Amirol

Main information

  • Trade name:
  • Amirol 10 mg Film coated tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Film coated tablet
  • Units in package:
  • Blister pack, PVC/Al, 50 tablets, 50 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • R.L. Fine Chem

Documents

Localization

  • Available in:
  • Amirol 10 mg Film coated tablet
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 13491
  • Authorization date:
  • 01-04-2008
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

AMIROL

Amitriptylinehydrochloride

Name ofMedicine

Amirol 10 Filmcoatedtablets10mg

Amirol 25 Filmcoatedtablets25mg

Presentation

AMIROL10mgtabletsareblue,filmcoatedbiconvextablets,9/32"diameter.Eachtabletcontains

10mg amitriptyline hydrochloride.

AMIROL25mgtabletsareyellow,filmcoatedbiconvextablets,9/32"diameter.Eachtabletcontains

25mg amitriptylinehydrochloride.

Forbothstrengthsdonothalvetablet,doseequivalentwhenthetabletisdividedhasnotbeen

established.

Uses

Actions

Amitriptylineisapotentantidepressantwithsedativeproperties.Themechanismofactioninhumans

isnotknown.Itisnotamonoamineoxidaseinhibitoranditdoesnotactprimarilybystimulationofthe

centralnervoussystem. Inbroad clinicaluse amitriptylinehasbeenfoundtobewelltolerated.

Amitriptylineinhibitsthemembranepumpmechanismresponsibleforuptakeofnorepinephrineand

serotonininadrenergicandserotonergicneurons.Pharmacologicallythisactionmaypotentiateor

prolongneuronalactivitysincereuptakeofthesebiogenicaminesisimportantphysiologicallyin

terminatingtransmittingactivity.Thisinterferencewiththereuptakeofnorepinephrineand/orserotonin

isbelievedbysome to underlie theantidepressant activityofamitriptyline.

Pharmacokinetics

Absorption

Appearsinplasmawithin30to60minutesafteroralingestionand5to10minutesafterintramuscular

injection. Approximately62% ofthe radioactive dosesof 14

C wasrecovered in humanurineafter oralor

intravenousadministration.Plasmalevelsareverylowwithbroadpeaksrangingfrom2-12hoursafter

administration.

Metabolism

Inonestudy,12normalsubjectsreceived25mgofamitriptylinet.i.d.;plasmaamitriptylinelevelswere

maximal(62 ± 20 ng/ml)at4hourspost therapy. Inanother studyin which 12 normalsubjectsreceived

25mg amitriptylinet.i.d.for 2 weeks, the plasma half-life averaged30hours.

Studiesinhumansfollowingoraladministrationof 14 C-labelledmedicineindicatedthatamitriptylineis

rapidlyabsorbedandmetabolised.Radioactivityoftheplasmawaspracticallynegligible,although

significantamountsofradioactivityappearedintheurineby4to6hoursandone-halftoone-thirdof

themedicinewasexcreted within 24 hours.

AmitriptylineismetabolisedbyN-demethylationandbridgehydroxylationinhumans,rabbit,andrat.

Virtuallytheentiredoseisexcretedasglucuronideorsulphateconjugateofmetabolites,withlittle

unchangedmedicineappearing in theurine. Othermetabolicpathwaysmaybeinvolved.

Excretion

Urine

Followinganintravenousdose,anaveragetotalof62.9%ofradioactivitywasexcretedin7days,with

25.1%beingexcretedinthefirst24hours.Followingoraladministration,anaveragetotalof63.0%of

radioactivitywasexcreted in 7days, with27.0% excreted in thefirst 24 hours.

Faeces

Followingoraladministration 14

C-labelledtablets,excretionofradioactivitywascalculatedtobe10.5%

(average)over7days;afterintravenousadministration,anaverageof12.7%wasrecoveredinthe

faecesin 7days.

Bile

Animalstudiesshowthatamitriptylineand itsmetabolitesare excreted in thebile.

Milk

Inonereport,following100mg/dayoforalamitriptyline,levelsof135-151ng/mlwerefoundinthe

breast milkofalactatingpatient.

Indications

AMIROLisrecommended for thetreatment ofdepression.

Dosage andAdministration

Depression

DosageConsiderations

Dosageshouldbeinitiatedatalowlevelandincreasedgradually,notingcarefullytheclinicalresponse

and anyevidence ofintolerance.

OralDosage.

Do nothalve tablet,dose equivalent when thetabletisdivided hasnot been established.

InitialAdult Dosagefor Outpatients

75mgofamitriptylineadayindivideddosesisusuallysatisfactory.Ifnecessary,thismaybeincreased

toatotalof150mgaday.Increasesaremadepreferablyinthelateafternoonand/orbedtimedoses.

Thesedativeeffectisusuallyrapidlyapparent.Theantidepressantactivitymaybeevidentwithin3or4

daysor maytake up to 30 daystodevelopadequately.

Alternatemethodsofinitiatingtherapyin outpatientsare tobegin therapywith50to100mg amitriptyline

preferablyintheeveningoratbedtime;thismaybeincreasedby25to50mgasnecessarytoatotalof

150mgperday.Initiatetherapywithone75mgcapsuleortabletpreferablyintheeveningor at bedtime

and increase,ifnecessary, totwo,or onein themorningand onein theevening.

Dosagefor Hospitalised Patients

100mgadaymayberequiredinitially.Thiscanbeincreasedgraduallyto200mgadayifnecessary.A

smallnumberofhospitalisedpatientsmayneedasmuch as300mg aday.

Dosagefor ElderlyPatients

Ingeneral,lowerdosagesarerecommendedforthesepatients.Inthoseelderlypatientswhomaynot

toleratehigherdoses,50mgdailymaybesatisfactory.Therequireddailydosemaybeadministered

eitherasdivided dosesor asasingle dose preferablyin theeveningor at bedtime.

AdolescentDepression

Notrecommendedforuseinadolescentpatients13-18yearsofageforthetreatmentofdepression,

unlessunderthe supervisionofaspecialist.

MaintenanceDosage

Theusualmaintenancedoseis50to100mgamitriptylineperday.Formaintenancetherapy,thetotal

dailydosagemaybegiveninasingledosepreferablyintheeveningoratbedtime.Whensatisfactory

improvementhasbeenreached,dosageshouldbereducedtothelowestamountthatwillmaintain

reliefofsymptoms.Itisappropriatetocontinuemaintenancetherapy3monthsorlongertolessenthe

possibilityofrelapse.

PlasmaLevels

Becauseofthewidevariationintheabsorptionanddistributionoftricyclicantidepressantsinbody

fluids,itisdifficulttodirectlycorrelateplasmalevelsandtherapeuticeffect.However,determinationof

plasmalevelsmaybeusefulinidentifyingpatientswhoappeartohavetoxiceffectsandmayhave

excessivelyhighlevels,orthoseinwhomlackofabsorptionornoncomplianceissuspected.

Adjustmentsindosageshouldbemadeaccordingtothepatient'sclinicalresponseandnotonthe

basisofplasma levels.

Contraindications

Amitriptylineiscontraindicated for thetreatment ofdepressionin patients12yearsofage

and under.

Amitriptylineiscontraindicated for thetreatment ofnocturnalenuresis.

Amitriptylineiscontraindicated in patientswhohave shown prior hypersensitivitytoit.

It should notbegivenconcomitantlywitha monoamineoxidase inhibitingcompound.

Hyperpyreticcrises, severe convulsions, anddeathshave occurredin patientsreceiving

tricyclicantidepressant andmonoamineoxidase inhibitingmedicinessimultaneously. When

it isdesiredtosubstitute amitriptylinefor a monoamineoxidase inhibitor, a minimumof14

daysshould be allowedtoelapse after thelatter isdiscontinued. Amitriptylineshould then

beinitiated cautiouslywithgradualincrease in dosage untiloptimumresponse isachieved.

Thismedicineiscontraindicatedfor use during theacuterecoveryphase following

myocardialinfarction.

SeeUse in PregnancyunderWarningsand Precautions.

Warnings and Precautions

ClinicalWorsening and SuicideRisk

PatientsofanyagewithMajorDepressiveDisordermayexperienceworseningoftheirdepression

and/ortheemergenceofsuicidalideationandbehaviour(suicidality),whetherornottheyaretaking

antidepressantmedications,andthisriskmaypersist untilsignificant remissionoccurs. Patientsshould

becloselymonitored,especiallyatthebeginningoftherapyorwhenthedoseischanged,untilsuch

improvement occurs.

Therehasbeenalong-standingconcernthatsomeantidepressantsmayhavearoleintheemergence

ofsuicidalityinsomepatients.Thepossibleriskofincreasedsuicidalityinpatientsappliestoall

classesofantidepressantmedicines,asavailabledataarenotadequatetoexcludethisriskforany

antidepressant.Therefore,considerationshouldbegiventochangingthetherapeuticregimen,

includingpossiblydiscontinuingthemedication,inpatientswhosedepressionispersistentlyworseor

whoseemergentsuicidalityissevere,abruptinonset,orwasnotpartofthepatient'spresenting

symptoms.Generally,whenstoppinganantidepressant,dosesshouldbetaperedratherthanstopped

abruptly.

Thefollowingsymptoms,anxiety,agitation,panicattacks,insomnia,irritability,hostility

(aggressiveness),impulsivity,akathisia(psychomotorrestlessness),hypomania,andmania,have

beenreportedinadultandpaediatricpatientsbeingtreatedwithantidepressantsformajordepressive

disorderaswellasforotherindications,bothpsychiatricandnon-psychiatric.Althoughacausallink

betweentheemergenceofsuchsymptomsandeithertheworseningofdepressionand/orthe

emergenceofsuicidalimpulseshasnotbeenestablished,considerationshouldbegiventochanging

thetherapeuticregimen,includingpossiblydiscontinuingthemedication,inpatientsforwhomsuch

symptomsare severe, abrupt in onset,or were not part ofthe patient'spresentingsymptoms.

Becauseofthepossibilityofco-morbiditybetweenmajordepressivedisorderandotherpsychiatricand

non-psychiatricdisorders,thesameprecautionsobservedwhentreatingpatientswithmajor

depressivedisordershouldbeobservedwhentreatingpatientswithotherpsychiatricandnon-

psychiatricdisorders.

Maniaand Bipolar Disorder

Amajordepressiveepisodemaybetheinitialpresentationofbipolardisorder.Itisgenerallybelieved

(thoughnotestablishedincontrolledtrials)thattreatingsuchanepisodewithanyantidepressantalone

mayincreasethelikelihoodofamixed/manicepisodeinpatientsatriskforbipolardisorder.Priorto

initiatingtreatmentwithanantidepressant,patientsshouldbeadequatelyscreenedtodetermineifthey

areatriskforbipolardisorder.Itshouldbenotedthatamitriptylineisnotapprovedforuseintreating

bipolar depression.

Information for Patientsand Families

Patientsandtheirfamiliesshouldbealertedabouttheneedtomonitorfortheemergenceofanxiety,

agitation,panicattacks,insomnia,irritability,hostility,impulsivity,akathisia,hypomania,mania,

worseningofdepression,andsuicidalideation,especiallyearlyduringantidepressanttreatment.Such

symptomsshouldbereportedtothepatient'sdoctor,especiallyiftheyaresevere,abruptinonset,or

were not part ofthe patient'spresentingsymptoms.

Thepatienthastherighttotreatmentmeetingappropriateethicalandprofessionalstandards,andthe

patientneedstobefullyinformedwithfrankdiscussionofrisk/benefitissuesrelatingtothemedicines

efficacyand safetywhen usedin thetreatment regimenproposed.

General

Amitriptylineshouldbeusedwithcautioninpatientswithahistoryofseizures,inpatientswithimpaired

liverfunctionand,becauseofitsatropine-likeaction,inpatientswithahistoryofurinaryretention,or

withnarrowangle glaucoma orincreasedintraocular pressure. Inpatientswithnarrow-angle glaucoma,

evenaveragedosesmayprecipitate an attack.

There hasbeenareport offataldysrhythmia occurring aslateas56hoursafter amitriptylineoverdose.

Discontinue themedicineseveraldaysbefore elective surgeryifpossible.

Hyperpyrexiahasbeenreportedwhentricyclicantidepressantsareadministeredwithanticholinergic

agentsor withneurolepticmedicines, particularlyduringhot weather.

Themedicinemayimpairalertnessinsomepatients;operationofautomobilesandotheractivities

made hazardousbydiminished alertnessshould be avoided.

Cardiovascular Disorders

Amitriptylineshouldbeusedwithcautioninpatientswithcardiovasculardisease,includingheart

failure,conductiondisorders,(e.g.AVblockgradesItoIII),orarrhythmias.CardiovascularandECG

monitoringshouldbeundertakeninsuchpatients.AnECGshouldbeperformedpriortostarting

treatment,atsteadystate,afteranincreaseindoseorafterstartinganypotentiallyinteracting

medicine.

Tricyclicantidepressantmedicines,includingamitriptyline,particularlywhengiveninhighdoses,have

beenreportedtoproduceQTcprolongation,arrhythmias(includingTorsadesdepointes-TdP),sinus

tachycardia,andprolongationoftheconductiontime.MyocardialInfarctionandstrokehavebeen

reported withmedicinesofthisclass(SeeAdverse Events).

AmitriptylineshouldbeusedwithcautioninpatientswithriskfactorsforQTcprolongation/TdP

includingcongenitallongQTsyndrome,age>65years,femalesex,structuralheartdisease/LV

dysfunction,medicalconditionssuchasrenalorhepaticdisease,useofmedicinesthatinhibitthe

metabolismofamitriptyline,andtheconcomitantuseofotherQTcprolongingmedicines(see

Interactions). Hypokalaemia andhypomagnesaemia should be correctedprior to treatment.

ConsiderationshouldbegiventostoppingamitriptylinetreatmentorreducingthedoseiftheQTc

intervalis>500msor increasesby>60ms.

EndocrineDisorders

Closesupervisionisrequiredwhenamitriptylineisgiventohyperthyroidpatientsorthosereceiving

thyroid medications.

CentralNervousSystemDisorders

Whenamitriptylineisusedtotreatthedepressivecomponentofschizophrenia,psychoticsymptoms

maybeaggravated.

Paranoiddelusions,withorwithoutassociatedhostility,maybeexaggerated.Inanyofthese

circumstances,itmaybeadvisabletoreducethedoseofamitriptylineortouseamajortranquillising

medicine, such asperphenazine, concurrently.

Use in Pregnancy

Amitriptylineshouldonlybeusedinpregnancyifconsiderednecessary,takingintoaccounttherisksof

untreateddepression, andunderthe close supervisionofaphysician.

Epidemiologicalstudieshavesuggestedanincreasedriskofcongenitalabnormalitiesassociatedwith

use oftricyclicantidepressantsin pregnancy.

Neonatesshouldbeobservedifmaternaluseofamitriptylinehascontinuedintothelaterstagesof

pregnancy, particularlyintothe third trimester.

Neonatesexposedtotricyclicantidepressants,lateinthethirdtrimesterhaveshoweddrugwithdrawal

symptomssuchasdyspnoea,lethargy,colicirritability,hypotensionorhypertensionandtremoror

spasms.

Epidemiologicaldatasuggeststhattheuse oftricyclicantidepressantsin pregnancymaybeassociated

withanincrease in pre-termdelivery.

NursingMothers

Amitriptylineisdetectableinbreastmilk.Becauseofthepotentialforseriousadversereactionsin

infantsfromamitriptyline,adecisionshouldbemadewhethertodiscontinuenursingordiscontinuethe

medicine.

AdverseEffects

Note:Includedinthelistingwhichfollowsareafewadversereactionswhichhavenotbeenreported

withthisspecificmedicine.However,pharmacologicalsimilaritiesamongthetricyclicantidepressant

medicinesrequire that each ofthe reactionsbeconsideredwhen amitriptylineisadministered.

Cardiovascular

Hypotension,syncope,hypertension,tachycardia,palpitation,myocardialinfarction,arrhythmias

(includingventriculartachycardia,ventricularfibrillationandTorsadesdepointes),,stroke,ECG

changes(includingQTcprolongation,non-specificSTandTwavechanges,andAVconduction

disorderssuch asheart block, bundle branch blockand widened QRScomplex).

CNSand Neuromuscular

Confusionalstates;disturbedconcentration;disorientation;delusions;hallucinations;excitement;

anxiety;restlessness;drowsiness;insomnia;nightmares;numbness;tingling,andparesthesiasofthe

extremities;peripheralneuropathy;incoordination;ataxia;tremors;coma;seizures;alterationinEEG

patterns;extrapyramidalsymptoms,includingabnormalinvoluntarymovementsand tardive dyskinesia;

dysarthria;tinnitus.

Anticholinergic

Drymouth,blurredvision,mydriasis,disturbanceofaccommodation,increasedintraocularpressure,

constipation, paralyticileus, hyperpyrexia,urinaryretention, dilatationofurinarytract.

Allergic

Skinrash,urticaria, photosensitization, oedema offace andtongue.

Haematologic

Bone marrow depression including agranulocytosis, leukopenia, eosinophilia, purpura,

thrombocytopenia.

Gastrointestinal

Nausea,epigastricdistress,vomiting,anorexia,stomatitis,peculiartaste,diarrhoea,parotidswelling,

blacktongue, rarelyhepatitis(includingaltered liver functionand jaundice).

Endocrine

Testicularswellingandgynecomastiainthemale,breastenlargementandgalactorrheainthefemale,

increasedordecreasedlibido,impotence,elevationorloweringofbloodsugarlevels,syndromeof

inappropriateADH (antidiuretichormone) secretion.

Other

Dizziness,weakness,fatigue,headache,weightgainorloss,oedema,increasedperspiration,urinary

frequency, mydriasis, drowsiness, alopecia.

WithdrawalSymptoms

Abruptcessationoftreatmentafterprolongedadministrationmayproducenausea,headache,and

malaise.Gradualdosagereductionhasbeenreportedtoproduce,withintwoweeks,transient

symptomsincludingirritability,restlessness,anddreamandsleepdisturbance.Thesesymptomsare

notindicativeofaddiction.Rareinstanceshavebeenreportedofmaniaorhypomaniaoccurringwithin

2-7 daysfollowingcessationofchronictherapywithtricyclicantidepressants.

AdverseEffects-CasualRelationshipUnknown

Thefollowingadditionaladverseeffectshavebeenreported;however,acasualrelationshiptotherapy

withamitriptylinehasnot been established.

BodyasaWhole

Lupus-like syndrome (migratoryarthritis, positive ANAand rheumatoid factor).

Interactions

Medicinesthat can prolong theQTcinterval

TheriskofQTcprolongationand/orventriculararrhythmias(e.g.torsadesdepointes)isincreasedwith

concomitantuseofothermedicineswhichprolongtheQTcinterval(e.g.someantipsychoticsand

antibiotics).Pleasecheckthedatasheetofothermedicinesadministeredforinformationontheir

effectsonthe QTinterval.

Fluoxetine

FluoxetinemarkedlyinhibitsCytochromeP4502D6,whichisinvolvedinthemetabolismofanumber

oftricyclicantidepressantsincludingamitriptyline.Patientsshouldbemonitoredforincreased

antidepressantplasmalevelsandtoxicitywhenfluoxetineisusedconcurrently.Adjustmentofthe

antidepressant dosage maybenecessary.

OtherAntidepressantMedicines

Thepotencyofamitriptylineissuchthatadditionofotherantidepressantmedicinesgenerallydoesnot

resultinanyadditionaltherapeuticbenefit.Untowardreactionshavebeenreportedafterthecombined

useofantidepressantagentshavingvaryingmodesofactivity.Accordingly,combineduseof

amitriptylinehydrochlorideandotherantidepressantmedicinesshouldbeundertakenonlywithdue

recognitionofthepossibilityofpotentiationand witha thoroughknowledgeofthe pharmacologyofboth

medicines.Therehavebeennoreportsofuntowardeventswhenpatientsreceivingamitriptylinewere

changedimmediatelytoprotriptylineor vice versa.

Guanethidine

Amitriptylinemayblockthe antihypertensive actionofguanethidineor similarlyactingcompounds.

AnticholinergicAgents/SympathomimeticMedicines

Whenamitriptylineisgivenwithanticholinergicagentsorsympathomimeticmedicines,including

epinephrinecombinedwithlocalanaesthetics,closesupervisionandcarefuladjustmentofdosageare

required.Paralyticileusmayoccurinpatientstakingtricyclicantidepressantsincombinationwith

anticholinergic-typemedicines.

Cimetidine

Cimetidineisreported to reduce hepaticmetabolismofcertain tricyclicantidepressants.

CentralNervousSystemDepressants

AmitriptylinemayenhancetheresponsetoalcoholandtheeffectsofbarbituratesandotherCNS

depressants.Cautionisadvisedifpatientsreceivelargedosesofethchlorvynolconcurrently.Transient

deliriumhasbeenreportedinpatientswhoweretreatedwith1gofethchlorvynoland75-150mgof

amitriptyline.

Disulfiram

Deliriumhasbeenreported withconcurrent administrationofamitriptylineand disulfiram.

ElectroshockTherapy

Concurrentadministrationofamitriptylineandelectroshocktherapymayincreasethehazardsof

therapy. Such treatment should be limitedtopatientsfor whomit isessential.

Overdosage

Cardiovascular

Cardiovascularsystem:hypotension,tachycardia,QTcprolongation,arrhythmias(includingTorsades

depointes), conductiondisorders, shock, heart failure, in veryrare casescardiacarrest.

Manifestations

Highdosesmaycausetemporaryconfusion,disturbedconcentration,ortransientvisualhallucinations.

Over-dosagemaycausedrowsiness;hypothermia;tachycardiaandotherarrhythmicabnormalities,

suchasbundlebranchblock;ECGevidenceofimpairedconduction;congestiveheartfailure;dilated

pupils;disordersofocularmotility;convulsions;severehypotension;stupor;comaand

polyradiculoneuropathy; constipation.

Othersymptomsmaybeagitation,hyperactivereflexes,musclerigidity,vomiting,hyperpyrexia,orany

ofthose listedunderAdverse Effects.

Allpatientssuspectedofhavingtakenanoverdoseshouldbeadmittedtoahospitalassoonas

possible.Treatmentissymptomaticandsupportive.Emptythestomachasquicklyaspossibleby

emesisfollowedbygastriclavageuponarrivalatthehospital.Followinggastriclavage,activated

charcoalmaybeadministered.Twentyto30gofactivatedcharcoalmaybegiveneveryfourtosix

hoursduringthefirst24to48hoursafteringestion.AnECGshouldbetakenandclosemonitoringof

cardiacfunctioninstitutedifthereisanysignofabnormality.Maintainanopenairwayandadequate

fluid intake;regulatebodytemperature.

Theintravenousadministrationof1-3mgofphysostigminesalicylatehasbeenreportedtoreversethe

symptomsoftricyclicantidepressantpoisoning.Becausephysostigmineisrapidlymetabolised,the

dosageofphysostigmineshouldberepeatedasrequiredparticularlyiflife-threateningsignssuchas

arrhythmias,convulsionsanddeepcomarecurorpersistaftertheinitialdoseofphysostigmine.

Because physostigmineitselfmaybetoxic, it isnot recommended forroutineuse.

Standardmeasuresshouldbeusedtomanagecirculatoryshockandmetabolicacidosis.Cardiac

arrhythmiasmaybetreatedwithneostigmine,pyridostigmine,orpropranolol.Shouldcardiacfailure

occur,theuseofdigitalisshouldbeconsidered.Closemonitoringofcardiacfunctionofnotlessthan

five daysisadvisable.

Anticonvulsantsmaybegiventocontrolconvulsions.AmitriptylineincreasestheCNSdepressant

actionbutnottheanticonvulsantactionofbarbiturates;therefore,aninhalationanaesthetic,diazepam,

or paraldehydeisrecommended for controlofconvulsions.

Dialysisisofnovaluebecause oflowplasma concentrationsofthe medicine.

Sinceoverdosageisoftendeliberate,patientsmayattemptsuicidebyothermeansduringtherecovery

phase.Deathsbydeliberateor accidentaloverdosage have occurredwiththisclassofmedicine.

Pharmaceutical Precautions

Store below25°C.

Medicine Classification

PrescriptionMedicine

Package Quantities

AMIROL10mg tablets: Blister packsof30 tablets.

AMIROL25mg tablets: Blister packsof30tablets.

Further Information

Nil.

Name andAddress

AFTPharmaceuticalsLtd

POBox33-203

Takapuna

AUCKLAND

Telephone: (09)488-0232

Facsimile:(09)488-0234

Date of Preparation

January2013

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21-12-2018

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

17-12-2018

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Een betaalbare woonplek, voldoende kansen op een opleiding en een baan, financiële zelfredzaamheid en voldoende zorg en ondersteuning. Basisbehoeften voor ieder mens, maar waaraan de 10.700 zwerfjongeren (18 – 27 jaar) in Nederland nog te vaak tekortkomen. Op die vier ‘levensbrede’ prioriteiten zal de staatssecretaris zich richten met zijn actieprogramma Zwerfjongeren, dat hij afgelopen oktober in Tweede Kamer aankondigde. Met het actieprogramma brengt hij lokale partijen en gemeenten, maar ook andere ve...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-12-2018


Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

FDA - U.S. Food and Drug Administration

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

Europe - EMA - European Medicines Agency

10-12-2018


Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Europe - EMA - European Medicines Agency

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

Europe - EMA - European Medicines Agency

29-11-2018


Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

28-11-2018

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, L...

FDA - U.S. Food and Drug Administration

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018


Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Europe - EMA - European Medicines Agency

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: 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, Treatment

Orphan designation: 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, Treatment

Orphan designation: 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, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency