Register Of Innovative Drugs

Transcription

1 Products for Human Use - Active Period Register Of s File" abiraterone acetate Zytiga Janssen Inc. N/A N/A aclidinium bromide Tudorza Genuair AstraZeneca Canada Inc. Duaklir Genuair N/A afatinib dimaleate Giotrif Boehringer Ingelheim (Canada) Ltd. N/A N/A aflibercept Eylea Bayer Inc. N/A N/A albiglutide Eperzan GlaxoSmithKline Inc. N/A N/A alectinib hydrochloride Alecensaro Hoffmann-La Roche Limited N/A N/A alirocumab Praluent Sanofi-aventis Canada Inc. N/A N/A alogliptin benzoate Nesina Takeda Canada Inc. Kazano Oseni N/A anthrax immune globulin (human) Anthrasil Emergent BioSolutions Canada Inc. N/A Yes antihemophilic factor (recombinant BDD), Fc fusion protein Eloctate Bioverativ Canada Inc. N/A Yes antihemophilic factor (recombinant), pegylated Adynovate Baxalta Canada Corporation N/A Yes antihemophilic factor (recombinant, B- domain deleted) (also known as simoctocog alfa) Nuwiq Octapharma Pharmazeutika Produktionsges.m.b.H N/A Yes antihemophilic factor VIII (recombinant), singlechain (also known as lonoctocog alfa) Afstyla CSL Behring Canada Inc. N/A Yes anthrax antigen filtrate Biothrax Emergent Biodefense Operations Lansing LLC N/A N/A Page 1 of

2 Products for Human Use - Active Period Register Of s File" apalutamide Erleada Janssen Inc. N/A N/A apixaban Eliquis Bristol-Myers Squibb Canada N/A Yes apremilast Otezla Celgene Inc. N/A N/A asenapine maleate Saphris Merck Canada Inc. N/A Yes asfotase alfa Strensiq Alexion Pharma International Sàrl N/A Yes asunaprevir Sunvepra Bristol-Myers Squibb Canada N/A N/A atezolizumab Tecentriq Hoffmann-La Roche Limited N/A N/A avelumab Bavencio EMD Serono, a Division of EMD Inc., Canada N/A N/A axitinib Inlyta Pfizer Canada Inc. N/A Yes azelastine hydrochloride Dymista Meda Pharmaceuticals Ltd. N/A Yes azilsartan medoxomil potassium Edarbi Valeant Canada LP Edarbyclor N/A baricitinib Olumiant Eli Lilly Canada Inc. N/A N/A bazedoxifene acetate Duavive Pfizer Canada Inc. N/A N/A belimumab Benlysta GlaxoSmithKline Inc. N/A N/A bendamustine hydrochloride Treanda Teva Canada Limited N/A Yes benralizumab Fasenra AstraZeneca Canada Inc. N/A Yes bepotastine besilate Bepreve Bausch and Lomb Incorporated N/A Yes Page 2 of

3 Products for Human Use - Active Period Register Of s File" bictegravir Biktarvy Gilead Sciences Canada, Inc. N/A N/A bilastine Blexten Aralez Pharmaceutials Canada Inc. N/A Yes blinatumomab Blincyto Amgen Canada Incorporated N/A Yes boceprevir Victrelis Merck Canada Inc. Victrelis Triple N/A bosutinib Bosulif Pfizer Canada Inc. N/A N/A botulism antitoxin heptavalent C/ D/F/ G (equine) Bat Emergent BioSolutions Inc. N/A Yes brentuximab vedotin Adcetris Seattle Genetics Inc. N/A N/A brexpiprazole Rexulti Otsuka Pharmaceutical Co. Ltd. N/A N/A brigatinib Alunbrig Takeda Canada Incorporated N/A N/A brivaracetam Brivlera UCB Canada Incorporated N/A Yes brodalumab Siliq Valeant Canada LP/Valeant Canada S.E.C. N/A N/A bromfenac sodium sesquihydrate Prolensa Bausch & Lomb Incorporated N/A N/A cabazitaxel Jevtana Sanofi-aventis Canada Inc. N/A Yes cabozantinib (supplied as cabozantinib (S)-malate) Cabometyx Ipsen Biopharmaceuticals Canada Inc. N/A N/A calcifediol Rayaldee Vifor Fresenius Medical Care Renal Pharma Ltd N/A N/A canagliflozin Invokana Janssen Inc. Invokamet Invokamet XR N/A Page 3 of

4 Products for Human Use - Active Period Register Of s File" carfilzomib Kyprolis Amgen Canada Inc. N/A N/A carglumic acid Carbaglu Orphan Europe Sarl N/A Yes catridecacog Tretten Novo Nordisk Canada Inc. N/A Yes catumaxomab Removab Fresenius Biotech GmbH N/A N/A ceftolozane Zerbaxa Merck Canada Inc. N/A N/A ceritinib Zykadia Novartis Pharmaceuticals Canada Inc. N/A N/A cerliponase alfa Brineura Biomarin International Limited N/A Yes clevidipine Cleviprex Chiesi Farmaceutici S.p.A. N/A N/A coagulation factor IX (recombinant), albumin fusion protein Idelvion CSL Behring Canada Inc. N/A Yes coagulation factor IX (recombinant), pegylated (nonacog beta pegol) Rebinyn Novo Nordisk Canada Inc. N/A Yes coagulation factor IX, Fc fusion protein Alprolix Bioverativ Canada Inc. N/A Yes cobimetinib Cotellic Hoffmann-La Roche Limited N/A N/A colesevelam hydrochloride Lodalis Valeant Canada LP / Valeant Canada S.E.C. N/A N/A collagenase clostridium histolyticum Xiaflex Endo Ventures Ltd. N/A N/A crisaborole Eucrisa Pfizer Canada Inc. N/A Yes Page 4 of

5 Products for Human Use - Active Period Register Of s File" crizotinib Xalkori Pfizer Canada Inc. N/A Yes cysteamine bitartrate Procysbi Horizon Pharma Ireland Ltd. N/A Yes dabrafenib mesylate Tafinlar Novartis Pharmaceuticals Canada Inc. N/A N/A daclatasvir Daklinza Bristol-Myers Squibb Canada N/A N/A daclizumab beta Zinbryta Biogen Canada Inc. N/A N/A dalbavancin (supplied as dalbavancin hydrochloride) Xydalba Cipher Pharmaceuticals Inc. N/A N/A damoctocog alfa pegol Jivi Bayer Inc. N/A Yes dapagliflozin propanediol Forxiga AstraZeneca Canada Inc. Xigduo Qtern N/A daratumumab Darzalex Janssen Inc. N/A N/A deferiprone Ferriprox ApoPharma Inc. N/A Yes defibrotide sodium Defitelio Jazz Pharmaceuticals Ireland Limited N/A Yes dienogest Visanne Bayer Inc. Natazia Yes difluprednate Durezol Novartis Pharmaceuticals Canada Inc. N/A Yes dimethyl fumarate Tecfidera Biogen Idec Canada Inc. N/A N/A dinutuximab Unituxin United Therapeutics Corporation N/A Yes dolutegravir sodium Tivicay ViiV Healthcare ULC Triumeq Juluca Yes doravirine Pifeltro Merck Canada Inc. Delstrigo N/A Page 5 of

6 Products for Human Use - Active Period Register Of s File" dulaglutide Trulicity Eli Lilly Canada Inc. N/A N/A dupilumab Dupixent Sanofi-Aventis Canada Inc. N/A N/A durvalumab Imfinzi AstraZeneca Canada Inc. N/A N/A edaravone Radicava Mitsubishi Tanabe Pharma Corporation N/A N/A edoxaban Lixiana Servier Canada Inc. N/A N/A efinaconazole Jublia Valeant Canada LP / Valeant Canada S.E.C. N/A N/A elagolix Orilissa AbbVie Corporation N/A N/A eliglustat tartrate Cerdelga Genzyme Canada, A division of Sanofiaventis Canada Inc. N/A N/A elosulfase alfa Vimizim Biomarin International Limited N/A Yes elotuzumab Empliciti Bristol-Myers Squibb Canada N/A N/A eltrombopag olamine Revolade Novartis Pharmaceuticals Canada Inc. N/A Yes eluxadoline Viberzi Allergan Pharma Co. N/A N/A elvitegravir, cobicistat Stribild Gilead Sciences Canada Inc. Tybost Vitekta Prezcobix Evotaz Genvoya Symtuza N/A emicizumab Hemlibra Hoffmann-La Roche Limited N/A Yes empagliflozin Jardiance Boehringer Ingelheim (Canada) Ltd. Synjardy Glyxambi N/A Page 6 of

7 Products for Human Use - Active Period Register Of s File" enzalutamide Xtandi Astellas Pharma Canada Inc. N/A N/A erenumab Aimovig Novartis Pharmaceuticals Canada Inc. N/A N/A eribulin mesylate Halaven Eisai Limited N/A N/A ertugliflozin Steglatro Merck Canada Inc. Steglujan Segluromet N/A eslicarbazepine acetate Aptiom Sunovion Pharmaceuticals Canada Inc. N/A Yes evolocumab Repatha Amgen Canada Inc. N/A Yes exenatide Byetta AstraZeneca Canada Inc. Bydureon N/A ezogabine Potiga GlaxoSmithKline Inc. N/A N/A fampridine Fampyra Biogen Idec Canada Inc. N/A N/A ferumoxytol Feraheme AMAG Pharmaceuticals Inc. N/A N/A fesoterodine fumarate Toviaz Pfizer Canada Inc. N/A Yes fidaxomicin Dificid Merck Canada Inc. N/A N/A finafloxacin Xtoro Alcon Canada Inc. N/A Yes fingolimod hydrochloride Gilenya Novartis Pharmaceuticals Canada Inc. N/A N/A flibanserin Addyi Sprout Pharmaceuticals Inc. N/A N/A Page 7 of

8 Register Of s Products for Human Use - Active Period florbetaben (18F) Neuraceq Isologic Innovative Radiopharmaceuticals Ltd. File" N/A N/A follitropin delta Rekovelle Ferring Inc. N/A N/A gadoterate meglumine Dotarem Guerbet N/A Yes galsulfase Naglazyme BioMarin Pharmaceutical Inc. N/A Yes glecaprevir, pibrentasvir Maviret AbbVie Corporation N/A N/A glycerol phenylbutyrate Ravicti Horizon Pharma Ireland Ltd. N/A Yes grazoprevir, elbasvir Zepatier Merck Canada Inc. N/A N/A guanfacine hydrochloride Intuniv XR Shire Pharma Canada ULC. N/A Yes guselkumab Tremfya Janssen Inc. N/A N/A haemagglutinin strain A (H5N1) Arepanrix H5N1 ID Biomedical Corporation of Quebec N/A Yes hemin Panhematin Recordati Rare Diseases Canada Inc. N/A N/A ibrutinib Imbruvica Janssen Inc. N/A N/A icatibant acetate Firazyr Shire Orphan Therapies Inc. N/A N/A idarucizumab Praxbind Boehringer Ingelheim (Canada) Ltd N/A N/A idelalisib Zydelig Gilead Sciences Canada Inc. N/A N/A indacaterol maleate Onbrez Breezhaler Novartis Pharmaceuticals Canada Inc. Ultibro Breezhaler N/A Page 8 of

9 Products for Human Use - Active Period Register Of s File" ingenol mebutate Picato Leo Pharma Inc. N/A N/A inotersen sodium Tegsedi Akcea Therapeutics Inc. N/A N/A inotuzumab ozogamicin Besponsa Pfizer Canada Inc. N/A N/A insulin degludec Tresiba Novo Nordisk Canada Inc. Xultophy Yes ioflupane ( 123 I) Datscan GE Healthcare Canada Inc. N/A N/A ipilimumab Yervoy Bristol-Myers Squibb Canada N/A Yes iron isomaltoside Monoferric Pharmacosmos A/S N/A N/A isavuconazole (supplied as isavuconazonium sulfate) Cresemba Avir Pharma Inc. N/A N/A ivabradine hydrochloride Lancora Servier Canada Inc. N/A Yes ivacaftor Kalydeco Vertex Pharmaceuticals (Canada) Inc. Orkambi Symdeko Yes ivermectin Rosiver Galderma Canada Inc. N/A N/A ixazomib (supplied as ixazomib citrate) Ninlaro Takeda Canada Inc. N/A N/A ixekizumab Taltz Eli Lilly Canada Inc. N/A N/A lanadelumab Takhzyro Shire Pharma Canada ULC N/A Yes ledipasvir Harvoni Gilead Sciences Canada Inc. N/A Yes lenvatinib mesylate Lenvima Eisai Limited N/A N/A letermovir Prevymis Merck Canada Inc. N/A N/A Page 9 of

10 Products for Human Use - Active Period Register Of s File" levomilnacipran hydrochloride Fetzima Allergan Inc. N/A N/A lifitegrast Xiidra Shire Pharma Canada ULC N/A N/A linaclotide Constella Forest Laboratories Canada Inc. N/A N/A linagliptin Trajenta Boehringer Ingelheim (Canada) Ltd. Jentadueto Glyxambi N/A lixisenatide Adlyxine Sanofi-aventis Canada Inc. Soliqua N/A lomitapide mesylate Juxtapid Aegerion Pharmaceuticals Canada Ltd. N/A N/A lubiprostone Amitiza Sucampo Pharma Americas LLC N/A N/A lumacaftor Orkambi Vertex Pharmaceuticals (Canada) Incorporated lurasidone hydrochloride Latuda Sunovion Pharmaceuticals Canada Inc. N/A Yes N/A Yes macitentan Opsumit Actelion Pharmaceuticals Ltd. N/A N/A mepolizumab Nucala GlaxoSmithKline Inc. N/A Yes midostaurin Rydapt Novartis Pharmaceuticals Canada Inc. N/A Yes mifepristone Mifegymiso Linepharma International Limited N/A Yes migalastat hydrochloride Galafold Amicus Therapeutics UK LTD N/A N/A mirabegron Myrbetriq Astellas Pharma Canada Inc. N/A N/A modified vaccinia virus (ankarabavarian nordic) Imvamune Bavarian Nordic A/S N/A N/A naloxegol oxalate Movantik Knight Therapeutics Inc. N/A N/A Page 10 of

11 Products for Human Use - Active Period Register Of s File" nebivolol hydrochloride Bystolic Allergan Inc. N/A N/A necitumumab Portrazza Eli Lilly Canada Inc. N/A N/A neisseria meningitidis serogroup A polysaccharide, neisseria meningitidis serogroup C polysaccharide, neisseria meningitidis serogroup W- 135 polysaccharide, neisseria meningitidis serogroup Y polysaccharide, conjugated to tetanus toxoid carrier protein Nimenrix Pfizer Canada Inc. N/A Yes Neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rlp2086) subfamily A and Neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rlp2086) subfamily B Trumenba Pfizer Canada Inc. N/A Yes netupitant Akynzeo Purdue Pharma N/A N/A nintedanib (supplied as nintedanib esilate) Ofev Boehringer Ingelheim (Canada) Ltd N/A N/A nivolumab Opdivo Bristol-Myers-Squibb Canada N/A N/A nusinersen Spinraza Biogen Canada Inc. N/A Yes obeticholic acid Ocaliva Intercept Pharmaceuticals Inc. N/A N/A obinutuzumab Gazyva Hoffmann-La Roche Limited N/A N/A ocrelizumab Ocrevus Hoffmann-La Roche Limited N/A N/A Page 11 of

12 Products for Human Use - Active Period Register Of s File" ocriplasmin Jetrea ThromboGenics N.V. N/A N/A ofatumumab Arzerra Novartis Pharmaceuticals Canada Inc. N/A N/A olaparib Lynparza AstraZeneca Canada Inc. N/A N/A olaratumab Lartruvo Eli Lilly Canada Inc. N/A N/A olodaterol hydrochloride Striverdi Respimat Boehringer Ingelheim (Canada) Ltd. Inspiolto Respimat N/A ombitasvir, paritaprevir, dasabuvir sodium Holkira Pak Abbvie Corporation Technivie N/A osimertinib mesylate Tagrisso AstraZeneca Canada Inc. N/A N/A ozenoxacin Ozanex Ferrer Internacional, S.A. N/A Yes palbociclib Ibrance Pfizer Canada Inc. N/A N/A palonosetron hydrochloride Aloxi Purdue Pharma Akynzeo N/A pasireotide diaspartate Signifor Novartis Pharmaceuticals Canada Inc. Signifor Lar N/A patiromer sorbitex calcium Veltassa Vifor Fresenius Medical Care Renal Pharma Ltd. N/A N/A peginterferon beta-1a Plegridy Biogen Idec Canada Inc. N/A N/A pembrolizumab Keytruda Merck Canada Inc. N/A Yes peramivir Rapivab BioCryst Pharmaceuticals Inc. N/A N/A perampanel Fycompa Eisai Limited N/A Yes pertuzumab Perjeta Hoffmann-La Roche Limited Perjeta-Herceptin Combo Pack N/A Page 12 of

13 Products for Human Use - Active Period Register Of s File" pirfenidone Esbriet Hoffmann-La Roche Limited N/A N/A plerixafor Mozobil Sanofi-aventis Canada Inc. N/A N/A polidocanol Varithena Provensis Ltd. N/A N/A pomalidomide Pomalyst Celgene Inc. N/A N/A ponatinib hydrochloride Iclusig Ariad Pharmaceuticals Inc. N/A N/A pralatrexate Folotyn Servier Canada Inc. N/A N/A propiverine hydrochloride Mictoryl / Mictoryl Duchesnay Inc. N/A Yes prucalopride succinate Resotran Janssen Inc. N/A N/A radium dichloride Xofigo Bayer Inc. N/A N/A ramucirumab Cyramza Eli Lilly Canada Inc. N/A N/A recombinant human papillomavirus types 31, 33, 45, 52 and Gardasil 9 Merck Canada Inc. N/A Yes recombinant neisseria meningitidis 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) Bexsero GlaxoSmithKline Inc. N/A Yes Page 13 of

14 Products for Human Use - Active Period recombinant porcine factor VIII (antihemophilic factor (recombinant), porcine sequence) Register Of s File" Obizur Shire Pharma Canada ULC N/A N/A regorafenib monohydrate Stivarga Bayer Inc. N/A N/A remestemcel-l Prochymal Osiris Therapeutics Inc. N/A Yes reslizumab Cinqair Teva Canada Limited N/A Yes ribociclib (supplied as ribociclib succinate) Kisqali Novartis Pharmaceuticals Canada Inc. N/A N/A rifaximin Zaxine Salix Pharmaceuticals Inc. N/A N/A rilpivirine hydrochloride Edurant Janssen Inc. Complera Odefsey Juluca Yes riociguat Adempas Bayer Inc. N/A N/A romidepsin Istodax Celgene Inc. N/A N/A rotigotine Neupro UCB Canada Inc. N/A N/A rubidium 82 chloride Ruby-Fill Jubilant Draximage Inc. N/A N/A rufinamide Banzel Eisai Limited N/A Yes rupatadine (supplied as rupatadine fumarate) Rupall Pediapharm Inc. N/A Yes ruxolitinib phosphate Jakavi Novartis Pharmaceuticals Canada Inc. N/A N/A sacubitril Entresto Novartis Pharmaceuticals Canada Inc. N/A N/A Page 14 of

15 Products for Human Use - Active Period Register Of s File" sarilumab Kevzara Sanofi-aventis Canada Inc. N/A N/A sebelipase alfa Kanuma Alexion Pharma GmbH N/A Yes secukinumab Cosentyx Novartis Pharmaceuticals Canada Inc. N/A N/A selexipag Uptravi Janssen Inc. N/A N/A semaglutide Ozempic Novo Nordisk Canada Inc. N/A N/A silodosin Rapaflo Purdue Pharma N/A N/A siltuximab Sylvant Janssen Inc. N/A N/A simeprevir Galexos Janssen Inc. N/A N/A sodium fluoride 18F NaF Plus Isologic Innovative Radiopharmaceuticals Ltd. N/A N/A sofosbuvir Sovaldi Gilead Sciences Canada Inc. Harvoni Epclusa Vosevi N/A stiripentol Diacomit Biocodex SA N/A Yes sucroferric oxyhydroxide Velphoro Vifor Fresenius Medical Care Renal Pharma Ltd. N/A N/A sugammadex sodium Bridion Merck Canada Inc. N/A N/A suvorexant Belsomra Merck Canada Inc. N/A N/A tafluprost Saflutan Purdue Pharma N/A N/A Page 15 of

16 Products for Human Use - Active Period Register Of s File" taliglucerase alfa Elelyso Pfizer Canada Inc. N/A Yes tedizolid phosphate Sivextro Merck Canada Inc. N/A N/A teduglutide Revestive Shire Pharmaceuticals Ireland Limited N/A N/A telaprevir Incivek Vertex Pharmaceuticals (Canada) Inc. N/A N/A telotristat ethyl (as telotristat etiprate) Xermelo Ipsen Biopharmaceuticals Canada Inc. N/A N/A tenofovir alafenamide hemifumarate Genvoya Gilead Sciences Canada Inc. Descovy Odefsey Vemlidy Symtuza Biktarvy teriflunomide Aubagio Genzyme Canada a division of Sanofiaventis Canada Inc Yes N/A N/A tesamorelin Egrifta Theratechnologies Inc. N/A N/A tezacaftor Symdeko Vertex Pharmaceuticals (Canada) Incorporated N/A Yes ticagrelor Brilinta AstraZeneca Canada Incorporated N/A N/A tisagenlecleucel / Kymriah Novartis Pharmaceuticals Canada Inc. N/A Yes tofacitinib Xeljanz Pfizer Canada Inc. N/A N/A tolvaptan Samsca Otsuka Pharmaceutical Co. Ltd. Jinarc N/A trametinib Mekinist Novartis Pharmaceuticals Canada Inc. N/A N/A Page 16 of

17 Products for Human Use - Active Period Register Of s File" trastuzumab emtansine Kadcyla Hoffmann-La Roche Limited N/A N/A trifluridine, tipiracil hydrochloride Lonsurf Taiho Pharma Canada Inc. N/A N/A turoctocog alfa Zonovate Novo Nordisk Canada Inc. N/A Yes ulipristal acetate Fibristal Allergan Inc. N/A N/A umeclidinium bromide Anoro Ellipta GlaxoSmithKline Inc. Incruse Ellipta N/A vandetanib Caprelsa Genzyme Canada, a division of Sanofiaventis Canada Inc. N/A N/A varicella-zoster virus glycoprotein E (ge) Shingrix GlaxoSmithKline Inc. N/A N/A vedolizumab Entyvio Takeda Canada Inc. N/A N/A velaglucerase alfa Vpriv Shire Human Genetic Therapies, Inc. N/A Yes velpatasvir Epclusa Gilead Sciences Canada Inc. Vosevi N/A vemurafenib Zelboraf Hoffmann-La Roche Ltd. N/A N/A venetoclax Venclexta AbbVie Corporation N/A N/A vernakalant hydrochloride Brinavess Cipher Pharmaceuticals Inc. N/A N/A vilanterol trifenatate Breo Ellipta GlaxoSmithKline Inc. Anoro Ellipta Trelegy Ellipta Yes vilazodone hydrochloride Viibryd Forest Laboratories Canada Inc. N/A N/A Page 17 of

18 Products for Human Use - Active Period Register Of s File" vismodegib Erivedge Hoffmann-La Roche Ltd. N/A N/A vorapaxar sulfate Zontivity Aralez Pharmaceuticals Trading DAC N/A N/A vortioxetine hydrobromide Trintellix Lundbeck Canada Inc. N/A Yes voxilaprevir Vosevi Gilead Sciences Canada Inc. N/A N/A *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 (1) of the Food and Drug Regulations ). Page 18 of

19 Products for Human Use - Expired Period Register Of s File" abatacept Orencia Bristol-Myers Squibb Canada N/A Yes acamprosate calcium Campral Mylan Pharmaceuticals ULC N/A N/A alglucosidase alfa Myozyme Genzyme Canada Inc. N/A Yes aliskiren hemifumarate Rasilez Novartis Pharmaceuticals Canada Inc. Rasilez HCT Rasilamlo N/A ambrisentan Volibris GlaxoSmithKline Inc. N/A N/A anidulafungin Eraxis Pfizer Canada Inc. N/A Yes aprepitant Emend Merck Frosst Canada Ltd. Emend Tri-Pack Emend IV N/A aripiprazole Abilify Bristol-Myers Squibb Canada Abilify Maintena Yes azacitidine Vidaza Celgene N/A N/A besifloxacin Besivance Bausch & Lomb Inc. N/A Yes canakinumab Ilaris Novartis Pharmaceuticals Canada Inc. N/A Yes ceftobiprole medocaril Zeftera Janssen Inc. N/A N/A certolizumab pegol Cimzia UCB Canada Inc. N/A N/A ciclesonide Alvesco Takeda Canada Inc. Omnaris Omnaris HFA Yes clofarabine Clolar Sanofi-aventis Canada Inc. N/A Yes dabigatran etexilate mesilate Pradaxa Boehringer Ingelheim (Canada) Ltd. N/A N/A Page 19 of

20 Products for Human Use - Expired Period Register Of s File" daptomycin Cubicin Cubist Pharmaceuticals, Incorporated N/A Yes darunavir ethanolate Prezista Janssen Inc. N/A Yes dasatinib monohydrate Sprycel Bristol-Myers Squibb Canada N/A N/A deferasirox Exjade Novartis Pharmaceuticals Canada Inc. N/A Yes degarelix acetate Firmagon Ferring Inc. N/A N/A denosumab Prolia Amgen Canada Inc. Xgeva N/A desvenlafaxine succinate Pristiq Pfizer Canada Inc. N/A Yes dexmedetomidine hydrochloride Precedex Pfizer Canada Inc. N/A Yes doripenem monohydrate Doribax Janssen Inc. N/A N/A dronedarone hydrochloride Multaq Sanofi-aventis Canada Inc. N/A N/A duloxetine hydrochloride Cymbalta Eli Lilly Canada Inc. N/A Yes eculizumab Soliris Alexion Pharma International Sàrl N/A Yes eplerenone Inspra Pfizer Canada Inc. N/A Yes etravirine Intelence Janssen Inc. N/A Yes everolimus Afinitor Novartis Pharmaceuticals Canada Inc. Certican Yes febuxostat Uloric Takeda Canada Inc. N/A N/A fludeoxyglucose 18F Cantrace Ipet Pharmaceuticals Inc. N/A N/A fluticasone furoate Avamys GlaxoSmithKline Inc. N/A Yes Page 20 of

21 Products for Human Use - Expired Period Register Of s File" gadofosveset trisodium Vasovist Berlex Canada Inc. N/A N/A gadoxetate disodium Primovist Bayer Inc. N/A N/A golimumab Simponi Janssen Inc. N/A N/A human C1 esterase inhibitor Berinert CSL Behring Canada Inc. Haegarda N/A idebenone Catena Santhera Pharmaceuticals Ltd. N/A Yes idursulfase Elaprase Shire Human Genetic Therapies, Inc. N/A Yes influenza virus type A (H1N1), influenza virus type A (H3N2), influenza virus type B FluMist AstraZeneca Canada Incorporated FluMist Quadrivalent Yes lacosamide Vimpat UCB Canada Inc. N/A N/A lanreotide Somatuline Autogel Ipsen Biopharm Limited N/A N/A lanthanum carbonate Fosrenol Shire BioChem Inc. N/A N/A lapatinib ditosylate Tykerb Novartis Pharmaceuticals Canada Inc. N/A N/A lenalidomide Revlimid Celgene N/A N/A liraglutide Victoza Novo Nordisk Canada Inc. Saxenda Xultophy N/A lisdexamfetamine dimesylate Vyvanse Shire Pharma Canada ULC. N/A Yes loteprednol etabonate Alrex Bausch & Lomb Inc. Lotemax Lotemax Ointment Lotemax Gel N/A lumiracoxib Prexige Novartis Pharmaceuticals Canada Inc. N/A N/A maraviroc Celsentri ViiV Healthcare ULC N/A N/A Page 21 of

22 Products for Human Use - Expired Period methoxy polyethylene gycol epoetin beta Register Of s File" Mircera Hoffmann-La Roche Ltd. N/A N/A methylnaltrexone bromide Relistor Salix Pharmaceuticals, Inc. N/A N/A micafungin sodium Mycamine Astellas Pharma Canada, Inc. N/A N/A natalizumab Tysabri Biogen Idec Canada Inc. N/A N/A nelarabine Atriance Novartis Pharmaceuticals Canada Inc. N/A Yes nepafenac Nevanac Alcon Canada Inc. Ilevro N/A nesiritide Natrecor Janssen Inc. N/A N/A nilotinib hydrochloride monohydrate Tasigna Novartis Pharmaceuticals Canada Inc. N/A N/A olmesartan medoxomil Olmetec Merck Canada Inc. Olmetec Plus Yes oxaliplatin Eloxatin Sanofi-aventis Canada Inc. N/A Yes paliperidone Invega Janssen Inc. Invega Sustenna Yes panitumumab Vectibix Amgen Canada Inc. N/A N/A pazopanib hydrochloride Votrient Novartis Pharmaceuticals Canada Inc. N/A N/A pneumococcal polysaccharide serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F Synflorix GlaxoSmithKline Inc. N/A Yes pneumococcal polysaccharide serotype 3, 5, 6A, 19A, Prevnar 13 Pfizer Canada Inc. N/A Yes posaconazole Posanol Merck Canada Inc. N/A Yes Page 22 of

23 Products for Human Use - Expired Period Register Of s File" prasugrel hydrochloride Effient Eli Lilly Canada Inc. N/A Yes raltegravir potassium Isentress Merck Frosst Canada Inc. N/A Yes ranibizumab Lucentis Novartis Opthalmics, Novartis Pharmaceuticals N/A N/A rasagiline mesylate Azilect Teva Pharmaceuticals Industries Ltd. N/A N/A recombinant human papillomavirus type 11 L1, type 16 L1, type 18 L1 & type 6 L1 protein Gardasil Merck Frosst Canada Ltd. N/A Yes retapamulin Altargo GlaxoSmithKline Inc. N/A Yes rivaroxaban Xarelto Bayer Healthcare N/A N/A roflumilast Daxas Takeda Canada Inc. N/A N/A romiplostim Nplate Amgen Canada Inc. N/A Yes rotavirus RIX4414 strain, live, attenuated (human) Rotarix GlaxoSmithKline Inc. N/A Yes rotavirus vaccine, live, oral type G1, type G2, type G3, type G4 & type P1(8) (human) Rotateq Merck Frosst Canada Ltd. N/A Yes sapropterin dihydrochloride Kuvan BioMarin Pharmaceutical Inc. N/A Yes saxagliptin hydrochloride Onglyza AstraZeneca Canada Inc. Komboglyze Qtern sitagliptin phosphate Januvia Merck Frosst Canada Ltd. Janumet Janumet XR N/A N/A Page 23 of

24 Products for Human Use - Expired Period Register Of s File" sitaxsentan sodium Thelin Pfizer Canada Inc. N/A N/A sorafenib Nexavar Bayer Inc. N/A N/A tapentadol hydrochloride Nucynta CR Janssen Inc. Nucynta IR Nucynta Extended Release N/A telavancin hydrochloride Vibativ Pendopharm Division of de Pharmascience Inc. N/A N/A telbivudine Sebivo Novartis Pharmaceuticals Canada Inc. N/A N/A temsirolimus Torisel Pfizer Canada Inc. N/A Yes tigecycline Tygacil Pfizer Canada Inc. N/A N/A tocilizumab Actemra Hoffmann-La Roche Ltd. N/A Yes trabectedin Yondelis Janssen Inc. N/A N/A ustekinumab Stelara Janssen Inc. N/A N/A varenicline tartrate Champix Pfizer Canada Inc. N/A Yes vorinostat Zolinza Merck Frosst Canada Ltd. N/A N/A ziprasidone hydrochloride monohydrate Zeldox Pfizer Canada Inc. N/A Yes zucapsaicin Zuacta Sanofi-aventis Canada Inc. N/A N/A *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 (1) of the Food and Drug Regulations). Page 24 of

25 Products for Veterinary Use - Active Period Register Of s File" afoxolaner Nexgard Merial Canada Inc. Nexgard Spectra avilamycin Surmax 100 Premix Elanco Canada Limited Surmax 200 Premix cefpodoxime proxetil Simplicef Zoetis Canada Inc. N/A clodronate disodium tetrahydrate Osphos Injection Dechra Ltd. N/A closantel sodium Flukiver Elanco Division Eli Lilly Canada Inc N/A derquantel Startect Zoetis Canada Inc. N/A dibotermin alfa (rhbmp-2) Truscient Zoetis Canada Inc. N/A fluralaner Bravecto Intervet Canada Corp. N/A gonadotropin releasing factor analogue - protein conjugate insulin human (recombinant) Improvest Zoetis Canada Inc. N/A Prozinc Boehringer Ingelheim Canada Ltd. N/A lotilaner Credelio Elanco Canada Limited N/A lubabegron Experior Elanco Canada Limited N/A oclacitinib maleate Apoquel Zoetis Canada Inc. N/A peforelin Maprelin XP-10 Modern Veterinary Therapeutics LLC N/A pegbovigrastim Imrestor Elanco Division Eli Lilly Canada Inc. N/A Page 25 of

26 Products for Veterinary Use - Active Period Register Of s File" pergolide mesylate Prascend Boehringer Ingelheim Canada Ltd. N/A permethrin Oridermyl Vétoquinol N.- A Inc. N/A phenobarbital Epiphen Vétoquinol N.- A Inc. N/A pradofloxacin Veraflox Bayer Inc., Bayer Healthcare, Animal Health N/A robenacoxib Onsior Elanco Canada Limited N/A sarolaner Simparica Zoetis Canada Inc. Revolution Plus telmisartan Semintra Boehringer Ingelheim Canada Ltd. N/A terbinafine Osurnia Elanco Canada Limited N/A tildipirosin Zuprevo Intervet Canada Corp. N/A tiludronic acid (as tiludronate disodium) triptorelin (as triptorelin acetate) Tildren CEVA Animal Health N/A Ovugel United-AH II, LLC N/A *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 (1) of the Food and Drug Regulations). Page 26 of

27 Products for Veterinary Use - Expired Period Register Of s File" acetaminophen Pracetam 20% O.S. Ceva Animal Health Inc. N/A buprenorphine hydrochloride Vetergesic Multidose Sogeval UK Limited N/A cefovecin sodium Convenia Zoetis Canada Inc. N/A cephalexin monohydrate Vetolexin Vétoquinol N.-A Inc. Cefaseptin dirlotapide Slentrol Zoetis Canada Inc. N/A emamectin benzoate Slice Intervet Canada Ltd. N/A emodepside / / firocoxib / fluoxetine hydrochloride / / Profender Bayer Healthcare, Animal Health Division N/A Previcox Merial Canada Inc. N/A Reconcile Elanco, Division Eli Lilly Canada Inc. N/A gamithromycin Zactran Merial Canada Inc. N/A ibafloxacin / imidapril hydrochloride / / Ibaflin gel Intervet Canada Ltd. N/A Prilium Vétoquinol N.-A Inc. N/A itraconazole Itrafungol Elanco, Division Eli Lilly Canada Inc. N/A Page 27 of

28 Products for Veterinary Use - Expired Period maropitant / / / Register Of s File" Cerenia Zoetis Canada Inc. N/A mitratapide Yarvitan Janssen Pharmaceutica N.V. N/A mometasone furoate monohydrate Mometamax Intervet Canada Corp. N/A ramipril / / Vasotop Intervet Canada Ltd. N/A sevoflurane Sevoflo Zoetis Canada Inc. N/A spinosad / / / / tepoxalin / / Comfortis Elanco, Division Eli Lilly Canada Inc. Trifexis Zubrin Schering Plough Canada Inc. N/A thiamazole Felimazole Dechra Ltd. N/A toceranib phosphate Palladia Zoetis Canada Inc. N/A toltrazuril Baycox Bayer Inc., Bayer Healthcare Animal Health Division N/A Page 28 of

29 Products for Veterinary Use - Expired Period trilostane / / / Register Of s File" Vetoryl Dechra Ltd. N/A tulathromycin Draxxin Pfizer Canada Inc., Animal Health Group N/A zilpaterol hydrochloride Zilmax Intervet Canada Ltd. N/A *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 (1) of the Food and Drug Regulations). The Minister of Health maintains a register of innovative drugs pursuant to sub-section C (9) of the Food and Drug Regulations. Page 29 of