Allopurinol Sandoz

Main information

  • Trade name:
  • Allopurinol Sandoz 100 mg Tablet
  • Dosage:
  • 100 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Bottle, plastic, HDPE, 200 tablets, 200 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Sicor (Societa Italiana Corticosteroidi) Srl

Documents

Localization

  • Available in:
  • Allopurinol Sandoz 100 mg Tablet
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 8597
  • Authorization date:
  • 28-10-1998
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

NEWZEALANDDATASHEET

Allopurinol Sandoz ®

AllopurinolPh Eur,tablets,100mgand300mg

Presentation

100 mg

White,round,plain,uncoatedtablets, scored on oneside.Each tabletcontainsallopurinol100 mg.

300 mg

Whitetooff-white,17 mmx7mmoblong,biconvexplain,uncoatedtabletswithabreakingnotch on

bothsides.Each tabletcontainsallopurinol300 mg.

Uses

Actions

Allopurinolisusedtodecrease uricacid concentrationsin plasma and/or urinewhenhyperuricaemia

isclinicallysignificant.

Pharmacotherapeuticgroup

M04AA01-Preparationsinhibitinguricacid production, allopurinol.

Mechanism ofaction

Allopurinolinhibitsxanthineoxidase, the enzymewhich catalysestheoxidation ofhypoxanthineto

xanthine,andofxanthineto urate/uricacid.

Pharmacodynamiceffects

Allopurinolanditsmain metabolite oxypurinollower the levelofuricacidinplasma and urinein two

ways:theinhibitionofxanthine oxidasereducesthe amountofhypoxanthineandxanthineconverted

tourate/uricacid;thisaction, in some butnotallhyperuricaemicpatients,makesmore hypoxanthine

and xanthineavailablefor reutilisation in the purine metaboliccycle,whichinturn,depressesoverall

denovopurinebiosynthesisviafeedbackinhibitionofhypoxanthine-guanine

phosphorbosyltransferase.

Withtheloweredurate/uricacidlevelsin serumandurineproducedbyallopurinolthere are also

increasedlevelsofthesubstrateshypoxanthineand xanthine. Plasma concentrationsofthese

oxypurinesare onlyslightlyincreased andthe rateandextentoftheirrenalclearance isgreaterthan

thatofuricacid.Intheabsence ofallopurinol, normalurinaryoutput ofoxypurinesisalmost solelyin

theformofuricacid.After administration ofallopurinol, itiscomposedofhypoxanthine,xanthineand

uricacid,eachwith different solubilityproperties. Consequently,theconcentrationofuricacidin

plasma isreducedwithoutexposing the urinarytract to anexcessiveloadofurate/uricacid,thus

decreasing the riskofcrystalluria. Byloweringtheuricacid concentrationintheplasma belowits

limitsofsolubility,allopurinolfacilitatesdissolutionoftophi. Althoughthelevelsofhypoxanthineand

xanthineare increased,theriskoftheirdeposition islessthanthatofuricacidastheyare more

solubleandare rapidlyclearedbythe kidney. Howevertoavoid xanthinestonesbeing deposited,itis

advisable to maintain ahigh fluidintake anda neutralor alkalineurinarypH, especiallyifinitialuric

acid concentrationsare high and the patientissymptomatic.

Reductionofthe urateconcentrationsinbodyfluidsbyallopurinolpermitsmobilisationand dissolution

ofuratedepositsanywherein thebody, thecommonest sitesbeingthoseintheskin,bones, joints

and kidneyinterstitialtissue.Therapeuticeffectstherefore include:theresolutionofskin tophiandthe

healing ofurate sinuses; eventualreductionin thefrequencyofattacksofacutegoutyarthritis,

improvement in jointmobility;reduction oftheurate load tobeexcreted viathekidney;preventionand

treatment ofacuteuricacidnephropathy; and,in thelong-term, reducedriskofrenalimpairment by

urate/uricacidand preventionanddissolution ofuricacid renalstones.

Onsetanddurationofaction

Serumurateconcentrationsusuallybegintodeclineslowlywithin 48 to72hoursreachingaplateau

after 1 to3weeksoftherapy.However,in patientswithtophaceousgoutor thosewhoare

undersecretorsofuricacid,adecline in serumuratelevelsmaybe delayed for thefirst fewmonths.

Pharmacokinetics

Absorption

Allopurinolisactivewhen givenorallyandisrapidlyabsorbedfromthe upper gastrointestinaltract.

Studieshave detected allopurinolintheblood30to 60 minutesafter dosing.Estimatesof

bioavailabilityvaryfrom67% to 90%.Peakplasma levelsofallopurinolgenerallyoccur approximately

1.5hoursafter oraladministration,butfallrapidlyandare barelydetectableafter sixhours. Peak

plasma levelsofoxypurinolgenerallyoccur threetofive hoursafter oraladministrationofallopurinol

andare muchmore sustained.

Distribution

Theapparentvolume ofdistributionofallopurinolisapproximately1.6litres/kg which suggests

relativelyextensiveuptakebytissues.Allopurinolisuniformlydistributedin totaltissuewaterwiththe

exclusionofthebrain,where concentrationsofthedrugsare approximately50%ofthose ofother

tissues.Within muscles, smallamountsofallopurinolandoxypurinolcrystalshavebeen found.

Allopurinolisnegligiblyboundbyplasma proteinsandtherefore variationsinprotein binding arenot

thought to significantlyalterclearance.Allopurinolandoxypurinolarepresent inbreast milk.

Biotransformation

Allopurinolisrapidlyconvertedin thebodytothepharmacologicallyactiveprincipalmetabolite

oxypurinolandother metabolitesincluding allopurinolriboside and oxypurinol-7-ribose.Peakplasma

levelsgenerallyoccur at1.5 hoursand4.5hoursfor allopurinolandoxypurinolrespectively.

Oxypurinolisalso an inhibitor ofxanthineoxidase.

Elimination

Eliminationofallopurinolismainlybymetabolicconversionto oxypurinolbyxanthineoxidaseand

aldehydeoxidase,withlessthan10%ofthe unchanged medicineand70%asoxypurinolexcretedin

theurine.Approximately20% ofthe ingestedallopurinolisexcretedunchangedinthe faeces.

Becauseofitsrapid oxidationtooxypurinoland arenalclearance rate approximatelythatof

glomerular filtration rate, allopurinolhasa plasma half-life ofaboutone totwohours.Littleallopurinol

isfoundin theurinesixhoursafter administration.Oxypurinol,however, hasalongerplasma half-life

(approximately15.0hours)andtherefore effectiveinhibitionofxanthineoxidase ismaintained over a

24hourperiodwith asingledailydoseofallopurinol.Patientswithnormalrenalfunctionwillgradually

accumulateoxypurinoluntilasteady-state plasma oxypurinolconcentration isreached.Such patients,

taking300mg ofallopurinolperdaywillgenerallyhaveplasma oxypurinolconcentrationsof5to10

mg/l.Whereasallopurinolisclearedessentiallybyglomerular filtration, oxypurinolisreabsorbed in the

kidneytubulesin amannersimilar to thereabsorptionofuricacid.

Therenalclearance ofhypoxanthineand xanthineisat least tentimesgreaterthan that ofuricacid.

Theincreasedxanthineand hypoxanthineintheurinehave notbeenaccompaniedbyproblemsof

nephrolithiasis.

Specialpatientconsiderations

Patientswithrenalimpairment:

Allopurinolandoxypurinolclearance isgreatlyreducedinpatientswithpoor renalfunction resultingin

higherplasma levelsin chronictherapy.Patientspresentingrenalimpairment, where creatinine

clearancevalueswerebetween10and20ml/min,showedplasma oxypurinolconcentrationsof

approximately30 mg/lafter prolongedtreatment with300mg allopurinolper day.Thisis

approximatelythe concentrationwhichwould be achievedbydosesof600 mg/dayin thosewith

normalrenalfunction.Areduction in the dose istherefore requiredinpatientswith renalimpairment.

Elderlypatients:

Pharmacokineticsin elderlyare not likelyto be alteredother thandue todeteriorationin renal

function.

Indications

Allopurinolismainlyusedin themanagement ofprimarygoutor secondaryhyperuricaemia

associatedwith chronicgout.Itisnot, however, used to treatanacuteattackofgoutasit hasno

analgesic,anti-Inflammatoryor uricosuricactivityandmayprolong the attack. Ifchanging therapy

fromauricosuricagent alone, thedose shouldbereducedgraduallywhileallopurinolisintroduced.In

severe casesofchronicgout,allopurinolcanbeusedtogetherwitha uricosuricagent unlessthelatter

iscontra-indicated.

Uricacidnephropathy.

Recurrent uricacidstoneformation.

Certainenzyme disordersorblood disorderswhichlead tooverproductionofurate(e.g. Lesch-Nyhan

syndrome;haemolyticanaemia).

Hyperuricaemia associatedwithmalignancyand cytotoxictherapywhich result inahighcellturnover

rate.

Thepreventionandtreatment ofcalciumoxalate/phosphate renalstonesin the presence ofhighuric

acidlevelsofthe blood and/or urine.

Dosageandadministration

AllopurinolSandozmaybetakenonce dailyafter a meal. Itisnormallywelltolerated, especiallyafter

food.Should thetotaldailydose exceed 300 mg and/orgastrointestinalintolerance be manifested,a

divideddosesregimenmaybeappropriate.Thedosage shouldbeadjustedbymonitoringserum

urate concentrationsandurinaryurate/uricacidlevelsatappropriateintervals.

Adults

Theaveragedailydoseis2to10 mg/kg bodyweight, or100 to 200mgformild conditions,300 to600

mgformoderatelysevere conditionsand700to 900mgforsevere conditions.

Initiatingtherapy

Allopurinolmayincrease the frequencyofacuteattacksduringthefirst fewmonthsoftherapy;itis

therefore recommended thatlowdosesbegiveninitiallyandslowlyincreased,and that anti-

inflammatoryagentsor colchicine shouldbegiven concomitantlyduringthisperiod asprophylactic

cover.In patientswithgoodrenalfunction,dosesof100 mg shouldbegivenandincreasedby50mg

to100 mg atweeklyintervalsuntilserumuratelevelsof0.6 mg permlare achieved.

Hyperuricaemia ofmalignancyor cancer therapy

Therapyshouldbeinitiated2to3 daysprior tocytotoxictherapyafterwhich maintenancedosesare

givenaccording toresponse.Adequatehydrationisessentialthroughout.

Children

Theaveragedailydoseis10 to20mg/kg bodyweightuptoa maximumof400mg daily. Usein

childrenisrarelyindicated,except in malignant conditionsand certain enzyme disorders.

Usein theelderly

Thelowestdose,whichproducessatisfactoryurate reduction,should beused.Specialattention to

dosageisnecessaryifthere isovert renaldysfunction.

Useinrenaldysfunction

Theexcretionofallopurinolanditsmetabolitesisprolongedso dosagereductionsare recommended.

Dosesof100 to 200mg dailyshould be used ifcreatinineclearanceisbetween 10to20ml/min.and

not more than100mg per dayshouldbeusedifclearance isless. These dosesmaybehalvedor

reducedevenfurtherwheninitiating therapyandthenslowlyincreased dependingonresponse.

Contraindications

Known hypersensitivitytoallopurinol, itsmetabolites, ortoanyofthe inactiveingredientslistedin

Further information.

Allopurinolshould notbe givenconcomitantlywithironsaltstopatientswith idiopathic

haemochromatosis, nor should itbegiven totheimmediate relativesofsuch patients.

Warningsandprecautions

Warnings

Allopurinolmustbewithdrawnimmediatelyand permanentlyatthefirst signsofintoleranceespecially

whena skin rash orotherallergicresponseoccurs.Insome instancesa skin rash maybefollowedby

more severe hypersensitivityreactionssuchasexfoliative,urticarial,and purpuriclesionsaswellas

Stevens-Johnsonsyndrome (erythemamultiforme exudativum), and/orgeneralised vasculitis,

irreversible hepatotoxicity,andonrareoccasionsdeath.

Precautions

Mild asymptomatichyperuricaemia per se isgenerallynot considered an indication forallopurinol

treatment. Fluid anddietarymodificationwithmanagement ofthe underlying cause maycorrect the

condition.Ingeneral, allopurinolshouldonlybeconsidered ifserumurateconcentrationsexceed0.8

to0.9 mg/mlwithan aimofreducing levelsto 0.6 mg/ml.

Allopurinoltreatment should notbestarteduntilanacuteattackofgouthascompletelysubsided,as

further attacksmaybeprecipitated.In the earlystagesoftreatment withallopurinol,aswithother

uricosuricagents,anacuteattackofgoutyarthritismaybeprecipitated. Therefore it isadvisable to

give prophylaxiswithasuitable anti-inflammatoryagentor colchicinefor atleastone month.The

literature should be consultedfor detailsofappropriatedosage and precuationsandwarnings.

Ifacuteattacksdevelop inpatientsreceiving allopurinol, treament should continue at thesame

dosagewhiletheacute attackistreatedwith asuitableanti-inflammatoryagent.

Inconditionswhere therate ofurateformationisgreatlyincreased (e.g.malignantdiseaseand its

treatment, Lesch-Nyhansyndrome) theconcentrationofxanthine in urinecouldapproach saturation

leadingtostoneformationin theurinarytract. Thisriskmaybeminimisedbyadequatefluidintaketo

achieveoptimalurine dilution.

Adequate therapywithallopurinolwilllead todissolutionoflarge uricacid renalpelvicstones,withthe

remotepossibilityofimpactionintheureter.

Theoccurrence ofhypersensitivityreactionstoallopurinolmaybe increasedinpatientswith

decreasedrenalfunction receivingthiazidesand allopurinolconcurrently. Forthisreason,inthis

clinicalsetting,such combinationsshouldbeadministeredwithcautionandpatientsshould be

observed closely.

Bone marrowdepressionhasbeen reportedinpatientsreceivingallopurinol, most ofwhomreceived

concomitant medicineswiththepotentialfor causingthiseffect. Thishasoccurredasearlyassix

weekstoaslong assixyearsafter theinitiationoftherapyofallopurinol.Rarelyapatient maydevelop

varying degreesofbonemarrow depression,affectingoneor more celllines,while receiving

allopurinolalone.

Allopurinol'sprimaryactionin treatinggoutistoinhibittheenzyme,xanthineoxidase.Xanthine

oxidase maybe involved inthe reductionand clearance ofhepaticallystored iron.Some rodent

studieshave found increasediron storagein animalstreatedwith allopurinol,while othershavenot.A

studyin28healthyvolunteersfoundnochangein hepaticiron storagewithallopurinoltreatment.

There are nohumanstudieswhich have investigated thesafetyofadministering allopurinoltopatients

withhaemochromatosis. Administrationofallopurinolto patientswith abnormaliron storage, including

haemochromatosis, shouldbeundertakenwithcaution.

Dosage reductionshould be considered for patientswithhepaticor renalimpairment.

Some patientswithpre-existingrenaldisease orpoorurate clearancehave shown arisein serum

urea during administrationofallopurinol. Althoughthemechanismresponsiblefor thishasnotbeen

established,patientswithimpairedrenalfunction shouldbecarefullyobserved duringtheearlystages

ofallopurinoladministrationanddosage decreasedor themedicinewithdrawn ifincreased

abnormalitiesin renalfunctionappear and persist.Patientsundertreatment for hypertensionor

cardiacinsufficiency, for example withdiureticsorACEinhibitors, mayhave some concomitant

impairment ofrenalfunction and allopurinolshouldbeusedwithcareinthisgroup.

Renalfailurein associationwithadministrationofallopurinolhasbeenobservedamong patientswith

hyperuricaemia secondarytoneoplasticdiseases.Concurrent conditionssuchasmultiple myeloma

and congestive myocardialdiseasewerepresentamongthose patientswhose renaldysfunction

increasedafter allopurinolwasbegun.Renalfailureisalso frequentlyassociatedwithgouty

nephropathyand rarelywith hypersensitivityreactionsassociatedwithallopurinol.Albuminuriahas

beenobservedamong patientswho developedclinicalgoutfollowing chronicglomerulonephritisand

chronicpyelonephritis.

Afew casesofreversibleclinicalhepatotoxicityhave beennoted in patientstakingallopurinol,andin

some patientsasymptomaticrisesin serumalkalinephosphatase orserumtransaminase have been

observed.Ifanorexia,weightlossor pruritusdevelopin patientsonallopurinol,evaluationofliver

functionshould bepartoftheirdiagnosticworkup. Inpatientswithpre-existingliverdisease,periodic

liver functiontestsare recommended duringtheearlystagesoftherapy.

Pregnancyand lactation

Usein pregnancy

Assigned CategoryB2bytheAustralianDrugEvaluationCommittee.Thiscategoryincludes

medicineswhichhavebeen takenbyonlyalimitednumberofpregnantwomenandwomenof

childbearingage,withoutan increase in the frequencyofmalformationor otherdirect orindirect

harmfuleffectsonthe humanfoetushaving beenobserved. Studiesin animalsareinadequate ormay

belacking, butavailable datashownoevidence ofanincreasedoccurrenceoffoetaldamage.

There isinadequate evidence ofsafetyofallopurinolinhumanpregancy,althoughit hasbeeninwide

use formanyyearswithoutapparentillconsequence.Use inpregnancyonlywhen thereisno safer

alternative andwhenthedisease itselfcarriesriskfor themother orunborn child.

Usein lactation

Reportsindicatethatallallopurinoland oxypurinolareexcreted in humanbreastmilk. Concentrations

of1.4 mg/litre allopurinoland53.7mg/litreoxypurinolhave beendemonstratedinbreast milkfroma

womantakingallopurinol300mg/day.However, thereare nodata concerning theeffectsof

allopurinoloritsmetabolitiesonthe breast-fedinfant.Allopurinolshould be usedwithcautionduring

breast feedingasthereisatheoreticalrisktotheinfantofallergicsensitisation.

Effects on abilitytodriveand usemachines

Thismedicineislikelyto produce minoror moderateadverseeffects.Since adverse effectssuch as

somnolence, vertigo andataxia have been reportedinpatientsreceiving allopurinol,patientsshould

exercise cautionbefore driving,using machineryorparticipatingin dangerousactivitieswhere

alertnessismandatoryuntiltheyare reasonablycertain that allopurinoldoesnotadverselyaffect

performance.

Other

Preclinicalsafetydata

Mutagenicity

Evidence frombiochemicalandother cytologicalinvestigationsstronglysuggeststhat allopurinolhas

nodeleteriouseffectsonDNAatanystageofthe cellcycle andisnotmutagenic.Cytogeneticstudies

showthatallopurinoldoesnotinduce chromosome aberrationsinhumanblood cellsin vitroat

concentrationsupto 100 mcg/mland invivo atdosesupto60mg/dayfor a mean period of40

months. Allopurinoldoesnotproduce nitroso compoundsinvitrooraffect lymphocyte transformation

in vitro.

Carcinogenicity

No evidenceofcarcinogenicityhasbeenfound in mice andratstreatedwithallopurinolfor up to two

years.

Teratogenicity

Onestudyofmice receiving intraperitonealdosesof50or 100 mg/kg on days10and13ofgestation

resultedin foetalabnormalities, howeverina similar studyinratsat120 mg/kgonday12ofgestation

noabnormalitieswereobserved.Extensive studiesofhighoraldosesofallopurinolofupto100

mg/kg/dayinmice, up to200 mg/kg/dayin ratsandupto150 mg/kg/dayinrabbitsduring days8 to16

ofthe gestationproduced no teratogeniceffects. An invitrostudyusingfoetalmouse salivaryglands

in culture to detectembryotoxicityindicatedthatallopurinolwouldnotbeexpectedtocause

embryotoxicitywithoutalsocausingmaternaltoxicity.

Adverseeffects

Adverse effectsin associationwithallopurinolare rarein theoveralltreatedpopulation andare mostly

ofaminornature. Theincidence ishigherin thepresence ofrenaland/orhepaticdisorders.

Adverse effectsare usuallyreversedbythe reductionofdosageor completewithdrawalofallopurinol.

Takingallopurinolafter mealsmayminimise gastrointestinaldisturbances.Where allergicreactions

occur, allopurinolshould bewithdrawnimmediately.

Skinreactions

These are themost common reactionsandmayoccuratanytime duringtreatment. Theymaybe

pruritic, maculopapular, sometimesscaly, sometimespurpuricand rarelyexfoliative.Severeskin

reactionsresemblingStevens-Johnsonand/or Lyellsyndrome associatedwith exfoliationandtoxic

epidermalnecrolysisoccurrarely.Skin reactionsmaybedelayed andrarelyhavebeen followedby

severehypersensitivityreactionswhich maybefatal.For thisreason,allopurinolshould bewithdrawn

immediatelyshouldsuch reactionsoccur. After recoveryfrommild reactions,allopurinolmay, if

desired,bereintroduced ata smalldoses(e.g.50mg/day)andgraduallyincreased. Ifthe rash recurs,

allopurinolshould bepermanentlywithdrawn.

Generalisedhypersensitivity

Hypersensitivityreactionscharacterised bypruritus,fever,chills,lymphadenopathy,arthralgia,

leucopeniaor leucocytosisand/or eosinophilia,have occurredoccasionally.Associatedvasculitisand

tissueresponse maybemanifestedinvariouswaysincludinghepatitis,intersitialnephritisand,very

rarely,epilepsy.Ifsuch reactionsdo occur, itmaybeat anytime during treatment.Inallcases,

allopurinolshould bewithdrawnimmediatelyandpermanently.

Corticosteroidsmaybebeneficialinovercominghypersensitivityskin reactions.Whengeneralised

hypersensitivityreactionshaveoccurred,concomitantthiazidediuretictreatment,a renaland/or

hepaticdisorderhasusuallybeenpresentparticularlywhentheoutcome hasbeen fatal.

Angioimmunoblasticlymphadenopathy

Angioimmunoblasticlymphadenopathyhasbeen described rarelyfollowingbiopsyofageneralised

lymphadenopathy. It appearstobereversibleonwithdrawalofallopurinol.

Hepaticfunction

Rare reportsofhepaticdysfunctionrangingfromasymptomaticrisesinliver functionteststo hepatitis

includinghepaticnecrosisandgranulomatoushepatitis,withoutovert evidenceofmore generalised

hypersensitivity,havebeendescribed.Granulomatoushepatitisappearsto bereversible on

withdrawalofallopurinol.

Gastrointestinal

Inearlyclincalstudies, nauseaand vomitingwere reported.Diarrhoea,abdominalpain,gastritisand

dyspepsiahavealsobeen reported.Further reportssuggest thatthesereactionsarenotasignificant

problemand canbe avoided bytakingallopurinolafter meals. Recurrent haematemesishasbeen

reportedasanextremelyrare event,ashassteatorrhoea.

Haematological

Bone marrowdepressionhasbeen reportedinpatientsduringallopurinoltherapy. However most

patientswere also receiving other medicineswithmyelosuppressive potentialconcomitantly. There

have beenoccasionalreportsoftransient reductioninthenumbersofcirculatingformedelementsof

theblood,usuallyin associationwithimpairedrenaland/orhepaticfunction.Adverse effectssuch as

leukocytosis,leukopenia, eosinophilia,thrombocytopenia,granulocytopenia,agranulocytosisand

aplasticanaemia,haveoccurredveryrarely. Theclinicalsignificancehasyettobe demonstrated.

Miscellaneous

Thefollowingcomplaintshavebeenreportedoccasionally:fever,generalmalaise,asthenia,

headache,vertigo,ataxia,somnolence,coma,depression, paralysis,paraesthesia,neuropathy,

peripheralneuritis, drowsiness, confusion,visualdisorder, cataract,macular changes, taste

perversion, stomatitis, changedbowelhabit,infertility,impotence,diabetesmellitus, hyperlipidaemia,

furunculosis, alopecia, discolouredhair,angina,hypertension,bradycardia, oedema,uraemia,

haematuria,angioedema,gynaecomastia.

There have beenincidencesofxanthine stone depositionandofimpactionofpartlydissolvedrenal

uricacid stonesin theureter. Adequatehydrationisimportantespeciallyin patientswithsignificant

hyperuricaemia andtophaceousdeposits. Alkalinisation oftheurinewillfurther reduce crystalluria.

On initiatingtherapy,patientsmayexperienceanincrease inacutegoutyattacks(refer toDosage

andAdministration).

Interactions

6-mercaptopurine andazathioprine

Azathioprineismetabolisedto6-mercaptopurinewhichisinactivatedbytheactionofxanthine

oxidase.When 6-mercaptopurine orazathioprineisgivenconcurrentlywithallopurinol, onlyone-

quarterofthe usualdose of6-mercaptopurineor azathioprine shouldbegiven because inhibition of

xanthineoxidasewillprolong theiractivity.

Ampicillinandamoxicillin

Anincreasein thefrequencyofskin rash hasbeenreportedamong patientsreceivingampicillin or

amoxicillinconcurrentlywith allopurinolcomparedtopatientswho arenot receiving both medicines.

Thecause ofthe reportedassociationhasnotbeenestablished.However, itisrecommended thatfor

patientsreceiving allopurinolan alternativetoampicillin oramoxicillinisusedwhere available.

AngiotensinConvertingEnzymeinhibitors:

Isolatedreportsindicate thatconcurrentadministration ofcaptoprilandallopurinolmaypredisposeto

hypersensitivityreactionse.g.Stevens-Johnson syndrome.Patientsonthecombinationshould be

monitored and ifareactionoccurs, use ofthe medicinesdiscontinued.

Chlorpropamide

Ifallopurinolisgivenconcomitantlywithchlorpropamidewhen renalfunctionispoor, theremaybe an

increasedriskofprolongedhypoglycaemicactivitybecause allopurinolandchlorpropamidemay

competefor excretioninfthe renaltubule.

Coumarinanticoagulants

There isnoevidence thatinteractionbetweenallopurinolandthecoumarinsseen underexperimental

conditionshasanyclinicalsignificance. However, allpatientsreceivinganticoagulantsmust be

carefullymonitored.

Cyclophosphamide,doxorubicin, bleomycin,procarbazine, mechloroethamine

Enhancedbonemarrowsuppressionbycyclophosphamideand othercytotoxicagentshasbeen

reportedamong patientswithneoplasticdisease (otherthanleukaemia), in thepresence of

allopurinol. However,inawellcontrolledstudyofpatientstreatedwithcyclophosphamide,

doxorubicin,bleomycin,procarbazineand/ormechlorethamine(mustinehydrochloride)allopurinoldid

not appear toincreasethetoxicreactionofthese cytotoxicagents.

Cyclosporin

Reportssuggest that theplasma concentrationofcyclosporin maybe increasedduring concomitant

treatment withallopurinol.Thepossibilityofenhancedcyclosporin toxicityshouldbeconsidered ifthe

drugsare co-administered.

Diuretics

Thiazidediureticsmayincrease the riskofseriousallopurinoltoxicity,includinghypersensitivity

reactionsandthecombinationshouldbemonitored,especiallyifrenalfunctioniscompromised.

Phenytoin

Allopurinolmayinhibit hepaticoxidationofphenytoinbutthe clinicalsignificancehasnotbeen

demonstrated.

Salicylatesanduricosuric agents

Oxypurinol, the majormetaboliteofallopurinolanditselftherapeuticallyactive,isexcreted bythe

kidneyin asimilarwaytourate. Hence drugswith uricosuricactivitysuchasprobenecid orlarge

dosesofsalicylatemayaccelerate the excretionofoxypurinol. Thismaydecreasethe therapeutic

activityofallopurinol, but the significanceneedstobeassessedineach case.

Theophylline

Experimentalstudiesoftheeffect ofallopurinolon theophyllinemetabolismhaveproduced

contradictoryfindings. Inhibitionoftheophyllinemetabolismhasbeenreported in normalsubjects

givenrelativelyhighdosesofallopurinol(300 mgtwicedaily)underexperimentalconditions. The

mechanismofthe interaction maybe explained byxanthine oxidase beinginvolved inthe

biotransformationoftheophyllinein humans.To avoid toxicity, theophylline levelsshould be

monitored in patientsstartingorincreasingallopurinoltherapy.

Vidarabine (adenine arabinoside)

Evidence suggeststhattheplasma half-life ofvidarabineisincreased in the presence ofallopurinol.

Whenthe twomedicinesare usedconcomitantly,extra vigilanceisnecessarytorecognise enhanced

toxiceffects.

Overdosage

Signsandsymptoms

Ingestionofupto22.5gallopurinolwithoutadverse effect hasbeen reported.Nausea, vomiting,

diarrhoeaanddizzinesshavebeen reportedina patientwho ingested 20gallopurinol. Recovery

followed generalsupportivemeasures.Massiveabsorptionofallopurinolmayleadtoconsiderable

inhibitionofxanthineoxidase activity,whichshould havenountoward effectsunless6-

mercaptopurineand/orazathioprineisbeingtakenconcomitantly.

Management

Thepatientshould be monitored andreceive normalsupportive measures. Adequatehydration to

maintainoptimumdiuresisfacilitatesexcretion ofallopurinolanditsmetabolites.Haemodialysismay

beusedifnecessary.

Pharmaceuticalprecautions

Instructionsfor use/handling

Nil.

Incompatibilities

Noneknown.

Specialprecautionsfor storage

Storeatorbelow25°C.

Medicineclassification

PrescriptionMedicine.

Packagequantities

AllopurinolSandoz100mg-Bottlesof200and 250tablets.

AllopurinolSandoz300mg-Bottlesof30and60tablets.

Furtherinformation

Instructionstopatients

Wherever possiblea highfluidintake sufficient toyielda dailyurinaryoutputof2litresand the

maintenanceofaneutraloralkaline urineare desirableinhyperuricaemicpatientswhether ornot

theyareonallopurinoltherapy.Allopurinolisbetter toleratediftakenafter meals. Dueto the

occasionaloccurrenceofdrowsiness, patientsshould be alertedtotheneed for due precautions

whenengaginginactivitieswhere alertnessismandatory.

List ofexcipients

Microcrystallinecellulose,cellulose,povidone,crospovidone,macrogol4000, talc,magnesium

stearate.

Nameandaddress

NovartisNew Zealand Limited

PrivateBag 65904 MairangiBay

AUCKLAND0754

Telephone: (09) 361 8100

Dateofpreparation

01Feburary2011

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-11-2018

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s).

Health Canada

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

9-1-2019

Pregabalin Sandoz (Sandoz GmbH)

Pregabalin Sandoz (Sandoz GmbH)

Pregabalin Sandoz (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2019)67 of Wed, 09 Jan 2019

Europe -DG Health and Food Safety

9-1-2019

Pregabalin Sandoz GmbH (Sandoz GmbH)

Pregabalin Sandoz GmbH (Sandoz GmbH)

Pregabalin Sandoz GmbH (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2019)66 of Wed, 09 Jan 2019

Europe -DG Health and Food Safety

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

26-11-2018

Ziextenzo (Sandoz GmbH)

Ziextenzo (Sandoz GmbH)

Ziextenzo (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)7961 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4802

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Rixathon (Sandoz GmbH)

Rixathon (Sandoz GmbH)

Rixathon (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6230 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

4-9-2018

Binocrit (Sandoz GmbH)

Binocrit (Sandoz GmbH)

Binocrit (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5856 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/725/II/WS/1406

Europe -DG Health and Food Safety

29-8-2018

Zarzio (Sandoz GmbH)

Zarzio (Sandoz GmbH)

Zarzio (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5764 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

27-8-2018

Duzallo (GrUnenthal GmbH)

Duzallo (GrUnenthal GmbH)

Duzallo (Active substance: allopurinol / lesinurad) - Centralised - Authorisation - Commission Decision (2018)5696 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4412

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

30-7-2018

Hyrimoz (Sandoz GmbH)

Hyrimoz (Sandoz GmbH)

Hyrimoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5097 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4320

Europe -DG Health and Food Safety

30-7-2018

Halimatoz (Sandoz GmbH)

Halimatoz (Sandoz GmbH)

Halimatoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5098 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4866

Europe -DG Health and Food Safety

30-7-2018

Hefiya (Sandoz GmbH)

Hefiya (Sandoz GmbH)

Hefiya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5099 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4865

Europe -DG Health and Food Safety

13-7-2018

Erelzi (Sandoz GmbH)

Erelzi (Sandoz GmbH)

Erelzi (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018)4712 of Fri, 13 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Temozolomide Sandoz (Sandoz GmbH)

Temozolomide Sandoz (Sandoz GmbH)

Temozolomide Sandoz (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018)4480 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Pemetrexed Sandoz (Sandoz GmbH)

Pemetrexed Sandoz (Sandoz GmbH)

Pemetrexed Sandoz (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)4485 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

23-5-2018

Zessly (Sandoz GmbH)

Zessly (Sandoz GmbH)

Zessly (Active substance: infliximab) - Centralised - Authorisation - Commission Decision (2018)3215 of Wed, 23 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4647

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety