欧洲091011上市药品.docx

欧洲091011上市药品.docx

《欧洲091011上市药品.docx》由会员分享，可在线阅读，更多相关《欧洲091011上市药品.docx（18页珍藏版）》请在冰豆网上搜索。

欧洲091011上市药品

NameoftheMedicinalProduct

ChondroCelect

MarketingAuthorisationHolder

TiGenixNV

Romeinsestraat12bus2

BE-3001Leuven

Belgium

ActiveSubstance

characterisedviableautologouscartilagecellsexpandedexvivoexpressingspecificmarkerproteins 

InternationalNonproprietaryNameorCommonName

characterisedviableautologouscartilagecellsexpandedexvivoexpressingspecificmarkerproteins 

Pharmaco-therapeuticGroup

--

ATCCode

--

TherapeuticIndication

Repairofsinglesymptomaticcartilagedefectsofthefemoralcondyleoftheknee（InternationalCartilageRepairSociety[ICRS]gradeIIIorIV）inadults.Concomitantasymptomaticcartilagelesions（ICRSgradeIorII）mightbepresent.DemonstrationofefficacyisbasedonarandomisedcontrolledtrialevaluatingtheefficacyofChondrocelectinpatientswithlesionsbetween1-5cm².

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

05October2009

Orphanmedicinalproductdesignationdate

Notapplicable

ProductOverview

NameoftheMedicinalProduct

Cimzia

MarketingAuthorisationHolder

UCBPharmaSA

AlléedelaRecherche60

B-1070Bruxelles

Belgium

ActiveSubstance

certolizumabpegol

InternationalNonproprietaryNameorCommonName

certolizumabpegol

Pharmaco-therapeuticGroup

Tumornecrosisfactoralpha（TNF-α）inhibitors

ATCCode

L04AB05

TherapeuticIndication

Cimzia,incombinationwithmethotrexate（MTX）,isindicatedforthetreatmentofmoderatetosevere,activerheumatoidarthritis（RA）inadultpatientswhentheresponsetodisease-modifyingantirheumaticdrugs（DMARDs）includingmethotrexate,hasbeeninadequate.

Cimziacanbegivenasmonotherapyincaseofintolerancetomethotrexateorwhencontinuedtreatmentwithmethotrexateisinappropriate.

CimziahasbeenshowntoreducetherateofprogressionofjointdamageasmeasuredbyX-rayandtoimprovephysicalfunction,whengivenincombinationwithmethotrexate.

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

1October2009

Orphanmedicinalproductdesignationdate

Notapplicable

ProductOverview

NameoftheMedicinalProduct

ClopidogrelMYLANPharma

MarketingAuthorisationHolder

MylanS.A.S.

117alléedesParcs

F-69800SaintPriest

France

ActiveSubstance

clopidogrelbesilate

InternationalNonproprietaryNameorCommonName

clopidogrel

Pharmaco-therapeuticGroup

Plateletaggregationinhibitorsexcl.heparin

ATCCode

B01AC04

TherapeuticIndication

Clopidogrelisindicatedinadultsforthepreventionofatherothromboticeventsin:

-Patientssufferingfrommyocardialinfarction（fromafewdaysuntillessthan35days）,ischaemicstroke（from7daysuntillessthan6months）orestablishedperipheralarterialdisease.

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

16October2009

Orphanmedicinalproductdesignationdate

Notapplicable

ProductOverview

NameoftheMedicinalProduct

CopaliaHCT

MarketingAuthorisationHolder

NovartisEuropharmLimited

WimblehurstRoad

Horsham

WestSussexRH125AB

UnitedKingdom

ActiveSubstance

amlodipinebesylate/valsartan/hydrochlorothiazide

InternationalNonproprietaryNameorCommonName

amlodipinebesylate/valsartan/hydrochlorothiazide

Pharmaco-therapeuticGroup

AngiotensinIIantagonists,plain（valsartan）,combinationswithdihydropyridinederivatives（amlodipine）andthiazidediuretics（hydrochlorothiazide）

ATCCode

C09DX01

TherapeuticIndication

Treatmentofessentialhypertensionassubstitutiontherapyinadultpatientswhosebloodpressureisadequatelycontrolledonthecombinationofamlodipine,valsartanandhydrochlorothiazide（HCT）,takeneitherasthreesingle-componentformulationsorasadual-componentandasingle-componentformulation.

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

4November2009

Orphanmedicinalproductdesignationdate

Notapplicable

ProductOverview

NameoftheMedicinalProduct

DafiroHCT

MarketingAuthorisationHolder

NovartisEuropharmLimited

WimblehurstRoad

Horsham

WestSussexRH125AB

UnitedKingdom

ActiveSubstance

amlodipinebesylate/valsartan/hydrochlorothiazide

InternationalNonproprietaryNameorCommonName

amlodipinebesylate/valsartan/hydrochlorothiazide

Pharmaco-therapeuticGroup

AngiotensinIIantagonists,plain（valsartan）,combinationswithdihydropyridinederivatives（amlodipine）andthiazidediuretics（hydrochlorothiazide）

ATCCode

C09DX01

TherapeuticIndication

Treatmentofessentialhypertensionassubstitutiontherapyinadultpatientswhosebloodpressureisadequatelycontrolledonthecombinationofamlodipine,valsartanandhydrochlorothiazide（HCT）,takeneitherasthreesingle-componentformulationsorasadual-componentandasingle-componentformulation.

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

4November2009

Orphanmedicinalproductdesignationdate

Notapplicable

NameoftheMedicinalProduct

ExforgeHCT

MarketingAuthorisationHolder

NovartisEuropharmLimited

WimblehurstRoad

Horsham

WestSussexRH125AB

UnitedKingdom

ActiveSubstance

amlodipinebesylate/valsartan/hydrochlorothiazide

InternationalNonproprietaryNameorCommonName

amlodipinebesylate/valsartan/hydrochlorothiazide

Pharmaco-therapeuticGroup

AngiotensinIIantagonists,plain（valsartan）,combinationswithdihydropyridinederivatives（amlodipine）andthiazidediuretics（hydrochlorothiazide）

ATCCode

C09DX01

TherapeuticIndication

Treatmentofessentialhypertensionassubstitutiontherapyinadultpatientswhosebloodpressureisadequatelycontrolledonthecombinationofamlodipine,valsartanandhydrochlorothiazide（HCT）,takeneitherasthreesingle-componentformulationsorasadual-componentandasingle-componentformulation.

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

16October2009

Orphanmedicinalproductdesignationdate

Notapplicable

ProductOverview

NameoftheMedicinalProduct

Ilaris

MarketingAuthorisationHolder

NovartisEuropharmLtd.

WimblehurstRoad

Horsham,WSussexRH125AB

UnitedKingdom

ActiveSubstance

canakinumab

InternationalNonproprietaryNameorCommonName

canakinumab

Pharmaco-therapeuticGroup

Interleukininhibitors

ATCCode

L04AC08

TherapeuticIndication

IlarisisindicatedforthetreatmentofCryopyrin-AssociatedPeriodicSyndromes（CAPS）inadults,adolescentsandchildrenaged4yearsandolderwithbodyweightabove15kg,including:

-Muckle-WellsSyndrome（MWS）,

-Neonatal-OnsetMultisystemInflammatoryDisease（NOMID）/ChronicInfantileNeurological,Cutaneous,ArticularSyndrome（CINCA）,

-SevereformsofFamilialColdAutoinflammatorySyndrome（FCAS）/FamilialColdUrticaria（FCU）presentingwithsignsandsymptomsbeyondcold-inducedurticarialskinrash.

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

23October2009

Orphanmedicinalproductdesignationdate

20March2007

ProductOverview

NameoftheMedicinalProduct

ImpridaHCT

MarketingAuthorisationHolder

NovartisEuropharmLimited

WimblehurstRoad

Horsham

WestSussexRH125AB

UnitedKingdom

ActiveSubstance

amlodipinebesylate/valsartan/hydrochlorothiazide

InternationalNonproprietaryNameorCommonName

amlodipinebesylate/valsartan/hydrochlorothiazide

Pharmaco-therapeuticGroup

AngiotensinIIantagonists,plain（valsartan）,combinationswithdihydropyridinederivatives（amlodipine）andthiazidediuretics（hydrochlorothiazide）

ATCCode

C09DX01

TherapeuticIndication

Treatmentofessentialhypertensionassubstitutiontherapyinadultpatientswhosebloodpressureisadequatelycontrolledonthecombinationofamlodipine,valsartanandhydrochlorothiazide（HCT）,takeneitherasthreesingle-componentformulationsorasadual-componentandasingle-componentformulation

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

15October2009

Orphanmedicinalproductdesignationdate

Notapplicable

ProductOverview

NameoftheMedicinalProduct

IrbesartanTeva

MarketingAuthorisationHolder

TevaPharmaB.V.

Computerweg10

NL-3542DRUtrecht

TheNetherlands

ActiveSubstance

irbesartan

InternationalNonproprietaryNameorCommonName

irbesartan

Pharmaco-therapeuticGroup

AngiotensinIIantagonists,plain

ATCCode

C09CA04

TherapeuticIndication

Treatmentofessentialhypertension.

Treatmentofrenaldiseaseinpatientswithhypertensionandtype2diabetesmellitusaspartofanantihypertensivemedicinalproductregimen（seesection5.1）.

DateofissueofMarketingAuthorisationvalidthroughouttheEuropeanUnion

30October2009

Orphanmedicinalproductdesignationdate

Notapplicable

ProductOverview

NameoftheMedicinalProduct

LamivudineTeva

MarketingAuthorisationHolder

TevaPharmaB.V.

Computerweg10

NL-3542DRUtrecht

TheNetherlands

ActiveSubstance

lamivudine

InternationalNonproprietaryNameorCommonName

lamivudine

Pharmaco-therapeuticGroup

Nucleosideandnucleotidereversetranscriptaseinhibitors

ATCCode

J05AF05

TherapeuticIndication

LamivudineTevaisindicatedforthetreatmentofchronichepatitisBinadultswith:

-compensatedliverdiseasewithevidenceofactiveviralreplication,persistentlyelevatedserumalanineaminotransferase（ALT）levelsandhistologicalevidenceofactiveliverinflammationand/orfibrosis.

-decompensatedliverdisease.

DateofissueofMarketingAuthorisationvalidthroughouttheEurop