Aciclovir Intraveous Infusion (Pfizer)

Main information

  • Trade name:
  • Aciclovir Intraveous Infusion (Pfizer) 25 mg/mL Solution for injection
  • Dosage:
  • 25 mg/mL
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Polyamp, 5x10 mL ampoule in foil sachet, 50 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Assia Chemical Industries Ltd

Documents

Localization

  • Available in:
  • Aciclovir Intraveous Infusion (Pfizer) 25 mg/mL Solution for injection
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 8399
  • Authorization date:
  • 02-06-1998
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

Datasheet

ACICLOVIR INTRAVENOUSINFUSION

Page1of6

March 2004

ACICLOVIR INTRAVENOUSINFUSION

Aciclovir Sodium25mg/mL

Presentation

AciclovirIntravenousInfusionisaclear,colourlesstopaleyellow,sterile,isotonic,preservative-free,

aqueoussolution.AciclovirIntravenousInfusioncontainsaciclovir,sodiumchloride(forisotonicity)and

Water for Injections BP.Itdoes not containpreservatives.

Uses

Actions

AciclovirisanantiviralagentwhichisactiveinvitroagainstHerpessimplex(HSV)typesIandIIand

Varicellazostervirus(VZV).However,therelationshipbetweeninvitrosensitivityofherpesvirusesto

Aciclovirandclinicalresponsetotherapyhasyettobeestablished.Aciclovirneedstobephosphorylated

totheactivecompound,aciclovirtriphosphate,inordertobecomeactiveagainstthevirus.Such

conversionisverylimitedinnormalcellsandinadditioncellularDNApolymeraseisnotverysensitive

totheactivecompound.However,ininfectedcellsHSVorVZVcodedthymidinekinasesfacilitatesthe

conversionofaciclovirtoaciclovirmonophosphatewhichisthenconvertedtoaciclovirtriphosphateby

cellularenzymes.Aciclovirtriphosphateactsasaninhibitorof,andsubstratefor,theherpesspecified

DNA polymerase, preventingfurtherviral DNA synthesis.

Animal studies indicate thatat highdosesaciclovir is cytotoxic.

Pharmacokinetics

Inadultstheterminalplasmahalf-lifeofaciclovirafterintravenousadministrationisabout2.9hours.

Approximately60%ofthedrugisexcretedunchangedbythekidneybyglomerularfiltrationandtubular

excretion.Whenaciclovirisgivenonehourafter1gramofprobenecidtheterminalhalf-lifeandthearea

undertheplasmaconcentrationtimecurveareextendedby18%and40%respectively.9-carboxy-

methoxy-methylguanineisthemajormetaboliteofaciclovirandaccountsfor10-15%ofthedose

excreted inthe urine.

Meansteadystatepeakplasmaconcentrations(C

max)followingaonehourinfusionof5mg/kgor

10mg/kgwere9.8±2.6SDand20.7±10.2SDg/mLrespectively.Thetroughplasmaconcentrations

min)were0.7±0.3SDand2.0±0.1SDg/mLrespectively.Inchildrenover1yearofagesimilar

meanpeak(C

max)andtrough(C

min)levelswereobservedwhenadoseof250mg/m 2 wassubstituted

for5mg/kgandadoseof500mg/m 2 wassubstitutedfor10mg/kg.Inchildrenaged0-3monthsthe

terminalplasmahalf-lifeisapproximately4hours.However,experienceisinsufficientatpresentto

recommendtherapyforthis age group.

Inpatientswithchronicrenalfailurethemeanterminalhalf-lifewasfoundtobe19.5±5.9SDhours.

Themeanaciclovirhalf-lifeduringhaemodialysiswas5.7hours.Plasmaaciclovirlevelsdropped

approximately60% during dialysis.

Plasmaproteinbinding is low (9to33%).

Indications

Aciclovir Intravenous Infusionis indicatedfor the purpose of:

1.PromotingresolutionofacuteclinicalmanifestationsofmucocutaneousHerpessimplexvirus

infections inimmunocompromised patients.

2.Treatmentofseverefirstepisodeprimaryornon-primarygenitalherpesinimmunocompetent

patients.

3.TreatmentofacutemanifestationsofVaricellazostervirusinfectioninimmunocompromised

patients.

4.TreatmentofHerpeszoster(shingles)inimmunocompetentpatientswhoshowverysevereacute

localorsystemicmanifestationsofthedisease.Benefitscanbeexpectedinpatientswithrash

Datasheet

ACICLOVIR INTRAVENOUSINFUSION

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March 2004

durationshorterthan72hours.Theuseoftheintravenousinfusionmaybewarrantedinonlyasmall

subgroupofimmunocompetent patients withshingles.

5.TreatmentofHerpessimplexencephalitis.

Dosageandadministration

Indications Immune Status Status

Herpessimplexinfection Normal or immunocompromised 5mg/kgevery8hours

VerySevereHerpes Zoster

infection(shingles) Normal 5mg/kgevery8hours

Varicellazosterinfection Immunocompromised 10mg/kgevery8hours

Herpessimplexencephalitis Normal or immunocompromised 10mg/kgevery8hours

Each dose shouldbe administered byslow intravenous infusionover a one hour period.

InpatientswithrenalimpairmentAciclovirIntravenousInfusionshouldbeadministeredwithcaution

since the drugis excretedbythe kidneys.The followingmodifications indosage are suggested.

Creatinine Clearance Dosage

25-50mL/min The recommended dose (5or10mg/kg)every12 hours

10-25mL/min The recommended dose (5or10mg/kg)every24 hours

0(anuric)-10mL/min The recommended dose shouldbe halved(2.5or5mg/kg) every

24hours andafter dialysis

Dosage inChildren:

ThedoseofAciclovirIntravenousInfusioninchildrenaged1-12yearsshouldbecalculatedonthebasis

ofbodysurface area.

ChildreninthisagegroupwithHerpessimplexinfections(exceptHerpessimplexencephalitis)or

VaricellazosterinfectionsshouldbegivenAciclovirIntravenousInfusiondosesof250mgpersquare

meter bodysurfacearea (equivalent to 5mg/kginadults).

ImmunocompromisedchildreninthisagegroupwithVaricellazostervirusinfectionorwithHerpes

simplexencephalitisshouldbegivenAciclovirIntravenousInfusionindosesof500mgpersquaremetre

ofbodysurface area (equivalent to10mg/kginadults).

Childrenwithimpairedrenalfunctionrequireanappropriatelymodifieddose,accordingtothedegreeof

impairment.

Dosage intheElderly:

Nodataareavailableonthisagegroup.However,ascreatinineclearanceisoftenlowintheelderly

special attentionshouldbegiventodosage reduction.

DurationofTreatment:

ItisrecommendedthatAciclovirIntravenousInfusionbeadministeredforfive-sevendaysinthe

treatmentof most infections andfor at least tendays inthe treatmentofHerpes simplexencephalitis.

Administration:

AciclovirIntravenousInfusionmaybeinjecteddirectlyintoaveinoveronehourbyacontrolledrate

infusionpump or be furtherdilutedforadministrationbyinfusion.

Forintravenousinjectionbyacontrolled-rateinfusionpumpasolutioncontaining25mgaciclovirpermL

is used.

Datasheet

ACICLOVIR INTRAVENOUSINFUSION

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March 2004

Forintravenousinfusionthedosagerequiredshouldbeaddedtoandmixedwithatleast50mLto100mL

ofinfusionsolution(listedbelow).Amaximumof250mgofaciclovirmaybeaddedto50mLofinfusion

solutionandamaximumof500mgofaciclovirmaybeaddedto100mLofinfusionsolution.After

additionofAciclovirIntravenousInfusionthemixtureshouldbeshakentoensurethoroughmixing.

AciclovirIntravenousInfusionwhendilutedinaccordancewiththeaboveschedulewillgiveanaciclovir

concentrationnot greater than 0.5% w/v.

Aciclovir Intravenous Infusionis known to be compatible withthe followinginfusionfluids andstable for

upto24hoursatroomtemperature(below25°C)whendilutedtoaconcentrationnotgreaterthan0.5%

w/vAciclovir:SodiumChlorideIntravenousInfusionBP(0.45%and0.9%w/v),SodiumChloride

(0.18%w/v)andDextrose(4%w/v)IntravenousInfusionBP,SodiumChloride(0.45%w/v)and

Dextrose(2.5%w/v)IntravenousInfusionBP,CompoundSodiumLactateIntravenousInfusionBP

(Hartmann'sSolution).

AciclovirIntravenousInfusioncontainsnopreservative.Dilutionshouldthereforebecarriedout

immediatelybeforeuseandanyunusedsolutionshouldbediscarded.Shouldvisibleturbidityor

crystallisationappear inthesolution before or duringinfusion, thepreparationshould be discarded.

Thesolutionshouldnotberefrigeratedasthiscausesprecipitationofcrystals.Thesecrystalsusuallydo

not redissolvewhen solution temperatureis broughttoroomtemperature.

Contraindications

Hypersensitivity toaciclovir orvalciclovir.

WarningsandPrecautions

AciclovirIntravenousInfusionisintendedforintravenousinfusiononlyandshouldnotbeusedbyany

otherroute.AciclovirintravenousinfusionhasapHofapproximately11.0andshouldnotbe

administeredbymouth.AciclovirIntravenousInfusionmustbegivenoveraperiodofatleastonehour

inordertoavoidrenaltubulardamage.Itshouldnotbeadministeredasabolusinjection.Althoughthe

aqueoussolubilityofaciclovirsodium(forinfusion)exceeds100mg/mL,precipitationofaciclovir

crystalsinrenaltubules,andtheconsequentrenaltubulardamage,canoccurifthemaximumsolubilityof

freeaciclovir(2.5mg/mLat37°Cinwater)isexceeded.Aciclovirinfusionmustbeaccompaniedby

adequatehydration.Sincemaximumurineconcentrationoccurswithinthefirstfewhoursfollowing

infusion,particularattentionshouldbegiventoestablishsufficienturineflowduringthatperiod.

Concomitantuseofothernephrotoxicdrugs,pre-existingrenaldiseaseanddehydrationincreasetherisk

offurther renal impairmentbyaciclovir.

Asaciclovirhasbeenassociatedwithreversibleencephalopathicchanges,itshouldbeusedwithcaution

inpatientswithunderlyingneurologicalabnormalities,significanthypoxiaorseriousrenal,hepaticor

electrolyteabnormalities.Itshouldalsobeusedwithcautioninpatientswhohavemanifested

neurologicalreactionstocytotoxicdrugsorarereceivingconcomitantlyinterferonorintrathecal

methotrexate.

Resistantstrains have been isolatedinvitroandinanimals followingtreatmentwithaciclovir.HSV

strains resistantinvitrotoaciclovir have alsobeenisolated fromimmunocompromised patients receiving

aciclovir forHerpessimplexinfections. Therefore the potential for the developmentof resistantHSV

strains inthe patients treatedwithaciclovir shouldbe borne inmind. The relationshipbetweeninvitro

sensitivityofherpes virusestoaciclovir andclinical response totherapyhasyettobe established.

Mutagenicity

AciclovirwasclastogenicinChinesehamstercellsinvivo,athighexposurelevelsalsocausing

nephrotoxicity(500mgand100mg/kgparenteraldose).Therewasalsoanincrease,thoughnot

statisticallysignificant,inchromosomaldamageatmaximumtolerateddoses(100mg/kg)ofaciclovirin

rats.Noactivitywasfoundinadominantlethalstudyinmiceorin4microbialassays.Positiveresults

wereobtainedin2of7genetictoxicityassaysusingmammaliancellsinvitro(positiveinhuman

Datasheet

ACICLOVIR INTRAVENOUSINFUSION

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March 2004

lymphocytesinvitroandonelocusinmouselymphomacells,negativeat2otherlociinmouse

lymphoma cells,and3lociina Chinesehamster ovarycell line).

Theresultsofthesemutagenicitytestsinvitroandinvivosuggestthataciclovirisunlikelytoposea

genetic threat toman attherapeutic dose levels.

Carcinogenicity

Aciclovirwaspositiveinoneoftwomousecelltransformationsystemsinvitro.Inoculationofthe

transformedcellsintoimmune-suppressedmiceresultedintumours.Thesedataaresuggestiveofan

oncogenic potential. However,thevalidityof this type ofstudyis unclear.

Lifetime oraldosingstudies inmice andrats gave noevidence fortumourigencitybut inthesespecies the

absorption of oral aciclovir is poor and possiblyself-limiting.

Impairment of fertility

Thereisnoexperienceoftheeffectofaciclovironhumanfertility.Theresultsofstudiesinanimals

indicatethat aciclovir shouldhave no effect onfertilityinman attherapeutic doses.

Useinpregnancy

Animalstudiesshowthataciclovircrossestheplacentareadily.Aciclovirwasnotteratogenicinmouse

(450mg/kg/dayorally),rabbit(50mg/kg/daysubcutaneouslyandintavenously)orrat(50mg/kg/day,

subcutaneously)whendosedthroughouttheperiodofmajororganogenesis.Thisexposureintherat

resultedinplasmalevelssimilartothemeansteady-statepeakconcentrationinhumansafter1hour

infusionsof10mg/kgevery8hours.Inadditionalstudiesinwhichratsweregiven3subcutaneousdoses

of100mg/kgaciclovirongestationday10,fetalabnormalities,suchasheadandtailanomalies,were

reported(exposurewas5-foldhumanlevelsafter10mg/kginfusions).Therehavebeennoadequateand

wellcontrolledstudiesconcerningthesafetyofaciclovirinpregnantwomen.Aciclovirshouldnotbe

usedduringpregnancyunlessthepotentialbenefittothepatientjustifiesthepotentialrisktothefetus.If

suppressivetherapyisusedintheperinatalperioditshouldnotbeassumedthatviralsheddinghas

ceased,orthattherisktothefetus/neonatehasdecreased.Pregnancyshouldbemanagedaccordingto

considerationnormallyapplicable topatients withgenital herpes.

Australiancategorisationdefinitionof:CategoryB3:Drugswhichhavebeentakenbyonlyalimited

numberofpregnantwomenandwomenofchildbearingage,withoutanincreaseinthefrequencyof

malformationorotherdirectorindirectharmfuleffectsonthehumanfetushavingbeenobserved.Studies

inanimalshaveshownevidenceofanincreasedoccurrenceoffetaldamage,thesignificanceofwhichis

considereduncertaininhumans.

Useinlactation

Limitedhumandatashowthataciclovirisexcretedinhumanmilk.Aciclovirshouldonlybe

administeredtonursingmothers ifthe benefits tothemotheroutweighthe potential risks tothe baby.

Effects onability todriveanduse machines:

Notapplicable.

AdverseEffects

Local:

Local inflammationor phlebitis at injectionsite.

Systemic:

Renal:Rapidincreasesinbloodureaandcreatininelevelsmayoccuroccasionallyinpatientsgiven

AciclovirIntravenousInfusion.Theseareusuallyreversiblebutprogressiontoacuterenalfailurecan

occurinrarecases.Theriskofrenaldamageisincreasedbybolusinjection,dehydration,concomitant

useofothernephrotoxicdrugsandpre-existingrenaldisease.Toavoidthiseffectthedrugshouldnotbe

givenas anintravenousbolusinjectionbutbyslow infusionover a one hourperiod.

Datasheet

ACICLOVIR INTRAVENOUSINFUSION

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March 2004

HypersensitivityandSkin:Rashesincludingphotosensitivity,urticaria,pruritis,feversandrarely

dyspnoea, angiodema andanaphylaxis.

Neurological:Approximately1%ofpatientsreceivingaciclovirhavemanifestedencephalopathic

changescharacterisedbyoneormoreofthefollowing:lethargy,obtundation,tremors,confusion,

hallucinations, agitation,somnolence, psychosis, seizures, andcoma.

Haematological: Decrease inhaematological indices(anaemia, thrombocytopenia, leucopenia).

Gastrointestinal:Nauseaandvomiting.

Liver:Reversibleincreasesinbilirubinandliverrelatedenzymes.Hepatitisandjaundicehavebeen

reportedonveryrare occasions.

Others: Lessfrequent adverse effectsinclude diaphoresis, haematuria, hypotensionandheadache.

Interactions

Acicloviriseliminatedprimarilyunchangedintheurineviarenaltubularsecretion.Anydrugs

administeredconcurrentlythatcompetewiththismechanismoraffectrenalphysiologymayincrease

aciclovirplasmaconcentration.Probenecidandcimetidineincreasestheaciclovirmeanhalf-lifeandarea

undertheplasmaconcentrationcurve.IncreasesinplasmaAUCsofaciclovirandoftheinactive

metaboliteofmycophenolatemofetil,animmunosuppressantagentusedintransplantpatients,havebeen

shownwhenthe drugsare coadministered.

Careisalsorequired(withmonitoringforchangesinrenalfunction)ifadministeringintravenous

aciclovir withdrugsthat affect other aspects ofrenal physiology(e.g.cyclosporin,tacrolimus).

Inpatientsover60yearsofageconcurrentuseofdiureticsincreasesplasmalevelsofaciclovirvery

significantly.Itisnotknownwhetherasimilareffectoccursinyoungadults.Inpatientsreceiving

Retrovir(zidovudine)nosignificantoverallincreaseintoxicitywasassociatedwiththeadditionof

aciclovir.Nodata areavailable oninteractionsbetweenaciclovir andotherantiretroviral therapies.

Aciclovirshouldbeusedwithcautioninpatientswhohavemanifestedneurologicalreactionstocytotoxic

drugs or are receivingconcomitantlyinterferonor intrathecalmethotrexate.

Overdosage

Overdosageofintravenousaciclovirhasresultedinelevationsofserumcreatinine,bloodureanitrogen

andsubsequentrenalfailure.Neurologicaleffectsincludingconfusion,hallucinations,agitation,seizures

andcomahavebeendescribedinassociationwithoverdosage.Adequatehydrationisessentialtoreduce

thepossibilityofcrystalformationintheurine.Aciclovircanberemovedfromcirculationby

haemodialysisandthismaythereforebeconsideredanoptioninthemanagementofoverdoseofthis

drug.

PharmaceuticalPrecautions

InstructionforUse/Handling

Store below 25°C. Donotrefrigerate.

Useonce onlyanddiscardanyremainingportion.

Once removedfromthe foil sachet,the productwill besuitable for useuptonine months.

AciclovirIntravenousInfusionisanantiviralagent.Whenhandling,alaboratorycoatandlatexgloves

areadequateprotection.Wheresolutionaccidentallycontactstheeyeorskin,theaffectedareashouldbe

rinsedthoroughly.Medicalattentionshouldbesoughtintheeventofeyecontamination.Following

accidentalswallowing,themouthshouldberinsedoutwithwaterensuringthatthemouthwashisnot

swallowedandthepersonshouldbegivenabout250mLofwatertodrink.Vomitingshouldnotbe

induced,butmedicalattentionshouldbesought.Itisunlikelythatfirstaidwouldberequiredasaresult

ofinhalation during normal use.

Datasheet

ACICLOVIR INTRAVENOUSINFUSION

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March 2004

Shelf life

The expirydate (month/year) is stated onthe package after EXP.

MedicineClassification

PrescriptionMedicine.

PackageQuantities

Aciclovir 250mgin10mL (sterile) polyethylene ampoules, flow wrapped (5'spack)

Aciclovir 500mgin20mL (sterile) polyethylene ampoules, flow wrapped (6'spack)

FurtherInformation

Aciclovirisasyntheticacyclicpurinenucleosideanalogue.Itschemicalnameis2-amino-9-[(2-

hydroxyethoxy)methyl]-1,9-dihydro-6H-purin-6-one. It is a white or almostwhite crystalline powder.

Thestructuralformulaisrepresentedbelow.

MolecularFormula: C

MolecularWeight: 225.2

CASNumber: 59277-89-3

NameandAddress

Pfizer New ZealandLtd

Level3,Pfizer House

14NormanbyRoad

MtEden

Auckland5

New Zealand

Ph: (09) 638 0000

DateofPreparation

23March2004

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Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

2-10-2018

Pemetrexed Pfizer (Pfizer Europe MA EEIG)

Pemetrexed Pfizer (Pfizer Europe MA EEIG)

Pemetrexed Pfizer (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6464 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4488/T/04

Europe -DG Health and Food Safety

2-10-2018

Vfend (Pfizer Europe MA EEIG)

Vfend (Pfizer Europe MA EEIG)

Vfend (Active substance: voriconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6490 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000387/T/0130

Europe -DG Health and Food Safety

24-9-2018

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

4-9-2018

XALKORI (Pfizer Europe MA EEIG)

XALKORI (Pfizer Europe MA EEIG)

XALKORI (Active substance: crizotinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5861 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002489/T/0059

Europe -DG Health and Food Safety

28-8-2018

LIFMIOR (Pfizer Europe MA EEIG)

LIFMIOR (Pfizer Europe MA EEIG)

LIFMIOR (Active substance: etanercept) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5700 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4167T/17

Europe -DG Health and Food Safety

27-8-2018

Nivestim (Pfizer Europe MA EEIG)

Nivestim (Pfizer Europe MA EEIG)

Nivestim (Active substance: Filgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5683 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1142/T/51

Europe -DG Health and Food Safety

27-8-2018

Somavert (Pfizer Europe MA EEIG)

Somavert (Pfizer Europe MA EEIG)

Somavert (Active substance: Pegvisomant ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5684 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000409/T/0087

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

Vyndaqel (Pfizer Europe MA EEIG)

Vyndaqel (Pfizer Europe MA EEIG)

Vyndaqel (Active substance: tafamidis) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5427 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2294/T/45

Europe -DG Health and Food Safety

7-8-2018

Inlyta (Pfizer Europe MA EEIG)

Inlyta (Pfizer Europe MA EEIG)

Inlyta (Active substance: Axitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5429 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2406/T/24

Europe -DG Health and Food Safety

6-8-2018

Rapamune (Pfizer Limited)

Rapamune (Pfizer Limited)

Rapamune (Active substance: sirolimus) - Centralised - 2-Monthly update - Commission Decision (2018)5384 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/II/164

Europe -DG Health and Food Safety

6-8-2018

DUAVIVE (Pfizer Europe MA EEIG)

DUAVIVE (Pfizer Europe MA EEIG)

DUAVIVE (Active substance: oestrogens conjugated / bazedoxifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5379 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2314/T/18

Europe -DG Health and Food Safety

6-8-2018

Conbriza (Pfizer Europe MA EEIG)

Conbriza (Pfizer Europe MA EEIG)

Conbriza (Active substance: bazedoxifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5388 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/913/T/47

Europe -DG Health and Food Safety

6-8-2018

Bosulif (Pfizer Europe MA EEIG)

Bosulif (Pfizer Europe MA EEIG)

Bosulif (Active substance: Bosutinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5372 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2373/T/32

Europe -DG Health and Food Safety

6-8-2018

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Active substance: Moroctocog alfa ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5374 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/232/T/146

Europe -DG Health and Food Safety

1-8-2018

Toviaz (Pfizer Europe MA EEIG)

Toviaz (Pfizer Europe MA EEIG)

Toviaz (Active substance: fesoterodine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5225 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/723/T/52

Europe -DG Health and Food Safety

1-8-2018

Lyrica (Pfizer Europe MA EEIG)

Lyrica (Pfizer Europe MA EEIG)

Lyrica (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5223 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/546/T/95

Europe -DG Health and Food Safety

1-8-2018

Viagra (Pfizer Europe MA EEIG)

Viagra (Pfizer Europe MA EEIG)

Viagra (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5203 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/202/T/98

Europe -DG Health and Food Safety

1-8-2018

IBRANCE (Pfizer Europe MA EEIG)

IBRANCE (Pfizer Europe MA EEIG)

IBRANCE (Active substance: palbociclib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5224 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3853/T/14

Europe -DG Health and Food Safety

1-8-2018

Revatio (Pfizer Europe MA EEIG)

Revatio (Pfizer Europe MA EEIG)

Revatio (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5221 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/638/T/82

Europe -DG Health and Food Safety

1-8-2018

Enbrel (Pfizer Europe MA EEIG)

Enbrel (Pfizer Europe MA EEIG)

Enbrel (Active substance: Etanercept) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5195 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/262/T/222

Europe -DG Health and Food Safety

1-8-2018

Inflectra (Pfizer Europe MA EEIG)

Inflectra (Pfizer Europe MA EEIG)

Inflectra (Active substance: Infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5206 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2778/T/64

Europe -DG Health and Food Safety

1-8-2018

Champix (Pfizer Europe MA EEIG)

Champix (Pfizer Europe MA EEIG)

Champix (Active substance: varenicline tartrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5197 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/699/T/71

Europe -DG Health and Food Safety

1-8-2018

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Active substance: Meningococcal group A, C, W-135 and Y conjugate vaccine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5220 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2226/T/80

Europe -DG Health and Food Safety

1-8-2018

Mylotarg (Pfizer Europe MA EEIG)

Mylotarg (Pfizer Europe MA EEIG)

Mylotarg (Active substance: gemtuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5233 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4204/T/1

Europe -DG Health and Food Safety

1-8-2018

Pregabalin Pfizer (Pfizer Limited)

Pregabalin Pfizer (Pfizer Limited)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5234 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/T/24

Europe -DG Health and Food Safety

1-8-2018

Tygacil (Pfizer Europe MA EEIG)

Tygacil (Pfizer Europe MA EEIG)

Tygacil (Active substance: Tigecycline) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5218 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/644/T/104

Europe -DG Health and Food Safety

30-7-2018

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Active substance: inotuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5104 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4119/T/7

Europe -DG Health and Food Safety

30-7-2018

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)5095 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4463

Europe -DG Health and Food Safety

27-7-2018

EU/3/13/1127 (Pfizer Europe MA EEIG)

EU/3/13/1127 (Pfizer Europe MA EEIG)

EU/3/13/1127 (Active substance: Inotuzumab ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5046 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/194/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Active substance: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate) - Transfer of orphan designation - Commission Decision (2018)5038 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/06/T/03

Europe -DG Health and Food Safety

27-7-2018

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Active substance: Gemtuzumab Ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5037 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/022/00/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Active substance: tafamidis) - Transfer of orphan designation - Commission Decision (2018)5066 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/420 (Pfizer Europe MA EEIG)

EU/3/06/420 (Pfizer Europe MA EEIG)

EU/3/06/420 (Active substance: Temsirolimus) - Transfer of orphan designation - Commission Decision (2018)5065 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/058/06/T/02

Europe -DG Health and Food Safety

19-7-2018

HES (hydroxyethyl starch)

HES (hydroxyethyl starch)

HES (hydroxyethyl starch) (Active substance: hydroxyethyl starch (HES), solutions for infusion) - Community Referrals - Art 107i - Commission Decision (2018)4832 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-107i/1457

Europe -DG Health and Food Safety

27-6-2018

Nexium Control (Pfizer Consumer Healthcare Limited)

Nexium Control (Pfizer Consumer Healthcare Limited)

Nexium Control (Active substance: esomeprazole) - Centralised - Renewal - Commission Decision (2018) 4111 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2618/R/21

Europe -DG Health and Food Safety

25-6-2018

Xeljanz (Pfizer Limited)

Xeljanz (Pfizer Limited)

Xeljanz (Active substance: Tofacitinib) - Centralised - Yearly update - Commission Decision (2018)4023 of Mon, 25 Jun 2018

Europe -DG Health and Food Safety

11-6-2018

BeneFIX (Pfizer Limited)

BeneFIX (Pfizer Limited)

BeneFIX (Active substance: Nonacog alfa) - Centralised - Yearly update - Commission Decision (2018)3778 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety