Comfortan 10 mg/ml inj. for dogs and cats

Main information

  • Trade name:
  • Comfortan 10 mg/ml inj. for dogs and cats
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Comfortan 10 mg/ml inj. for dogs and cats
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • methadone, combinations excl. psycholeptics
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0150/001
  • Authorization date:
  • 23-02-2011
  • EU code:
  • NL/V/0150/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Comfortan10mg/ml,solutionforinjectionfordogsandcats

Spain,Italy,Portugal:Semfortan10mg/ml,solutionforinjectionfordogsandcats

France:Comfortan,solutionforinjectionfordogsandcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Methadone 8.9mg

equivalenttomethadonehydrochloride 10mg

Excipient(s):

Methylparahydroxybenzoate(E218)1.0mg

Propylparahydroxybenzoate(E216)0.2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Aclearcolourlesstopaleyellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats.

4.2 Indicationsforuse,specifyingthetargetspecies

Analgesiaindogsandcats

Premedicationforgeneralanaesthesiaorneuroleptanalgesiaindogsandcatsincombination

withaneurolepticdrug

4.3Contra-indications

Donotuseinknowncasesofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseinanimalswithadvancedrespiratoryfailure.

Donotuseinanimalswithsevereliverandrenaldysfunction.

4.4Specialwarningsforeachtargetspecies

Duetothevariableindividualresponsetomethadone,animalsshouldberegularlymonitoredto

ensuresufficientefficacyforthedesiredeffectduration.Useoftheproductmustbepreceded

byathoroughclinicalexamination.Incatspupildilatationisseenlongaftertheanalgesiceffect

hasdisappeared.Itisthereforenotanadequateparametertoassessclinicalefficacyofthe

administereddose.

Greyhoundsmayrequirehigherdosesthanotherbreedstoachieveefficaciousplasmalevels.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Methadonemayoccasionallycauserespiratorydepressionandaswithotheropioiddrugs,care

shouldbetakenwhentreatinganimalswithimpairedrespiratoryfunctionoranimalsthatare

receivingdrugsthatcancauserespiratorydepression.Toensuresafeuseoftheproduct,treated

animalsshouldbemonitoredregularly,includingexaminationofheartrateandrespiratoryrate.

Asmethadoneismetabolisedbytheliver,itsintensityanddurationofactionmaybeaffectedin

animalswithimpairedliverfunction.Incaseofrenal,cardiacorhepaticdysfunctionorshock,

theremaybegreaterriskassociatedwiththeuseoftheproduct.Thesafetyofmethadonehas

notbeendemonstratedindogslessthan8weeksandcatslessthan5monthsofage.Theeffect

ofanopioidonheadinjuryisdependentonthetypeandseverityoftheinjuryandtherespiratory

supportsupplied.Safetyhasnotbeenfullyevaluatedinclinicallycompromisedcats.Duetothe

riskofexcitation,repeatedadministrationincatsshouldbeusedwithcare.Thebenefit/riskratio

forusingtheproductshouldbemadebytheattendingveterinarian.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Methadonecancauserespiratorydepressionfollowingspillageontheskinoraccidentalself

injection.Avoidskin,eyesandmouthcontactandwearimpermeablegloveswhenhandlingthe

product.Incaseofspillingontheskinorsplashingintheeyes,washimmediatelywithlarge

amountsofwater.Removecontaminatedclothes.

Peoplewithknownhypersensitivitytomethadoneshouldavoidcontactwiththeveterinary

medicinalproduct.Methadonehasthepotentialtocausestillbirths.Pregnantwomenareadvised

nottohandletheproduct.

Inthecaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackage

inserttothephysicianbutDONOTDRIVEassedationmayoccur.

ADVICETODOCTORS:Methadoneisanopioidwhosetoxicitymaycauseclinicaleffects

includingrespiratorydepressionorapnoea,sedation,hypotensionandcoma.Whenrespiratory

depressionoccurscontrolledventilationshouldbeinstalled.Administrationoftheopioid

antagonistnaloxonetoreversethesymptomsisrecommended.

4.6 Adversereactions(frequencyandseriousness)

Cats:Respiratorydepressionmaybeseen.Mildexcitatoryreactionshavebeenobserved:lip

licking,vocalisation,urination,defaecation,mydriasis,hyperthermiaanddiarrhoea.Hyperalgesia

hasbeenreported.Allreactionsweretransient.

Dogs:Respiratorydepressionmaybeseen.Mildreactionshavebeenobserved:panting,lip

licking,salivation,vocalisation,irregularbreathing,hypothermia,fixedstareandbodytremors.

Occasionalurinationanddefaecationcanbeseenwithinthefirsthourpostdose.Allreactions

weretransient.

4.7 Useduringpregnancy,lactationorlay

Methadonediffusesacrosstheplacenta.

Studiesinlaboratoryanimalshaveshownadverseeffectsonreproduction.

Thesafetyoftheproductduringpregnancyandlactationhasnotbeenassessedintarget

species.Theuseoftheproductisnotrecommendedduringpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Forconcurrentusewithneurolepticsrefertosection4.9.

Methadonecanpotentiatetheeffectsofanalgesics,centralnervoussysteminhibitersand

substancesthatcauserespiratorydepression.Concomitantorsubsequentuseoftheveterinary

medicinalproductwithbuprenorphinemayleadtolackofefficacy.

4.9 Amountstobeadministeredandadministrationroute

Analgesia

Dogs:0.5to1mgmethadonehydrochlorideperkgbodyweight,subcutaneously,intramuscularly

orintravenously(correspondingto0.05to0.1ml/kg)

Cats:0.3to0.6mgmethadonehydrochlorideperkgbodyweight,intramuscularly(corresponding

to0.03to0.06ml/kg)

Toensureaccuracyofdosingincats,anappropriatelycalibratedsyringeshouldbeusedto

administertheproduct.

Astheindividualresponsetomethadoneisvaried,anddependspartlyonthedosage,theageof

thepatient,individualdifferencesinpainsensitivityandgeneralconditiontheoptimaldosing

regimenshouldbeindividuallybased.Indogsonsetofactionis1hourfollowingsubcutaneous

administration,approximately15minutesfollowingintramuscularinjectionandwithin10minutes

followingintravenousinjection.Durationofeffectisapproximately4hoursfollowing

intramuscularorintravenousadministration.Incatsonsetofactionis15minutesfollowing

administrationandthedurationofeffectis4hoursinaverage.Theanimalshouldbeexamined

regularlytoassessifadditionalanalgesiaissubsequentlyrequired.

Premedicationand/orneuroleptanalgesia

Dogs:

MethadoneHCl0.5-1mg/kg,IV,SCorIM

Combinationse.g.:

MethadoneHCl0.5mg/kg,IV+e.g.midazolamordiazepam

Inductionwithpropofol,maintenanceonisofluraneinoxygen.

MethadoneHCl0.5mg/kg+e.gacepromazine

Inductionwiththiopentoneorpropofoltoeffect,maintenanceonisofluraneinoxygen.

orinductionwithdiazepamandketamine

MethadoneHCl0.5-1.0mg/kg,IVorIM+α

-agonist(e.g.xylazineormedetomidine)

Inductionwithpropofol,maintenancewithisofluraneincombinationwithfentanylortotal

intravenousanaesthesia(TIVA)protocol:maintenancewithpropofolincombinationwith

fentanyl

TIVAprotocol:inductionpropofol,toeffect.Maintenancewithpropofolandremifentanil

Chemical-physicalcompatibilityhasonlybeendemonstratedfordilutions1:5withthefollowing

solutionsforinfusion:sodiumchloride0.9%,Ringersolution,andglucose5%.

Cats:

MethadoneHCl0.3to0.6mg/kg,IM

-InductionwithBenzodiazepine(e.g.midazolam)anddissociative(e.g.ketamine)

-Withatranquilizer(e.g.acepromazine)andNSAID(meloxicam)orsedative(e.g.α

agonist).:

-Inductionwithpropofol,maintenancewithisofluraneinoxygen.

Dosesdependonthedesireddegreeofanalgesiaandsedation,desireddurationofeffectandthe

concurrentuseofotheranalgesicsandanaesthetics.

Whenusedincombinationwithotherproducts,lowerdosagescanbeused.

Forsafeusewithotherpharmaceuticals,referencemustbemadetotherelevantproduct

literature.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

A1.5foldoverdoseresultedintheeffectsdescribedinsection4.6.

Cats:Incaseofoverdoses(>2mg/kg)thefollowingsignscanbeobserved:increasedsalivation,

excitation,hindlegparalysisandlossofrightingreflex.Seizures,convulsionandhypoxiawere

alsorecordedinsomecats.Adoseof4mg/kgcouldbefatalincats.Respiratorydepressionhas

beendescribed.

Dogs:Respiratorydepressionhasbeendescribed.

Methadonecanbeantagonizedbynaloxone.Naloxoneshouldbegiventoeffect.Astartingdose

of0.1mg/kgintravenouslyisrecommended.

4.11Withdrawalperiod(s

Notapplicable.

5. PHARMACOLOGICALPARTICULARS

Pharmacotherapeuticgroup:Diphenylpropylaminederivatives,ATCvet-code:QN02AC52

5.1 Pharmacodynamicproperties

Methadoneisstructurallyunrelatedtootheropium-derivedanalgesicsandexistsasaracemic

mixture.Eachenantiomerhasaseparatemodeofaction;thed-isomernoncompetitively

antagonizestheNMDAreceptorandinhibitsnorepinephrinereuptake;thel-isomerisaµ-opioid

receptoragonist..

Therearetwosubtypesµ

andµ

.Theanalgesiceffectsofmethadonearebelievedtobe

mediatedbyboththeµ

andµ

2 subtypes,whereastheµ

2 subtypeappearstomediaterespiratory

depressionandinhibitionofgastrointestinalmotility.Theµ

subtypeproducessupraspinal

analgesiaandtheµ

2 receptorsproducespinalanalgesia.

Methadonehastheabilitytoproduceprofoundanalgesia.Itcanalsobeusedforpremedication

anditcanassistintheproductionofsedationincombinationwithtranquilizersorsedatives.The

durationofeffectsmayvaryfrom1.5to6.5hours.Opioidsproduceadose-dependent

respiratorydepression.Veryhighdosesmayresultinconvulsions.

5.2 PharmacokineticParticulars

Indogsmethadoneisabsorbedveryrapidly(T

5-15min)followingintramuscularinjectionof

0.3to0.5mg/kg. T

tendstobelateratthehigherdoselevelsindicatingthatanincreasein

dosetendstoprolongtheabsorptionphase.Therateandextentofsystemicexposureofdogsto

methadoneappearstobecharacterisedbydose-independent(linear)kineticsfollowing

intramuscularadministration.Thebioavailabilityishighandrangesbetween65.4and100%,with

ameanestimateof90%.Followingsubcutaneousadministrationof0.4mg/kgmethadoneis

absorbedslower(T

15–140min)andbioavailabilityis79±22%.Indogsvolumeof

distributionatsteadystate(V

)was4.84and6.11L/kginmalesandfemalesrespectively. The

terminalhalf-lifeisintherange0.9to2.2hoursfollowingintramuscularadministration,andis

independentofdoseandsex.Theterminalhalf-lifemaybeslightlylongerfollowingintravenous

administration.Theterminalhalf-liferangesfrom6.4to15hoursfollowingsubcutaneous

administration.Totalplasmaclearance(CL)ofmethadonefollowingintravenousadministration

ishigh2.92to3.56L/h/kgorca70%to85%ofthecardiacplasmaoutputindogs(4.18L/h/kg).

Incatsmethadoneisalsorapidlyabsorbedfollowingintramuscularinjection(peakvaluesoccur

at20min),howeverwhentheproductisadministeredinadvertentlysubcutaneously(orin

anotherpoorlyvascularisedarea)absorptionwillbeslower.Theterminalhalf-lifeisintherange

of6to15hours.Clearanceismediumtolowwithamean(sd)valueof9.06(3.3)ml/kg/min.

Methadoneisextensivelyproteinbound(60to90%).Theopioidsarelipophilicandweakbases.

Thesephysiochemicalpropertiesfavourintracellularaccumulation.Consequently,opioidshavea

largevolumeofdistribution,whichgreatlyexceedstotalbodywater.Asmallamount(3to4%in

thedog)oftheadministereddoseisexcretedunchangedintheurine;theremainderis

metabolizedintheliverandsubsequentlyexcreted.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Sodiumchloride

Sodiumhydroxide(forpHadjustment)

Hydrochloricacid(forpHadjustment)

Waterforinjections

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproductexcepttheinfusionsolutionsindicatedin

section4.9.

Theproductisincompatiblewithinjectionfluidscontainingmeloxicamoranyothernonaqueous

solution.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

Chemicalandphysicalstabilityofthedilutionshasbeendemonstratedfor4hoursat25°C,

protectedfromlight.Frommicrobiologicalpointofviewthedilutionsshouldbeusedimmediately

6.4 Specialprecautionsforstorage

Storeintheoriginalpackagetoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

-VialsofuncolouredglasstypeI[Ph.Eur.]filledwith5,10,20,25,30and50ml.

-TefloncoatedchlorobutylrubberstoppertypeI[Ph.Eur.]securedwithaluminiumcap.

1vialinacardboardbox

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25

5531AEBladel,theNetherlands

8. MARKETINGAUTHORISATIONNUMBER

--------

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

02/2011

10.DATEOFREVISIONOFTHETEXT

MM/YYYY}or<monthYYYY

07/2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

ThisproductfallswithintheregimeofcontrolleddrugsScheduleII.

LABELLINGANDPACKAGELEAFLET

A.LABELLING

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

{NATURE/TYPE}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Comfortan10mg/ml,solutionforinjectionfordogsandcats

Spain,Italy,Portugal:Semfortan10mg/ml,solutionforinjectionfordogsandcats

France:Comfortan,solutionforinjectionfordogsandcats

Methadone

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:

Activesubstance:

Methadonehydrochloride10mg

Excipient(s):

Methylparahydroxybenzoate(E218)1.0mg

Propylparahydroxybenzoate(E216)0.2mg

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

5/10/20/25/30/50ml

5. TARGETSPECIES

Dogsandcats

6. INDICATION(S)

---

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year}

Oncebroached,useby..

11. SPECIALSTORAGECONDITIONS

Storeintheoriginalpackagtoprotectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25

5531AEBladel,theNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

-------

17. MANUFACTURER’SBATCHNUMBER

Batch{number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

{NATURE/TYPE}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Comfortan10mg/ml,solutionforinjectionfordogsandcats

Spain,Italy,Portugal:Semfortan10mg/ml,solutionforinjectionfordogsandcats

France:Comfortan,solutionforinjectionfordogsandcats

Methadone

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Eachmlcontains:

Activesubstance:

Methadonehydrochloride10mg

Excipient(s):

Methylparahydroxybenzoate(E218)1.0mg

Propylparahydroxybenzoate(E216)0.2mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

5/10/20/25/30ml

4. ROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

5. WITHDRAWALPERIOD

Notapplicable

6. BATCHNUMBER

Batch{number}

7. EXPIRYDATE

EXP{month/year}

Oncebroached,/opened,useby…

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

Comfortan10mg/ml,solutionforinjectionfordogsandcats.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

EurovetAnimalHealthB.V.

Handelsweg25

5531AEBladel,theNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Comfortan10mg/ml,solutionforinjectionfordogsandcats

Spain,Italy:Semfortanmethadone10mg/ml,solutionforinjectionfordogsandcats.

France:Comfortan,solutionforinjectionfordogsandcats

Methadone

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

Activesubstance:

Methadone 8.9mg

equivalenttomethadonehydrochloride 10mg,

Excipient(s):

Methylparahydroxybenzoate(E218)1.0mg

Propylparahydroxybenzoate(E216)0.2mg

4. INDICATION(S)

Analgesiaindogsandcats

Premedicationforgeneralanaesthesiaorneuroleptanalgesiaindogsandcatsincombinationwitha

neurolepticdrug.

5. CONTRAINDICATIONS

Donotuseinknowncasesofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseinanimalswithadvancedrespiratoryfailure.

Donotuseinanimalswithsevereliverandrenaldysfunction.

6. ADVERSEREACTIONS

Cats:Respiratorydepressionmaybeseen.Mildexcitatoryreactionshavebeenobservedincats:lip

licking,vocalisation,urination,defaecation,mydriasis,hyperthermiaanddiarrhoea.

Hyperalgesiahasbeenreported.Allreactionsweretransient.

Dogs:Respiratorydepressionmaybeseen.Mildreactionshavebeenobserved:panting,liplicking,

salivation,vocalisation,irregularbreathing,hypothermia,fixedstareandbodytremors.Occasional

urinationanddefaecationcanbeseenwithinthefirsthourpostdose.

Allreactionsweretransient.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogsandcats

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Analgesia

Dogs:0.5to1mgmethadonehydrochlorideperkgbodyweight,subcutaneously,intramuscularlyor

intravenously(correspondingto0.05to0.1ml/kg).

Cats:0.3to0.6mgperkgbodyweight,intramuscularly(correspondingto0.03to0.06ml/kg).

Toensureaccuracyofdosingincats,anappropriatelycalibratedsyringeshouldbeusedtoadminister

theproduct.

Astheindividualresponsetomethadoneisvaried,anddependspartlyonthedosage,theageofthe

patient,individualdifferencesinpainsensitivityandgeneralcondition(diseases,etc.),theoptimaldosing

regimenshouldbeindividuallybased.Indogsonsetofactionis1hourfollowingsubcutaneous

administration,approximately15minutesfollowingintramuscularinjectionandwithin10minutes

followingintravenousinjection.Durationofeffectisapproximately4hoursfollowingintramuscularor

intravenousadministration..Incatsonsetofactionis15minutesfollowingadministrationandthe

durationofeffectis4hoursinaverage.Theanimalshouldbeexaminedregularlytoassessifadditional

analgesiaissubsequentlyrequired.

Premedicationand/orneuroleptanalgesia

Dogs:

MethadoneHCl0.5-1mg/kg,IV,SCorIM

Combinationse.g.:

MethadoneHCl0.5mg/kg,IV+e.g.midazolamordiazepam

Inductionwithpropofol,maintenanceonisofluraneinoxygen.

MethadoneHCl0.5mg/kg+e.g.acepromazine

Inductionwiththiopentoneorpropofoltoeffect,maintenanceonisofluraneinoxygen.orinductionwith

diazepamandketamine.

MethadoneHCl0.5-1.0mg/kg,IVorIM+α

–agonist(e.g.xylazineormedetomidine)

Inductionwithpropofol,maintenancewithisofluraneincombinationwithfentanylortotalintravenous

anaesthesia(TIVA)protocol:maintenancewithpropofolincombinationwithfentanyl.

TIVAprotocol:inductionpropofol,toeffect.Maintenancewithpropofolandremifentanil.

Chemical-physicalcompatibilityhasonlybeendemonstratedfordilutions1:5withthefollowing

solutionsforinfusion:sodiumchloride0.9%,Ringersolution,andglucose5%.

Formatiert:Nichtunterstrichen

MethadoneHCl0.3to0.6mg/kg,IM

-InductionwithBenzodiazepine(e.g.midazolam)anddissociative(e.g.ketamine)

-Withatranquilizer(e.g.acepromazine)andNSAID(meloxicam)orsedative(e.g.α

-agonist):

-Inductionwithpropofol,maintenancewithisofluraneinoxygen.

Dosesdependonthedesireddegreeofanalgesiaandsedation,desireddurationofeffectandthe

concurrentuseofotheranalgesicsandanaesthetics.

Whenusedincombinationwithotherproducts,lowerdosagescanbeused.

Forsafeusewithotherpharmaceuticals,referencemustbemadetotherelevantproductliterature.

9. ADVICEONCORRECTADMINISTRATION

Refertosection8.

10. WITHDRAWALPERIOD

Notapplicable

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeintheoriginalpackagetoprotectfromlight.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

Chemicalandphysicalstabilityofthedilutionshasbeendemonstratedfor4hoursat25°C,protected

fromlight.Frommicrobiologicalpointofviewthedilutionsshouldbeusedimmediately

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Methadonemayoccasionallycauserespiratorydepressionandaswithotheropioiddrugs,careshould

betakenwhentreatinganimalswithimpairedrespiratoryfunctionoranimalsthatarereceivingdrugs

thatcancauserespiratorydepression.Toensuresafeuseoftheproduct,treatedanimalsshouldbe

monitoredregularly,includingexaminationofheartrateandrespiratoryrate.

Asmethadoneismetabolisedbytheliver,itsintensityanddurationofactionmaybeaffectedinanimals

withimpairedliverfunction.Incaseofrenal,cardiacorhepaticdysfunction,orshock,theremaybe

greaterriskassociatedwiththeuseoftheproduct.Thesafetyofmethadonehasnotbeen

demonstratedindogslessthan8weeksandcatslessthan5monthsofage.Theeffectofanopioidon

headinjuryisdependentonthetypeandseverityoftheinjuryandtherespiratorysupportsupplied.

Safetyhasnotbeenfullyevaluatedinclinicallycompromisedcats.Duetotheriskofexcitation,

repeatedadministrationincatsshouldbeusedwithcare.Thebenefit/riskratioforusingtheproduct

shouldbemadebytheattendingveterinarian.

Duetothevariableindividualresponsetomethadone,animalsshouldberegularlymonitoredtoensure

sufficientefficacyforthedesiredeffectduration.Useoftheproductmustbeprecededbyathorough

clinicalexamination.Incatspupildilatationisseenlongaftertheanalgesiceffecthasdisappeared.Itis

thereforenotanadequateparametertoassessclinicalefficacyoftheadministereddose.

Greyhoundsmayrequirehigherdosesthanotherbreedstoachieveefficaciousplasmalevels.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Methadonecancauserespiratorydepressionfollowingspillageontheskinoraccidentalselfinjection.

Avoidskin,eyesandmouthcontactandwearimpermeablegloveswhenhandlingtheproduct.Incase

ofspillingontheskinorsplashingintheeyes,washimmediatelywithlargeamountsofwater.Remove

contaminatedclothes.

Peoplewithknownhypersensitivitytomethadoneshouldavoidcontactwiththeveterinarymedicinal

product.Methadonehasthepotentialtocausestillbirths.Pregnantwomenareadvisednottohandlethe

product.

Inthecaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackage

inserttothephysicianbutDONOTDRIVEassedationmayoccur.

ADVICETODOCTORS:Methadoneisanopioidwhosetoxicitymaycauseclinicaleffects

includingrespiratorydepressionorapnoea,sedation,hypotensionandcoma.Whenrespiratory

depressionoccurscontrolledventilationshouldbeinstalled.Administrationoftheopioidantagonist

naloxonetoreversethesymptomsisrecommended.

Interactions:

Forconcurrentusewithneurolepticsrefertosection8.

Methadonecanpotentiatetheeffectsofanalgesics,centralnervoussysteminhibitersandsubstances

thatcauserespiratorydepression.Concomitantorsubsequentuseoftheveterinarymedicinalproduct

withbuprenorphinemayleadtolackofefficacy.

Incompatibilities:

Donotmixwithanyotherveterinaryproductexcepttheinfusionsolutionsindicatedinsection8.

Theproductisincompatiblewithinjectionfluidscontainingmeloxicamoranyothernonaqueous

solution.

Useduringpregnancyandlactation:

Methadonediffusesacrosstheplacenta.

Studiesinlaboratoryanimalshaveshownadverseeffectsonreproduction.

Thesafetyoftheproductduringpregnancyandlactationhasnotbeenassessedintargetspecies.The

useoftheproductisnotrecommendedduringpregnancy.

Overdose:

A1.5foldoverdoseresultedintheeffectsdescribedinsection6.

Cats:Incaseofoverdoses(>2mg/kg)thefollowingsignscanbeobserved:increasedsalivation,

excitation,hindlegparalysisandlossofrightingreflex.Seizures,convulsionandhypoxiawerealso

recordedinsomecats.Adoseof4mg/kgcouldbefatalincats.Respiratorydepressionhasbeen

described.

Dogs:Respiratorydepressionhasbeendescribed.

Methadonecanbeantagonizedbynaloxone.Naloxoneshouldbegiventoeffect.Astartingdoseof0.1

mg/kgintravenouslyisrecommended.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

July2012

15. OTHERINFORMATION

Notallpacksizesmaybemarketed.

ThisproductfallswithintheregimeofcontrolleddrugsScheduleII

17-12-2018


Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

12-12-2018

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

FDA - U.S. Food and Drug Administration

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

Europe - EMA - European Medicines Agency

10-12-2018


Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Europe - EMA - European Medicines Agency

5-12-2018

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

Europe - EMA - European Medicines Agency

29-11-2018


Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018


Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Europe - EMA - European Medicines Agency

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

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

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

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

7-6-2018

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Heartworm disease can be fatal to pets, but it is also preventable. Learn more about the dangers of heartworm disease and the importance of year-round prevention.

FDA - U.S. Food and Drug Administration

6-6-2018

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

FDA - U.S. Food and Drug Administration

11-5-2018

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

FDA - U.S. Food and Drug Administration

10-5-2018

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

FDA - U.S. Food and Drug Administration

19-4-2018

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

FDA - U.S. Food and Drug Administration

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

23-2-2018

Bella all Natural Issues Voluntary Nationwide Recall of Diet Capsules Labeled as Bella, Due to Presence of Sibutramine

Bella all Natural Issues Voluntary Nationwide Recall of Diet Capsules Labeled as Bella, Due to Presence of Sibutramine

Bella All Natural is voluntarily recalling its Diet Capsules labeled as Bella, Lot Number MFD:10.15.2017 EXP: 10.14.2019, to the consumer level.

FDA - U.S. Food and Drug Administration

28-5-2014

More than 10,000 websites shut down in global operation

More than 10,000 websites shut down in global operation

The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 we...

Danish 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

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

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

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

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

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/WAPabvM811

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/YRV0lVSRkh

FDA - U.S. Food and Drug Administration

21-5-2018

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/GzY50eEVp9

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

28-3-2018

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2007 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/083/10/T/01

Europe -DG Health and Food Safety