Register of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal
Ingredient(s) Footnote 1
Submission Number Innovative Drug Manufacturer Drug(s) Containing the Medicinal Ingredient / Variations Notice of Compliance Date yyyy-mm-dd 6 Year
"No File"
Date
Pediatric Extension Yes/No Data Protection Ends
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
Oseni
2013-11-27 2019-11-27 N/A 2021-11-27
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 BDD), Fc fusion protein 163447 Eloctate Bioverativ Canada Inc. N/A 2014-08-22 2020-08-22 Yes 2023-02-22
antihemophilic factor (recombinant), pegylated 189709 Adynovate Baxalta Canada Corporation N/A 2016-11-17 2022-11-17 Yes 2025-05-17
antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 Jivi Bayer Inc. N/A 2018-10-18 2024-10-18 Yes 2027-04-18
antihemophilic factor (recombinant, B-domain deleted) (also known as simoctocog alfa) 169551 Nuwiq Octapharma Pharmazeutika Produktionsges.m.b.H N/A 2014-10-23 2020-10-23 Yes 2023-04-23
antihemophilic factor VIII (recombinant), singlechain (also known as lonoctocog alfa) 190891 Afstyla CSL Behring Canada Inc. N/A 2016-12-12 2022-12-12 Yes 2025-06-12
anthrax antigen filtrate 212387 Biothrax Emergent Biodefense Operations Lansing LLC N/A 2018-12-13 2024-12-13 N/A 2026-12-13
antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated (turoctocog alfa pegol) 218531 Esperoct Novo Nordisk Canada Inc. N/A 2019-07-04 2025-07-04 Yes 2028-01-04
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., Canada N/A 2017-12-18 2023-12-18 N/A 2025-12-18
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
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 heptavalen C/ D/ F/ G - (equine) 190645 Bat Emergent BioSolutions Inc. N/A 2016-12-08 2022-12-08 Yes 2025-06-08
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
cabazitaxel 137421 Jevtana Sanofi-aventis Canada Inc. N/A 2011-06-16 2017-06-16 Yes 2019-12-16
cabozantinib (supplied as cabozantinib (S)-malate) 206230 Cabometyx Ipsen Biopharmaceuticals Canada Inc. N/A 2018-09-14 2024-09-14 N/A 2026-09-14
calcifediol 205392 Rayaldee Vifor Fresenius Medical Care Renal Pharma Ltd N/A 2018-07-10 2024-07-10 N/A 2026-07-10
canagliflozin 157505 Invokana Janssen Inc. Invokamet
Invokamet XR
2014-05-23 2020-05-23 N/A 2022-05-23
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), albumin fusion protein (rIX-FP) 180793 Idelvion CSL Behring Canada Inc. N/A 2016-01-26 2022-01-26 Yes 2024-07-26
coagulation factor IX (recombinant), pegylated (nonacog beta pegol) 201114 Rebinyn Novo Nordisk Canada Inc. N/A 2017-11-29 2023-11-29 Yes 2026-05-29
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
colesevelam hydrochloride 133463 Lodalis Valeant Canada LP / Valeant Canada S.E.C. N/A 2011-09-22 2017-09-22 N/A 2019-09-22
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
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 hydrochloride) 212390 Xydalba Cipher Pharmaceuticals Inc. N/A 2018-09-04 2024-09-04 N/A 2026-09-04
dapagliflozin propanediol 160877 Forxiga AstraZeneca Canada Inc. Xigduo
Qtern
2014-12-12 2020-12-12 N/A 2022-12-12
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
Juluca
Dovato
2013-10-31 2019-10-31 Yes 2022-05-01
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 N/A 2025-11-30
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 S.E.C. N/A 2013-10-02 2019-10-02 N/A 2021-10-02
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-aventis Canada Inc. N/A 2017-04-21 2023-04-21 N/A 2025-04-21
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
Vitekta
Prezcobix
Evotaz
Genvoya
Symtuza
2012-11-26 2018-11-26 N/A 2020-11-26
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
Glyxambi
2015-07-23 2021-07-23 N/A 2023-07-23
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
erenumab 208607 Aimovig Novartis Pharmaceuticals Canada Inc. N/A 2018-08-01 2024-08-01 N/A 2026-08-01
eribulin mesylate 141946 Halaven Eisai Limited N/A 2011-12-14 2017-12-14 N/A 2019-12-14
ertugliflozin 204724 Steglatro Merck Canada Inc. Steglujan
Segluromet
2018-05-09 2024-05-09 N/A 2026-05-09
eslicarbazepine acetate 165665 Aptiom Sunovion Pharmaceuticals Canada Inc. N/A 2014-07-08 2020-07-08 Yes 2023-01-08
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
ferumoxytol 133250 Feraheme AMAG Pharmaceuticals Inc. N/A 2011-12-08 2017-12-08 N/A 2019-12-08
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 Radiopharmaceuticals Ltd. N/A 2017-02-22 2023-02-22 N/A 2025-02-22
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
glecaprevir, pibrentasvir 202233 Maviret AbbVie Corporation N/A 2017-08-16 2023-08-16 Yes 2026-02-16
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
indacaterol maleate 143984 Onbrez Breezhaler Novartis Pharmaceuticals Canada Inc. Ultibro Breezhaler 2011-12-06 2017-12-06 N/A 2019-12-06
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
isavuconazole (supplied as isavuconazonium sulfate) 208919 Cresemba Avir Pharma Inc. N/A 2018-12-19 2024-12-19 N/A 2026-12-19
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
Symdeko
2012-11-26 2018-11-26 Yes 2021-05-26
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 sulfate) 219998 Vitrakvi Bayer Inc. N/A 2019-07-10 2025-07-10 Yes 2028-01-10
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 Shire Pharma Canada ULC 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
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) Incorporated N/A 2016-01-26 2022-01-26 Yes 2024-07-26
lurasidone hydrochloride 145406 Latuda Sunovion Pharmaceuticals Canada Inc. N/A 2012-06-13 2018-06-13 Yes 2020-12-13
lutetium177 Lu oxodotreotide 217184 Lutathera Advanced Accelerator Applications USA, Inc. N/A 2019-01-09 2025-01-09 N/A 2027-01-09
macitentan 161372 Opsumit Janssen Inc. N/A 2013-11-06 2019-11-06 N/A 2021-11-06
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-bavarian nordic) 144762 Imvamune Bavarian Nordic A/S N/A 2013-11-21 2019-11-21 N/A 2021-11-21
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 polysaccharide, neisseria meningitidis serogroup C polysaccharide, neisseria meningitidis serogroup W-135 polysaccharide, neisseria meningitidis serogroup Y polysaccharide, conjugated to tetanus toxoid carrier protein 154290 Nimenrix Pfizer Canada Inc. N/A 2013-03-05 2019-03-05 Yes 2021-09-05
neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily A and Neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily B 195550 Trumenba Pfizer Canada Inc. N/A 2017-10-05 2023-10-05 Yes 2026-04-05
neratinib maleate 218224 Nerlynx Puma Biotechnology 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 esilate) 176043 Ofev Boehringer Ingelheim (Canada) Ltd N/A 2015-06-25 2021-06-25 N/A 2023-06-25
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 sodium 174739 Holkira Pak Abbvie Corporation Technivie 2014-12-22 2020-12-22 N/A 2022-12-22
osimertinib mesylate 188171 Tagrisso AstraZeneca Canada Inc. N/A 2016-07-05 2022-07-05 N/A 2024-07-05
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 Pharma Ltd. N/A 2018-10-03 2024-10-03 N/A 2026-10-03
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 Combo Pack 2013-04-12 2019-04-12 N/A 2021-04-12
pirfenidone 153849 Esbriet Hoffmann-La Roche Limited N/A 2012-10-01 2018-10-01 N/A 2020-10-01
plerixafor 142638 Mozobil Sanofi-aventis Canada Inc. N/A 2011-12-08 2017-12-08 N/A 2019-12-08
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
pralatrexate 207545 Folotyn Servier Canada Inc. N/A 2018-10-26 2024-10-26 N/A 2026-10-26
ponatinib hydrochloride 165121 Iclusig Ariad Pharmaceuticals Inc. N/A 2015-04-02 2021-04-02 N/A 2023-04-02
propiverine hydrochloride 188323 Mictoryl / Mictoryl Pediatric Duchesnay Inc. N/A 2017-01-05 2023-01-05 Yes 2025-07-05
prucalopride succinate 141157 Resotran Janssen Inc. N/A 2011-12-07 2017-12-07 N/A 2019-12-07
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 types 31, 33, 45, 52 and 58 170006 Gardasil 9 Merck Canada Inc. N/A 2015-02-05 2021-02-05 Yes 2023-08-05
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) 147275 Bexsero GlaxoSmithKline Inc. N/A 2013-12-06 2019-12-06 Yes 2022-06-06
recombinant porcine factor VIII (antihemophilic factor (recombinant), porcine sequence) 177290 Obizur Shire Pharma Canada ULC N/A 2015-10-14 2021-10-14 N/A 2023-10-14
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 succinate) 203884 Kisqali Novartis Pharmaceuticals Canada Inc. N/A 2018-03-02 2024-03-02 N/A 2026-03-02
rifaximin 161256 Zaxine Salix Pharmaceuticals Inc. N/A 2013-08-13 2019-08-13 N/A 2021-08-13
rilpivirine hydrochloride 137484 Edurant Janssen Inc. Complera
Odefsey
Juluca
2011-07-21 2017-07-21 Yes 2020-01-21
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
rubidium 82 chloride 138823 Ruby-Fill Jubilant Draximage Inc. N/A 2011-09-20 2017-09-20 N/A 2019-09-20
rufinamide 139913 Banzel Eisai Limited N/A 2011-06-22 2017-06-22 Yes 2019-12-22
rupatadine (supplied as rupatadine fumarate) 186488 Rupall Pediapharm Inc. N/A 2016-07-20 2022-07-20 Yes 2025-01-20
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
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 Radiopharmaceuticals Ltd. N/A 2013-02-11 2019-02-11 N/A 2021-02-11
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
Epclusa
Vosevi
2013-12-13 2019-12-13 N/A 2021-12-13
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 Pharma Ltd. N/A 2018-01-05 2024-01-05 N/A 2026-01-05
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
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
Odefsey
Vemlidy
Symtuza
Biktarvy
2015-11-27 2021-11-27 Yes 2024-05-27
teriflunomide 160646 Aubagio Genzyme Canada a division of Sanofi-aventis Canada Inc. N/A 2013-11-14 2019-11-14 N/A 2021-11-14
tesamorelin 131836 Egrifta Theratechnologies Inc. N/A 2014-04-29 2020-04-29 N/A 2022-04-29
tezacaftor 211292 Symdeko Vertex Pharmaceuticals (Canada) Incorporated N/A 2018-06-27 2024-06-27 Yes 2026-12-27
tisagenlecleucel 213547 / 213698 Kymriah Novartis Pharmaceuticals Canada Inc. N/A 2018-09-05 2024-09-05 Yes 2027-03-05
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
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-aventis Canada Inc. N/A 2012-01-12 2018-01-12 N/A 2020-01-12
varicella-zoster virus glycoprotein E (gE) 200244 Shingrix GlaxoSmithKline Inc. N/A 2017-10-13 2023-10-13 N/A 2025-10-13
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
vemurafenib 148693 Zelboraf Hoffmann-La Roche Ltd. N/A 2012-02-15 2018-02-15 N/A 2020-02-15
venetoclax 190761 Venclexta AbbVie Corporation N/A 2016-09-30 2022-09-30 N/A 2024-09-30
vernakalant hydrochloride 190817 Brinavess Cipher Pharmaceuticals Inc. N/A 2017-03-13 2023-03-13 N/A 2025-03-13
vilanterol trifenatate 157301 Breo Ellipta GlaxoSmithKline Inc. Anoro Ellipta
Trelegy Ellipta
2013-07-03 2019-07-03 Yes 2022-01-03
vilazodone hydrochloride 176820 Viibryd Allergan Inc. N/A 2015-07-16 2021-07-16 N/A 2023-07-16
vismodegib 154608 Erivedge Hoffmann-La Roche Ltd. N/A 2013-07-12 2019-07-12 N/A 2021-07-12
von willebrand factor (recombinant) (vonicog alfa) 213188 Vonvendi Shire Pharma Canada ULC N/A 2019-01-10 2025-01-10 N/A 2027-01-10
vorapaxar sulfate 179320 Zontivity Aralez Pharmaceuticals Trading DAC N/A 2016-05-13 2022-05-13 N/A 2024-05-13
vortioxetine hydrobromide 159019 Trintellix Lundbeck Canada Inc. N/A 2014-10-22 2020-10-22 Yes 2023-04-22
voxilaprevir 202324 Vosevi Gilead Sciences Canada Inc. N/A 2017-08-16 2023-08-16 N/A 2025-08-16

Products for Human Use - Expired Data Protection Period

Medicinal
Ingredient(s) Footnote 1
Submission Number Innovative Drug Manufacturer Drug(s) Containing the Medicinal
Ingredient / Variations
Notice of Compliance Date yyyy-mm-dd 6 Year
"No File"
Date
Pediatric Extension Yes/No Data Protection Ends
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
  • Rasilamlo
2007-11-14 2013-11-14 N/A 2015-11-14
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
  • Emend IV
2007-08-24 2013-08-24 N/A 2015-08-24
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 2011-07-06 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
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
ciclesonide 101419 Alvesco Takeda Canada Inc.
  • Omnaris
  • Omnaris HFA
2006-09-11 2012-09-11 Yes 2015-03-11
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
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 hydrochloride 126931 Precedex Pfizer Canada Inc. N/A 2009-12-09 2015-12-09 Yes 2018-06-09
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
eltrombopag olamine 123984 Revolade Novartis Pharmaceuticals Canada Inc. N/A 2011-01-12 2011-01-12 Yes 2019-07-12
eplerenone 120440 Inspra Pfizer Canada Inc. N/A 2009-02-26 2015-02-26 Yes 2017-08-26
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
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
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
influenza virus type A (H1N1), influenza virus type A (H3N2), influenza virus type B 129379 FluMist AstraZeneca Canada Incorporated FluMist Quadrivalent 2010-06-22 2016-06-22 Yes 2018-12-22
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
human C1 esterase inhibitor 121221 Berinert CSL Behring Canada Inc. Haegarda 2010-05-31 2016-05-31 N/A 2018-05-31
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 Glyxambi 2011-07-28 2017-07-28 N/A 2019-07-28
liraglutide 119928 Victoza Novo Nordisk Canada Inc.
  • Saxenda
  • Xultophy
2010-05-21 2016-05-21 N/A 2018-05-21
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
  • Lotemax Ointment
  • Lotemax Gel
2008-12-23 2014-12-23 N/A 2016-12-23
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 epoetin beta 106461 Mircera Hoffmann-La Roche Ltd. N/A 2008-03-31 2014-03-31 N/A 2016-03-31
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
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 monohydrate 110305 Tasigna Novartis Pharmaceuticals Canada Inc. N/A 2008-09-09 2014-09-09 N/A 2016-09-09
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
pneumococcal polysaccharide serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F 119056 Synflorix GlaxoSmithKline Inc. N/A 2008-12-11 2014-12-11 Yes 2017-06-11
pneumococcal polysaccharide serotype 3, 5, 6A, 19A 122881 Prevnar 13 Pfizer Canada Inc. N/A 2009-12-21 2015-12-21 Yes 2018-06-21
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
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 Pharmaceuticals N/A 2007-06-26 2013-06-26 N/A 2015-06-26
rasagiline mesylate 101846 Azilect Teva Pharmaceuticals Industries Ltd. N/A 2006-08-17 2012-08-17 N/A 2014-08-17
recombinant human papillomavirus type 11 L1, type 16 L1, type 18 L1 & type 6 L1 protein 102682 Gardasil Merck Frosst Canada Ltd., N/A 2006-07-10 2012-07-10 Yes 2015-01-10
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, attenuated (human) 109624 Rotarix GlaxoSmithKline Inc. N/A 2007-10-09 2013-10-09 Yes 2016-04-09
rotavirus vaccine, live, oral type G1, type G2, type G3, type G4 & type P1(8) (human) 100399 Rotateq Merck Frosst Canada Ltd. N/A 2006-08-01 2012-08-01 Yes 2015-02-01
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
  • Qtern
2009-09-14 2015-09-14 N/A 2017-09-14
silodosin 121740 Rapaflo Purdue Pharma N/A 2011-01-11 2017-01-11 N/A 2019-01-11
sitagliptin phosphate 103039 Januvia Merck Frosst Canada Ltd.
  • Janumet
  • Janumet XR
2007-12-14 2013-12-14 N/A 2015-12-14
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
Nucynta Extended Release
2010-12-02 2016-12-02 N/A 2018-12-02
telaprevir 142482 Incivek Vertex Pharmaceuticals (Canada) Inc. N/A 2011-08-16 2017-08-162 N/A 2019-08-10
telavancin hydrochloride 107792 Vibativ Pendopharm Division of de Pharmascience Inc. N/A 2009-09-29 2015-09-29 N/A 2017-09-29
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
varenicline tartrate 104007 Champix Pfizer Canada Inc. N/A 2007-01-24 2013-01-24 Yes 2015-07-24
velaglucerase alfa 132604 Vpriv Shire Human Genetic Therapies, Inc. N/A 2010-10-01 2016-10-01 Yes 2019-04-01
vorinostat 104562 Zolinza Merck Frosst Canada Ltd. N/A 2009-06-11 2015-06-11 N/A 2017-06-11
ziprasidone hydrochloride monohydrate 078188 Zeldox Pfizer Canada Inc. N/A 2007-08-27 2013-08-27 Yes 2016-02-27
zucapsaicin 121952 Zuacta Sanofi aventis Canada Inc. N/A 2010-07-15 2016-07-15 N/A 2018-07-15
Products for Veterinary Use - Active Data Protection Period
Medicinal
Ingredient(s) Footnote 1
Submission
Number
Innovative Drug Manufacturer Drug(s) Containing the Medicinal Ingredient / Variations Notice of Compliance Date yyyy-mm-dd 6 Year
"No File"
Date
Data Protection Ends
afoxolaner 163768 Nexgard Merial Canada Inc. Nexgard Spectra 2014-07-08 2020-07-08 2022-07-08
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 tetrahydrate 172789 Osphos Injection Dechra Ltd. N/A 2015-05-06 2021-05-06 2023-05-06
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 (recombinant) 150211 Prozinc Boehringer Ingelheim Canada Ltd. N/A 2013-04-24 2019-04-24 2021-04-24
lotilaner 193712 Credelio Elanco Canada Limited N/A 2017-12-29 2023-12-29 2025-12-29
lubabegron 166199 Experior 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
pergolide mesylate 158770 Prascend Boehringer Ingelheim Canada Ltd. N/A 2013-09-05 2019-09-05 2021-09-05
phenobarbital 142445 Epiphen Vetoquinol 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
robenacoxib 128703 Onsior Elanco Canada Limited N/A 2011-10-03 2017-10-03 2019-10-03
sarolaner 177679 Simparica Zoetis Canada Inc. Revolution Plus 2016-02-11 2022-02-11 2024-02-11
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 tiludronate disodium) 171467 Tildren CEVA Animal Health N/A 2014-12-22 2020-12-22 2022-12-22
triptorelin (as triptorelin acetate) 161303 Ovugel United-AH II, LLC N/A 2014-04-25 2020-04-25 2022-04-25

Products for Veterinary Use - Expired Data Protection Period

Medicinal Ingredient(s) Footnote 1 Submission
Number
Innovative Drug Manufacturer Drug(s) Containing the Medicinal Ingredient / Variations Notice of Compliance Date yyyy-mm-dd 6 Year "No File"
Date
Data Protection Ends
acetaminophen 110139 Pracetam 20% O.S. Ceva Animal Health Inc. N/A 2009-03-05 2015-03-05 2017-03-05
buprenorphine hydrochloride 126077 Vetergesic Multidose Sogeval UK Limited N/A 2010-02-03 2016-02-03 2018-02-03
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 / 112106 / 112107 Profender Bayer Healthcare, Animal Health Division N/A 2008-08-28 2014-08-28 2016-08-28
firocoxib 110661 / 110379 Previcox Merial Canada Inc. N/A 2007-09-28 2013-09-28 2015-09-28
fluoxetine hydrochloride 109825 / 109826 / 110429 Reconcile Elanco, Division Eli Lilly Canada Inc. N/A 2008-03-28 2014-03-28 2016-03-28
gamithromycin 125823 Zactran Merial Canada Inc. N/A 2010-03-29 2016-03-29 2018-03-29
gonadotropin releasing factor analogue - protein conjugate 140525 Improvest Zoetis Canada Inc. N/A 2011-06-22 2017-06-22 2019-06-22
ibafloxacin 110655 / 110657 Ibaflin gel Intervet Canada Ltd. N/A 2008-01-15 2014-01-15 2016-01-15
imidapril hydrochloride 110445 / 110450 / 110476 Prilium Vetoquinol N A Inc. N/A 2007-07-12 2013-07-12 2015-07-12
itraconazole 109769 Itrafungol Elanco, Division Eli Lilly Canada Inc. N/A 2008-09-23 2014-09-23 2016-09-23
maropitant 110342 / 110344 / 110347 / 110348 Cerenia Zoetis Canada Inc. N/A 2007-09-20 2013-09-20 2015-09-20
mitratapide 111600 Yarvitan Janssen Pharmaceutica N.V. N/A 2009-02-20 2015-02-20 2017-02-20
mometasone furoate monohydrate 110289 Mometamax Intervet Canada Corp. N/A 2010-02-22 2016-02-22 2018-02-22
permethrin 133818 Oridermyl Vétoquinol N.- A Inc.  N/A 2011-02-18 2017-02-18 2019-02-18
ramipril 110296 / 110297 / 110298 Vasotop Intervet Canada Ltd. N/A 2008-09-05 2014-09-05 2016-09-05
sevoflurane 110109 Sevoflo Zoetis Canada Inc. N/A 2008-03-28 2014-03-28 2016-03-28
spinosad 112198 / 112199 / 112202 / 112203 / 112204 Comfortis Elanco, Division Eli Lilly Canada Inc. Trifexis 2009-08-24 2015-08-24 2017-08-24
tepoxalin 109950 / 109956 / 109963 Zubrin Schering Plough Canada Inc. N/A 2007-10-01 2013-10-01 2015-10-01
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 Division N/A 2010-08-20 2016-08-20 2018-08-20
trilostane 110023 / 110025 / 110221 / 113566 Vetoryl Dechra Ltd. N/A 2009-01-30 2015-01-30 2017-01-30
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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