Narcostart

Main information

  • Trade name:
  • Narcostart 1 mg/ml solution for injection for cats and dogs
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Narcostart 1 mg/ml solution for injection for cats and dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Medetomidine
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0138/001
  • Authorization date:
  • 30-03-2011
  • EU code:
  • NL/V/0138/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

PartIB Summaryofproductcharacteristics,labelandpackageinsert

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostart1 mg/ml–SolutionforInjectionforCatsandDogs

(NL,AT,BE,CZ,EL,HU,IS, IE,LU,PL,SK)

Sedastart1 mg/ml–SolutionforInjectionforCatsandDogs

(SE,NO, DK, ES, PT,IT,UK, FI)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1 mlsolutionforinjectioncontains:

Activesubstance: Medetomidine(ashydrochloride) 0.85 mg

(equivalentto 1.0 mgmedetomidinehydrochloride)

Excipients: Methylparahydroxybenzoate(E218) 1.0 mg

Propylparahydroxybenzoate(E216) 0.2 mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Aclearcolourless,sterileaqueoussolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

DogandCat

4.2 Indicationsforuse, specifyingthetargetspecies

In dogsand cats:

Sedationto facilitatehandling.Premedicationpriortogeneralanaesthesia.

In cats:

Incombinationwithketamineforgeneralanaesthesiaforminorsurgicalproceduresof

shortduration.

4.3 Contraindications

Donotuseinanimalswith:

- severecardiovasculardiseaseorrespiratorydiseasesorimpairedliveror

kidneyfunction.

- mechanicaldisturbancesofthegastrointestinaltract(torsioventriculi,

incarcerations,oesophagalobstructions).

- pregnancy.

- diabetesmellitus.

- stateofshock,emaciationorseriousdebilitation.

Donotuseconcomitantlywithsympathomimeticamines.

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyother

excipients.

Donotuseinanimalswithocularproblemswhereanincreaseinintraocularpressure

wouldbedetrimental.

4.4 Specialwarningsforeachtargetspecies

Medetomidinemaynotprovideanalgesiathroughouttheentireperiodofsedation,

thereforeconsiderationshouldbegiventoprovidingadditionalanalgesiaforpainful

procedures.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Aclinicalexaminationshouldbecarriedoutinallanimalsbeforetheuseofveterinary

medicinalproductsforsedationand/orgeneralanaesthesia.

Higherdosesofmedetomidineshouldbeavoidedinlargebreeddogs.Careshouldbe

takenwhencombiningmedetomidinewithotheranaestheticsorsedativesbecauseof

itsmarkedanaestheticsparingeffects.Thedoseoftheanaestheticshouldbereduced

accordinglyandtitratedtoresponseduetoconsiderablevariabilityinrequirements

betweenpatients.Beforeusinganycombinations,thewarningsandcontra-indications

intheproductliteraturefortheotherproductsshouldbeobserved.

Animalsshouldbefasted12 hoursbeforeanaesthesia.

Theanimalshouldbeplacedinacalmandquietsurroundingtoletthesedationgain

itsmaximumeffect.Thistakesabout10-15minutes.Oneshouldnotstartany

procedureorgiveothermedicinesbeforemaximumsedationisreached.

Treatedanimalsshouldbekeptwarmandataconstanttemperature,bothduringthe

procedureandrecovery.

Theeyesshouldbeprotectedbyasuitablelubricant.

Nervous,aggressiveorexcitedanimalsshouldbegiventhepossibilitytocalmdown

beforeinitiationoftreatment.

Sickanddebilitateddogsandcatsshouldonlybepremedicatedwithmedetomidine

beforeinductionandmaintenanceofgeneralanaesthesiabasedonarisk-benefit

assessment.

Careshouldbetakenwithuseofmedetomidineinanimalswithcardiovascular

disease,orwhichareelderlyoringeneralpoorhealth.Liverandkidneyfunction

shouldbeevaluatedpriortouse.

Asketaminealonecanelicitcramps,alpha-2antagonistsshouldbeadministerednot

before30-40 min.afterketamine.

Medetomidinemaycauserespiratorydepressionandunderthesecircumstances,

manualventilationandoxygenmaybeadministered.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproductto animals

1.Inthecaseofaccidentaloralintakeorself-injection,seekmedicaladvice

immediatelyandshowthepackageinserttothephysicianbutDONOTDRIVEas

sedationandchangesinbloodpressuremayoccur.

2.Avoidskin,eyeormucosalcontact.

3.Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

4.Removecontaminatedclothesthatareindirectcontactwithskin.

5.Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantlywith

freshwater.Ifsymptomsoccur,seek theadviceofaphysician.

6.Ifpregnantwomenhandletheproduct,specialcautionshouldbeobservednotto

self-injectasuterinecontractionsanddecreasedfoetalbloodpressuremayoccur

afteraccidentalsystemicexposure.

7.Advicetodoctors:

Medetomidineisanalpha2-adrenoreceptoragonist,symptomsafterabsorption

mayinvolveclinicaleffectsincludingdose-dependentsedation,respiratory

depression,bradycardia,hypotension,adrymouth,andhyperglycaemia.

Ventriculararrhythmiashavealsobeenreported.Respiratoryandhaemodynamic

symptomsshouldbetreatedsymptomatically.

4.6 Adversereactions(frequencyandseriousness)

Bradycardiawithatrioventricularblock(1 st

and2 nd

degree)andoccasionally

extrasystolia.Vasoconstrictionofcoronaryartery.Decreasedcardiacoutput.Blood

pressurewillincreaseinitiallyafteradministrationandthenreturntonormal,or

slightlybelownormal.Somedogsandmostcatswillvomitwithin5-10minutesof

injection.Catsmayalsovomitonrecovery.Sensitivitytoloudnoisesisobservedin

someindividuals.

Increaseddiuresis.Hypothermia.Respiratorydepression,cyanosis,painatinjection

siteandmuscletremormaybeseen.Inindividualcasesreversiblehyperglycaemiadue

to depressionofinsulinsecretion.

Incirculatoryandrespiratorydepressionmanualventilationandanoxygen

supplementmaybeindicated.Atropinemayincreasethecardiacrate.Dogswitha

bodyweightoflessthan10kgmayshowtheundesirableeffectsmentionedabove

moreoften.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasnotbeenestablishedduringpregnancyandlactation.

Thereforeitshouldnotbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministrationofothercentralnervoussystemdepressantsshouldbe

expectedtopotentiatetheeffectofeitheractivesubstance.Appropriatedose

adjustmentshouldbemade.

Medetomidinehasmarkedanaestheticsparingeffects.Seealsosection4.5.

Theeffectsofmedetomidinemaybeantagonizedbyadministrationofatipamezoleor

yohimbine.

4.9 Amountto beadministeredandadministrationroute

Narcostartisintendedfor:

Dogs:Intramuscularorintravenousinjection.

Cats:Intramuscularinjection.

Useofanappropriatelygraduatedsyringeisrecommendedtoensureaccuratedosing

whenadministeringsmallvolumes

Dogs:

ForsedationNarcostartshouldbeadministeredattherateof750μgmedetomidine

hydrochloridei.v.or1000μgmedetomidinehydrochloridei.m.persquaremeterof

bodysurface.Usethetablebelowtodeterminethecorrectdosageonthebasisofbody

weight:

Maximaleffectisobtainedwithin15-20minutes.Clinicaleffectisdose-dependent,

lastingfrom30-180 minutes.

Narcostartdosagesinmlandcorrespondingamountofmedetomidinehydrochloride

inμg/kgbw):

Bodyweight

[kg] i.v.–Injection

[ml] corresp.to

[μg/kgbw] i.m.–Injection

[ml] corresp.to

[μg/kgbw]

1 0.08 80.0 0.10 100.0

2 0.12 60.0 0.16 80.0

3 0.16 53.3 0.21 70.0

4 0.19 47.5 0.25 62.5

5 0.22 44.0 0.30 60.0

6 0.25 41.7 0.33 55.0

7 0.28 40.0 0.37 52.9

8 0.30 37.5 0.40 50.0

9 0.33 36.7 0.44 48.9

10 0.35 35.0 0.47 47.0

12 0.40 33.3 0.53 44.2

14 0.44 31.4 0.59 42.1

16 0.48 30.0 0.64 40.0

18 0.52 28.9 0.69 38.3

20 0.56 28.0 0.74 37.0

25 0.65 26.0 0.86 34.4

30 0.73 24.3 0.98 32.7

35 0.81 23.1 1.08 30.9

40 0.89 22.2 1.18 29.5

50 1.03 20.6 1.37 27.4

60 1.16 19.3 1.55 25.8

70 1.29 18.4 1.72 24.6

80 1.41 17.6 1.88 23.5

90 1.52 16.9 2.03 22.6

100 1.63 16.3 2.18 21.8

Forpremedication,Narcostartshouldbeadministeredatadosageof10-40µg

medetomidinehydrochlorideperkgbodyweight,correspondingto0.1–0.4ml

Narcostartper10kgbodyweight.Theexactdosedependsonthecombinationof

drugsusedandthedosage(s)oftheotherdrug(s).Thedoseshouldfurthermorebe

adjustedtothetypeofsurgery,lengthofprocedureandpatienttemperamentand

weight.Premedicationwithmedetomidinewillsignificantlyreducethedosageofthe

inductionagentrequiredandwillreducevolatileanaestheticrequirementsfor

maintenanceanaesthesia.Allanaestheticagentsusedforinductionormaintenanceof

anaesthesiashouldbeadministeredtoeffect.Beforeusinganycombinations,product

literaturefortheotherproductsshouldbeobserved.Seealsosection4.5.

Cats:

Formoderate-deepsedationandrestraintofcatsNarcostartshouldbeadministeredat

adosageof50–150μgmedetomidinehydrochloride/kgbw(corresp.to0.05–0.15

mlNarcostart/kgbw).

ForanaesthesiaNarcostartshouldbeadministeredatadosageof80μg

medetomidinehydrochloride/kgbw(corresp.to0.08mlNarcostart/kgbw)and2.5

to7.5mgketamine/kgbw.Usingthisdosageanaesthesiaoccurswithin3–4minutes

andisapparentfor20–50minutes.Forlongerlastingproceduresadministrationhas

toberepeatedbyusing½oftheinitialdose(i.e.40μgmedetomidinehydrochloride

(corresp.to0.04mlNarcostart/kgbw)and2.5–3.75mgketamine/kgbw)or3.0

mgketamine/kgbwalone.Alternatively,forlongerlastingproceduresanaesthesia

maybeextendedbyuseoftheinhalationagentsisofluraneorhalothane,withoxygen

oroxygen/nitrousoxide.Seesection4.5

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Inthecaseofoverdosethemainsignsareprolongedanaesthesiaorsedation.Insome

casescardio-respiratoryeffectsmayoccur.Fortreatmentofthesecardio-respiratory

effectsofanoverdoseitisrecommendedtoadministeranalpha-2antagoniste.g.

atipamezoleoryohimbine,providedthatreversalofsedationisnotdangeroustothe

patient(atipamezoledoesnotreversetheeffectsofketaminewhichmaycause

seizuresindogsandelicitcrampsincatswhenusedalone).Useatipamezole

hydrochloride5mg/mlintramuscularlyinthedoginthesamevolumeasNarcostart,

inthecatusehalfthevolume.Therequireddoseofatipamezolehydrochloride

correspondsindogstothe5-folddoseofthemedetomidinehydrochloridedoseinmg

administeredbeforeandincatstothe2.5-folddose.Alpha-2antagonistsshouldbe

administerednotbefore30-40 min.afterketamine.

Ifitisimperativeto reversebradycardiabutmaintainsedation,atropinemaybeused.

4.11 Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Sedative/Analgesic

ATCvetcode: QN05CM91

5.1 Pharmacodynamicproperties

TheactiveingredientofNarcostartis(R,S)-4-[1-(2,3-dimethylphenyl)-ethyl)]-

imidazole-hydrochloride(INN:Medetomidine),asedativecompoundwithanalgesic

andmyorelaxingproperties.Medetomidineisaselective,specificandhighly

efficaciousalpha-2-receptoragonist.Theactivationofalpha-2receptorsleadstoa

decreaseinreleaseandturnoverofnorepinephrineinthecentralnervoussystem,

leadingtosedation,analgesiaandbradycardia.Intheperipherymedetomidinecauses

vasoconstrictionviastimulationofpostsynapticalpha-2adrenoceptors,leadingtoa

transientarterialhypertension.Within1–2hoursarterialbloodpressurefallsbackto

normotensionorslighthypotension.Therespiratoryratemaybetransientlydecreased.

Depthanddurationofsedationandanalgesiaaredoserelated.Profoundsedationand

recumbency,withreducedsensitivitytoenvironmentalstimuli(sounds,etc.),areseen

withmedetomidine.Medetomidineactssynergisticallywithketamineandopiates,

suchasfentanyl,leadingtobetteranaesthesia.Theamountofvolatileanaesthetics,

suchashalothane,willbereducedbymedetomidine.Besideitssedative,analgesicand

myo-relaxingproperties,medetomidinealsoexertshypothermicandmydriaticeffects,

inhibitssalivationanddecreasesintestinalmotility.

5.2 Pharmacokineticparticulars

Afterintramuscularadministrationmedetomidineisrapidlyandnearlycompletely

absorbedfromtheinjectionsiteandpharmacokineticsisverysimilartointravenous

administration.Maximalplasmaconcentrationsarereachedwithin15and20minutes.

Plasmahalf-lifeisconsideredtobe1.2hoursinthedogand1.5hoursinthecat.

Medetomidineismainlyoxidisedintheliver,asmalleramountundergoesmethylation

inthekidneys.Metaboliteswillbeexcretedmainlyviaurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Sodiumchloride

Hydrochloricacid(forpH-adjustment)

Sodiumhydroxide(forpH-adjustment)

WaterforInjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale: 3 years.

Shelf-lifeafterfirstopeningtheimmediatepackaging: 28 days

6.4 Specialprecautionsforstorage

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Glass(typeI)vialsclosedwithbromobutylrubberclosuressecuredwithaluminium

crimpcaps.

1 x1 glassvialwith10 ml.

5 x1 glassvialswith10 ml.

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

NL-3421 GWOudewater.

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

9. DATEOFFIRSTAUTHORISATION

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Carton

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostart1 mg/ml-SolutionforInjectionforCatsandDogs

Medetomidinehydrochloride

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1 mlsolutionforinjectioncontains:

Activesubstance:

Medetomidine(ashydrochloride) 0.85mg

(equivalentto1.00mgmedetomidinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218)1.0 mg

Propylparahydroxybenzoate(E216)0.2 mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

1 vialwith10 mlsolutionforinjection.

5 vialswith10 mlsolutionforinjectioneach.

5. TARGETSPECIES

DogsandCats.

6. INDICATIONS

In dogsand cats:

Sedationto facilitatehandling.Premedicationpriortogeneralanaesthesia.

In cats:

Incombinationwithketamineforgeneralanaesthesiaforminorsurgicalproceduresof

shortduration.

7. METHODANDROUTE(S)OFADMINISTRATION

Theproductisintendedfor:

Dogs: Intramuscularorintravenousinjection.

Cats: Intramuscularinjection.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP:

Shelflifeafterfirstbroachingthevial:28 days.

Oncebroached,useby……………………….

11.SPECIALSTORAGECONDITIONS

Donotfreeze.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithlocal

requirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Vial

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostart1 mg/ml-SolutionforInjectionforCatsandDogs

Medetomidinehydrochloride

2. QUANTITYOFTHEACTIVESUBSTANCE

1 mlsolutionforinjectioncontains:

Activesubstance:

Medetomidine(ashydrochloride) 0.85mg

(equivalentto1.0mgmedetomidinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218) 1.0 mg

Propylparahydroxybenzoate(E216) 0.2 mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

1 vialwith10 mlsolutionforinjection.

4. ROUTE(S)OFADMINISTRATION

Dogs: Intramuscularorintravenousinjection.

Cats: Intramuscularinjection.

5. WITHDRAWALPERIOD

Notapplicable.

6. BATCHNUMBER

Batch:

7. EXPIRYDATE

EXP:

Onceopened,useby28 days.

Keep outofthereachandsightofchildren.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

PACKAGELEAFLET

Narcostart1 mg/ml-SolutionforInjectionforCatsandDogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

Manufacturerforthebatchrelease:

ProdulabPharmaB.V.

Forellenweg16

4941 SJRaamsdonksveer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Narcostart1 mg/ml-SolutionforInjectionforCatsandDogs

Activesubstance:Medetomidinehydrochloride

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER

INGREDIENT(S)

Narcostartisaclearcolourless,sterileaqueoussolutionforinjectioncontaining:

Activesubstance:

Medetomidine(ashydrochloride) 0.85mg/ml

(equivalentto1.0mg/mlmedetomidinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218) 1.0 mg/ml

Propylparahydroxybenzoate(E216) 0.2 mg/ml

4. INDICATION(S)

In dogsand cats:

Sedationto facilitatehandling.Premedicationpriortogeneralanaesthesia.

In cats:

Incombinationwithketamineforgeneralanaesthesiaforminorsurgicalproceduresof

shortduration.

5. CONTRAINDICATIONS

Donotuseinanimalswith:

- severecardiovasculardiseaseorrespiratorydiseasesorimpairedliveror

kidneyfunction.

- mechanicaldisturbancesofthegastrointestinaltract(torsioventriculi,

incarcerations,oesophagalobstructions).

- pregnancy.

- diabetesmellitus.

- stateofshock,emaciationorseriousdebilitation.

Donotuseconcomitantlywithsympathomimeticamines.

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyother

excipients.

Donotuseinanimalswithocularproblemswhereanincreaseinintraocularpressurewould

bedetrimental.

6. ADVERSEREACTIONS

Bradycardiawithatrioventricularblock(1 st and2 nd degree)andoccasionallyextrasystolia.

Vasoconstrictionofcoronaryartery.Decreasedcardiacoutput.Bloodpressurewillincrease

initiallyafteradministrationandthenreturntonormal,orslightlybelownormal.Somedogs

andmostcatswillvomitwithin5-10minutesofinjection.Catsmayalsovomitonrecovery.

Sensitivitytoloudnoisesisobservedinsomeindividuals.

Increaseddiuresis.Hypothermia.Respiratorydepression,cyanosis,painatinjectionsiteand

muscletremormaybeseen.Inindividualcasesreversiblehyperglycaemiaduetodepression

ofinsulinsecretion

Incirculatoryandrespiratorydepressionmanualventilationandoxygensupplementmaybe

indicated.Atropinemayincreasethecardiacrate.Dogswithabodyweightoflessthan10kg

mayshowtheundesirableeffectsmentionedabovemoreoften.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthispackageleaflet,please

informyourveterinarysurgeon

7. TARGETSPECIES

Dogandcat.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF

ADMINISTRATION

Narcostartisintendedfor:

Dogs:Intramuscularorintravenousinjection.

Cats:Intramuscularinjection.

Useofanappropriatelygraduatedsyringeisrecommendedtoensureaccuratedosingwhen

administeringsmallvolumes

Dogs:

ForsedationNarcostartshouldbeadministeredattherateof750μgmedetomidine

hydrochloridei.v.or1000μgmedetomidinehydrochloridei.m.persquaremeterofbody

surface.Usethetablebelowto determinethecorrectdosageonthebasisofbodyweight:

Maximaleffectisobtainedwithin15-20minutes.Clinicaleffectisdose-dependent,lasting

from30-180 minutes.

Narcostartdosagesinmlandcorrespondingamountofmedetomidinehydrochlorideinμg/kg

bw):

Bodyweight

[kg] i.v.–Injection

[ml] corresp.to

[μg/kgbw] i.m.–Injection

[ml] corresp.to

[μg/kgbw]

1 0.08 80.0 0.10 100.0

2 0.12 60.0 0.16 80.0

3 0.16 53.3 0.21 70.0

4 0.19 47.5 0.25 62.5

5 0.22 44.0 0.30 60.0

6 0.25 41.7 0.33 55.0

7 0.28 40.0 0.37 52.9

8 0.30 37.5 0.40 50.0

9 0.33 36.7 0.44 48.9

10 0.35 35.0 0.47 47.0

12 0.40 33.3 0.53 44.2

14 0.44 31.4 0.59 42.1

16 0.48 30.0 0.64 40.0

18 0.52 28.9 0.69 38.3

20 0.56 28.0 0.74 37.0

25 0.65 26.0 0.86 34.4

30 0.73 24.3 0.98 32.7

35 0.81 23.1 1.08 30.9

40 0.89 22.2 1.18 29.5

50 1.03 20.6 1.37 27.4

60 1.16 19.3 1.55 25.8

70 1.29 18.4 1.72 24.6

80 1.41 17.6 1.88 23.5

90 1.52 16.9 2.03 22.6

100 1.63 16.3 2.18 21.8

Forpremedication,Narcostartshouldbeadministeredatadosageof10-40µgmedetomidine

hydrochlorideperkgbodyweight,correspondingto0.1–0.4mlNarcostartper10kgbody

weight.Theexactdosedependsonthecombinationofdrugsusedandthedosage(s)ofthe

otherdrug(s).Thedoseshouldfurthermorebeadjustedtothetypeofsurgery,lengthof

procedureandpatienttemperamentandweight.Premedicationwithmedetomidinewill

significantlyreducethedosageoftheinductionagentrequiredandwillreducevolatile

anaestheticrequirementsformaintenanceanaesthesia.Allanaestheticagentsusedfor

inductionormaintenanceofanaesthesiashouldbeadministeredtoeffect.Beforeusingany

combinations,productliteraturefortheotherproductsshouldbeobserved.Seealsosection

4.5.

Cats:

Formoderate-deepsedationandrestraintofcatsNarcostartshouldbeadministeredata

dosageof50–150μgmedetomidinehydrochloride/kgbw(corresp.to0.05–0.15ml

Narcostart/kgbw).

ForanaesthesiaNarcostartshouldbeadministeredatadosageof80μgmedetomidine

hydrochloride/kgbw(corresp.to0.08mlNarcostart/kgbw)and2.5to7.5mgketamine/

kgbw.Usingthisdosageanaesthesiaoccurswithin3–4minutesandisapparentfor20–50

minutes.Forlongerlastingproceduresadministrationhastoberepeatedbyusing½ofthe

initialdose(i.e.40μgmedetomidinehydrochloride(corresp.to0.04mlNarcostart/kgbw)

and2.5–3.75mgketamine/kgbw)or3.0mgketamine/kgbwalone.Alternatively,for

longerlastingproceduresanaesthesiamaybeextendedbyuseoftheinhalationagents

isofluraneorhalothane,withoxygenoroxygen/nitrousoxide.

9. ADVICEONCORRECTADMINISTRATION

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

10. WITHDRAWALPERIOD

Notapplicable

11. SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

Donotfreeze.

Donotuseaftertheexpirydatestatedonthelabelandonthecarton.

Shelf-lifeafterfirstopeningthecontainer:28 days

12. SPECIALWARNING(S)

Medetomidinemaynotprovideanalgesiathroughouttheentireperiodofsedation,therefore

considerationshouldbegivento providingadditionalanalgesiaforpainfulprocedures.

Specialprecautionsforuseinanimals

Aclinicalexaminationshouldbecarriedoutinallanimalsbeforetheuseofveterinary

medicinalproductsforsedationand/orgeneralanaesthesia.

Higherdosesofmedetomidineshouldbeavoidedinlargebreeddogs.Careshouldbetaken

whencombiningmedetomidinewithotheranaestheticsorsedativesbecauseofitsmarked

anaestheticsparingeffects.Thedoseoftheanaestheticshouldbereducedaccordinglyand

titratedtoresponseduetoconsiderablevariabilityinrequirementsbetweenpatients.Before

usinganycombinations,thewarningsandcontra-indicationsintheproductliteratureforthe

otherproductsshouldbeobserved.

Animalsshouldbefasted12 hoursbeforeanaesthesia.

Theanimalshouldbeplacedinacalmandquietsurroundingtoletthesedationgainits

maximumeffect.Thistakesabout10-15minutes.Oneshouldnotstartanyprocedureorgive

othermedicinesbeforemaximumsedationisreached.

Treatedanimalsshouldbekeptwarmandataconstanttemperature,bothduringthe

procedureandrecovery.

Theeyesshouldbeprotectedbyasuitablelubricant.

Nervous,aggressiveorexcitedanimalsshouldbegiventhepossibilitytocalmdownbefore

initiationoftreatment

Sickanddebilitateddogsandcatsshouldonlybepremedicatedwithmedetomidinebefore

inductionandmaintenanceofgeneralanaesthesiabased onarisk-benefitassessment.

Careshouldbetakenwithuseofmedetomidineinanimalswithcardiovasculardisease,or

whichareelderlyoringeneralpoorhealth.Liverandkidneyfunctionshouldbeevaluated

priortouse.

Asketaminealonecanelicitcramps,alpha-2antagonistsshouldbeadministerednotbefore

30-40 min.afterketamine.

Medetomidinemaycauserespiratorydepressionandunderthesecircumstances,manual

ventilationandoxygenmaybeadministered.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

1. Inthecaseofaccidentaloralintakeorself-injection,seekmedicaladviceimmediately

andshowthepackageinserttothephysicianbutDONOTDRIVEassedationand

changesinbloodpressuremayoccur.

2. Avoidskin,eyeormucosalcontact.

3. Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

4. Removecontaminatedclothesthatareindirectcontactwithskin.

5. Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantlywithfresh

water.Ifsymptomsoccur,seek theadviceofaphysician.

6. Ifpregnantwomenhandletheproduct,specialcautionshouldbeobservednottoself-

injectasuterinecontractionsanddecreasedfoetalbloodpressuremayoccurafter

accidentalsystemicexposure.

7. Advicetodoctors:

Medetomidineisanalpha2-adrenoreceptoragonist,symptomsafterabsorptionmay

involveclinicaleffectsincludingdose-dependentsedation,respiratorydepression,

bradycardia,hypotension,adrymouth,andhyperglycaemia.Ventriculararrhythmias

havealsobeenreported.Respiratoryandhaemodynamicsymptomsshouldbetreated

symptomatically.

Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasnotbeenestablishedduringpregnancyandlactation.Therefore

itshouldnotbeusedduringpregnancyandlactation.

Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministrationofothercentralnervoussystemdepressantsshouldbe

expectedtopotentiatetheeffectofeitheractivesubstance.Appropriatedoseadjustment

shouldbemade.

Medetomidinehasmarkedanaestheticsparingeffects.

Theeffectsofmedetomidinemaybeantagonizedbyadministrationofatipamezoleor

yohimbine.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Inthecaseofoverdosethemainsignsareprolongedanaesthesiaorsedation.Insomecases

cardio-respiratoryeffectsmayoccur.Fortreatmentofthesecardio-respiratoryeffectsofan

overdoseitisrecommendedtoadministeranalpha-2antagoniste.g.atipamezoleor

yohimbine,providedthatreversalofsedationisnotdangeroustothepatient(atipamezole

doesnotreversetheeffectsofketaminewhichmaycauseseizuresindogsandelicitcrampsin

catswhenusedalone).Useatipamezolehydrochloride5mg/mlintramuscularlyinthedogin

thesamevolumeasNarcostart,inthecatusehalfthevolume.Therequireddoseof

atipamezolehydrochloridecorrespondsindogstothe5-folddoseofthemedetomidine

hydrochloridedoseinmgadministeredbeforeandincatstothe2.5-folddose.Alpha-2

antagonistsshouldbeadministerednotbefore30-40 min.afterketamine.

Ifitisimperativeto reversebradycardiabutmaintainsedation,atropinemaybeused.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<MM/YYYY>

15. OTHERINFORMATION

1 x1 glassvialwith10 ml.

5 x1 glassvialswith10 ml.

Notallpack sizesmaybemarketed.

28-11-2018

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

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

Update - medicine shortage

Therapeutic Goods Administration - Australia

29-6-2018

Pending EC decision:  Dexdor, dexmedetomidine, Opinion date: 28-Jun-2018

Pending EC decision: Dexdor, dexmedetomidine, Opinion date: 28-Jun-2018

Europe - EMA - European Medicines Agency

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

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

Europe -DG Health and Food Safety

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

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

6-8-2018

Dexdor (Orion Corporation)

Dexdor (Orion Corporation)

Dexdor (Active substance: dexmedetomidine) - Centralised - 2-Monthly update - Commission Decision (2018)5377 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2268/II/26

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

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

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

6-6-2018

Cepedex (CP-Pharma Handelsgesellschaft mbH)

Cepedex (CP-Pharma Handelsgesellschaft mbH)

Cepedex (Active substance: dexmedetomidine) - Centralised - Yearly update - Commission Decision (2018)3684 of Wed, 06 Jun 2018

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety