Enurace 50

Main information

  • Trade name:
  • Enurace 50
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Enurace 50
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ephedrine
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0122/001
  • Authorization date:
  • 11-10-2011
  • EU code:
  • NL/V/0122/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

UK,NL,IT,BE,DE,ES: ENURACE50,50mgtabletsfordogs

FR: ENURACEgrandchien

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

40.7mgEphedrineequivalentto50mgEphedrineHydrochloride.

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablets.

Round,whitetabletwithbreaklineononesideandinscriptionENURACE50ontheotherside.

4. CLINICALPARTICULARS

4.1 Targetspecies

Ovariohysterectomisedfemaledogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofurinaryincontinencecausedbyurethralsphinctermechanismincompetencein

ovariohysterectomisedfemaledogs.

4.3 Contraindications

Donotuseindogswithglaucoma.

DonotuseincaseofhypersensitivitytoEphedrineortoanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

Thisproductisnotsuitablefortreatmentofinappropriateurinationresultingofbehaviourproblems.

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Donotusetheproductindogsunder20kilogramofbodyweight.

Asephedrineisanalphaandbetaadrenergicreceptoragonist,theproductshouldbeusedwithcaution

indogswithcardiovasculardiseaseandonlyafteracomprehensiverisk/benefitanalysisbythe

attendingveterinarian.

Thedog’scardiovascularfunctionalityshouldbecarefullyassessedbeforethestartofthetreatment

withtheproductanditshouldbeperiodicallymonitoredduringthetreatment.

Inaddition,asimilarapproachshouldbeadoptedinanimalssufferingfrompartialurethral

obstruction,hypertension,diabetesmellitus,hyperadrenocorticism,hyperthyroidismorother

metabolicdisorders.ItshouldbementionedthatthePolyuria/Polydipsia(PU/PD)frequently

accompanyingtheaforementionedconditionsmaybefalselydiagnosedasurinaryincontinence.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproduct

toanimals

Ephedrinehydrochloridecouldbetoxicifingested.Adverseeffectsmayincludeinsomniaand

nervousness,dizziness,headache,increasedbloodpressure,increasedsweatingandnausea.

Ingestionmaybefatal,especiallyinchildren.Toavoidaccidentalingestion,theproductmustbeused

andkeptoutofthereachofchildren.Alwaysreplacethecapsecurelyafteruse.

Intheeventofaccidentalingestion,mostimportantlybychildren,seekimmediatemedicalattention

showingthephysicianthepackageinsert.

Itisstronglyrecommendedthatpregnantwomenshouldwearglovesforadministration.

Washhandsafteradministration.

4.6 Adversereactions(frequencyandseriousness)

Cardiovasculareffectsliketachycardia,atrialfibrillation,stimulationoftheheartactivity;and

vasoconstriction.

Stimulationofthecentralnervoussystemleadingtosleeplessness,excitation,anxietyandmuscle

tremors.

Panting

Mydriasis

Cystitis

Bronchodilatationanddecreaseofmucusreleaseintherespiratorymucosalmembranes.

Reductionofthemotilityandtoneoftheintestinalwall.

DuetothenatureofEphedrinethementionedeffectscanoccurattherecommendedtherapeuticdose,

withanxietyandcardiovasculareffectsbeingthemostprevalent.In10%ofthetreatments,side

effectshavebeenobservedinefficacystudies.

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Ephedrinemayinteractwithothersympathicomimetics.

Ephedrinemayenhanceglucocorticoidmetabolism.

ConcomitantusewithMAO-inhibitorsmaycausehypertension.

Ephedrinecanenhancetheactivityofproductsofthesameclassastheophylline.

Volatileanaestheticsmayenhancethesensitivityofthemyocardiumtothecardiovasculareffects

ofEphedrine.

Concomitantusewithcardiacglycosides,quinineandtricyclicantidepressantscancause

arrhythmias.

Vascularconstrictionscanoccurafterconcomitanttreatmentwithergotalkaloidsandoxytocin.

SubstancesleadingtoanincreaseinpHoftheurineareabletoprolongtheexcretionof

ephedrine,whereassubstancesleadingtoadecreaseinpHoftheurineareabletoacceleratethe

excretionofephedrine.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministrationonly.

Astartingdoseof2mgEphedrineHClperkgofbodyweightperday,dividedintwooraldosesis

recommended.Dogscanbedosedaccordingtothefollowingtable:

Weight

(kg) Dose

(mg/day) Dose(Numberoftablets)

perday 1 st gift 2 nd gift

20-30 50 1 ½ ½

31-40 75 1½ ½ 1

41-50 100 2 1 1

Desiredtherapeuticeffectandoccurrenceofadverseeffectshavetobemonitoredapproximatelyat14

days,1month,3monthsand6monthsafterthestart.Basedontheobservedeffectincomparisonwith

theexpectedeffectandtakingintoaccounttheoccurrenceofadverseeffects,theindividualdose

shouldbeadjusted.Thedoseshouldbeadjustedtofindthelowesteffectivedose.

Oncetheeffectivedosehasbeenestablished,dogsshouldstillbemonitoredatregularintervals,e.g.

everysixmonths.

Theproductshouldbeadministeredbeforemealsinapieceoffood.

Amaximumdoseof5mg/kgofbodyweightperdayhastoberespected.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Thesignsofoverdoseresemblethoseoftheadversereactionsasdescribedinsection4.6.Incaseof

overdose,itisusefultoaccelerateexcretionofephedrinebyacidificationoftheurineandenhanced

diuresis.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:symphaticomimetic

ATCvetcode:QG04BX90

5.1 Pharmacodynamicproperties

Ephedrinedirectlystimulatesalpha-andbeta-adrenergicreceptors,presentinallorgansystems.It

alsostimulatesthereleaseofcatecholaminesfromsympathicneurons.SinceEphedrinepassesthe

blood-brainbarrier,italsoinduceseffectsthataremediatedthroughthecentralnervoussystem.

Ephedrinespecificallycausesacontractionoftheinternalurethralsphinctermusclesandarelaxation

ofthebladdermusclesthroughasympathicomimeticactionontheadrenergicreceptors.

5.2 Pharmacokineticparticulars

Ephedrineisrapidlyabsorbedandthebioavailabilityishigh.Ephedrineiswidelydistributedoverthe

body.DegradationbydemethylationtoNorephedrineisthemajormetabolicpathway.Within48

hours,urinaryexcretionaccountsforeliminationof80to90%oftheadministereddose,athigh

urinaryacidity.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

ColloidalSilica

LactoseMonohydrate

MicrocrystallineCellulose

MagnesiumStearate

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcontainer.

Dividedtabletsshouldbereturnedintheoriginalpackageandusedinthesubsequentdose.Closethe

captotheclick.

6.5 Natureandcompositionofimmediatepackaging

WhiteLDPEcontainercontaining100tabletswithpolyurethanecover-upandcapwithachild-

resistantclosure.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

NL:REGNL8125

BE:BEV303581

DE:400971.00.00

UK:Vm32742/4002

FR:FR/V/67594140/2008

SP:2074ESP

IT:AICn.103878/017

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

16September2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobesuppliedonlyonveterinaryprescription.

LABELLINGANDPACKAGELEAFLET

A. LABELLING

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

{CARTONLABEL/BOX}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ENURACE 50,50mgtabletsfordogs

FR:ENURACEgrandchien

(EphedrineHCl)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Pertablet50mgEphedrineHCl.

3. PHARMACEUTICALFORM

Tablets.

4. PACKAGESIZE

100tablets

5. TARGETSPECIES

Dogs

6. INDICATION

7. METHODANDROUTEOFADMINISTRATION

Oral,withfood.1-3mg/kg/daydividedin2doses.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNINGS

Accidentalingestionbyman,especiallychildren,isdangerous.Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXPmonth/year

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25°C.

Storeintheoriginalpackage.

Dividedtabletsshouldbereturnedintheoriginalpackageandusedinthesubsequentdose.Closethe

captotheclick.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS

Disposal:readpackageleaflet

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE

Foranimaltreatmentonly–Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

16. MARKETINGAUTHORISATIONNUMBER(S)

NL:REGNL8125

BE:BEV303581

DE:400971.00.00

UK:Vm32742/4002

FR:FR/V/67594140/2008

SP:2074ESP

IT:AICn.103878/017

17. MANUFACTURER’SBATCHNUMBER

BatchYYP000

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

{PAPERLABEL/POLYETHYLENECONTAINER}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ENURACE 50,50mgtabletsfordogs

FR:ENURACEgrandchien

(EphedrineHCl)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Pertablet50mgEphedrineHCl.

3. PHARMACEUTICALFORM

Tablets

4. PACKAGESIZE

100tablets

5. TARGETSPECIES

Dogs

6. INDICATION(S)

7. METHODANDROUTEOFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNINGS

Accidentalingestionbyman,especiallychildren,isdangerous.Closethecaptotheclick.Readthe

packageleafletbeforeuse

10. EXPIRYDATE

EXPmonth/year

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25°C.

Storeintheoriginalcontainer.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE

Foranimaltreatmentonly–Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

16. MARKETINGAUTHORISATIONNUMBER(S)

NL:REGNL8125

BE:BEV303581

DE:400971.00.00

UK:Vm32742/4002

FR:FR/V/67594140/2008

SP:2074ESP

IT:AICn.103878/017

17. MANUFACTURER’SBATCHNUMBER

BatchYYP000

B. PACKAGELEAFLET

PACKAGELEAFLET

UK,NL,IT,BE,DE,ES: ENURACE50,50mgtabletsfordogs

FR: ENURACEgrandchien

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Marketingauthorisationholder

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

Manufacturerforthebatchrelease

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

ACEPharmaceuticalsBV

Schepenveld41

3891ZKZeewolde

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ENURACE50,50mgtabletsfordogs

FR:ENURACEgrandchien

(EphedrineHCl)

3. STATEMENTOFTHEACTIVESUBSTANCES.

Theproductcontains50mgEphedrineHClpertablet,correspondingwith40.7mgEphedrine.The

tabletcanbedividedintwoequalparts,eachpartcontaining25mgEphedrineHCl.

4. INDICATION(S)

Treatmentofunwantedlossofurine(urinaryincontinence)duetotoolowtensioninthecircular

musclesclosingtheurethra(urethralsphinctermechanismincompetence)inovariohysterectomised

femaledogs.

5. CONTRAINDICATIONS

Donotusetheproductindogswithincreasedpressureintheeye(glaucoma).

DonotuseincaseofhypersensitivitytoEphedrineortoanyoftheexcipients.

6. ADVERSEREACTIONS

Disordersoftheheartandbloodcirculation(tachycardia,atriumfibrillation,stimulationofthe

heartactivity;vasoconstriction).

Stimulationofthecentralnervoussystem,leadingtosleeplessness,excitation,anxietyand

tremblingofthemuscles(muscletremors).

Panting.

Dilatationofthepupils(mydriasis).

Bladderinfection(cystitis).

Relaxationofthemusclesofthelungs(bronchodilatation)anddecreaseofmucusreleaseinthe

lungs(respiratorymucosalmembranes).

Reductionofthemotion(motility)andtension(tone)oftheintestinalwall.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Ovariohysterectomisedfemaledogs.

8. DOSAGEFOREACHSPECIES,ROUTEANDMETHODOFADMINISTRATION

Fororaladministrationonly.

Giveastartingdoseof2mgEphedrineHCl/kg/day,dividedintwooraldoses.

Doseaccordingtothefollowingdosingscheme:

Weight

(kg) Dose

(mg/day) Dose(Numberoftablets)

perday 1 st gift 2 nd gift

20-30 50 1 ½ ½

31-40 75 1½ ½ 1

41-50 100 2 1 1

Desiredtherapeuticeffectandoccurrenceofadverseeffectshavetobemonitoredapproximatelyat14

days,1month,3monthsand6monthsafterthestart.Basedontheobservedeffectincomparisonwith

theexpectedeffectandtakingintoaccounttheoccurrenceofadverseeffects,theindividualdose

shouldbeadjusted.Thedoseshouldbeadjustedtofindthelowesteffectivedose.Oncetheeffective

dosehasbeenestablished,dogsshouldstillbemonitoredatregularintervals,e.g.everysixmonths.

Theproductshouldbeadministeredbeforemealsinapieceoffood.

Amaximumdoseof5mg/kgofbodyweightperdayhastoberespected.

9. ADVICEONCORRECTADMINISTRATION

Pregnantwomenshouldweregloves.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25°C.

Storeintheoriginalcontainer.

Returndividedtabletintheoriginalpackageandusethistabletinthesubsequentdose.Closethecap

totheclick.

Donotuseaftertheexpirydatestatedonthelabelafter“exp.”.

12. SPECIALWARNINGS

Donotusetheproductindogsunder20kgbodyweight.

Thisproductisnotsuitablefortreatmentofinappropriateurinationresultingofbehaviour

problems.

Asephedrineisanalphaandbetaadrenergicreceptoragonist,theproductshouldbeusedwith

cautionindogswithcardiovasculardiseaseandonlyafteracomprehensiverisk/benefitanalysisby

theattendingveterinarian.

Thedog’scardiovascularfunctionalityshouldbecarefullyassessedbeforethestartofthetreatment

withtheproductanditshouldbeperiodicallymonitoredduringthetreatment.

Inaddition,asimilarapproachshouldbeadoptedinanimalssufferingfrompartialurethral

obstruction,hypertension,diabetesmellitus,hyperadrenocorticism,hyperthyroidismorother

metabolicdisorders.ItshouldbementionedthatthePolyuria/Polydipsia(PU/PD)frequently

accompanyingtheaforementionedconditionsmaybefalselydiagnosedasurinaryincontinence.

Ephedrinemayinteractwithothersympathicomimetics.

Ephedrinemayenhancethemetabolismofhormonesofthepituitarygland(glucocorticoid

metabolism).

ConcomitantusewithMAO-inhibitors(usedfortreatmentofdepression)maycauseincreased

bloodpressure(hypertension).

EphedrinecanenhancetheactivityofproductsofthesameclassasTheophyllin(usedintreatment

ofepilepsy).

Volatileanaestheticsmayenhancethesensitivityoftheheartmuscle(myocardium)totheeffects

onheartandbloodvessels(cardiovasculareffects)ofEphedrine.

Concomitantusewithcardiacglycosides(usedtoincreasethepumpforceoftheheart),Quinine

(anti-infection)andtricyclicantidepressants(usedfortreatmentofdepressions)cancausedisorders

oftheheartrhythm(arrhythmias).

Constrictionsofthebloodvessels(vascularconstrictions)canoccurafterconcomitanttreatment

withergotalkaloidsandOxytocin(bothusedfortheinductionoflabour).

SubstancesleadingtoanincreaseinpHoftheurineareabletoprolongtheexcretionofephedrine,

whereassubstancesleadingtoadecreaseinpHoftheurineareabletoacceleratetheexcretionof

ephedrine.

Thesignsofoverdoseresemblethoseoftheadversereactionsasdescribedinsection6.Incaseof

overdose,itisusefultoaccelerateexcretionofephedrinebyacidificationoftheurineandenhanced

diuresis.

Warningsonaccidentalingestion

Ephedrinehydrochloridecouldbetoxicifingested.Adverseeffectsmayincludeinsomniaand

nervousness,dizziness,headache,increasedbloodpressure,increasedsweatingandnausea.

Ingestionmaybefatal,especiallyinchildren.Toavoidaccidentalingestion,theproductmustbeused

andkeptoutofthereachofchildren.Alwaysreplacethecapsecurelyafteruse.

Intheeventofaccidentalingestion,mostimportantlybychildren,seekimmediatemedicalattention

showingthephysicianthepackageinsert.

Itisstronglyrecommendedthatpregnantwomenshouldwearglovesforadministration.

Washhandsafteradministration.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

16September2011

15. OTHERINFORMATION

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

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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

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

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

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

19-6-2018

Aerinaze (Merck Sharp and Dohme Limited)

Aerinaze (Merck Sharp and Dohme Limited)

Aerinaze (Active substance: desloratadine; pseudoephedrine sulphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3930 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/772/T/37

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety