AFT-Pamidronate

Main information

  • Trade name:
  • AFT-Pamidronate 90 mg Powder for injection
  • Dosage:
  • 90 mg
  • Pharmaceutical form:
  • Powder for injection
  • Units in package:
  • Vial, Type I clear 15 mL vial, bromobutyl stopper/Al seal/plastic cover, 1 dose unit
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Pharmascience Inc

Documents

Localization

  • Available in:
  • AFT-Pamidronate 90 mg Powder for injection
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12051
  • Authorization date:
  • 08-04-2005
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

AFT-Pamidronate

PamidronatedisodiumpowderforIntravenousInfusion30mg,60mgand90mg

Presentation

AFT-Pamidronate30mgisawhitetopracticallywhitelyophilisedpowderwhich

whenreconstitutedwith10mLwaterforinjectionresultsinaclear,colourlesssolution

containing3mg/mLPamidronatedisodium.

AFT-Pamidronate60mgisawhitetopracticallywhitelyophilisedpowderwhich

whenreconstitutedwith10mLwaterforinjectionresultsinaclear,colourlesssolution

containing6mg/mLPamidronatedisodium.

AFT-Pamidronate90mgisawhitetopracticallywhitelyophilisedpowderwhich

whenreconstitutedwith10mLwaterforinjectionresultsinaclear,colourlesssolution

containing9mg/mLPamidronatedisodium.

Uses

Actions

Pamidronatedisodium,theactivesubstanceofAFT-Pamidronate,isapotent

inhibitorofosteoclasticboneresorption.Itbindsstronglytohydroxyapatitecrystals

andinhibitstheformationanddissolutionofthesecrystalsinvitro.Inhibitionof

osteoclasticboneresorptioninvivomaybeatleastpartlyduetobindingofthedrug

tothebonemineral.

Pamidronatesuppressestheaccessionofosteoclastprecursorsontotheboneand

theirsubsequenttransformationintothemature,resorbingosteoclasts.However,the

localanddirectantiresorptiveeffectofbone-boundbisphosphonateappearstobe

thepredominantmodeofactioninvitroandinvivo.

Experimentalstudieshavedemonstratedthatpamidronateinhibitstumour-induced

osteolysiswhengivenpriortooratthetimeofinoculationortransplantationwith

tumourcells.BiochemicalchangesreflectingtheinhibitoryeffectofAFT-Pamidronate

ontumour-inducedhypercalcaemia,arecharacterisedbyadecreaseinserum

calciumandphosphateandsecondarilybydecreasesinurinaryexcretionofcalcium,

phosphate,andhydroxyproline.

Hypercalcaemiacanleadtoadepletioninthevolumeofextracellularfluidanda

reductionintheglomerularfiltrationrate(GFR).Bycontrollinghypercalcaemia,

pamidronateimprovesGFRandlowerselevatedserumcreatininelevelsinmost

patients.

Clinicaltrialsinpatientswithpredominantlylyticbonemetastasesormultiple

myelomashowedthatpamidronatepreventedordelayedskeletal-relatedevents

(hypercalcaemia,fractures,radiationtherapy,surgerytobone,spinalcord

compression)anddecreasedbonepain.Whenusedincombinationwithstandard

anticancertreatment,pamidronateledtoadelayinprogressionofbonemetastases.

Inaddition,osteolyticbonemetastaseswhichhaveprovedrefractorytocytotoxicand

hormonaltherapymayshowradiologicalevidenceofdiseasestabilisationor

sclerosis.

Paget'sdiseaseofbone,whichischaracterisedbylocalareasofincreasedbone

resorptionandformationwithqualitativechangesinboneremodelling,respondswell

totreatmentwithpamidronate.Clinicalandbiochemicalremissionofthediseasehas

beendemonstratedbybonescintigraphy,decreasesinurinaryhydroxyprolineand

serumalkalinephosphatase,andbysymptomaticimprovement.

Pharmacokinetics

Pamidronatehasastrongaffinityforcalcifiedtissues,andtotaleliminationof

pamidronatefromthebodyisnotobservedwithinthetimeframeofexperimental

studies.Calcifiedtissuesarethereforeregardedassiteof"apparentelimination".

Pamidronatedisodiumisgivenbyintravenousinfusion.Bydefinition,absorptionis

completeattheendoftheinfusion.

Plasmaconcentrationsofpamidronateriserapidlyafterthestartofaninfusionand

fallrapidlywhentheinfusionisstopped.Theapparenthalf-lifeinplasmaisabout0.8

hours.Apparentsteady-stateconcentrationsarethereforeachievedwithinfusionsof

morethanabout2-3hours'duration.Peakplasmapamidronateconcentrationsof

about10nmol/mLareachievedafteranintravenousinfusionof60mggivenover1

hour .

Inanimalsandinman,asimilarpercentageofthedoseisretainedinthebodyafter

eachdoseofpamidronatedisodium.Thustheaccumulationofpamidronateinbone

isnotcapacity-limited,andisdependentsolelyonthetotalcumulativedose

administered.

Thepercentageofcirculatingpamidronateboundtoplasmaproteinsisrelativelylow

(about54%),andincreaseswhencalciumconcentrationsarepathologically

elevated.

Pamidronatedoesnotappeartobeeliminatedbybiotransformation.Afteran

intravenousinfusion,about20-55%ofthedoseisrecoveredintheurinewithin72

hoursasunchangedpamidronate.Withinthetimeframeofexperimentalstudiesthe

remainingfractionofthedoseisretainedinthebody.Thepercentageofthedose

retainedinthebodyisindependentofboththedose(range15-180mg)andthe

infusionrate(range1.25-60mg/h).Theeliminationofpamidronateintheurineis

biexponential,withapparenthalf-livesofabout1.6and27hours.Theapparenttotal

plasmaclearanceisabout180mL/minandtheapparentrenalclearanceisabout54

mL/min.Thereisatendencyfortherenalclearanceofpamidronatetocorrelatewith

creatinineclearance.

Hepaticandmetabolicclearanceofpamidronateisinsignificant.Impairmentofliver

functionisthereforenotexpectedtoinfluencethepharmacokineticsofpamidronate.

Pamidronatethusdisplayslittlepotentialfordrug-druginteractionsbothatthe

metaboliclevelandatthelevelofproteinbinding(seeabove).

ThemeanplasmaAUCisapproximatelydoubledinpatientswithsevererenal

impairment(creatinineclearance<30mL/min).Urinaryexcretionratedecreaseswith

decreasingcreatinineclearance,althoughthetotalamountexcretedintheurineis

notgreatlyinfluencedbyrenalfunction.Bodyretentionofpamidronateistherefore

similarinpatientswithandwithoutimpairedrenalfunction,anddoseadjustmentis

notnecessaryinthesepatientswhenusingtherecommendeddoseschedule.

Indications

Treatmentofconditionsassociatedwithincreasedosteoclastactivity:

Predominantlylyticbonemetastasesandmultiplemyeloma

Metastaticbonepain

Tumour-inducedhypercalcaemia

Paget'sdiseaseofbone

DosageandAdministration

AFT-Pamidronatemustneverbegivenasabolusinjection(seeWarningsand

Precautions).Eachvialisforsingleuseonly.AFT-Pamidronatepowdershouldbe

completelydissolvedin10mlwaterforinjectionbeforethereconstitutedsolutionis

withdrawnfromthevialfordilution.AFT-Pamidronateshouldbedilutedinacalcium-

freeinfusionsolutione.g.0.9%sodiumchlorideor5%glucoseandinfusedslowly.

Theinfusionrateshouldnotexceed60mg/h(1mg/min),andtheconcentrationof

pamidronateintheinfusionsolutionshouldnotexceed90mg/250mL.Adoseof90

mgshouldnormallybeadministeredasa2-hourinfusionin250mLofinfusion

solution.However,inpatientswithmultiplemyelomaandinpatientswithtumour-

inducedhypercalcaemia,itisrecommendednottoexceed90mgin500mLover4

hours.

Inordertominimiselocalreactionsattheinfusionsite,thecannulashouldbe

insertedcarefullyintoarelativelylargevein.

AdultsandElderly

Predominantlylyticbonemetastasesandmultiplemyeloma

TherecommendeddoseofAFT-Pamidronateforthetreatmentofpredominantlylytic

bonemetastasesandmultiplemyelomais90mgadministeredasasingleinfusion

every4weeks.

Inpatientswithbonemetastaseswhoreceivechemotherapyat3-weeklyintervals

AFT-Pamidronate90mgmayalsobegivenona3-weeklyschedule.

Tumour-inducedhypercalcaemia

Itisrecommendedthatpatientsberehydratedwithnormalsalinebeforeorduring

treatment.

ThetotaldoseofAFT-Pamidronatetobeusedforatreatmentcoursedependson

thepatient'sinitialserumcalciumlevels.Thefollowingguidelinesarederivedfrom

clinicaldataonuncorrectedcalciumvalues.However,doseswithintherangesgiven

arealsoapplicableforcalciumvaluescorrectedforserumproteinoralbuminin

rehydratedpatients.

Initialserumcalcium

mmol/L mg% RecommendedtotalDose(mg)

Upto3.0 Upto12.0 15–30

3.0–3.5 12.0–14.0 30–60

3.5–4.0 14.0–16.0 60-90

>4.0 >16.0 90

ThetotaldoseofAFT-Pamidronatemaybeadministeredeitherinasingleinfusionor

inmultipleinfusionsover2-4consecutivedays.Themaximumdosepertreatment

courseis90mgforbothinitialandrepeatedcourses.

Asignificantdecreaseinserumcalciumisgenerallyobserved24-48hoursafter

administrationofAFT-Pamidronate,andnormalisationisusuallyachievedwithin3to

7days.Ifnormocalcaemiaisnotachievedwithinthistime,afurtherdosemaybe

given.Thedurationoftheresponsemayvaryfrompatienttopatient,andtreatment

canberepeatedwheneverhypercalcaemiarecurs.Clinicalexperiencetodate

suggeststhatpamidronatemaybecomelesseffectiveasthenumberoftreatments

increases.

Paget'sdiseaseofbone

TherecommendedtotaldoseofAFT-Pamidronateforatreatmentcourseis180-210

mg.Thiscanbeadministeredeitherin6unitdosesof30mgonceaweek(totaldose

180mg),orin3unitdosesof60mgeveryotherweek.Ifunitdosesof60mgare

used,itisrecommendedtostartthetreatmentwithaninitialdoseof30mg(total

dose210mg).

Thisregimen,omittingtheinitialdose,canberepeatedafter6monthsuntilremission

ofdiseaseisachieved,orwhenrelapseoccurs.

Renalimpairment

Pharmacokineticstudiesindicatethatnodoseadjustmentisnecessaryinpatients

withanydegreeofrenalimpairment.However,untilfurtherexperienceisgaineda

maximuminfusionrateof20mg/hisrecommendedinrenallyimpairedpatients.

Children

Thereisnoclinicalexperiencewithpamidronateinchildren.

Contraindications

Knownhypersensitivitytopamidronate,otherbisphosphonatesormannitol.

WarningsandPrecautions

AFT-Pamidronateshouldnotbegivenasabolusinjection,butshouldalwaysbe

dilutedandgivenasaslowintravenousinfusion(seeDosageandAdministration).

AFT-Pamidronateshouldnotbegivenwithotherbisphosphonatesbecausetheir

combinedeffectshavenotbeeninvestigated.

Serumelectrolytes,calciumandphosphateshouldbemonitoredfollowinginitiationof

therapywithAFT-Pamidronate.Patientswhohaveundergonethyroidsurgerymay

beparticularlysusceptibletodevelophypocalcaemiaduetorelative

hypoparathyroidism.

Patientsreceivingfrequentinfusionsofpamidronateoveraprolongedperiodoftime,

especiallythosewithpre-existingrenaldiseaseorapredispositiontorenal

impairment(e.g.patientswithmultiplemyelomaand/ortumour-induced

hypercalcaemia),shouldhaveperiodicevaluationsofstandardlaboratoryandclinical

parametersofrenalfunctionasdeteriorationofrenalfunction(includingrenalfailure)

hasbeenreportedfollowinglong-termtreatmentwithpamidronateinpatientswith

multiplemyeloma.However,underlyingdiseaseprogressionand/orconcomitant

complicationswerealsopresentandthereforeacausalrelationshipwithpamidronate

isunproven.

Inpatientswithcardiacdisease,especiallyintheelderly,additionalsalineoverload

mayprecipitatecardiacfailure(leftventricularfailureorcongestiveheartfailure).

Fever(influenza-likesymptoms)mayalsocontributetothisdeterioration.

PatientswithPaget'sdiseaseofthebone,whoareatriskofcalciumorvitaminD

deficiency,shouldbegivenoralcalciumsupplementsandvitaminDinorderto

minimisetheriskofhypocalcaemia.

Osteonecrosisofthejawhasbeenreportedinpatientswithcancerreceiving

treatmentregimensincludingbisphosphonates.Manyofthethesepatientswerealso

receivingchemotherapyandcorticosteroids.Themajorityofreportedcaseshave

beenassociatedwithdentalproceduressuchastoothextraction.Manyhadsignsof

localinfectionincludingosteomyelitis.Adentalexaminationwithappropriate

preventativedentistryshouldbeconsideredpriortotreatmentwithbisphosphonates

inpatientswithconcomitantriskfactors.Patientsandtheirdentistsshouldbe

advisedofthereportsofosteonecrosisofthejawsothatdentalsymptoms

developingduringtreatmentcanbefullyassessedbeforecommencingdental

procedures.Whileontreatment,thesepatientsshouldavoidinvasivedental

proceduresifpossible.

UseduringPregnancyandLactation

CategoryB3

Inpregnantrats,pamidronatehasbeenshowntocrosstheplacentalbarrierand

accumulateinfoetalboneinamannersimilartothatobservedinadultanimals.

Pamidronatehasbeenshowntoincreasethelengthofgestationandparturitionin

rats,resultinginanincreasingpupmortalitywhengivenorallyatdosesof60mg/kg

andabove(0.7timesthehighestrecommendedhumandoseforasingleintravenous

infusion).TherewasnounequivocalevidenceforteratogenicityinstudieswithI.V.

administrationofpamidronatetopregnantratsalthoughhighdoses(12and15

mg/kg/day)wereassociatedwithmaternaltoxicityandfoetaldevelopmental

abnormalities(foetaloedemaandshortenedbones)anddosesof6mg/kgandabove

withreducedossification.LowerI.V.pamidronatedoses(1-6mg/kg/day)interfered

(pre-partumdistressandfetotoxicity)withnormalparturitionintheratandthismay

beassociatedwithmaternalhypocalcaemia.

OnlylowI.V.doseshavebeeninvestigatedinrabbits,andthehighestdoseused(1.5

mg/kg/day)wasassociatedwithanincreasedresorptionrateandreduced

ossification.Therewasnoevidenceofteratogenicity.

Itisnotknownifpamidronatecrossesthehumanplacenta.AFT-Pamidronateshould

notbegiventopregnantwomenunlesslife-threateninghypercalcaemiacannotbe

controlledbyothermeans.

Thereisnoclinicalexperienceinlactatingwomenanditisunknownifpamidronate

oritsmetabolitespassintohumanmilk.Howeverastudyinlactatingratshasshown

thatpamidronatewillpassintothemilk.Thereforeforsafetyreasonsmotherstaking

AFT-Pamidronateshouldnotbreast-feedtheirinfants.

UseinChildren

Thereislimitedclinicalexperienceinchildren.AFT-Pamidronateshouldnotbegiven

tochildrenunlessothermeasureshaveeitherfailedtocontrollife-threatening

hypercalcaemiaoraredeemedinappropriate.AFT-Pamidronateisonly

recommendedforuseinadultpatients.

Effectsonabilitytodriveandusemachines

Patientsshouldbewarnedthatinrarecasessomnolenceand/ordizzinessmay

occurfollowingAFT-Pamidronateinfusion,inwhichcasetheyshouldnotdrive,

operatepotentiallydangerousmachinery,orengageinotheractivitiesthatmaybe

hazardousbecauseofdecreasedalertness.

AdverseEffects

Adversereactionstopamidronateareusuallymildandtransient.Themostcommon

adversereactionsareasymptomatichypocalcaemiaandfever(anincreaseinbody

temperatureof1-2°C),typicallyoccurringwithinthefirst48hoursofinfusion.Fever

usuallyresolvesspontaneouslyanddoesnotrequiretreatment.

Symptomatichypocalcaemiaisrare.

Localsoft-tissueinflammationattheinfusionsitealsooccursespeciallyatthe

highestdose(90mg).

Frequencyestimateforthereactionsbelowisasfollows:

Verycommon:>10%,

Common:>1and<10%,

Uncommon:>0.1%and<1%,

Rare:>0.01%and<0.1%

Veryrare:<0.01%.

Biochemicalchanges

Verycommon:hypocalcaemia,hypophosphataemia

Common:hypokalaemia,hypomagnesaemia,increaseinserumcreatinine

Uncommon:abnormalliverfunctiontests,increaseinserumurea

Veryrare:hyperkalaemia,hypernatraemia

Blood

Common:anaemia,thrombocytopenia,lymphocytopenia

Veryrare:leukopenia

Cardiovascular

Common:hypertension

Uncommon:hypotension

Veryrare:leftventricularfailure(dyspnoea,pulmonaryoedema),congestiveheart

failure(oedema)duetofluidoverload

Centralnervoussystem

Common:symptomatichypocalcaemia(paraesthesia,tetany),headache,insomnia,

somnolence

Uncommon:seizures,agitation,dizziness,lethargy

Veryrare:confusion,visualhallucinations

Gastrointestinal

Common:nausea,vomiting,anorexia,abdominalpain,diarrhoea,constipation,

gastritis

Uncommon:dyspepsia

Generaldisordersandadministrationsiteconditions

Verycommon:feverandinfluenza-likesymptomssometimesaccompaniedby

malaise,rigor,fatigueandflushes

Common:reactionsattheinfusionsite(pain,swelling,induration,phlebitis,

thrombophlebitis)

Immunesystem

Uncommon:allergicreactionsincludinganaphylactoidreactions,

bronchospasm/dyspnoea,Quincke’s(angioneurotic)oedema

Veryrare:anaphylacticshock

Infection

Veryrare:reactivationofherpessimplex,reactivationofHerpeszoster

Musculoskeletal

Common:transientbonepain,arthralgia,myalgia,generalisedpain

Uncommon:musclecramps

Renal

Uncommon:acuterenalfailure

Rare:focalsegmentalglomerulosclerosisincludingthecollapsingvariant,nephrotic

syndrome

Veryrare:deteriorationofpre-existingrenaldisease,haematuria

Skin

Common:rash

Uncommon:pruritus

Specialsenses

Common:conjunctivitis

Uncommon:uveitis(iritis,iridocyclitis)

Veryrare:scleritis,episcleritis,xanthopsia

Manyoftheseeffectsmayhavebeenrelatedtotheunderlyingdisease.

Postmarketingveryrarecasesofosteonecrosis(primarilyofthejaw)havebeen

reportedinpatientstreatedwithbisphosphonates.Manyhadsignsoflocalinfection

includingosteomyelitis.Themajorityofthereportsrelatedtocancerpatients

followingtoothextractionsorotherdentalsurgeries.Osteonecrosisofthejawhas

multiplewelldocumentedriskfactorsincludingadiagnosisofcancer,concomitant

therapiese.g.chemotherapy,radiotherapy,corticosteroidsandco-morbidconditions

e.g.anaemia,coagulopathies,infection,pre-existingoraldisease.Althoughcausality

cannotbedetermineditisprudenttoavoiddentalsurgeryasrecoverymaybe

prolonged(seeWarningsandPrecautions)

Interactions

Pamidronatehasbeenadministeredconcomitantlywithcommonlyusedanticancer

agentswithoutinteractionsoccurring.

Pamidronatehasbeenusedincombinationwithcalcitonininpatientswithsevere

hypercalcaemia,resultinginasynergisticeffectproducingamorerapidfallinserum

calcium.

Pamidronateshouldnotbeusedconcomitantlywithotherbisphosphonates.

Careshouldbetakenwhenpamidronateisusedwithotherpotentiallynephrotoxic

drugs.

Inmultiplemyelomapatients,theriskofrenaldysfunctionmaybeincreasedwhen

pamidronateisusedincombinationswiththalidomide.

Becausepamidronatebindstoboneitcaninterferewithbonescintigraphy

examinations.

Overdosage

Patientswhohavereceiveddoseshigherthanthoserecommendedshouldbe

carefullymonitored.Intheeventofclinicallysignificanthypocalcaemiawith

paraesthesia,tetanyandhypotension,reversalmaybeachievedwithaninfusionof

calciumgluconate.

PharmaceuticalPrecautions

Storebelow25°C.

AFT-Pamidronateshouldbeusedimmediatelyafterreconstitutionanddilutionand

anyunusedmaterialdiscarded.Ifthereconstitutedordilutedproductcannotbeused

immediatelyitcanbestoredunderrefrigeration(2-8°C)forupto24hours.

AFT-PamidronateshouldnotbeaddedtoI.V.infusionsolutionscontainingcalcium.

MedicinesClassification

PrescriptionMedicine

PackageQuantities

AFT-Pamidronateisavailableinsinglevialpackscontaining:

30mgdisodiumpamidronatepervial

60mgdisodiumpamidronatepervial

90mgdisodiumpamidronatepervial

FurtherInformation

AFT-PamidronatepowderforIVinfusionalsocontainsmannitolandphosphoricacid.

NameandAddress

AFTPharmaceuticalsLtd

POBox33.203

Takapuna

Auckland

Email:customer.service@aftpharm.com

DateofPreparation

28November2006

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Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

9-4-2010

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders) was open for consultation until 15 March 2010.

Danish Medicines Agency

17-12-2009

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders).

Danish Medicines Agency

10-1-2019


Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid, Treatment of dermatomyositis, , Positive

Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid, Treatment of dermatomyositis, , Positive

Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid, Treatment of dermatomyositis, , 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

19-12-2018


Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018


Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Europe - EMA - European Medicines Agency

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

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

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

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

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

8-3-2018

Mycophenolate mofetil, mycophenolic acid

Mycophenolate mofetil, mycophenolic acid

Mycophenolate mofetil, mycophenolic acid (Active substance: mycophenolate mofetil or mycophenolic acid) - Centralised - Art 28 - (PSUR - Commission Decision (2018)1540 of Thu, 08 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10550/201705

Europe -DG Health and Food Safety

5-2-2018

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Active substance: oxalic acid dihydrate) - New authorisation - Commission Decision (2018)684 of Mon, 05 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4296

Europe -DG Health and Food Safety