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Active Data Protection Period Register of Innovative Drugs

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Active Data Protection Period Register of Innovative Drugs Register Of Innovative Drugs Products for Human Use - Active Data Protection Period Notice of Drug(s) Containing Pediatric Submission Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer the Medicinal Extension Number Date File" Date Ends Ingredient / Variations Yes / No yyyy-mm-dd abemaciclib 215268 Verzenio Eli Lilly Canada Inc. N/A 2019-04-08 2025-04-08 N/A 2027-04-08 acalabrutinib 214504 Calquence AstraZeneca Canada Inc. N/A 2019-08-23 2025-08-23 N/A 2027-08-23 aclidinium bromide 157598 Tudorza Genuair AstraZeneca Canada Inc. Duaklir Genuair 2013-07-29 2019-07-29 N/A 2021-07-29 afatinib dimaleate 158730 Giotrif Boehringer Ingelheim (Canada) Ltd. N/A 2013-11-01 2019-11-01 N/A 2021-11-01 aflibercept 149321 Eylea Bayer Inc. N/A 2013-11-08 2019-11-08 N/A 2021-11-08 albiglutide 165145 Eperzan GlaxoSmithKline Inc. N/A 2015-07-15 2021-07-15 N/A 2023-07-15 alectinib hydrochloride 189442 Alecensaro Hoffmann-La Roche Limited N/A 2016-09-29 2022-09-29 N/A 2024-09-29 alirocumab 183116 Praluent Sanofi-aventis Canada Inc. N/A 2016-04-11 2022-04-11 N/A 2024-04-11 alogliptin benzoate 158335 Nesina Takeda Canada Inc. Kazano 2013-11-27 2019-11-27 N/A 2021-11-27 Oseni anthrax antigen filtrate 212387 Biothrax Emergent Biodefense Operations N/A 2018-12-13 2024-12-13 N/A 2026-12-13 Lansing LLC anthrax immune globulin (human) 200446 Anthrasil Emergent BioSolutions Canada Inc. N/A 2017-11-06 2023-11-06 Yes 2026-05-06 antihemophilic factor (recombinant 163447 Eloctate Bioverativ Canada Inc. N/A 2014-08-22 2020-08-22 Yes 2023-02-22 BDD), Fc fusion protein antihemophilic factor (recombinant), 189709 Adynovate Shire Pharma Canada ULC N/A 2016-11-17 2022-11-17 Yes 2025-05-17 pegylated antihemophilic factor (recombinant, B- 169551 Nuwiq Octapharma Pharmazeutika N/A 2014-10-23 2020-10-23 Yes 2023-04-23 domain deleted) (also known as Produktionsges.m.b.H simoctocog alfa) antihemophilic factor (recombinant, B- 210935 Jivi Bayer Inc. N/A 2018-10-18 2024-10-18 Yes 2027-04-18 domain deleted, pegylated) (also known as damoctocog alfa pegol) Page 1 of 30 2019-12-19 Register Of Innovative Drugs Products for Human Use - Active Data Protection Period Notice of Drug(s) Containing Pediatric Submission Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer the Medicinal Extension Number Date File" Date Ends Ingredient / Variations Yes / No yyyy-mm-dd antihemophilic factor VIII (recombinant), 190891 Afstyla CSL Behring Canada Inc. N/A 2016-12-12 2022-12-12 Yes 2025-06-12 singlechain (also known as lonoctocog alfa) antihemophilic factor VIII (recombinant, 218531 Esperoct Novo Nordisk Canada Inc. N/A 2019-07-04 2025-07-04 Yes 2028-01-04 B-domain truncated), PEGylated (turoctocog alfa pegol) apalutamide 211942 Erleada Janssen Inc. N/A 2018-07-03 2024-07-03 N/A 2026-07-03 apixaban 141873 Eliquis Bristol-Myers Squibb Canada N/A 2011-12-16 2017-12-16 Yes 2020-06-16 apremilast 169862 Otezla Celgene Inc. N/A 2014-11-12 2020-11-12 N/A 2022-11-12 asenapine maleate 127427 Saphris Merck Canada Inc. N/A 2011-10-07 2017-10-07 Yes 2020-04-07 asfotase alfa 179340 Strensiq Alexion Pharma International Sàrl N/A 2015-08-14 2021-08-14 Yes 2024-02-14 asunaprevir 172617 Sunvepra Bristol-Myers Squibb Canada N/A 2016-03-09 2022-03-09 N/A 2024-03-09 atezolizumab 196843 Tecentriq Hoffmann-La Roche Limited N/A 2017-04-12 2023-04-12 N/A 2025-04-12 avelumab 204052 Bavencio EMD Serono, a Division of EMD Inc., N/A 2017-12-18 2023-12-18 N/A 2025-12-18 Canada axicabtagene ciloleucel 218389 Yescarta Gilead Sciences Canada Inc N/A 2019-02-13 2025-02-13 N/A 2027-02-13 axitinib 144404 Inlyta Pfizer Canada Inc. N/A 2012-07-12 2018-07-12 Yes 2021-01-12 azelastine hydrochloride 169604 Dymista Meda Pharmaceuticals Ltd. N/A 2014-10-23 2020-10-23 Yes 2023-04-23 azilsartan medoxomil potassium 145305 Edarbi Valeant Canada LP Edarbyclor 2012-03-08 2018-03-08 N/A 2020-03-08 baricitinib 193687 Olumiant Eli Lilly Canada Inc. N/A 2018-08-17 2024-08-17 N/A 2026-08-17 bazedoxifene acetate 160681 Duavive Pfizer Canada Inc. N/A 2014-10-23 2020-10-23 N/A 2022-10-23 bendamustine hydrochloride 149814 Treanda Teva Canada Limited N/A 2012-08-24 2018-08-24 Yes 2021-02-24 Page 2 of 30 2019-12-19 Register Of Innovative Drugs Products for Human Use - Active Data Protection Period Notice of Drug(s) Containing Pediatric Submission Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer the Medicinal Extension Number Date File" Date Ends Ingredient / Variations Yes / No yyyy-mm-dd benralizumab 204008 Fasenra AstraZeneca Canada Inc. N/A 2018-02-22 2024-02-22 Yes 2026-08-22 bepotastine besilate 179294 Bepreve Bausch and Lomb Incorporated N/A 2016-07-27 2022-07-27 Yes 2025-01-27 bictegravir 203718 Biktarvy Gilead Sciences Canada, Inc. N/A 2018-07-10 2024-07-10 N/A 2026-07-10 bilastine 184231 Blexten Aralez Pharmaceutials Canada Inc. N/A 2016-04-21 2022-04-21 Yes 2024-10-21 blinatumomab 181723 Blincyto Amgen Canada Incorporated N/A 2015-12-22 2021-12-22 Yes 2024-06-22 bosutinib 152211 Bosulif Pfizer Canada Inc. N/A 2014-03-07 2020-03-07 N/A 2022-03-07 botulism antitoxin heptavalent C/ D/F/ G 190645 Bat Emergent BioSolutions Inc. N/A 2016-12-08 2022-12-08 Yes 2025-06-08 – (equine) brentuximab vedotin 154851 Adcetris Seattle Genetics Inc. N/A 2013-02-01 2019-02-01 N/A 2021-02-01 brexpiprazole 192684 Rexulti Otsuka Pharmaceutical Co. Ltd. N/A 2017-02-16 2023-02-16 N/A 2025-02-16 brigatinib 210369 Alunbrig Takeda Canada Incorporated N/A 2018-07-26 2024-07-26 N/A 2026-07-26 brivaracetam 183355 Brivlera UCB Canada Incorporated N/A 2016-03-09 2022-03-09 Yes 2024-09-09 brodalumab 195317 Siliq Bausch Health, Canada Inc. N/A 2018-03-06 2024-03-06 N/A 2026-03-06 bromfenac sodium sesquihydrate 171657 Prolensa Bausch & Lomb Incorporated N/A 2015-03-26 2021-03-26 N/A 2023-03-26 burosumab 216239 Crysvita Kyowa Kirin Limited N/A 2018-12-05 2024-12-05 Yes 2027-06-05 cabozantinib (supplied as cabozantinib 206230 Cabometyx Ipsen Biopharmaceuticals Canada Inc. N/A 2018-09-14 2024-09-14 N/A 2026-09-14 (S)-malate) calcifediol 205392 Rayaldee Vifor Fresenius Medical Care Renal N/A 2018-07-10 2024-07-10 N/A 2026-07-10 Pharma Ltd canagliflozin 157505 Invokana Janssen Inc. Invokamet 2014-05-23 2020-05-23 N/A 2022-05-23 Invokamet XR Page 3 of 30 2019-12-19 Register Of Innovative Drugs Products for Human Use - Active Data Protection Period Notice of Drug(s) Containing Pediatric Submission Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer the Medicinal Extension Number Date File" Date Ends Ingredient / Variations Yes / No yyyy-mm-dd carfilzomib 184479 Kyprolis Amgen Canada Inc. N/A 2016-01-15 2022-01-15 N/A 2024-01-15 carglumic acid 171358 Carbaglu Orphan Europe Sarl N/A 2015-04-10 2021-04-10 Yes 2023-10-10 catridecacog 152228 Tretten Novo Nordisk Canada Inc. N/A 2012-07-19 2018-07-19 Yes 2021-01-19 catumaxomab 142629 Removab Fresenius Biotech GmbH N/A 2012-05-11 2018-05-11 N/A 2020-05-11 ceftolozane 178006 Zerbaxa Merck Canada Inc. N/A 2015-09-30 2021-09-30 N/A 2023-09-30 cemiplimab 218718 Libtayo Sanofi-Aventis Canada Inc. N/A 2019-04-10 2025-04-10 N/A 2027-04-10 cenegermin 218145 Oxervate Dompé farmaceutici S.p.A. N/A 2019-02-08 2025-02-08 N/A 2027-02-08 ceritinib 175702 Zykadia Novartis Pharmaceuticals Canada Inc. N/A 2015-03-27 2021-03-27 N/A 2023-03-27 cerliponase alfa 216539 Brineura Biomarin International Limited N/A 2018-12-19 2024-12-19 Yes 2027-06-19 coagulation factor IX (recombinant), 180793 Idelvion CSL Behring Canada Inc. N/A 2016-01-26 2022-01-26 Yes 2024-07-26 albumin fusion protein (rIX-FP) coagulation factor IX (recombinant), 201114 Rebinyn Novo Nordisk Canada Inc. N/A 2017-11-29 2023-11-29 Yes 2026-05-29 pegylated (nonacog beta pegol) coagulation factor IX, Fc fusion protein 163614 Alprolix Bioverativ Canada Inc. N/A 2014-03-20 2020-03-20 Yes 2022-09-20 cobimetinib 182788 Cotellic Hoffmann-La Roche Limited N/A 2016-02-22 2022-02-22 N/A 2024-02-22 collagenase clostridium histolyticum 147788 Xiaflex Endo Ventures Ltd. N/A 2012-07-05 2018-07-05 N/A 2020-07-05 crisaborole 206906 Eucrisa Pfizer Canada Inc. N/A 2018-06-07 2024-06-07 Yes 2026-12-07 crizotinib 145155 Xalkori Pfizer Canada Inc. N/A 2012-04-25 2018-04-25 Yes 2020-10-25 cysteamine bitartrate 191347 Procysbi Horizon Pharma Ireland Ltd. N/A 2017-06-13 2023-06-13 Yes 2025-12-13 Page 4 of 30 2019-12-19 Register Of Innovative Drugs Products for Human Use - Active Data Protection Period Notice of Drug(s) Containing Pediatric Submission Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer the Medicinal Extension Number Date File" Date Ends Ingredient / Variations Yes / No yyyy-mm-dd dabrafenib mesylate 157590 Tafinlar Novartis Pharmaceuticals Canada Inc.
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