc | On request | Pending | |
| Alencensaro | Hoffmann-La Roche Limited | On request | Pending | |
| Imbruvica | Janssen Inc | On request | Pending | |
| Velcade | Janssen Inc | On request | Pending | |
| Remicade | Janssen Inc | On request | Pending | |
| Exjade | Novartis Pharmaceuticals Canada Inc | On request | Pending | |
| Tasigna | Novartis Pharmaceuticals Canada Inc | On request | Pending | |
| Cimzia | UCB Canada Inc | On request | Pending | |
| Voxzogo | BioMarin International Limited | Proactive | Active | 2026-01-21 |
| Truvada | Gilead Sciences Inc | On request | Active | 2026-01-21 |
| Imuldosa | Accord Healthcare Inc | Proactive | Active | 2026-01-21 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2026-01-22 |
| Gazyva | Hoffmann-La Roche Limited | Proactive | Active | 2026-01-22 |
| Yorvipath | Pendopharm Division of Pharmascience Inc | Proactive | Active | 2026-01-28 |
| Hyrnuo | Bayer Inc | Proactive | Active | 2026-01-29 |
| Recarbrio | Merck Canada Inc | Proactive | Active | 2026-01-30 |
| Livmarli | Mirum Pharmaceuticals, Inc. | Proactive | Active | 2026-01-30 |
| Ajovy | Teva Canada Limited | Proactive | Active | 2026-01-30 |
| Enflonsia | Merck Canada Inc | Proactive | Active | 2026-01-30 |
| Duratocin | Ferring Inc | Proactive | Active | 2026-02-03 |
| Keytruda | Merck Canada Inc | Proactive | Active | 2026-02-03 |
| Xenpozyme | Sanofi-Aventis Canada Inc | Proactive | Active | 2026-02-04 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2026-02-05 |
| Lunsumio | Hoffmann-La Roche Limited | Proactive | Active | 2026-02-06 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2026-02-09 |
| Tezspire | AstraZeneca Canada Inc | Proactive | Active | 2026-02-09 |
| Cibinqo | Pfizer Canada ULC | Proactive | Active | 2026-02-10 |
| Talzenna | Pfizer Canada ULC | Proactive | Active | 2026-02-10 |
| Spikevax | Moderna Biopharma Canada Corporation | Proactive | Active | 2026-02-10 |
| Rifapentine Tablets | Macleods Pharmaceuticals Limited | Proactive | Active | 2026-02-12 |
| Sulcrate | AbbVie Corporation | On request | Pending | |
| Humira | AbbVie Corporation | On request | Pending | |
| Keytruda | Merck Canada Inc | On request | Pending | |
| Sandimmune | Novartis Pharmaceuticals Canada Inc | On request | Pending | |
| Adruxe | Dr. Reddy's Laboratories SA | Proactive | Active | 2026-02-13 |
| Darzalex | Janssen Inc | On request | Active | 2026-02-17 |
| Praluent | Sanofi-Aventis Canada Inc | On request | Active | 2026-02-17 |
| Tepadina | Adienne Sa | Proactive | Active | 2026-02-17 |
| Ocrevus | Hoffmann-La Roche Limited | Proactive | Active | 2026-02-17 |
| Comirnaty | BionTech Manufacturing GMBH | Proactive | Active | 2026-02-18 |
| Nuvaxovid | Novavax Inc. | Proactive | Active | 2026-02-19 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2026-02-20 |
| Koselugo | Alexion Pharma GMBH | Proactive | Active | 2026-02-25 |
| Ozempic | Novo Nordisk Canada Inc | Proactive | Active | 2026-02-25 |
| Mint-Citalopram Solution | Mint Pharmaceuticals Inc | Proactive | Active | 2026-02-25 |
| Takhzyro | Takeda Canada Inc | Proactive | Active | 2026-03-02 |
| Balansya | Orimed Pharma Inc | Proactive | Active | 2026-03-04 |
| Saphnelo | AstraZeneca Canada Inc | Proactive | Active | 2026-03-05 |
| Cysklar | Leadiant Biosciences, Inc. | Proactive | Active | 2026-03-06 |
| Bildyos | Shanghai Henlius Biotech, Inc. | Proactive | Active | 2026-03-09 |
| Clobivis | Apotex Inc | Proactive | Active | 2026-03-13 |
| Alecensaro | Hoffmann-La Roche Limited | On request | Active | 2026-03-13 |
| Nexplanon | Merck Canada Inc | On request | Active | 2026-03-13 |
| Adstiladrin | Ferring Inc | Proactive | Active | 2026-03-16 |
| Lokelma | AstraZeneca Canada Inc | Proactive | Active | 2026-03-24 |
| Menquadfi | Sanofi Pasteur Limited | Proactive | Active | 2026-03-26 |
| Adtralza | Leo Pharma Inc | Proactive | Active | 2026-03-27 |
| Libtayo | Regeneron Canada Company | Proactive | Active | 2026-03-27 |
| Camcevi 21mg (3-month) | Accord Healthcare Inc | Proactive | Active | 2026-03-31 |
| Zepbound | Eli Lilly Canada Inc | Proactive | Active | 2026-04-02 |
| Mounjaro | Eli Lilly Canada Inc | Proactive | Active | 2026-04-02 |
| Xbryk | Samsung BioEpis Co., Ltd | Proactive | Active | 2026-04-07 |
| Empaveli | Swedish Orphan Biovitrum AB (Publ) | Proactive | Active | 2026-04-08 |
| Yeytuo | Gilead Sciences Canada Inc | Proactive | Active | 2026-04-09 |
| Vueway | Bracco Imaging Canada | Proactive | Active | 2026-04-09 |
| Neffy | ARS Pharmaceuticals Operations, Inc. | Proactive | Active | 2026-04-09 |
| Upgolyv | Jamp Pharma Corporation | Proactive | Active | 2026-04-10 |
| Ozempic | Novo Nordisk Canada Inc | Proactive | Active | 2026-04-16 |
| Tevimbra | Beigene Switzerland GMBH | Proactive | Active | 2026-04-16 |
| Minjuvi | Incyte Corporation | Proactive | Active | 2026-04-17 |
| Obodence | Samsung BioEpis Co., Ltd | Proactive | Active | 2026-04-17 |
| Bosaya | Biosimilar Collaborations Ireland Limited | Proactive | Active | 2026-04-17 |
| Vevzuo | Biosimilar Collaborations Ireland Limited | Proactive | Active | 2026-04-17 |
| Bomyntra | Fresenius Kabi Canada Ltd | Proactive | Active | 2026-04-18 |
| Connexxence | Fresenius Kabi Canada Ltd | Proactive | Active | 2026-04-18 |
| Abrysvo | Pfizer Canada ULC | Proactive | Active | 2026-04-20 |
| Rozlytrek | Hoffmann-La Roche Limited | Proactive | Active | 2026-04-20 |
| Ayvakyt | Blueprint Medicines Corporation | Proactive | Active | 2026-04-20 |
| Zejula | GlaxoSmithKline Inc | Proactive | Active | 2026-04-21 |
| Bekemv | Amgen Canada Inc | Proactive | Active | 2026-04-22 |
| Tagrisso | AstraZeneca Canada Inc | On request | Active | 2026-04-24 |
| Keytruda | Merck Canada Inc | Proactive | Active | 2026-04-24 |
| Venclexta | AbbVie Corporation | Proactive | Active | 2026-04-28 |
| Bevqolva | Curateq Biologics Private Limited | Proactive | Active | 2026-04-28 |
| Fabhalta | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2026-04-30 |
| Kisunla | Eli Lilly Canada Inc | Proactive | Active | 2026-04-30 |
| Beyfortus | Sanofi Pasteur Limited | Proactive | Active | 2026-05-07 |
| Tecentriq SC | Hoffmann-La Roche Limited | Proactive | Active | 2026-05-11 |
| Orkambi | Vertex Pharmaceuticals (Canada) Incoporated | Proactive | Active | 2026-05-13 |
| Iheezo | Apotex Inc | Proactive | Active | 2026-05-14 |
| Thyconvi | Biosyent Pharma Inc | Proactive | Active | 2026-05-15 |
| Uplizna | Amgen Canada Inc | Proactive | Active | 2026-05-19 |
| Eylea HD | Bayer Inc | Proactive | Active | 2026-05-25 |
| Krystexxa | Amgen Canada Inc | Proactive | Active | 2026-05-28 |
| Zynyz | Incyte Corporation | Proactive | Active | 2026-05-28 |
| Loargys | Immedica Pharma AB | Proactive | Active | 2026-05-29 |
| Ojemda | Ipsen Biopharmaceuticals Canada Inc | Proactive | Active | 2025-05-29 |
| Stelara | Janssen Inc | On request | Active | 2026-06-04 |
| Tremfya | Janssen Inc | On request | Active | 2026-06-04 |
| Keytruda | Merck Canada Inc | Proactive | Active | 2026-06-05 |
| Nucala | GlaxoSmithKline Inc | Proactive | Active | 2026-06-09 |
| Sarclisa | Sanofi-Aventis Canada Inc | Proactive | Active | 2026-06-10 |
| Ranvu | Apotex Inc | Proactive | Active | 2026-06-10 |
| Zepbound Kwikpen | Eli Lilly Canada Inc | Proactive | Active | 2026-06-11 |
| Breyanzi | Bristol-Myers Squibb Canada | Proactive | Active | 2026-06-12 |
| Pimjetmi | EMD Serono A Division of EMD Inc Canada | Proactive | Active | 2026-06-12 |
| Exdensur | GlaxoSmithKline Inc | Proactive | Active | 2026-06-15 |
| Epysqli | Samsung BioEpis Co., Ltd | Proactive | Active | 2026-06-17 |
| Welireg | Merck Canada Inc | Proactive | Active | 2026-06-17 |
| Rybrevant | Janssen Inc | Proactive | Active | 2026-06-18 |
| Boey | AbbVie Corporation | Proactive | Active | 2026-06-22 |
| Akeega | Janssen Inc | Proactive | Active | 2026-06-23 |
| Mounjaro | Eli Lilly Canada Inc | Proactive | Active | 2026-06-23 |
| Shingrix | GlaxoSmithKline Inc | Proactive | Active | 2026-06-24 |
| Braftovi | Pfizer Canada ULC | Proactive | Active | 2026-06-25 |
| Imdelltra | Amgen Canada Inc | Proactive | Active | 2026-06-25 |
| Padcev | Pfizer Canada ULC | Proactive | Active | 2026-06-26 |
| Vimkunya | Bavarian Nordic AS | Proactive | Active | 2026-06-26 |
| Imdelltra | Amgen Canada Inc | Proactive | Active | 2026-07-02 |
| Koselugo | Alexion Pharma GMBH | Proactive | Active | 2026-07-02 |
| Vanrafia | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2026-07-02 |
Medical devices
| Device name | Manufacturer | Process | Status | Start Date |
|---|---|---|---|---|
| Lutonix 018 Drug Coated Balloon PTA Catheter | Lutonix, Inc | Proactive | Active | 2022-10-13 |
| CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | Proactive | Active | 2024-10-21 |
| Sentio System | Oticon Medical AB | Proactive | Active | 2025-01-23 |
| Edwards Pascal Precision Transcatheter Valve Repair System | Edwards Lifesciences LLC | Proactive | Active | 2025-02-06 |
| Striate+ And Perform | Orthocell Ltd | Proactive | Active | 2025-02-25 |
| Amicus System | Fresenius Kabi AG | Proactive | Active | 2025-04-08 |
| Edwards Sapien 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent | Edwards Lifesciences LLC | Proactive | Active | 2025-04-24 |
| Edwards Evoque Tricuspid Valve Replacement System | Edwards LIfesciences LLC | Proactive | Active | 2025-07-14 |
| Passeo-18 Lux Paclitaxel-Releasing Percutaneous Transluminal Angioplasty Balloon Catheter | Biotronik AG | Proactive | Active | 2025-09-15 |
| Myval Octacor Transcatheter Heart Valve System | Meril Life Sciences Pvt., Ltd. | On request | Active | 2026-06-03 |
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