Active Data Protection Period Register of Innovative Drugs

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. N/A 2013-07-16 2019-07-16 N/A 2021-07-16 daclatasvir 172616 Daklinza Bristol-Myers Squibb Canada N/A 2015-08-13 2021-08-13 N/A 2023-08-13 daclizumab beta 190458 Zinbryta Biogen Canada Inc. N/A 2016-12-08 2022-12-08 N/A 2024-12-08 dacomitinib 214572 Vizimpro Pfizer Canada Inc. N/A 2019-02-26 2025-02-26 N/A 2027-02-26 dalbavancin (supplied as dalbavancin 212390 Xydalba Cipher Pharmaceuticals Inc. N/A 2018-09-04 2024-09-04 N/A 2026-09-04 hydrochloride) dapagliflozin propanediol 160877 Forxiga AstraZeneca Canada Inc. Xigduo 2014-12-12 2020-12-12 N/A 2022-12-12 Qtern daratumumab 187648 Darzalex Janssen Inc. N/A 2016-06-29 2022-06-29 N/A 2024-06-29 deferiprone 162924 Ferriprox ApoPharma Inc. N/A 2015-02-13 2021-02-13 Yes 2023-08-13 defibrotide sodium 200808 Defitelio Jazz Pharmaceuticals Ireland Limited N/A 2017-07-10 2023-07-10 Yes 2026-01-10 dienogest 132174 Visanne Bayer Inc. Natazia 2011-10-12 2017-10-12 Yes 2020-04-12 difluprednate 154517 Durezol Novartis Pharmaceuticals Canada Inc. N/A 2013-11-04 2019-11-04 Yes 2022-05-04 dimethyl fumarate 154776 Tecfidera Biogen Idec Canada Inc. N/A 2013-04-03 2019-04-03 Yes 2021-10-03 dinutuximab 212066 Unituxin United Therapeutics Corporation N/A 2018-11-28 2024-11-28 Yes 2027-05-28 dolutegravir sodium 161084 Tivicay ViiV Healthcare ULC Triumeq 2013-10-31 2019-10-31 Yes 2022-05-01 Juluca Dovato doravirine 211293 Pifeltro Merck Canada Inc. Delstrigo 2018-10-12 2024-10-12 N/A 2026-10-12 dulaglutide 168671 Trulicity Eli Lilly Canada Inc. N/A 2015-11-10 2021-11-10 N/A 2023-11-10 dupilumab 201285 Dupixent Sanofi-Aventis Canada Inc. N/A 2017-11-30 2023-11-30 Yes 2026-05-30

Page 5 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 durvalumab 202953 Imfinzi AstraZeneca Canada Inc. N/A 2017-11-03 2023-11-03 N/A 2025-11-03 edaravone 214391 Radicava Mitsubishi Tanabe Pharma Corporation N/A 2018-10-03 2024-10-03 N/A 2026-10-03 edoxaban 187363 Lixiana Servier Canada Inc. N/A 2016-11-04 2022-11-04 N/A 2024-11-04 efinaconazole 159416 Jublia Valeant Canada LP / Valeant Canada N/A 2013-10-02 2019-10-02 N/A 2021-10-02 S.E.C. elagolix 209513 Orilissa AbbVie Corporation N/A 2018-10-05 2024-10-05 N/A 2026-10-05 eliglustat tartrate 183050 Cerdelga Genzyme Canada, A division of Sanofi- N/A 2017-04-21 2023-04-21 N/A 2025-04-21 aventis Canada Inc. elosulfase alfa 170340 Vimizim Biomarin International Limited N/A 2014-07-02 2020-07-02 Yes 2023-01-02 elotuzumab 188144 Empliciti Bristol-Myers Squibb Canada N/A 2016-06-21 2022-06-21 N/A 2024-06-21 eluxadoline 190162 Viberzi Allergan Inc. N/A 2017-01-26 2023-01-26 N/A 2025-01-26 elvitegravir, cobicistat 152198 Stribild Gilead Sciences Canada Inc. Tybost 2012-11-26 2018-11-26 N/A 2020-11-26 Vitekta Prezcobix Evotaz Genvoya Symtuza emicizumab 212635 Hemlibra Hoffmann-La Roche Limited N/A 2018-08-02 2024-08-02 Yes 2027-02-02 empagliflozin 162552 Jardiance Boehringer Ingelheim (Canada) Ltd. Synjardy 2015-07-23 2021-07-23 N/A 2023-07-23 Glyxambi enasidenib mesylate 217033 Idhifa Celgene Inc. N/A 2019-02-06 2025-02-06 N/A 2027-02-06

enzalutamide 159678 Xtandi Astellas Pharma Canada Inc. N/A 2013-05-29 2019-05-29 N/A 2021-05-29 erdafitinib 224529 Balversa Janssen Inc. N/A 2019-10-25 2025-10-25 N/A 2027-10-25

Page 6 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 erenumab 208607 Aimovig Novartis Pharmaceuticals Canada Inc. N/A 2018-08-01 2024-08-01 N/A 2026-08-01 ertugliflozin 204724 Steglatro Merck Canada Inc. Steglujan 2018-05-09 2024-05-09 N/A 2026-05-09 Segluromet eslicarbazepine acetate 165665 Aptiom Sunovion Pharmaceuticals Canada N/A 2014-07-08 2020-07-08 Yes 2023-01-08 Inc. evolocumab 178234 Repatha Amgen Canada Inc. N/A 2015-09-10 2021-09-10 Yes 2024-03-10 ezogabine 134659 Potiga GlaxoSmithKline Inc. N/A 2012-10-18 2018-10-18 N/A 2020-10-18 fampridine 132859 Fampyra Biogen Idec Canada Inc. N/A 2012-02-10 2018-02-10 N/A 2020-02-10 fesoterodine fumarate 142326 Toviaz Pfizer Canada Inc. N/A 2012-02-09 2018-02-09 Yes 2020-08-09 fidaxomicin 151086 Dificid Merck Canada Inc. N/A 2012-06-07 2018-06-07 N/A 2020-06-07 finafloxacin 172450 Xtoro MerLion Pharmaceuticals GmbH N/A 2016-03-11 2022-03-11 Yes 2024-09-11 flibanserin 189352 Addyi Sprout Pharmaceuticals Canada, Ltd. N/A 2018-02-27 2024-02-27 N/A 2026-02-27 florbetaben (18F) 193105 Neuraceq Isologic Innovative N/A 2017-02-22 2023-02-22 N/A 2025-02-22 Radiopharmaceuticals Ltd. follitropin delta 188743 Rekovelle Ferring Inc. N/A 2018-03-22 2024-03-22 N/A 2026-03-22 gadoterate meglumine 186333 Dotarem Guerbet N/A 2016-11-26 2022-11-26 Yes 2025-05-26 galcanezumab 219521 Emgality Eli Lilly Canada Inc. N/A 2019-07-30 2025-07-30 N/A 2027-07-30 galsulfase 159020 Naglazyme BioMarin Pharmaceutical Inc. N/A 2013-09-16 2019-09-16 Yes 2022-03-16 gemtuzumab ozogamicin 223091 Mylotarg Pfizer Canada ULC N/A 2019-11-28 2025-11-28 Yes 2028-05-28 glecaprevir, pibrentasvir 202233 Maviret AbbVie Corporation N/A 2017-08-16 2023-08-16 Yes 2026-02-16

Page 7 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 glycerol phenylbutyrate 174219 Ravicti Horizon Pharma Ireland Ltd. N/A 2016-03-18 2022-03-18 Yes 2024-09-18 grazoprevir, elbasvir 185866 Zepatier Merck Canada Inc. N/A 2016-01-19 2022-01-19 N/A 2024-01-19 guanfacine hydrochloride 150741 Intuniv XR Shire Pharma Canada ULC. N/A 2013-07-05 2019-07-05 Yes 2022-01-05 guselkumab 200590 Tremfya Janssen Inc. N/A 2017-11-10 2023-11-10 N/A 2025-11-10 haemagglutinin strain A (H5N1) 115398 Arepanrix H5N1 ID Biomedical Corporation of Quebec N/A 2013-02-13 2019-02-13 Yes 2021-08-13 hemin 212276 Panhematin Recordati Rare Diseases Canada Inc. N/A 2018-07-13 2024-07-13 N/A 2026-07-13 ibrutinib 174029 Imbruvica Janssen Inc. N/A 2014-11-17 2020-11-17 N/A 2022-11-17 icatibant acetate 162918 Firazyr Shire Orphan Therapies Inc. N/A 2014-06-04 2020-06-04 Yes 2022-12-04 idarucizumab 182503 Praxbind Boehringer Ingelheim (Canada) Ltd N/A 2016-04-29 2022-04-29 N/A 2024-04-29 idelalisib 172652 Zydelig Gilead Sciences Canada Inc. N/A 2015-03-27 2021-03-27 N/A 2023-03-27 ingenol mebutate 153285 Picato Leo Pharma Inc. N/A 2013-01-30 2019-01-30 N/A 2021-01-30 inotersen sodium 214274 Tegsedi Akcea Therapeutics Inc. N/A 2018-10-03 2024-10-03 N/A 2026-10-03 inotuzumab ozogamicin 204077 Besponsa Pfizer Canada Inc. N/A 2018-03-15 2024-03-15 N/A 2026-03-15 insulin degludec 198124 Tresiba Novo Nordisk Canada Inc. Xultophy 2017-08-25 2023-08-25 Yes 2026-02-25 ioflupane (123I) 201481 Datscan GE Healthcare Canada Inc. N/A 2017-12-07 2023-12-07 N/A 2025-12-07 ipilimumab 138178 Yervoy Bristol-Myers Squibb Canada N/A 2012-02-01 2018-02-01 Yes 2020-08-01 iron isomaltoside 1000 193890 Monoferric Pharmacosmos A/S N/A 2018-06-22 2024-06-22 N/A 2026-06-22

Page 8 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 isavuconazole (supplied as 208919 Cresemba Avir Pharma Inc. N/A 2018-12-19 2024-12-19 N/A 2026-12-19 isavuconazonium sulfate) ivabradine hydrochloride 166949 Lancora Servier Canada Inc. N/A 2016-12-23 2022-12-23 Yes 2025-06-23 ivacaftor 155318 Kalydeco Vertex Pharmaceuticals (Canada) Inc. Orkambi 2012-11-26 2018-11-26 Yes 2021-05-26 Symdeko ivermectin 172733 Rosiver Galderma Canada Inc. N/A 2015-04-22 2021-04-22 N/A 2023-04-22 ixazomib (supplied as ixazomib citrate) 190498 Ninlaro Takeda Canada Inc. N/A 2016-08-04 2022-08-04 N/A 2024-08-04 ixekizumab 184993 Taltz Eli Lilly Canada Inc. N/A 2016-05-25 2022-05-25 N/A 2024-05-25 lanadelumab 213920 Takhzyro Shire Pharma Canada ULC N/A 2018-09-19 2024-09-19 Yes 2027-03-19 larotrectinib (supplied as larotrectinib 219998 Vitrakvi Bayer Inc. N/A 2019-07-10 2025-07-10 Yes 2028-01-10 sulfate) latanoprostene bunod 211732 Vyzulta Bausch & Lomb Incorporated N/A 2018-12-27 2024-12-27 N/A 2026-12-27 ledipasvir 173180 Harvoni Gilead Sciences Canada Inc. N/A 2014-10-15 2020-10-15 Yes 2023-04-15 lenvatinib mesylate 180877 Lenvima Eisai Limited N/A 2015-12-22 2021-12-22 N/A 2023-12-22 letermovir 204165 Prevymis Merck Canada Inc. N/A 2017-11-01 2023-11-01 N/A 2025-11-01 levomilnacipran hydrochloride 167319 Fetzima Allergan Inc. N/A 2015-05-08 2021-05-08 N/A 2023-05-08 lifitegrast 199810 Xiidra Novartis Pharmaceuticals Canada Inc. N/A 2017-12-22 2023-12-22 N/A 2025-12-22 linaclotide 161056 Constella Forest Laboratories Canada Inc. N/A 2013-12-02 2019-12-02 N/A 2021-12-02 lixisenatide 193862 Adlyxine Sanofi-aventis Canada Inc. Soliqua 2017-05-25 2023-05-25 N/A 2025-05-25 lomitapide mesylate 160385 Juxtapid Aegerion Pharmaceuticals Canada Ltd. N/A 2014-02-04 2020-02-04 N/A 2022-02-04 lorlatinib 215733 Lorbrena Pfizer Canada ULC N/A 2019-02-22 2025-02-22 N/A 2027-02-22

Page 9 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 lubiprostone 179333 Amitiza Sucampo Pharma Americas LLC N/A 2015-10-14 2021-10-14 N/A 2023-10-14 lumacaftor 181715 Orkambi Vertex Pharmaceuticals (Canada) N/A 2016-01-26 2022-01-26 Yes 2024-07-26 Incorporated lurasidone hydrochloride 145406 Latuda Sunovion Pharmaceuticals Canada N/A 2012-06-13 2018-06-13 Yes 2020-12-13 Inc. lutetium 177Lu oxodotreotide 217184 Lutathera Advanced Accelerator Applications N/A 2019-01-09 2025-01-09 N/A 2027-01-09 USA, Inc. macitentan 161372 Opsumit Janssen Inc. N/A 2013-11-06 2019-11-06 Yes 2022-05-06 mepolizumab 179850 Nucala GlaxoSmithKline Inc. N/A 2015-12-03 2021-12-03 Yes 2024-06-03 midostaurin 201101 Rydapt Novartis Pharmaceuticals Canada Inc. N/A 2017-07-21 2023-07-21 Yes 2026-01-21 mifepristone 160063 Mifegymiso Linepharma International Limited N/A 2015-07-29 2021-07-29 Yes 2024-01-29 migalastat hydrochloride 196956 Galafold Amicus Therapeutics UK LTD N/A 2017-09-05 2023-09-05 N/A 2025-09-05 mirabegron 153806 Myrbetriq Astellas Pharma Canada Inc. N/A 2013-03-06 2019-03-06 N/A 2021-03-06 modified vaccinia virus (ankara- 144762 Imvamune Bavarian Nordic A/S N/A 2013-11-21 2019-11-21 N/A 2021-11-21 bavarian nordic) naloxegol oxalate 167790 Movantik Knight Therapeutics Inc. N/A 2015-06-02 2021-06-02 N/A 2023-06-02 nebivolol hydrochloride 152353 Bystolic Allergan Inc. N/A 2012-12-21 2018-12-21 N/A 2020-12-21 necitumumab 193689 Portrazza Eli Lilly Canada Inc. N/A 2017-03-16 2023-03-16 N/A 2025-03-16 neisseria meningitidis serogroup A 154290 Nimenrix Pfizer Canada Inc. N/A 2013-03-05 2019-03-05 Yes 2021-09-05 polysaccharide, neisseria meningitidis serogroup C polysaccharide, neisseria meningitidis serogroup W-135 polysaccharide, neisseria meningitidis serogroup Y polysaccharide, conjugated to tetanus toxoid carrier protein

Page 10 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 Neisseria meningitidis serogroup B 195550 Trumenba Pfizer Canada Inc. N/A 2017-10-05 2023-10-05 Yes 2026-04-05 recombinant lipoprotein 2086 (rLP2086) subfamily A and Neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily B neratinib maleate 218224 Nerlynx Knight Therapeutics Inc. N/A 2019-07-16 2025-07-16 N/A 2027-07-16 netupitant 196495 Akynzeo Purdue Pharma N/A 2017-09-28 2023-09-28 N/A 2025-09-28 nintedanib (supplied as nintedanib 176043 Ofev Boehringer Ingelheim (Canada) Ltd N/A 2015-06-25 2021-06-25 N/A 2023-06-25 esilate) niraparib 216792 Zejula GlaxoSmithKline Inc. N/A 2019-06-27 2025-06-27 N/A 2027-06-27 nivolumab 180828 Opdivo Bristol-Myers-Squibb Canada N/A 2015-09-25 2021-09-25 N/A 2023-09-25 nusinersen 200070 Spinraza Biogen Canada Inc. N/A 2017-06-29 2023-06-29 Yes 2025-12-29 obeticholic acid 198418 Ocaliva Intercept Pharmaceuticals Inc. N/A 2017-05-24 2023-05-24 N/A 2025-05-24 obinutuzumab 168227 Gazyva Hoffmann-La Roche Limited N/A 2014-11-25 2020-11-25 N/A 2022-11-25 ocrelizumab 198094 Ocrevus Hoffmann-La Roche Limited N/A 2017-08-14 2023-08-14 N/A 2025-08-14 ocriplasmin 161356 Jetrea ThromboGenics N.V. N/A 2013-08-13 2019-08-13 N/A 2021-08-13 ofatumumab 128188 Arzerra Novartis Pharmaceuticals Canada Inc. N/A 2012-03-09 2018-03-09 N/A 2020-03-09 olaparib 182823 Lynparza AstraZeneca Canada Inc. N/A 2016-04-29 2022-04-29 N/A 2024-04-29 olaratumab 203478 Lartruvo Eli Lilly Canada Inc. N/A 2017-11-23 2023-11-23 N/A 2025-11-23 olodaterol hydrochloride 155649 Striverdi Respimat Boehringer Ingelheim (Canada) Ltd. Inspiolto Respimat 2013-06-11 2019-06-11 N/A 2021-06-11 ombitasvir, paritaprevir, dasabuvir 174739 Holkira Pak Abbvie Corporation Technivie 2014-12-22 2020-12-22 N/A 2022-12-22 sodium osimertinib mesylate 188171 Tagrisso AstraZeneca Canada Inc. N/A 2016-07-05 2022-07-05 N/A 2024-07-05

Page 11 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 ozenoxacin 192925 Ozanex Ferrer Internacional, S.A. N/A 2017-05-01 2023-05-01 Yes 2025-11-01 palbociclib 182048 Ibrance Pfizer Canada Inc. N/A 2016-03-16 2022-03-16 N/A 2024-03-16 palonosetron hydrochloride 145491 Aloxi Purdue Pharma Akynzeo 2012-03-14 2018-03-14 N/A 2020-03-14 pasireotide diaspartate 145005 Signifor Novartis Pharmaceuticals Canada Inc. Signifor Lar 2013-09-23 2019-09-23 N/A 2021-09-23 patiromer sorbitex calcium 210368 Veltassa Vifor Fresenius Medical Care Renal N/A 2018-10-03 2024-10-03 N/A 2026-10-03 Pharma Ltd. patisiran (as patisiran sodium) 221896 Onpattro Alnylam Netherlands B.V. N/A 2019-06-07 2025-06-07 N/A 2027-06-07 peginterferon beta-1a 166974 Plegridy Biogen Idec Canada Inc. N/A 2015-08-10 2021-08-10 N/A 2023-08-10 pembrolizumab 175884 Keytruda Merck Canada Inc. N/A 2015-05-19 2021-05-19 Yes 2023-11-19 peramivir 191280 Rapivab BioCryst Pharmaceuticals Inc. N/A 2017-01-05 2023-01-05 N/A 2025-01-05 perampanel 153747 Fycompa Eisai Limited N/A 2013-04-04 2019-04-04 Yes 2021-10-04 pertuzumab 158419 Perjeta Hoffmann-La Roche Limited Perjeta-Herceptin 2013-04-12 2019-04-12 N/A 2021-04-12 Combo Pack pirfenidone 153849 Esbriet Hoffmann-La Roche Limited N/A 2012-10-01 2018-10-01 N/A 2020-10-01 plecanatide 215288 Trulance Cipher Pharmaceuticals Inc. N/A 2019-10-10 2025-10-10 N/A 2027-10-10 polidocanol 177359 Varithena Provensis Ltd. N/A 2015-08-04 2021-08-04 N/A 2023-08-04 pomalidomide 165891 Pomalyst Celgene Inc. N/A 2014-01-20 2020-01-20 Yes 2022-07-20 ponatinib hydrochloride 165121 Iclusig Ariad Pharmaceuticals Inc. N/A 2015-04-02 2021-04-02 N/A 2023-04-02 pralatrexate 207545 Folotyn Servier Canada Inc. N/A 2018-10-26 2024-10-26 N/A 2026-10-26 prasterone 198822 Intrarosa Endoceutics Inc. N/A 2019-11-01 2025-11-01 N/A 2027-11-01

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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 propiverine hydrochloride 188323 Mictoryl / Mictoryl Pediatric Duchesnay Inc. N/A 2017-01-05 2023-01-05 Yes 2025-07-05 radium - 223 dichloride 161312 Xofigo Bayer Inc. N/A 2013-12-12 2019-12-12 N/A 2021-12-12 ramucirumab 176810 Cyramza Eli Lilly Canada Inc. N/A 2015-07-16 2021-07-16 N/A 2023-07-16 ravulizumab 217955 Ultomiris Alexion Pharma GmbH N/A 2019-08-28 2025-08-28 N/A 2027-08-28 recombinant human papillomavirus 170006 Gardasil 9 Merck Canada Inc. N/A 2015-02-05 2021-02-05 Yes 2023-08-05 types 31, 33, 45, 52 and 58 recombinant neisseria meningitidis 147275 Bexsero GlaxoSmithKline Inc. N/A 2013-12-06 2019-12-06 Yes 2022-06-06 group B NHBA fusion protein, recombinant neisseria meningitidis group B NadA fusion protein, recombinant neisseria meningitidis group B FHBP fusion protein, outer membrane vesicle (neisseria meningitidis group B NZ98/254 strain) recombinant porcine factor VIII 177290 Obizur Shire Pharma Canada ULC N/A 2015-10-14 2021-10-14 N/A 2023-10-14 (antihemophilic factor (recombinant), porcine sequence) regorafenib monohydrate 157970 Stivarga Bayer Inc. N/A 2013-03-11 2019-03-11 Yes 2021-09-11 remestemcel-L 150026 Prochymal Osiris Therapeutics Inc. N/A 2012-05-17 2018-05-17 Yes 2020-11-17 reslizumab 185873 Cinqair Teva Canada Limited N/A 2016-07-20 2022-07-20 Yes 2025-01-20 ribociclib (supplied as ribociclib 203884 Kisqali Novartis Pharmaceuticals Canada Inc. N/A 2018-03-02 2024-03-02 N/A 2026-03-02 succinate) rifaximin 161256 Zaxine Salix Pharmaceuticals Inc. N/A 2013-08-13 2019-08-13 N/A 2021-08-13

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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 rilpivirine hydrochloride 137484 Edurant Janssen Inc. Complera 2011-07-21 2017-07-21 Yes 2020-01-21 Odefsey Juluca riociguat 162761 Adempas Bayer Inc. N/A 2013-09-19 2019-09-19 N/A 2021-09-19 risankizumab 215753 Skyrizi AbbVie Corporation N/A 2019-04-17 2025-04-17 N/A 2027-04-17 romidepsin 152293 Istodax Celgene Inc. N/A 2013-10-16 2019-10-16 N/A 2021-10-16 romosozumab 197713 Evenity Amgen Canada Inc. N/A 2019-06-17 2025-06-17 N/A 2027-06-17 rotigotine 145523 Neupro UCB Canada Inc. N/A 2013-03-21 2019-03-21 N/A 2021-03-21 rufinamide 139913 Banzel Eisai Limited N/A 2011-06-22 2017-06-22 Yes 2019-12-22 rupatadine (supplied as rupatadine 186488 Rupall Pediapharm Inc. N/A 2016-07-20 2022-07-20 Yes 2025-01-20 fumarate) ruxolitinib phosphate 151723 Jakavi Novartis Pharmaceuticals Canada Inc. N/A 2012-06-19 2018-06-19 N/A 2020-06-19 sacubitril 182734 Entresto Novartis Pharmaceuticals Canada Inc. N/A 2015-10-02 2021-10-02 N/A 2023-10-02 safinamide (as safinamide mesylate) 207115 Onstryv Valeo Pharma Inc. N/A 2019-01-10 2025-01-10 N/A 2027-01-10 sarilumab 191745 Kevzara Sanofi-aventis Canada Inc. N/A 2017-01-12 2023-01-12 N/A 2025-01-12 sebelipase alfa 204085 Kanuma Alexion Pharma GmbH N/A 2017-12-15 2023-12-15 Yes 2026-06-15 secukinumab 170732 Cosentyx Novartis Pharmaceuticals Canada Inc. N/A 2015-02-27 2021-02-27 N/A 2023-02-27 selexipag 182114 Uptravi Janssen Inc. N/A 2016-01-20 2022-01-20 N/A 2024-01-20 semaglutide 202059 Ozempic Novo Nordisk Canada Inc. N/A 2018-01-04 2024-01-04 N/A 2026-01-04 siltuximab 174291 Sylvant Janssen Inc. N/A 2014-12-03 2020-12-03 N/A 2022-12-03

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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 simeprevir 164021 Galexos Janssen Inc. N/A 2013-11-18 2019-11-18 N/A 2021-11-18 sodium fluoride 18F 145561 NaF Plus Isologic Innovative N/A 2013-02-11 2019-02-11 N/A 2021-02-11 Radiopharmaceuticals Ltd. sodium zirconium cyclosilicate 218799 Lokelma AstraZeneca Canada Inc. N/A 2019-07-25 2025-07-25 N/A 2027-07-25 sofosbuvir 165043 Sovaldi Gilead Sciences Canada Inc. Harvoni 2013-12-13 2019-12-13 N/A 2021-12-13 Epclusa Vosevi stiripentol 142417 Diacomit Biocodex SA N/A 2012-12-21 2018-12-21 Yes 2021-06-21 sucroferric oxyhydroxide 201492 Velphoro Vifor Fresenius Medical Care Renal N/A 2018-01-05 2024-01-05 N/A 2026-01-05 Pharma Ltd. sugammadex sodium 180385 Bridion Merck Canada Inc. N/A 2016-02-05 2022-02-05 N/A 2024-02-05 suvorexant 196367 Belsomra Merck Canada Inc. N/A 2018-11-29 2024-11-29 N/A 2026-11-29 tafluprost 165596 Saflutan Purdue Pharma N/A 2014-05-26 2020-05-26 N/A 2022-05-26 talazoparib (supplied as talazoparib 220584 Talzenna Pfizer Canada ULC N/A 2019-09-06 2025-09-06 N/A 2027-09-06 tosylate) taliglucerase alfa 140854 Elelyso Pfizer Canada Inc. N/A 2014-05-29 2020-05-29 Yes 2022-11-29 tedizolid phosphate 173603 Sivextro Merck Canada Inc. N/A 2015-03-17 2021-03-17 N/A 2023-03-17 teduglutide 180223 Revestive Shire Pharmaceuticals Ireland Limited N/A 2015-09-04 2021-09-04 Yes 2024-03-04 telotristat ethyl (as telotristat etiprate) 208730 Xermelo Ipsen Biopharmaceuticals Canada Inc. N/A 2018-10-10 2024-10-10 N/A 2026-10-10 tenofovir alafenamide hemifumarate 181399 Genvoya Gilead Sciences Canada Inc. Descovy 2015-11-27 2021-11-27 Yes 2024-05-27 Odefsey Vemlidy Symtuza Biktarvy

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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 teriflunomide 160646 Aubagio Genzyme Canada a division of Sanofi- N/A 2013-11-14 2019-11-14 Yes 2022-05-14 aventis Canada Inc. tesamorelin 131836 Egrifta Theratechnologies Inc. N/A 2014-04-29 2020-04-29 N/A 2022-04-29 tezacaftor 211292 Symdeko Vertex Pharmaceuticals (Canada) N/A 2018-06-27 2024-06-27 Yes 2026-12-27 Incorporated tisagenlecleucel 213547 / Kymriah Novartis Pharmaceuticals Canada Inc. N/A 2018-09-05 2024-09-05 Yes 2027-03-05 213698 tofacitinib 154642 Xeljanz Pfizer Canada Inc. N/A 2014-04-17 2020-04-17 Yes 2022-10-17 trametinib 157665 Mekinist Novartis Pharmaceuticals Canada Inc. N/A 2013-07-18 2019-07-18 N/A 2021-07-18 trastuzumab emtansine 162414 Kadcyla Hoffmann-La Roche Limited N/A 2013-09-11 2019-09-11 N/A 2021-09-11 trifarotene 221945 Aklief Galderma Canada Inc. N/A 2019-11-25 2025-11-25 Yes 2028-05-25 trifluridine, tipiracil hydrochloride 205852 Lonsurf Taiho Pharma Canada Inc. N/A 2018-01-25 2024-01-25 N/A 2026-01-25 turoctocog alfa 170796 Zonovate Novo Nordisk Canada Inc. N/A 2014-12-08 2020-12-08 Yes 2023-06-08 ulipristal acetate 156861 Fibristal Allergan Inc. N/A 2013-06-24 2019-06-24 N/A 2021-06-24 umeclidinium bromide 161585 Anoro Ellipta GlaxoSmithKline Inc. Incruse Ellipta 2013-12-23 2019-12-23 N/A 2021-12-23 vandetanib 126822 Caprelsa Genzyme Canada, a division of Sanofi- N/A 2012-01-12 2018-01-12 N/A 2020-01-12 aventis Canada Inc. varicella-zoster virus glycoprotein E 200244 Shingrix GlaxoSmithKline Inc. N/A 2017-10-13 2023-10-13 N/A 2025-10-13 (gE) vedolizumab 169414 Entyvio Takeda Canada Inc. N/A 2015-01-29 2021-01-29 N/A 2023-01-29 velpatasvir 190521 Epclusa Gilead Sciences Canada Inc. Vosevi 2016-07-11 2022-07-11 N/A 2024-07-11

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*The medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient (subsection C.08.004.1(1) of the Food and Drug Regulations ).

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Products for Human Use - Expired Data Protection Period Drug(s) Containing Notice of Pediatric Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Extension Number Ingredient / Date File" Date Ends Yes / No Variations yyyy-mm-dd abatacept 098531 Orencia Bristol-Myers Squibb Canada N/A 2006-06-29 2012-06-29 Yes 2014-12-29 abiraterone acetate 138343 Zytiga Janssen Inc. N/A 2011-07-27 2017-07-27 N/A 2019-07-27 acamprosate calcium 103287 Campral Mylan Pharmaceuticals ULC N/A 2007-03-16 2013-03-16 N/A 2015-03-16 alglucosidase alfa 103381 Myozyme Genzyme Canada Inc. N/A 2006-08-14 2012-08-14 Yes 2015-02-14 aliskiren hemifumarate 105388 Rasilez Novartis Pharmaceuticals Canada Inc. Rasilez HCT 2007-11-14 2013-11-14 N/A 2015-11-14 Rasilamlo ambrisentan 113287 Volibris GlaxoSmithKline Inc. N/A 2008-03-20 2014-03-20 N/A 2016-03-20 anidulafungin 110202 Eraxis Pfizer Canada Inc. N/A 2007-11-14 2013-11-14 Yes 2016-05-14 aprepitant 108483 Emend Merck Frosst Canada Ltd. Emend Tri-Pack 2007-08-24 2013-08-24 N/A 2015-08-24 Emend IV aripiprazole 120192 Abilify Bristol-Myers Squibb Canada Abilify Maintena 2009-07-09 2015-07-09 Yes 2018-01-09 azacitidine 127108 Vidaza Celgene N/A 2009-10-23 2015-10-23 N/A 2017-10-23 belimumab 137699 Benlysta GlaxoSmithKline Inc. N/A 2011-07-06 2017-07-06 N/A 2019-07-06 besifloxacin 123400 Besivance Bausch & Lomb Inc. N/A 2009-10-23 2015-10-23 Yes 2018-04-23 boceprevir 141556 Victrelis Merck Canada Inc. Victrelis Triple 2011-07-29 2017-07-29 N/A 2019-07-29 cabazitaxel 137421 Jevtana Sanofi-aventis Canada Inc. N/A 2011-06-16 2017-06-16 Yes 2019-12-16 canakinumab 131009 Ilaris Novartis Pharmaceuticals Canada Inc. N/A 2010-02-26 2016-02-26 Yes 2018-08-26 ceftobiprole medocaril 112752 Zeftera Janssen Inc. N/A 2008-06-26 2014-06-26 N/A 2016-06-26 certolizumab pegol 120296 Cimzia UCB Canada Inc. N/A 2009-08-12 2015-08-12 N/A 2017-08-12

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Products for Human Use - Expired Data Protection Period Drug(s) Containing Notice of Pediatric Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Extension Number Ingredient / Date File" Date Ends Yes / No Variations yyyy-mm-dd ciclesonide 101419 Alvesco Takeda Canada Inc. Omnaris 2006-09-11 2012-09-11 Yes 2015-03-11 Omnaris HFA clevidipine 125287 Cleviprex Chiesi Farmaceutici S.p.A. N/A 2011-04-15 2017-04-15 N/A 2019-04-15 clofarabine 121874 Clolar Sanofi-aventis Canada Inc. N/A 2009-07-16 2015-07-16 Yes 2018-01-16 colesevelam hydrochloride 133463 Lodalis Valeant Canada LP / Valeant Canada N/A 2011-09-22 2017-09-22 N/A 2019-09-22 S.E.C. dabigatran etexilate mesilate 114887 Pradaxa Boehringer Ingelheim (Canada) Ltd. N/A 2008-06-10 2014-06-10 N/A 2016-06-10 daptomycin 102320 Cubicin Cubist Pharmaceuticals, Incorporated N/A 2007-09-24 2013-09-24 Yes 2016-03-24 darunavir ethanolate 103324 Prezista Janssen Inc. N/A 2006-07-28 2012-07-28 Yes 2015-01-28 dasatinib monohydrate 104993 Sprycel Bristol-Myers Squibb Canada N/A 2007-03-26 2013-03-26 N/A 2015-03-26 deferasirox 099621 Exjade Novartis Pharmaceuticals Canada Inc. N/A 2006-10-18 2012-10-18 Yes 2015-04-18 degarelix acetate 120421 Firmagon Ferring Inc. N/A 2009-11-16 2015-11-16 N/A 2017-11-16 denosumab 121139 Prolia Amgen Canada Inc. Xgeva 2010-08-06 2016-08-06 N/A 2018-08-06 desvenlafaxine succinate 115439 Pristiq Pfizer Canada Inc. N/A 2009-02-04 2015-02-04 Yes 2017-08-04 dexmedetomidine 126931 Precedex Pfizer Canada Inc. N/A 2009-12-09 2015-12-09 Yes 2018-06-09 hydrochloride doripenem monohydrate 113640 Doribax Janssen Inc. N/A 2009-09-02 2015-09-02 N/A 2017-09-02 dronedarone hydrochloride 121065 Multaq Sanofi-aventis Canada Inc. N/A 2009-08-11 2015-08-11 N/A 2017-08-11 duloxetine hydrochloride 110028 Cymbalta Eli Lilly Canada Inc. N/A 2007-11-01 2013-11-01 Yes 2016-05-01 eculizumab 122467 Soliris Alexion Pharma International Sàrl N/A 2009-01-28 2015-01-28 Yes 2017-07-28

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Products for Human Use - Expired Data Protection Period Drug(s) Containing Notice of Pediatric Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Extension Number Ingredient / Date File" Date Ends Yes / No Variations yyyy-mm-dd eltrombopag olamine 123984 Revolade Novartis Pharmaceuticals Canada Inc. N/A 2011-01-12 2017-01-12 Yes 2019-07-12 eplerenone 120440 Inspra Pfizer Canada Inc. N/A 2009-02-26 2015-02-26 Yes 2017-08-26 eribulin mesylate 141946 Halaven Eisai Limited N/A 2011-12-14 2017-12-14 N/A 2019-12-14 etravirine 113100 Intelence Janssen Inc. N/A 2008-03-27 2014-03-27 Yes 2016-09-27 everolimus 125809 Afinitor Novartis Pharmaceuticals Canada Inc. Certican 2009-12-14 2015-12-14 Yes 2018-06-14 exenatide 128932 Byetta AstraZeneca Canada Inc. Bydureon 2011-01-13 2017-01-13 N/A 2019-01-13 febuxostat 129969 Uloric Takeda Canada Inc. N/A 2010-09-22 2016-09-22 N/A 2018-09-22 ferumoxytol 133250 Feraheme AMAG Pharmaceuticals Inc. N/A 2011-12-08 2017-12-08 N/A 2019-12-08 fingolimod hydrochloride 137516 Gilenya Novartis Pharmaceuticals Canada Inc. N/A 2011-03-09 2017-03-09 N/A 2019-03-09 fludeoxyglucose 18F 091404 Cantrace Ipet Pharmaceuticals Inc. N/A 2006-07-27 2012-07-27 N/A 2014-07-27 fluticasone furoate 107372 Avamys GlaxoSmithKline Inc. N/A 2007-08-14 2013-08-14 Yes 2016-02-14 gadofosveset trisodium 096420 Vasovist Berlex Canada Inc. N/A 2006-10-31 2012-10-31 N/A 2014-10-31 gadoxetate disodium 127609 Primovist Bayer Inc. N/A 2010-01-14 2016-01-14 N/A 2018-01-14 golimumab 120525 Simponi Janssen Inc. N/A 2009-04-07 2015-04-07 N/A 2017-04-07 human C1 esterase inhibitor 121221 Berinert CSL Behring Canada Inc. Haegarda 2010-05-31 2016-05-31 N/A 2018-05-31 idebenone 117672 Catena Santhera Pharmaceuticals Ltd. N/A 2008-07-23 2014-07-23 Yes 2017-01-23 idursulfase 109857 Elaprase Shire Human Genetic Therapies, Inc. N/A 2007-06-13 2013-06-13 Yes 2015-12-13 indacaterol maleate 143984 Onbrez Breezhaler Novartis Pharmaceuticals Canada Inc. Ultibro Breezhaler 2011-12-06 2017-12-06 N/A 2019-12-06

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Products for Human Use - Expired Data Protection Period Drug(s) Containing Notice of Pediatric Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Extension Number Ingredient / Date File" Date Ends Yes / No Variations yyyy-mm-dd influenza virus type A (H1N1), 129379 FluMist AstraZeneca Canada Incorporated FluMist Quadrivalent 2010-06-22 2016-06-22 Yes 2018-12-22 influenza virus type A (H3N2), influenza virus type B lacosamide 116632 Vimpat UCB Canada Inc. N/A 2010-09-30 2016-09-30 N/A 2018-09-30 lanreotide 098949 Somatuline Autogel Ipsen Biopharm Limited N/A 2006-07-17 2012-07-17 N/A 2014-07-17 lanthanum carbonate 102240 Fosrenol Shire BioChem Inc. N/A 2006-10-17 2012-10-17 N/A 2014-10-17 lapatinib ditosylate 110294 Tykerb Novartis Pharmaceuticals Canada Inc. N/A 2009-05-15 2015-05-15 N/A 2017-05-15 lenalidomide 111952 Revlimid Celgene N/A 2008-01-17 2014-01-17 N/A 2016-01-17 linagliptin 140881 Trajenta Boehringer Ingelheim (Canada) Ltd. Jentadueto 2011-07-28 2017-07-28 N/A 2019-07-28 Glyxambi liraglutide 119928 Victoza Novo Nordisk Canada Inc. Saxenda 2010-05-21 2016-05-21 N/A 2018-05-21 Xultophy lisdexamfetamine dimesylate 120534 Vyvanse Shire Pharma Canada ULC. N/A 2009-02-19 2015-02-19 Yes 2017-08-19 loteprednol etabonate 117199 Alrex Bausch & Lomb Inc. Lotemax 2008-12-23 2014-12-23 N/A 2016-12-23 Lotemax Ointment Lotemax Gel lumiracoxib 102465 Prexige Novartis Pharmaceuticals Canada Inc. N/A 2006-11-02 2012-11-02 N/A 2014-11-02 maraviroc 112435 Celsentri ViiV Healthcare ULC N/A 2007-09-21 2013-09-21 N/A 2015-09-21 methoxy polyethylene gycol 106461 Mircera Hoffmann-La Roche Ltd. N/A 2008-03-31 2014-03-31 N/A 2016-03-31 epoetin beta methylnaltrexone bromide 114266 Relistor Salix Pharmaceuticals, Inc. N/A 2008-03-28 2014-03-28 N/A 2016-03-28 micafungin sodium 078577 Mycamine Astellas Pharma Canada, Inc. N/A 2007-05-22 2013-05-22 N/A 2015-05-22 natalizumab 093001 Tysabri Biogen Idec Canada Inc. N/A 2006-09-28 2012-09-28 N/A 2014-09-28

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Products for Human Use - Expired Data Protection Period Drug(s) Containing Notice of Pediatric Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Extension Number Ingredient / Date File" Date Ends Yes / No Variations yyyy-mm-dd nelarabine 099994 Atriance Novartis Pharmaceuticals Canada Inc. N/A 2007-09-22 2013-09-22 Yes 2016-03-22 nepafenac 114004 Nevanac Alcon Canada Inc. Ilevro 2008-04-17 2014-04-17 N/A 2016-04-17 nesiritide 111760 Natrecor Janssen Inc. N/A 2007-11-08 2013-11-08 N/A 2015-11-08 nilotinib hydrochloride 110305 Tasigna Novartis Pharmaceuticals Canada Inc. N/A 2008-09-09 2014-09-09 N/A 2016-09-09 monohydrate olmesartan medoxomil 115991 Olmetec Merck Canada Inc. Olmetec Plus 2008-10-28 2014-10-28 Yes 2017-04-28 oxaliplatin 109965 Eloxatin Sanofi-aventis Canada Inc. N/A 2007-06-15 2013-06-15 Yes 2015-12-15 paliperidone 108748 Invega Janssen Inc. Invega Sustenna 2007-09-26 2013-09-26 Yes 2016-03-26 panitumumab 105601 Vectibix Amgen Canada Inc. N/A 2008-04-03 2014-04-03 N/A 2016-04-03 pazopanib hydrochloride 128332 Votrient Novartis Pharmaceuticals Canada Inc. N/A 2010-05-27 2016-05-27 N/A 2018-05-27 plerixafor 142638 Mozobil Sanofi-aventis Canada Inc. N/A 2011-12-08 2017-12-08 N/A 2019-12-08 pneumococcal polysaccharide 119056 Synflorix GlaxoSmithKline Inc. N/A 2008-12-11 2014-12-11 Yes 2017-06-11 serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F pneumococcal polysaccharide 122881 Prevnar 13 Pfizer Canada Inc. N/A 2009-12-21 2015-12-21 Yes 2018-06-21 serotype 3, 5, 6A, 19A,

posaconazole 108193 Posanol Merck Canada Inc. N/A 2007-03-26 2013-03-26 Yes 2015-09-26 prasugrel hydrochloride 121143 Effient Eli Lilly Canada Inc. N/A 2010-04-16 2016-04-16 Yes 2018-10-16 prucalopride succinate 141157 Resotran Janssen Inc. N/A 2011-12-07 2017-12-07 N/A 2019-12-07

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Products for Human Use - Expired Data Protection Period Drug(s) Containing Notice of Pediatric Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Extension Number Ingredient / Date File" Date Ends Yes / No Variations yyyy-mm-dd raltegravir potassium 113408 Isentress Merck Frosst Canada Inc. N/A 2007-11-27 2013-11-27 Yes 2016-05-27 ranibizumab 110233 Lucentis Novartis Opthalmics, Novartis N/A 2007-06-26 2013-06-26 N/A 2015-06-26 Pharmaceuticals rasagiline mesylate 101846 Azilect Teva Pharmaceuticals Industries Ltd. N/A 2006-08-17 2012-08-17 N/A 2014-08-17 recombinant human 102682 Gardasil Merck Frosst Canada Ltd. N/A 2006-07-10 2012-07-10 Yes 2015-01-10 papillomavirus type 11 L1, type 16 L1, type 18 L1 & type 6 L1 protein retapamulin 109037 Altargo GlaxoSmithKline Inc. N/A 2008-03-19 2014-03-19 Yes 2016-09-19 rivaroxaban 119111 Xarelto Bayer Healthcare N/A 2008-09-15 2014-09-15 N/A 2016-09-15 roflumilast 127683 Daxas Takeda Canada Inc. N/A 2010-11-23 2016-11-23 N/A 2018-11-23 romiplostim 117327 Nplate Amgen Canada Inc. N/A 2009-02-19 2015-02-19 Yes 2017-08-19 rotavirus RIX4414 strain, live, 109624 Rotarix GlaxoSmithKline Inc. N/A 2007-10-09 2013-10-09 Yes 2016-04-09 attenuated (human) rotavirus vaccine, live, oral 100399 Rotateq Merck Frosst Canada Ltd. N/A 2006-08-01 2012-08-01 Yes 2015-02-01 type G1, type G2, type G3, type G4 & type P1(8) (human) rubidium 82 chloride 138823 Ruby-Fill Jubilant Draximage Inc. N/A 2011-09-20 2017-09-20 N/A 2019-09-20 sapropterin dihydrochloride 128151 Kuvan BioMarin Pharmaceutical Inc. N/A 2010-04-30 2016-04-30 Yes 2018-10-30 saxagliptin hydrochloride 123854 Onglyza AstraZeneca Canada Inc. Komboglyze 2009-09-14 2015-09-14 N/A 2017-09-14 Qtern silodosin 121740 Rapaflo Purdue Pharma N/A 2011-01-11 2017-01-11 N/A 2019-01-11

Page 23 of 30 2019-12-19 Register Of Innovative Drugs

Products for Human Use - Expired Data Protection Period Drug(s) Containing Notice of Pediatric Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Extension Number Ingredient / Date File" Date Ends Yes / No Variations yyyy-mm-dd sitagliptin phosphate 103039 Januvia Merck Frosst Canada Ltd. Janumet 2007-12-14 2013-12-14 N/A 2015-12-14 Janumet XR sitaxsentan sodium 101934 Thelin Pfizer Canada Inc. N/A 2007-05-30 2013-05-30 N/A 2015-05-30 sorafenib 102070 Nexavar Bayer Inc. N/A 2006-07-28 2012-07-28 N/A 2014-07-28 tapentadol hydrochloride 133167 Nucynta CR Janssen Inc. Nucynta IR 2010-12-02 2016-12-02 N/A 2018-12-02 Nucynta Extended Release telaprevir 142482 Incivek Vertex Pharmaceuticals (Canada) Inc. N/A 2011-08-16 2017-08-16 N/A 2019-08-10 telavancin hydrochloride 107792 Vibativ Pendopharm Division of de Pharmascience N/A 2009-09-29 2015-09-29 N/A 2017-09-29 Inc. telbivudine 104469 Sebivo Novartis Pharmaceuticals Canada Inc. N/A 2006-11-28 2012-11-28 N/A 2014-11-28 temsirolimus 109201 Torisel Pfizer Canada Inc. N/A 2007-12-21 2013-12-21 Yes 2016-06-21 ticagrelor 132218 Brilinta AstraZeneca Canada Incorporated N/A 2011-05-30 2017-05-30 N/A 2019-05-30 tigecycline 094870 Tygacil Pfizer Canada Inc. N/A 2006-09-14 2012-09-14 N/A 2014-09-14 tocilizumab 121089 Actemra Hoffmann-La Roche Ltd. N/A 2010-04-30 2016-04-30 Yes 2018-10-30 tolvaptan 139413 Samsca Otsuka Pharmaceutical Co. Ltd. Jinarc 2011-07-25 2017-07-25 N/A 2019-07-25 trabectedin 124729 Yondelis Janssen Inc. N/A 2010-05-13 2016-05-13 N/A 2018-05-13 ustekinumab 114272 Stelara Janssen Inc. N/A 2008-12-12 2014-12-12 N/A 2016-12-12

Page 24 of 30 2019-12-19 Register Of Innovative Drugs

Page 25 of 30 2019-12-19 Register Of Innovative Drugs Products for Veterinary Use - Active Data Protection Period Notice of Drug(s) Containing Submission Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer the Medicinal Number Date File" Date Ends Ingredient / Variations yyyy-mm-dd afoxolaner 163768 Nexgard Boehringer Ingelheim Animal Health Nexgard Spectra 2014-07-08 2020-07-08 2022-07-08 Canada Inc. avilamycin 156949 Surmax 100 Premix Elanco Canada Limited Surmax 200 Premix 2014-02-18 2020-02-18 2022-02-18 cefpodoxime proxetil 149164 Simplicef Zoetis Canada Inc. N/A 2012-12-06 2018-12-06 2020-12-06 clodronate disodium 172789 Osphos Injection Dechra Ltd. N/A 2015-05-06 2021-05-06 2023-05-06 tetrahydrate closantel sodium 180678 Flukiver Elanco Division Eli Lilly Canada Inc N/A 2015-11-24 2021-11-24 2023-11-24 derquantel 184844 Startect Zoetis Canada Inc. N/A 2016-04-27 2022-04-27 2024-04-27 dibotermin alfa (rhBMP-2) 148153 Truscient Zoetis Canada Inc. N/A 2012-11-20 2018-11-20 2020-11-20 fluralaner 166320 Bravecto Intervet Canada Corp. N/A 2014-05-23 2020-05-23 2022-05-23 fluralaner, moxidectin 220589 Vitrecto Intervet Canada Corp. N/A 2019-08-23 2025-08-23 2027-08-23 grapiprant 211760 Galliprant Elanco Canada Limited N/A 2019-01-08 2025-01-08 2027-01-08 insulin human 150211 Prozinc Boehringer Ingelheim Canada Ltd. N/A 2013-04-24 2019-04-24 2021-04-24 (recombinant) lotilaner 193712 Credelio Elanco Canada Limited N/A 2017-12-29 2023-12-29 2025-12-29 lubabegron 166199 Experior 10 Elanco Canada Limited N/A 2018-11-07 2024-11-07 2026-11-07 oclacitinib maleate 159090 Apoquel Zoetis Canada Inc. N/A 2014-07-15 2020-07-15 2022-07-15 peforelin 190986 Maprelin XP-10 Modern Veterinary Therapeutics LLC N/A 2017-06-19 2023-06-19 2025-06-19 pegbovigrastim 148171 Imrestor Elanco Division Eli Lilly Canada Inc. N/A 2016-03-09 2022-03-09 2024-03-09

Page 26 of 30 2019-12-19 Register Of Innovative Drugs Products for Veterinary Use - Active Data Protection Period Notice of Drug(s) Containing Submission Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer the Medicinal Number Date File" Date Ends Ingredient / Variations yyyy-mm-dd pergolide mesylate 158770 Prascend Boehringer Ingelheim Canada Ltd. N/A 2013-09-05 2019-09-05 2021-09-05 phenobarbital 142445 Epiphen Vétoquinol N.- A Inc. N/A 2012-04-04 2018-04-04 2020-04-04 pradofloxacin 161227 Veraflox Bayer Inc., Bayer Healthcare, Animal Health N/A 2015-01-29 2021-01-29 2023-01-29 sarolaner 177679 Simparica Zoetis Canada Inc. Revolution Plus 2016-02-11 2022-02-11 2024-02-11 Simparica Trio telmisartan 158760 Semintra Boehringer Ingelheim Canada Ltd. N/A 2013-12-12 2019-12-12 2021-12-12 terbinafine 170344 Osurnia Elanco Canada Limited N/A 2015-03-26 2021-03-26 2023-03-26 tildipirosin 148052 Zuprevo Intervet Canada Corp. N/A 2012-06-13 2018-06-13 2020-06-13 tiludronic acid (as 171467 Tildren CEVA Animal Health N/A 2014-12-22 2020-12-22 2022-12-22 tiludronate disodium) triptorelin (as triptorelin 161303 Ovugel United-AH II, LLC N/A 2014-04-25 2020-04-25 2022-04-25 acetate) *The medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient (subsection C.08.004.1(1) of the Food and Drug Regulations).

Page 27 of 30 2019-12-19 Register Of Innovative Drugs Products for Veterinary Use - Expired Data Protection Period Drug(s) Containing Notice of Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Number Ingredient / Date File" Date Ends Variations yyyy-mm-dd acetaminophen 110139 Pracetam 20% O.S. Ceva Animal Health Inc. N/A 2009-03-05 2015-03-05 2017-03-05 buprenorphine 126077 Vetergesic Multidose Sogeval UK Limited N/A 2010-02-03 2016-02-03 2018-02-03 hydrochloride cefovecin sodium 110061 Convenia Zoetis Canada Inc. N/A 2007-05-30 2013-05-30 2015-05-30 cephalexin monohydrate 126970 Vetolexin Vétoquinol N.-A Inc. Cefaseptin 2010-06-24 2016-06-24 2018-06-24 dirlotapide 110110 Slentrol Zoetis Canada Inc. N/A 2008-08-14 2014-08-14 2016-08-14 emamectin benzoate 109976 Slice Intervet Canada Ltd. N/A 2009-06-29 2015-06-29 2017-06-29 emodepside 112103 / Profender Bayer Healthcare, Animal Health Division N/A 2008-08-28 2014-08-28 2016-08-28 112106 / 112107 firocoxib 110661 / Previcox Merial Canada Inc. N/A 2007-09-28 2013-09-28 2015-09-28 110379 fluoxetine hydrochloride 109825 / Reconcile Elanco, Division Eli Lilly Canada Inc. N/A 2008-03-28 2014-03-28 2016-03-28 109826 / 110429 gamithromycin 125823 Zactran Merial Canada Inc. N/A 2010-03-29 2016-03-29 2018-03-29 gonadotropin releasing 140525 Improvest Zoetis Canada Inc. N/A 2011-06-22 2017-06-22 2019-06-22 factor analogue - protein conjugate ibafloxacin 110655 / Ibaflin gel Intervet Canada Ltd. N/A 2008-01-15 2014-01-15 2016-01-15 110657

Page 28 of 30 2019-12-19 Register Of Innovative Drugs Products for Veterinary Use - Expired Data Protection Period Drug(s) Containing Notice of Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Number Ingredient / Date File" Date Ends Variations yyyy-mm-dd imidapril hydrochloride 110445 / Prilium Vétoquinol N.-A Inc. N/A 2007-07-12 2013-07-12 2015-07-12 110450 / 110476 itraconazole 109769 Itrafungol Elanco, Division Eli Lilly Canada Inc. N/A 2008-09-23 2014-09-23 2016-09-23 maropitant 110342 / Cerenia Zoetis Canada Inc. N/A 2007-09-20 2013-09-20 2015-09-20 110344 / 110347 / 110348 mitratapide 111600 Yarvitan Janssen Pharmaceutica N.V. N/A 2009-02-20 2015-02-20 2017-02-20 mometasone furoate 110289 Mometamax Intervet Canada Corp. N/A 2010-02-22 2016-02-22 2018-02-22 monohydrate permethrin 133818 Oridermyl Vétoquinol N.- A Inc. N/A 2011-02-18 2017-02-18 2019-02-18

ramipril 110296 / Vasotop Intervet Canada Ltd. N/A 2008-09-05 2014-09-05 2016-09-05 110297 / 110298 robenacoxib 128703 Onsior Elanco Canada Limited N/A 2011-10-03 2017-10-03 2019-10-03 sevoflurane 110109 Sevoflo Zoetis Canada Inc. N/A 2008-03-28 2014-03-28 2016-03-28 spinosad 112198 / Comfortis Elanco, Division Eli Lilly Canada Inc. Trifexis 2009-08-24 2015-08-24 2017-08-24 112199 / 112202 / 112203 / 112204

Page 29 of 30 2019-12-19 Register Of Innovative Drugs Products for Veterinary Use - Expired Data Protection Period Drug(s) Containing Notice of Submission the Medicinal Compliance 6 Year "No Data Protection Medicinal Ingredient(s)* Innovative Drug Manufacturer Number Ingredient / Date File" Date Ends Variations yyyy-mm-dd tepoxalin 109950 / Zubrin Schering Plough Canada Inc. N/A 2007-10-01 2013-10-01 2015-10-01 109956 / 109963 thiamazole 125706 Felimazole Dechra Ltd. N/A 2009-08-25 2015-08-25 2017-08-25

toceranib phosphate 123643 Palladia Zoetis Canada Inc. N/A 2009-12-01 2015-12-01 2017-12-01

toltrazuril 122525 Baycox Bayer Inc., Bayer Healthcare Animal Health N/A 2010-08-20 2016-08-20 2018-08-20 Division trilostane 110023 / Vetoryl Dechra Ltd. N/A 2009-01-30 2015-01-30 2017-01-30 110025 / 110221 / 113566 tulathromycin 112161 Draxxin Pfizer Canada Inc., Animal Health Group N/A 2006-08-31 2012-08-31 2014-08-31 zilpaterol hydrochloride 110019 Zilmax Intervet Canada Ltd. N/A 2009-03-18 2015-03-18 2017-03-18

The Minister of Health maintains a register of innovative drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug Regulations .

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