No.NameActivesubstance
1Rasagilineratiopharmrasagiline
2SevelamercarbonateZentivasevelamercarbonate
3Viekiraxombitasvir/paritaprevir/ritonavir
4Exvieradasabuvirsodium
5Ofevnintedanib
6Cosentyxsecukinumab
7Senshioospemifene
8Otezlaapremilast
9Zontivityvorapaxarsulfate
10Cerdelgaeliglustat
11Holoclar
exvivoexpandedautologoushuman
cornealepithelialcellscontaining
stemcells
12Clopidogrelratiopharmclopidogrelhydrogensulphate
13Xydalbadalbavancinhcl
14Xadagosafinamidemethanesulfonate
15Tasermitysevelamerhydrochloride
16Vantobratobramycin
17Raplixahumanfibrinogen/humanthrombin
18Orbactivoritavancindiphosphate
2015年欧洲药监局EMA批准的91个新药
19Ikervisciclosporin
20Saxendaliraglutide
21Kengrexalcangrelor
22Sivextrotedizolidphosphate
23Mysimbabupropionhydrochloride/naltrexonehydrochloride
24Dutrebislamivudine/raltegravirpotassium
25Quinsairlevofloxacin
26Ristempapegfilgrastim
27Zykadiaceritinib
28VoriconazoleHospiravoriconazole
29Synjardyempagliflozin/metformin
30Jinarctolvaptan
31Akynzeonetupitant/palonosetronhydrochloride
32Lenvimalenvatinibmesylate
33Gardasil9
humanpapillomavirusvaccine[types
6,11,16,18,31,33,45,52,58]
(recombinant,adsorbed)
34PregabalinSandozGmbHpregabalin
35Opdivonivolumab
36Lixianaedoxabantosylate
37DuloxetineMylanduloxetine
38Lumarklutetium,isotopeofmass177
39PregabalinSandozpregabalin
40AripiprazoleZentivaaripiprazole
41PregabalinMylanPharmapregabalin
42PregabalinMylanpregabalin
43AripiprazolePharmathenaripiprazole
44Hetlioztasimelteon
45Evotazatazanavirsulfate/cobicistat
46PregabalinZentivapregabalin
47Repathaevolocumab
48Keytrudapembrolizumab
49NivolumabBMSnivolumab
50BortezomibAccordbortezomib
51Omidriaketorolac/phenylephrine
52Unituxindinutuximab
53Odomzosonidegibdiphosphate
54AripiprazoleSandozaripiprazole
55Respreezahumanalpha1-proteinaseinhibitor
56DuloxetineZentivaduloxetine
57Strensiqasfotasealfa
58Kanumasebelipasealfa
59DocetaxelHospiraUKLimiteddocetaxel
60PregabalinAccordpregabalin
61Farydakpanobinostatlactateanhydrous
62IvabradineAnpharmivabradine
63Raxoneidebenone
64PemetrexedLillypemetrexed
65Intunivguanfacinehydrochloride
66Zalvisosufentanil
67Zerbaxaceftolozanesulfate/tazobactamsodium
68PemetrexedSandozpemetrexeddisodiumhemipentahydrate
69Praluentalirocumab
70Fexericferriccitratecoordinationcomplex
71Cresembaisavuconazole
72Edistridedapagliflozinpropanediolmonohydrate
73Obizursusoctocogalfa
74Ebymectdapagliflozinpropanediolmonohydrate/metformin
hydrochloride75AripiprazoleAccordaripiprazole
76Ionsysfentanylhydrochloride
77Entrestosacubitril/valsartan
78Numientlevodopa/carbidopa
79Kyproliscarfilzomib
80Genvoyaelvitegravir/cobicistat/emtricitabine/tenofoviralafenamide
81Eloctaefmoroctocogalfa
82Orkambilumacaftor/ivacaftor
83CinacalcetMylancinacalcethydrochloride
84PemetrexedHospirapemetrexed
85Kolbamcholicacid
86Cotelliccobimetinibhemifumarate
87Praxbindidarucizumab
88Blincytoblinatumomab
89Ravictiglycerolphenylbutyrate
90Pemetrexedmedacpemetrexed
91Nucalamepolizumab
TherapeuticareaDateofauthorisation
ParkinsonDisease12/01/2015
HyperphosphatemiaRenalDialysis15/01/2015
HepatitisC,Chronic15/01/2015
HepatitisC,Chronic15/01/2015
IdiopathicPulmonaryFibrosis15/01/2015
Arthritis,PsoriaticPsoriasis15/01/2015
Postmenopause15/01/2015
Arthritis,PsoriaticPsoriasis15/01/2015
MyocardialInfarction19/01/2015
GaucherDisease19/01/2015
CornealDiseasesStemCell
Transplantation17/02/2015
AcuteCoronarySyndromeMyocardial
InfarctionPeripheralVascular
DiseasesStroke
19/02/2015
SkinDiseases,BacterialSoftTissue
Infections19/02/2015
ParkinsonDisease24/02/2015
HyperphosphatemiaRenalDialysis26/02/2015
CysticFibrosisRespiratoryTract
Infections18/03/2015
Hemostasis,Surgical19/03/2015
SkinDiseases,BacterialSoftTissue
Infections19/03/2015
2015年欧洲药监局EMA批准的91个新药
CornealDiseases19/03/2015
ObesityOverweight23/03/2015
AcuteCoronarySyndromeVascular
SurgicalProcedures23/03/2015
SkinDiseases,BacterialSoftTissue
Infections23/03/2015
ObesityOverweight26/03/2015
HIVInfections26/03/2015
CysticFibrosisRespiratoryTract
Infections26/03/2015
Neutropenia13/04/2015
Carcinoma,Non-Small-CellLung06/05/2015
AspergillosisBacterialInfectionsand
MycosesCandidiasis27/05/2015
DiabetesMellitus,Type227/05/2015
PolycysticKidney,Autosomal
Dominant27/05/2015
CancerNauseaVomiting27/05/2015
ThyroidNeoplasms28/05/2015
Condylomata
AcuminataImmunizationPapillomavirus
InfectionsUterineCervicalDysplasia
10/06/2015
AnxietyDisordersEpilepsy19/06/2015
Melanoma19/06/2015
StrokeVenousThromboembolism19/06/2015
AnxietyDisordersDepressiveDisorder,
MajorDiabeticNeuropathiesNeuralgia19/06/2015
RadionuclideImaging19/06/2015
AnxietyDisordersEpilepsyNeuralgia19/06/2015
BipolarDisorderSchizophrenia25/06/2015
AnxietyDisordersEpilepsyNeuralgia25/06/2015
AnxietyDisordersEpilepsy25/06/2015
BipolarDisorderSchizophrenia30/06/2015
SleepDisorders,CircadianRhythm03/07/2015
HIVInfections13/07/2015
AnxietyDisordersEpilepsy17/07/2015
DyslipidemiasHypercholesterolemia17/07/2015
Melanoma17/07/2015
Carcinoma,Non-Small-CellLung20/07/2015
MultipleMyeloma20/07/2015
LensImplantation,IntraocularPain,
Postoperative28/07/2015
Neuroblastoma14/08/2015
Carcinoma,BasalCell14/08/2015
BipolarDisorderSchizophrenia20/08/2015
GeneticDiseases,InbornLungDiseases20/08/2015
AnxietyDisordersDepressiveDisorder,
MajorDiabetesMellitusNeuralgia20/08/2015
Hypophosphatasia28/08/2015
LipidMetabolism,InbornErrors28/08/2015
BreastNeoplasmsCarcinoma,Non-
Small-CellLungHeadandNeck
NeoplasmsProstaticNeoplasmsStomach
Neoplasms
28/08/2015
AnxietyDisordersEpilepsy28/08/2015
MultipleMyeloma28/08/2015
AnginaPectoris08/09/2015
OpticAtrophy,Hereditary,Leber08/09/2015
Carcinoma,Non-Small-Cell
LungMesothelioma14/09/2015
AttentionDeficitDisorderwith
Hyperactivity17/09/2015
Pain,Postoperative18/09/2015
BacterialInfections18/09/2015
Carcinoma,Non-Small-Cell
LungMesothelioma18/09/2015
Dyslipidemias23/09/2015
HyperphosphatemiaRenalDialysis23/09/2015
Aspergillosis15/10/2015
DiabetesMellitus,Type209/11/2015
HemophiliaA11/11/2015
DiabetesMellitus,Type216/11/2015
BipolarDisorderSchizophrenia16/11/2015
Pain,Postoperative19/11/2015
HeartFailure19/11/2015
ParkinsonDisease19/11/2015
MultipleMyeloma19/11/2015
HIVInfections19/11/2015
HemophiliaA19/11/2015
CysticFibrosis19/11/2015
HypercalcemiaHyperparathyroidism,
Secondary19/11/2015
Carcinoma,Non-Small-Cell
LungMesothelioma20/11/2015
Metabolism,InbornErrors20/11/2015
Melanoma20/11/2015
Hemorrhage20/11/2015
PrecursorCellLymphoblastic
Leukemia-Lymphoma23/11/2015
UreaCycleDisorders,Inborn27/11/2015
Carcinoma,Non-Small-Cell
LungMesothelioma27/11/2015
Asthma02/12/2015
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