Arrow - Amlo 5

Main information

  • Trade name:
  • Arrow - Amlo 5 5 mg Tablet
  • Dosage:
  • 5 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, PVC/PVDC, 28 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Glochem Industries Limited

Documents

Localization

  • Available in:
  • Arrow - Amlo 5 5 mg Tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 14445
  • Authorization date:
  • 26-04-2010
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

DATASHEET

Arrow-Amlo5&Arrow-Amlo10

Amlodipinebesilate5mg&10mgTablets

Presentation

Arrow-Amlo5(5mgtablets)arewhitetooffwhite,round,biconvex,uncoatedtablets.

Arrow-Amlo10(10mgtablets)arewhitetooffwhite,round,biconvex,uncoatedtablets.

Inadditiontoamlodipinebesylate,eachtabletcontainsthefollowinginactive

ingredients:

Calciumhydrogenphosphatedihydrate

Microcrystallinecellulose

Silicacolloidalanhydrous

Sodiumstarchglycollate

Magnesiumstearate

Uses

Actions

Amlodipineisacalciumioninfluxinhibitor(slowchannelblockerorcalciumion

antagonist)andinhibitsthetransmembraneinfluxofcalciumionsintocardiacand

smoothmuscle.Themechanismoftheantihypertensiveactionofamlodipineisduetoa

directrelaxanteffectonvascularsmoothmuscle.

Theprecisemechanismbywhichamlodipinerelievesanginahasnotbeenfully

determinedbutamlodipinereducestotalischaemicburdenbythefollowingtwoactions:

 Amlodipinedilatesperipheralarteriolesandthusreducesthetotalperipheral

resistance(afterload)againstwhichtheheartworks.Sincetheheartrateremains

stable,thisunloadingoftheheartreducesmyocardialenergyconsumptionand

oxygenrequirements.

 Themechanismofactionofamlodipinealsoprobablyinvolvesdilatationofthe

maincoronaryarteriesandcoronaryarterioles,bothinnormalandischaemic

regions.Thisdilatationincreasesmyocardialoxygendeliveryinpatientswith

coronaryarteryspasm(Prinzmetal'sorvariantangina)andbluntssmokinginduced

coronaryvasoconstriction.

Inpatientswithhypertension,oncedailydosingprovidesclinicallysignificantreductions

ofbloodpressureinboththesupineandstandingpositionsthroughoutthe24hour

interval.Duetotheslowonsetofaction,acutehypotensionisnotafeatureofamlodipine

administration.Inpatientswithangina,oncedailyadministrationofamlodipineincreases

totalexercisetime,timetoanginaonsetandtimeto1mmSTsegmentdepression,and

decreasesbothanginaattackfrequencyandnitroglycerinetabletconsumption.

UseinPatientswithHeartFailure

HaemodynamicstudiesandexercisebasedcontrolledclinicaltrialinNYHAClassII-IV

heartfailurepatientshaveshownthatamlodipinedidnotleadtoclinicaldeteriorationas

measuredbyexercisetolerance,leftventricularejectionfractionandclinical

symptomatology.Aplacebo-controlledstudy(PRAISE)designedtoevaluatepatients

withNYHAClassIII-IVheartfailurereceivingdigoxin,diuretics,andangiotensin

convertingenzyme(ACE)inhibitorshasshownthatamlodipinedidnotleadtoan

increaseinriskmortalityorcombinedmortalityandmorbidityinpatientswithheart

failure.Inafollow-up,long-term,placebocontrolledstudy(PRAISE-2)ofamlodipinein

patientswithNYHAIIIandIVheartfailurewithoutclinicalsymptomsorobjective

findingssuggestiveofunderlyingischaemicdisease,onstabledosesofACEinhibitors,

digitalisanddiuretics,amlodipinehasnoeffectontotalcardiovascularmortality.Inthis

samepopulationamlodipinewasassociatedwithincreasedreportsofpulmonaryoedema

despitenosignificantdifferenceintheincidenceofworseningheartfailureascompared

toplacebo(Referto"WarningsandPrecautions").Amlodipinehasnotbeenassociated

withanyadversemetaboliceffectsorchangesinplasmalipidsandissuitableforusein

patientswithasthma,diabetes,andgout.

Pharmacokinetics

Amlodipineiswellabsorbedorallywithpeakbloodlevelsoccurring6-12hourspost-

dose.Oraladministrationofasingletherapeuticdosegaveameanabsolute

bioavailabilityof64%(range52-88%).Thevolumeofdistributionisapproximately20

L/kg.Theabsorptionofamlodipineisunaffectedbyconsumptionoffood.Theterminal

plasmaeliminationhalf-lifeisabout35-50hoursandisconsistentwithoncedailydosing.

Steadystateplasmalevelsarereachedafter7-8daysofconsecutivedosing.Amlodipine

isextensivelymetabolisedbythelivertoinactivemetaboliteswith10%oftheparent

compoundand60%ofmetabolitesexcretedintheurine.Invitrostudieshaveshownthat

approximately97.5%ofcirculatingamlodipineisboundtoplasmaproteins.Amlodipine

isnotdialysable.

Indications

Amlodipineisindicatedforthefirstlinetreatmentofhypertensionandcanbeusedasthe

soleagenttocontrolbloodpressureinthemajorityofpatients.Patientsnotadequately

controlledonasingleantihypertensiveagentmaybenefitfromtheadditionof

amlodipine,whichhasbeenusedincombinationwithathiazidediuretic,beta

adrenoceptorblockingagent,oranangiotensin-convertingenzymeinhibitor.

Amlodipineisindicatedforthefirstlinetreatmentofmyocardialischaemia,whetherdue

tofixedobstruction(stableangina)and/orvasospasm/vasoconstriction(Prinzmetal'sor

variantangina)ofcoronaryvasculature.

Amlodipinemaybeusedwheretheclinicalpresentationsuggestsapossible

vasospastic/vasoconstrictivecomponentbutwherevasospasm/vasoconstrictionhasnot

beenconfirmed.Amlodipinemaybeusedaloneasmonotherapy,orincombinationwith

otherantianginaldrugsinpatientswithanginathatisrefractorytonitratesand/orbeta

blockers.

DosageandAdministration

Forbothhypertensionandangina,theusualinitialdoseis5mgamlodipineoncedaily

whichmaybeincreasedtoamaximumdoseof10mgdependingontheindividual

patient'sresponse.Nodoseadjustmentofamlodipineisrequireduponconcomitant

administrationofthiazidediuretics,betablockers,andangiotensin-convertingenzyme

inhibitors.Thetimetoreachpeakplasmaconcentrationsofamlodipineissimilarin

elderlyandyoungersubjects.Amlodipineclearancetendstobedecreasedwithresulting

increasesinAUCandeliminationhalf-lifeinelderlypatients.IncreasesinAUCand

eliminationhalf-lifeinpatientswithcongestiveheartfailurewereasexpectedforthe

patientagegroupstudied.Amlodipine,usedatsimilardosesinelderlyoryounger

patients,isequallywelltolerated.Thereforenormaldosageregimensarerecommended.

Amlodipineisextensivelymetabolisedtoinactivemetaboliteswith10%excretedas

unchangeddrugintheurine.Changesinamlodipineplasmaconcentrationsarenot

correlatedwithdegreeofrenalimpairment.Amlodipinemaybeusedinsuchpatientsat

normaldoses.

Amlodipineisnotrecommendedforuseinchildren.

Contraindications

Amlodipinetabletsarecontraindicatedinpatientswithaknownsensitivitytoamlodipine,

dihydropyridinesoranyoftheinactiveingredients.

WarningsandPrecautions

Inalongtermplacebo-controlledstudy(PRAISE-2)ofamlodipineinpatientswith

NYHAIIIandIVheartfailureofnonischaemicetiology,amlodipinewasassociatedwith

increasedreportsofpulmonaryoedemadespitenosignificantdifferenceintheincidence

ofworseningheartfailureascomparedtoplacebo(Referto"USES-UseinPatientswith

HeartFailure").Safetyofamlodipineinhumanpregnancyorlactationhasnotbeen

established.Amlodipinedidnotdemonstrateanyfoetotoxicorteratogenicpotentialin

animalreproductivestudiesotherthantodelayparturitionandprolonglaborinratsata

doselevelfiftytimesthemaximumrecommendeddoseinhumans.Nomutagenicactivity

hasbeenfoundintestsforgenemutationsorcytogenicassays.Accordingly,usein

pregnancyisrecommendedonlywhenthereisnosaferalternativeandwhenthedisease

itselfcarriesgreaterriskforthemotherandfetus.Aswithallcalciumchannelblockers,

amlodipinehalf-lifeisprolongedinpatientswithimpairedliverfunctionanddosage

recommendationshavenotbeenestablished.Thecompoundshouldthereforebe

administeredwithcautioninthesepatients.Safetyandeffectivenessofamlodipinein

childrenhavenotbeenestablished.Clinicalexperiencewithamlodipineindicatesthatit

isunlikelytoimpairapatient'sabilitytodrive.

AdverseEffects

Amlodipineiswell-tolerated.Inplacebocontrolledclinicaltrialsinvolvingpatientswith

hypertensionorangina,themostcommonlyobservedsideeffectswereheadache,edema,

fatigue,somnolence,nausea,abdominalpain,flushing,palpitationsanddizziness.In

theseclinicaltrialsnopatternofclinicallysignificantlaboratorytestabnormalitiesrelated

toamlodipinehasbeenobserved.Lesscommonlyobservedsideeffectsinmarketing

experienceinclude:

AutonomicNervous:drymouth,increasedsweating

BodyAsAWhole:asthenia,backpain,malaise,pain,weightincrease/decrease

Cardiovascular,General:hypotension,syncope

Central&PeripheralNervous:hypertonia,hypoesthesia/paresthesia,peripheral

neuropathy,tremor

Endocrine:gynaecomastia

Gastrointestinal:alteredbowelhabits,dyspepsia(includinggastritis),gingival

hyperplasia,pancreatitis,vomiting

Metabolic/Nutritional:hyperglycaemia

Musculoskeletal:arthralgia,musclecramps,myalgia

Platelet/Bleeding/Clotting:purpura,thrombocytopenia

Psychiatric:impotence,insomnia,moodchanges

Respiratory:coughing,dyspnoea,rhinitis

Skin/Appendages:alopecia,skindiscoloration,urticaria

Specialsenses:tasteperversion,tinnitus

Urinary:increasedurinaryfrequency,micturitiondisorder,nocturia

Vascular(Extracardiac):vasculitis

Vision:visualdisturbances

WhiteBloodCell/R.E.S.:leucopenia

Rarely,allergicreactionsincludingpruritis,rash,angioedemaanderythemamultiforme

havebeenreported.

Hepatitis,jaundiceandhepaticenzymeelevationshavealsobeenreportedvery

infrequently(mostlyconsistentwithcholestasis).Somecasessevereenoughtorequire

hospitalizationhavebeenreportedinassociationwithuseofamlodipine.Inmany

instances,causalassociationisuncertain.

Aswithothercalciumchannelblockersthefollowingadverseeventshavebeenrarely

reportedandcannotbedistinguishedfromthenaturalhistoryoftheunderlyingdisease:

myocardialinfarction,arrhythmia(includingbradycardia,ventriculartachycardiaand

atrialfibrillation)andchestpain.

Interactions

Amlodipinehasbeensafelyadministeredwiththiazidediuretics,betablockers,alpha

blockers,angiotensin-convertingenzymeinhibitors,long-actingnitrates,sublingual

glyceryltrinitrate,non-steroidalanti-inflammatoryagents,antibiotics,andoral

hypoglycaemicagents.Invitrodatafromstudieswithhumanplasmaindicatethat

amlodipinehasnoeffectonproteinbindingofthedrugstested(digoxin,phenytoin,

warfarin,orindomethacin).

SpecialStudies:Effectofotheragentsonamlodipine

Cimetidine: Co-administrationofamlodipinewithcimetidinedidnotalterthe

pharmacokineticsofamlodipine.

GrapefruitJuice: Co-administrationof240mLofgrapefruitjuicewithasingleoraldose

ofamlodipine10mgin20healthvolunteershadnosignificanteffectonthe

pharmacokineticsofamlodipine.

Aluminium/Magnesium(antacid): Co-administrationofanaluminium/magnesiumantacid

withasingledoseofamlodipinehadnosignificanteffectonthepharmacokineticsof

amlodipine.

Sildenafil: Asingle100mgdoseofsildenafilinsubjectswithessentialhypertensionhad

noeffectonthepharmacokineticsparametersofamlodipine.Whenamlodipineand

sildenafilwereusedincombination,eachagentindependentlyexerteditsownblood

pressureloweringeffect.

SpecialStudies:Effectofamlodipineonotheragents

Atorvastatin :Co-administrationofmultiple10mgdosesofamlodipinewith80mgof

atorvastatinresultedinnosignificantchangeinthesteadystatepharmacokinetic

parametersofatorvastatin.

Digoxin: Co-administrationofamlodipinewithdigoxindidnotchangeserumdigoxin

levelsordigoxinrenalclearanceinnormalvolunteers.

Ethanol(alcohol): Singleandmultiple10mgdosesofamlodipinehadnosignificant

effectonthepharmacokineticsofethanol.

Warfarin:Co-administrationofamlodipinewithwarfarindidnotchangethewarfarin

prothrombinresponsetime.

Cyclosporin :Pharmacokineticstudieswithcyclosporinhavedemonstratedthat

amlodipinedoesnotsignificantlyalterthepharmacokineticsofcyclosporin.

Overdosage

Availabledatasuggestthatgrossoverdosagecouldresultinexcessiveperipheral

vasodilatationandpossiblyreflextachycardia.Markedandprobablyprolongedsystemic

hypotensionuptoanincludingshockwithfataloutcomehavebeenreported.

Administrationofactivatedcharcoaltohealthyvolunteersimmediatelyoruptotwo

hoursafteringestionofamlodipine10mghasbeenshowntosignificantlydecrease

amlodipineabsorption.Gastriclavagemaybeworthwhileinsomecases.Clinically

significanthypotensionduetoamlodipineoverdosagecallsforactivecardiovascular

supportincludingfrequentmonitoringofcardiacandrespiratoryfunction,elevationof

extremities,andattentiontocirculatingfluidvolumeandurineoutput.Avasoconstrictor

maybehelpfulinrestoringvasculartoneandbloodpressure,providedthatthereisno

contraindicationtoitsuse.Intravenouscalciumgluconatemaybebeneficialinreversing

theeffectsofcalciumchannelblockade.Dialysisisnotlikelytobeofbenefitsince

amlodipineishighlyprotein-bound.

PharmaceuticalPrecautions

Donotstoreabove25°C.

Storeintheoriginalpackage.

MedicineClassification

PrescriptionMedicine

PackageQuantities

Arrow-Amlo5(5mgTablets):Blisterpackscontaining28,56or84tabletsandHDPE

containerscontaining100,250or500tablets.

Arrow-Amlo10(10mgTablets):Blisterpackscontaining28,56or84tabletsand

HDPEcontainerscontaining100,250or500tablets.

Notallpacksizesmaybemarketed

FurtherInformation

Amlodipinebesylateisadihydropyridinederivative,andhasthefollowingchemical

name:

3-ethyl5-methyl2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-l,4-dihydro-6-methyl-3,

5-pyridinedicarboxylatebenzenesulphonate.

Amlodipinebesylateisslightlysolubleinwaterandsparinglysolubleinethanol,andhas

amolecularweightof567.1(freebase408.9).

NameandAddress

Sponsor

ArrowPharmaceuticals(NZ)Limited

MountEdenCentralBusinessPark

33aNormanbyRoad,MtEden

Auckland,NewZealand

DateofPreparation

14February2011

1-1-2019

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classifi...

FDA - U.S. Food and Drug Administration

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

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

6-12-2018


Amlodipine besilate / ramipril: List of nationally authorised medicinal products - PSUSA/00000181/201803

Amlodipine besilate / ramipril: List of nationally authorised medicinal products - PSUSA/00000181/201803

Amlodipine besilate / ramipril: List of nationally authorised medicinal products - PSUSA/00000181/201803

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine / irbesartan, decision type: , therapeutic area: , PIP number: P/0145/2018

Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine / irbesartan, decision type: , therapeutic area: , PIP number: P/0145/2018

Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine / irbesartan, decision type: , therapeutic area: , PIP number: P/0145/2018

Europe - EMA - European Medicines Agency

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

Exforge (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4085 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/716/T/96

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety

11-6-2018

Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

Dafiro (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3753 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/776/T/99

Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

Copalia (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3695 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/774/T/97

Europe -DG Health and Food Safety

4-6-2018

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Active substance: telmisartan / amlodipine) - Centralised - Yearly update - Commission Decision (2018)3625 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety