Arrow - Amlo 10

Main information

  • Trade name:
  • Arrow - Amlo 10 10 mg Tablet
  • Dosage:
  • 10 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:
  • Dr Reddy's Laboratories Limited

Documents

Localization

  • Available in:
  • Arrow - Amlo 10 10 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:
  • 14446
  • 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

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

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

12-7-2018

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

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: 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

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

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

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

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

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

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

13-8-2018

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Active substance: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast) - Orphan designation - Commission Decision (2018)5277 of Mon, 13 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/028/18

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

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