Xylasol

Main information

  • Trade name:
  • Xylasol 20 mg/ml Xylasol 100 mg/ml
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Xylasol 20 mg/ml Xylasol 100 mg/ml
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Xylazine
  • Therapeutic area:
  • Cattle Food, Horses Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0158/002
  • Authorization date:
  • 22-02-2012
  • EU code:
  • NL/V/0158/002
  • Last update:
  • 09-08-2016

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

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

A.LABELLING

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CARTONBOX

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Xylasol100 mg/ml,solutionforinjectionforcattleandhorses

(BE,ES, FR,HU,IE,IT,NLandUK)

Xysolvet.100mg/ml,solutionforinjectionforcattleandhorses

(DK, FI,NOandSE)

Xylavet100 mg/ml,solutionforinjectionforcattleandhorses

(AT,DE)

Xylazine(ashydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Perml:

Activesubstance:

Xylazine(ashydrochloride) 100.0 mg

(equivalentto 116.55 mgxylazinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218) 1.0 mg

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

Bottle

10 ml

25 ml

50 ml

5. TARGETSPECIES

Cattle(≥200 kg)andhorses.

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

Cattle:intramuscular.

Horses:intravenous.

Thestoppershouldnotbepuncturedmorethan20 times.

Numberofpunctures:.................

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Cattle:

Meatandoffal: 1 day

Milk: zerohours

Horses:

Meatandoffal: 1 day

Milk: zerohours

9. SPECIALWARNING(S),IFNECESSARY

Accidentalinjectionisdangerous–read thepackageleafletbeforeuse.

Accidentalintakeandcontactwithskin,eyesandmucousmembranesisdangerous–read the

packageleafletbeforeuse.

10.EXPIRYDATE

EXP:<month/year>

Shelflifeafterfirstopeningtheimmediatepackaging:28 days.

Oncebroached/opened,useby…..

11.SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.

12.SPECIFICPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposeofwastematerialinaccordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Administrationonlybyaveterinarysurgeon.

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

BE,DK,ES, FI,FR, HU,IE,IT,NO, SEandUK:

LeVetB.V.

Wilgenweg7

3421 TVOudewater

TheNetherlands

AT,DE,NL:

CP-PharmaHandelsges.mbH

Ostlandring13, 31303 Burgdorf,Germany

16.MARKETINGAUTHORISATIONNUMBER(S)

<to becompletednationally>

17.MANUFACTURER’SBATCHNUMBER

Batch:<number>

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Bottle

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Xylasol100 mg/ml,solutionforinjectionforcattleandhorses

(BE,ES, FR,HU,IE,IT,NLandUK)

Xysolvet.100 mg/ml,solutionforinjectionforcattleandhorses

(DK, FI,NOandSE)

Xylavet100 mg/ml,solutionforinjectionforcattleandhorses

(AT,DE)

Xylazine(ashydrochloride)

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Containsperml:

Xylazine(ashydrochloride)100.0 mg

(equivalentto 116.55 mgxylazinehydrochloride)

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

10 ml

25 ml

50 ml

4. ROUTE(S)OFADMINISTRATION

Cattle:intramuscular.

Horses:intravenous.

5. WITHDRAWALPERIOD

Cattle:

Meatandoffal: 1 day

Milk: zerohours

Horses:

Meatandoffal: 1 day

Milk: zerohours

6. BATCHNUMBER

Batch:<number>

7. EXPIRYDATE

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

EXP:<month/year>

Shelflifeafterfirstopeningtheimmediatepackaging:28 days.

Oncebroached/opened,useby…

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

9. SPECIALWARNING(S),IFNECESSARY

Seepackageleafletforuserwarnings.

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

B. PACKAGELEAFLET

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

PACKAGELEAFLET

Xylasol100 mg/ml,solutionforinjectionforcattleandhorses

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLE

FORBATCHRELEASE, IFDIFFERENT

Marketingauthorisationholder

BE,DK,ES, FI,FR, HU,IE,IT,NO, SEandUK:

LeVetB.V.

Wilgenweg7

3421 TVOudewater

TheNetherlands

AT,DE,NL:

CP-PharmaHandelsges.mbH

Ostlandring13, 31303 Burgdorf,Germany

Manufacturerforthebatchrelease:

CP-PharmaHandelsges.mbH

Ostlandring13, 31303 Burgdorf,Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Xylasol100 mg/ml,solutionforinjectionforcattleandhorses

(BE,ES, FR,HU,IE,IT,NLandUK)

Xysolvet.100 mg/ml,solutionforinjectionforcattleandhorses

(DK, FI,NOandSE)

Xylavet100 mg/ml,solutionforinjectionforcattleandhorses

(AT,DE)

Xylazine(ashydrochloride)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENTS

perml:

Activesubstance:

Xylazine(ashydrochloride): 100.0 mg

(equivalentto 116.55 mgxylazinehydrochloride)

Excipients:

Methylparahydroxybenzoate(E218) 1.0 mg

Clear,colourlesssolution.

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

4. INDICATION(S)

Sedation.

Premedicationincombinationwithananaesthetic.

5. CONTRAINDICATIONS

Donotuseinanimalswithgastrointestinalobstructionasthemusclerelaxantproperties

ofthedrugappearto accentuatetheeffectsoftheobstructionandbecauseofpossible

vomiting.

Donotuseinanimalswithsevererenalorhepaticimpairment,respiratorydysfunction,

cardiacabnormalities,hypotensionand/orshock.

Donotuseindiabeticanimals.

Donotuseinanimalswithahistoryofseizures.

Donotuseincattleweighinglessthan200 kgbodyweight.Donotuseinfoalsyounger

than2 weeks.

Donotuseduringthelaststageofpregnancy(dangerofprematurebirth),exceptat

parturition(seesection12).

6. ADVERSEREACTIONS

Ingeneral,sideeffects,typicalforanα2-adrenergicagonist,likebradycardia,reversible

arrhythmiaandhypotensioncanoccur.Thermoregulationcanbeinfluencedand

consequentlybodytemperaturecandecreaseorincreasedependantontheambient

temperature.Depressionofrespirationand/orrespiratoryarrestcanoccur.

Cattle

Incattlexylazinemayinduceprematureparturition,anditalsoreducesimplantationof

theovum.

Cattle,whichhavereceivedhighdosesofxylazinesometimessufferfromloosefaeces

for24 hoursafterwards.

Otheradversereactionsincludesnoring,profoundsalivation,ruminalatony,atonyofthe

tongue,regurgitation,bloating,nasalstridor,hypothermia,bradycardia,increased

urinationandreversibleprolapseofthepenis.

Horses

Horsesoftensweatastheeffectsofthesedationarewearingoff.

Severebradycardiaandreducedrespiratoryratehavebeenreportedespeciallyinhorses.

Followingadministrationtohorses,atransientrisefollowedbyafallinbloodpressure

usuallyoccurs.

Morefrequenturinationhasbeenreported

Muscletremorsandmovementinresponsetosharpauditoryorphysicalstimuliare

possible.Althoughrare,violentreactionshavebeenreportedinhorsesfollowingthe

administrationofxylazine.

Ataxiaandreversibleprolapseofthepenismayoccur.

Inveryrarecasesxylazinemayinducemildcolicasthegutmotilityisdepressed

temporarily.Asapreventivemeasurethehorseshouldreceivenofeedaftersedation

untiltheeffecthasfadedcompletely.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinform

yourveterinarysurgeon.

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

7. TARGETSPECIES

Cattle(≥200 kg)andhorses.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Cattle:intramuscular.

Horses:intravenous.

*Cattle:

Dosage:

Dosageforcattle

Dosagelevel§ xylazine

(mg/kg) Xylasol100 mg/ml

(ml/100kg) Xylasol100 mg/ml

(ml/500kg)

I 0.05 0.05 0.25

II 0.1 0.1 0.5

III 0.2 0.2 1

IV 0.3 0.3 1.5

§§Dose1:Sedation,withaslightdecreaseofmuscletone.Theabilityto standis

maintained.

Dose2:Sedation,markeddecreaseofmuscletoneandsomeanalgesia.Theanimalusually

remainsstanding,butmayliedown.

Dose3:Deepsedation,furtherdecreaseofmuscletoneandadegreeofanalgesia.The

animalliesdown.

Dose4:Verydeepsedation,aprofounddecreaseinmuscletoneandadegreeofanalgesia.

Theanimalliesdown.

*Horses

Dosage:singledoseof0.6-1 mgxylazineperkgbodyweight.

(0.6-1 mlproductper100 kgbodyweight).

Thestoppershouldnotbepuncturedmorethan20 times.

Thenumberofpuncturesshouldberecordedontheouterpackaging

9. ADVICEONCORRECTADMINISTRATION

Theintravenousinjectionto horsesshouldbegivenslowly.

10.WITHDRAWALPERIOD

Cattle:

Meatandoffal: 1 day

Milk: zerohours

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

Horses:

Meatandoffal: 1 day

Milk: zerohours

11.SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

Donotrefrigerateorfreeze.

DonotuseaftertheexpirydatestatedonthevialandthecartonafterEXP.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

12.SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Horses:

Xylazineinhibitsthenormalintestinalmotility.Therefore,itshouldonlybeusedin

horseswithcolic,thatarenotresponsiveto analgesics.Theuseofxylazineshouldbe

avoidedinhorseswithcaecalmalfunction.

Aftertreatmentofhorseswithxylazine,theanimalsarereluctantto walk,so whenever

possiblethedrugshouldbeadministeredintheplacewherethetreatment/investigation

isgoingtotakeplace.

Cautionshouldbetakenintheadministrationoftheproducttohorsessusceptibleto

laminitis.

Horseswithairwaydiseaseormalfunctionmaydeveloplife-threateningdyspnoea.

Thedoseshouldbekeptaslowaspossible.

Theassociationwithotherpre-anaestheticagentsoranaestheticagentsshouldbethesubjectofa

benefit/riskassessment.Thisassessmentshouldconsiderthecompositionoftheproducts,their

doseandthenatureofthesurgery.Recommendeddosagesarelikelytovaryaccordingtothe

choiceoftheanaestheticassociation.

Cattle:

Ruminantsarehighlysusceptibleto theeffectsofxylazine.Normallycattleremain

standingatthelowerdoses, butsomeanimalsmayliedown.Atthehighest

recommendeddosesmostanimalswillliedownandsomeanimalsmaylapseinlateral

recumbency.

Reticulo-ruminalmotorfunctionsaredepressedafterinjectionofxylazine.Thismay

resultsinbloat.Itisadvisabletowithholdfeedandwaterforseveralhoursbefore

administrationofxylazine.

Incattletheabilitytoeructate,coughandswallowisretainedbutreducedduringthe

periodofsedation,thereforecattlemustbecloselywatchedduringtherecoveryperiod:

theanimalsshouldbemaintainedinsternalrecumbency.

Incattlelifethreateningeffectsmayoccurafterintramusculardosesabove0.5 mg/kg

bodyweight(respiratoryandcirculatoryfailure).Thereforeveryprecisedosingis

required.

Thisproductshouldonlybeusedincattleweighing200 kgormore.Sinceitishighly

concentrated,aslightdeviationfromtheactualvolumeto beinjectedmaycauseserious

adversereactions.Incasecattleweighinglessthan200 kgneedto betreated,xylazine

withalowerstrengthshouldbeused(e.g.20 mg/ml).

Theassociationwithotherpre-anaestheticagentsoranaestheticagentsshouldbethesubjectofa

benefit/riskassessment.Thisassessmentshouldconsiderthecompositionoftheproducts,their

doseandthenatureofthesurgery.Recommendeddosagesarelikelytovaryaccordingtothe

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

choiceoftheanaestheticassociation.

Specialprecautionsforuseinanimals

Keep theanimalscalm,becausetheymayrespondto externalstimuli.

Avoidintra-arterialadministration.

Tympanymayoccasionallyoccurinrecumbentcattleandcanbeavoidedbymaintaining

theanimalinsternalrecumbency.

Toavoidaspirationofsalivaorfood,lowertheanimal’sheadandneck.Fasttheanimals

beforeuseoftheproduct.

Olderandexhaustedanimalsaremoresensitiveto xylazine,whilstnervousorhighly

excitableanimalsmayrequirearelativelyhighdose.

Incaseofdehydration,xylazineshouldbeusedcautiously.

Donotexceedtherecommendeddosage.

Followingadministrationanimalsshouldbeallowedto restquietlyuntilthefulleffect

hasbeenreached.

Itisadvisedtocoolanimalswhentheambienttemperatureisabove25°Candto keep

animalswarmatlowtemperatures.

Forpainfulprocedures,xylazineshouldalwaysbeusedincombinationwithlocalor

generalanaesthesia.

Xylazineproducesacertaindegreeofataxia;therefore,xylazinemustbeusedcautiously

inproceduresinvolvingthedistalextremitiesandinstandingcastrationsinthehorse.

Treatedanimalsshouldbemonitoreduntiltheeffecthasfadedtotally(e.g.cardiacand

respiratoryfunction,alsointhepost-operativephase)andshouldbesegregatedtoavoid

bullying.

Specialprecautionsto betakenby thepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentaloralintakeorself-injection,seek medicaladviceimmediatelyand

showthepackageleafletto thephysicianbutDONOTDRIVEassedationandchanges

inbloodpressuremayoccur.

Avoidskin,eyeormucosalcontact.

Washtheexposedskinimmediatelyafterexposurewithlargeamountsofwater.

Removecontaminatedclothesthatareindirectcontactwithskin.

Inthecaseofaccidentalcontactoftheproductwitheyes,rinseabundantlywithfresh

water.Ifsymptomsoccur,seek theadviceofaphysician.

Ifpregnantwomenhandletheproduct,specialcautionshouldbeobservednotto self-

injectasuterinecontractionsanddecreasedfoetalbloodpressuremayoccurafter

accidentalsystemicexposure.

Advicetodoctors:

Xylazineisanα2-adrenoreceptoragonist,symptomsafterabsorptionmayinvolveclinical

effectsincludingdose-dependentsedation,respiratorydepression,bradycardia,

hypotension,adrymouthandhyperglycaemia.Ventriculararrhythmiashavealsobeen

reported.Respiratoryandhaemodynamicsymptomsshouldbetreatedsymptomatically.

Useduringpregnancy,lactationorlay

Althoughlaboratorystudiesinratshavenotshownanyevidenceofteratogenicor

foetotoxiceffectstheuseoftheproductduringthefirsttwotrimestersofpregnancyshould

onlybemadeaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Donotuseinthelaterstagesofpregnancy(particularlyincattle)exceptatparturition,

becausexylazinecausesuterinecontractionsanditmayinduceprematurelabour.

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

Donotuseincattlereceivingovumtransplantsastheincreaseduterinetonemayreduce

thechanceofimplantationoftheovum.

Interactionwithothermedicinalproductsandotherformsofinteraction

OtherCNSdepressantagents(barbiturates,narcotics,anaesthetics,tranquillizers,etc.)may

causeadditiveCNSdepressionifusedwithxylazine.Dosagesoftheseagentsmayneedto

bereduced.Xylazineshouldthereforebeusedcautiouslyincombinationwithneuroleptics

ortranquillizers.

Xylazineshouldnotbeusedincombinationwithsympathomimeticdrugssuchas

epinephrineasventriculararrhythmiamayfollow.

Theconcurrentintravenoususeofpotentiatedsulphonamideswithalpha-2agonistshas

beenreportedtocausecardiacarrhythmiaswhichmaybefatal.Whilstnosucheffectshave

beenreportedwiththisproduct,itisrecommendedthatintravenousadministrationof

Trimethoprim/Sulphonamidecontainingproductsshouldnotbeundertakenwhenhorses

havebeensedatedwithxylazine.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Intheeventofanaccidentaloverdose,cardiacarrhythmias,hypotension,andprofound

CNSandrespiratorydepressionmayoccur.Seizureshavealsobeenreportedafteran

overdose.Xylazinecanbeantagonizedbyα2-adrenergicantagonists.

Thefollowingantidotesarerecommendedinoverdose:

TargetspeciesActivesubstance Dosage

Cattle Atipamezole

Yohimbine

4-Aminopyridine 0.03 mg/kg

0.125 mg/kg

0.3 mg/kg

Horses Atipamezol 0.15 mg/kg

Totreattherespiratorydepressanteffectsofxylazine,mechanicallyrespiratorysupport

withorwithoutrespiratorystimulants(e.g.doxapram)canberecommended.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.These

measuresshouldhelpto protecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<DDmonthYYYY>

15.OTHERINFORMATION

Bottlescontaining10 ml,25 mlor50 ml.

Notallpack sizesmaybemarketed.

Xylazine100mg/ml,solutionforinjection NL/V/0158/001-002/IB/002

Packaging,Labelling

andPackageLeaflet

Administrationonlybyaveterinarysurgeon.

MAnumber:

<to beestablishednationally.

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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

23-7-2018

PecFent (Kyowa Kirin Holdings B.V.)

PecFent (Kyowa Kirin Holdings B.V.)

PecFent (Active substance: Fentanyl ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4890 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1164/T/46

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

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

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

4-6-2018

Yervoy (Bristol-Myers Squibb Pharma EEIG)

Yervoy (Bristol-Myers Squibb Pharma EEIG)

Yervoy (Active substance: ipilimumab) - Centralised - 2-Monthly update - Commission Decision (2018)3618 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2213/II/55

Europe -DG Health and Food Safety