Clavubactin 50/12.5

Main information

  • Trade name:
  • Clavubactin 50/12.5
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clavubactin 50/12.5
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ampicillin and enzyme inhibitor
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0110/001
  • Authorization date:
  • 30-03-2011
  • EU code:
  • NL/V/0110/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN®50/12.5MGtabletsforcatsanddogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances: quantity

Amoxicillin

(asamoxicillintrihydrate) 50mg

Clavulanicacid

(aspotassiumclavulanate) 12.5mg

Excipient(s):

Saccharinsodium 0.70mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Yellowish-whitetolightyellowoblongtabletwithbreakmarkonbothsides.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionsincatsanddogscausedbybacteriasensitivetoamoxicillinincombinationwith

clavulanicacid,particularly:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwithStaphylococci(including

beta-lactamaseproducingstrains)andStreptococci.

- UrinarytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducingstrains),

Streptococci,Escherichiacoli(includingbeta-lactamaseproducingstrains),Fusobacterium

necrophorumandProteusspp.

- RespiratorytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducing

strains),StreptococciandPasteurellae.

- EnteritisassociatedwithEscherichiacoli(includingbeta-lactamaseproducingstrains)and

Proteusspp.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,Corynebacteria,

Staphylococci(includingbeta-lactamaseproducingstrains),Streptococci,Bacteroidesspp

(includingbeta-lactamaseproducingstrains),FusobacteriumnecrophorumandPasteurellae.

4.3 Contraindications

Donotuseinanimalswithknownhypersensivitytopenicillinorothersubstancesofthebeta-lactam

group.

Donotuseinseriousdysfunctionofthekidneysaccompaniedbyanuriaandoliguria.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

4.4 Specialwarningsforeachtargetspecies

Noneknown.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Nationalveterinaryguidelinesandpracticeswithrespecttotheuseofbroad-spectrumantibiotics

shouldbetakenintoaccount.

Donotuseincaseofbacteriasensitivetosmallspectrumpenicillinsortoamoxicillinassingle

substance.

Itisadvisedthatuponinitiatingtherapyappropriatesensitivitytestingisperformedandthattherapyis

continuedonlyaftersusceptibilitytothecombinationhasbeenestablished.

Inappropriateuseoftheproductmayincreasetheprevalenceofresistantbacteriaandmaydecrease

itseffectiveness.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbecarefullyevaluated.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivityreactions(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeserious.

- Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

- Whilehandlingtheproduct,avoidcontactwiththeskinandeyes.

- Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladvise

andshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

- Washhandsafteruse.

4..6Adversereactions(frequencyandseriousness)

Mildgastrointestinalsymptoms(diarrhea,nauseaandvomiting)mayoccurafteradministrationofthe

product.

Allergicreactions(skinreactions,anaphylaxia)mayoccasionallyoccur.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenicorfetotoxiceffects.

Nostudieshavebeenconductedinthepregnantandlactatingdogsandcats.Useonlyaccordingtothe

benefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Chloramphenicol,macrolides,sulfonamides,andtetracyclinesmayinhibittheantibacterialeffectsof

penicillins.

4.9 Amountstobeadministeredandadministrationroute

Posology

Fororaladministrationindogsandcats.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

Dosage

Therecommendeddoseis12.5mgofcombinedactivesubstance(=10mgamoxicillinand2.5mg

clavulanicacid)perkgbodyweight,twicedaily.

Animalweight Dosage

Upto2.5kg 1

tabletClavubactin®50/12.5

2.5-5kg 1tabletClavubactin®50/12.5

5-7.5kg 1 1 /

tabletClavubactin®50/12.5

7.5-10kg 2tabletsClavubactin®50/12.5

10-12.5kg 1

tabletClavubactin®250/62.5or2 1

tabletsofClavubactin®50/12.5

12.5-25kg 1tabletClavubactin®250/62.5

25-37.5kg 1 1 /

tabletClavubactin®250/62.5

37.5-50kg 1tabletClavubactin®500/125or2tabletsofClavubactin®250/62.5

Inrefractorycasesofskininfections,adoubledoseisrecommended(25mgperkgbodyweight,twice

daily).

Durationoftherapy

- Themajorityofroutinecasesrespondto5–10daysoftherapy.

- Inchroniccases,,alongercaseoftherapyisrecommendedasfollows:

Chronicskininfections 10-30daysorlongerinclinicalrefractorycasesorindeep

bacterialpyoderma(upto6-8weeks)dependingonclinical

response

Chroniccystitis 10-28days

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Mildgastrointestinalsymptoms(diarrhea,nauseaandvomiting)mayoccurmorefrequentlyafter

overdoseoftheproduct.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

5.1 Pharmacodynamicproperties

ATCvetcode:QJ01CR02

Amoxicillinisasemi-syntheticpenicillinwithbactericidalaction,belongingtothebetalactamantibiotic

group.Clavulanicacidisabeta-lactamaseinhibitorwithasimilarstructuretothepenicillinnucleus.

Resistancetoantibioticsfromthepenicillingroupisoftencausedbybeta-lactamaseenzymes.These

enzymesdestroytheantibioticbeforeitcanactonthebacteriathemselves.

Clavulanicacidbreaksthroughthisbacterialdefencemechanismbyinactivatingthebetalactamase.

Bacteriaproducingextra-chromosomalbeta-lactamases,whichareconsequentlyresistantto

amoxicillin,demonstrateinvitrosusceptibilityinthepresenceofclavulanicacid.Inveterinarypractice,

goodclinicalefficacyhasbeendemonstratedwitharatioof1partclavulanicacidto4partsamoxicillin.

Invitrothecombinationamoxicillin+clavulanicacidisactiveagainstawiderangeofclinically

importantaerobicandanaerobicbacteria.Goodsusceptibilityisshownwithseveralgram-positive

bacteriaincludingStaphylococci(includingbeta-lactamaseproducingstrains,MIC900.6

g/ml),

Clostridia(MIC900.5

g/ml),CorynebacteriaandStreptococci,andgram-negativebacteriaincluding

Bacteroidesspp(includingbetalactamaseproducingstrains,MIC900.5

g/ml),Pasteurellae(MIC90

0.12

g/ml),Escherichiacoli(includingbeta-lactamaseproducingstrains,MIC908

g/ml)and

Proteusspp(MIC900.5

g/ml).VariablesusceptibilityisfoundinsomeE.coliandKlebsiellaspp.

SusceptibilitytestsonbacterialpathogensfromcanineandfelineoriginrevealedthefollowingMIC50

valuesforafixedcombinationofamoxicillinandclavulanicacid(2:1):Proteusspp0.5

g/ml,

Staphylococcusintermedius0.094µg/ml,andBordetellabronchiseptica4µg/ml.

BacteriawithaMIC90of<2µg/mlareconsideredbeingsusceptibleandthosewithaMIC90of>8

µg/mlbeingresistant.ResistanceisshownamongEnterobacterspp,Pseudomonasaeruginosaand

methicillin-resistantStaphylococcusaureus.AtrendinresistanceofE.coliisreported.

5.2 Pharmacokineticparticulars

Thepharmacokineticbehaviourofclavulanicacidisroughlycomparablewiththatofamoxicillin.

Amoxicilliniswellabsorbedafteroraladministration.Indogs,thesystemicbioavailabilityis60-70%.

Amoxicillin(pKa2.8)hasarelativelysmallapparentdistributionvolume,lowplasma-proteinbinding

(34%indogs)andashorteliminationhalf-lifeperiodduetoactivetubularexcretionbythekidneys.

Afterabsorption,highestconcentrationsarefoundinthekidneys(urine)andbile,followedbytheliver,

lungs,heartandspleen.

Distributionofamoxicillinintocerebrospinalfluidislowunlessthemeningesareinflamed.

Clavulanicacid(pKa2.7)isalsowellabsorbedafteroraladministration.Penetrationintocerebrospinal

fluidispoor.Plasma-proteinbindingisabout25%andtheeliminationhalflifevalueisshort.Clavulanic

acidislargelyeliminatedbyrenalexcretion(unchangedintheurine).

ThepharmacokineticparametersofClavubactin®tabletsindogsandcatsafteroraladministrationofa

doseof25mgactivematerial(=20mgamoxicillin+5mgclavulanicacid)perkgbodyweightare

summarizedinthefollowingtable.

Cmax tmax t1/2 AUC∞

(µg/ml) (hour) (hour) h.µg/ml

Dog

Amoxicillin 11.41±2.74 1.38±0.41 1.52±0.19 36.57±7.31

Clavulanicacid 2.06±1.05 0.95±0.33 0.71±0.23 3.14±1.21

Cat

Amoxicillin 12.87±2.12 1.47±0.44 1.24±0.28 38.74±4.68

Clavulanicacid 4.60±1.68 0.72±0.26 0.63±0.16 6.18±2.19

Thereisevidencethatabsorptionofamoxicillinisanactiveprocessbothinanimalspeciesandinman

whichissaturableathigherdosesandisinfluencedbythepresenceofclavulanicacidwhichmay

competeforthesamedipeptidecarrier-mediatedsystem.Thismayalsoexplaintheobservedvariability

ofclavulanicacidabsorptionintargetspecies.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

microcrystallinecellulose,hypromellose,crospovidone,povidone,macrogol6000,stearicacid,saccharin

sodium,vanillaflavour,quinolineyellowlacquer(E104),titaniumdioxide(E171),colloidalanhydrous

silicaandmagnesiumstearate.

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

2years.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcontainer.

Storeoutofthereachofchildren.

Duringtherapytablethalvesshouldbestoredinadryplace(preferablyinthealuminium/aluminium

strip);nonusedhalvesaftertreatmentshouldbedisposed.

6.5 Natureandcompositionofimmediatepackaging

Aluminium/aluminiumstripswith2tablets,inacardboardboxcontaining5strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining5strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining25strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining50strips.

Aluminium/aluminiumstripswith10tablets,inacardboardboxcontaining10strips.

Aluminium/aluminiumstripswith10tablets,inacardboardboxcontaining25strips.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Wilgenweg7

NL-3421TVOudewater

theNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobeestablishednationally.

9. DATEOFRENEWALOFTHEAUTHORISATION

24April2007

10 DATEOFREVISIONOFTHETEXT

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Cardboardbox

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN50/12,5mgtabletsfordogsandcats.

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances:

Amoxicillin(asamoxicillintrihydrate) 50mg

Clavulanicacid(aspotassiumclavulanate) 12.5mg

Adjuvant(s):

Saccharinsodium 0.70mg

3. PHARMACEUTICALFORM

Tablet.

4. PACKAGESIZE

Aluminium/aluminiumstripswith2tablets,inacardboardboxcontaining5strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining5strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining25strips.

Aluminium/aluminiumstripswith4tablets,inacardboardboxcontaining50strips.

Aluminium/aluminiumstripswith10tablets,inacardboardboxcontaining10strips.

Aluminium/aluminiumstripswith10tablets,inacardboardboxcontaining25strips.

Notallpacksizesmaybemarketed.

5. TARGETSPECIES

Dogandcat.

6. INDICATION(S)

Treatmentofinfectionsincatsanddogscausedbybacteriasensitivetoamoxicillinincombinationwith

clavulanicacid,particularly:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwithStaphylococci(including

beta-lactamaseproducingstrains)andStreptococci.

- UrinarytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducingstrains),

Streptococci,Escherichiacoli(includingbeta-lactamaseproducingstrains),Fusobacterium

necrophorumandProteusspp.

- RespiratorytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducing

strains),StreptococciandPasteurellae.

- EnteritisassociatedwithEscherichiacoli(includingbeta-lactamaseproducingstrains)and

Proteusspp.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,Corynebacteria,

Staphylococci(includingbeta-lactamaseproducingstrains),Streptococci,Bacteroidesspp

(includingbeta-lactamaseproducingstrains),FusobacteriumnecrophorumandPasteurellae.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

<EXP{month/year}>

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25°C.

Storeintheoriginalpackage.

Duringtherapytablethalvesshouldbestoredinadryplace(preferablyinthealuminium/aluminium

strip);nonusedhalvesaftertreatmentshouldbedisposed.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasureswillhelp

toprotecttheenvironment.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Name:LeVetB.V.

Address:Wilgenweg7

3421TVOudewater

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

Tobeestablishednationally.

17. MANUFACTURER’SBATCHNUMBER

BatchLot{number}

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

(Aluminium/aluminiumstrip)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN50/12,5mgtabletvet.

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

3. EXPIRYDATE

EXP{month/year}………

4. BATCHNUMBER

LOT…….

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

CLAVUBACTIN50/12,5 mg tabletsfordogsandcats

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Name: LeVetB.V.

Address: Wilgenweg7

3421TVOudewater

TheNetherlands

Manufacturerforthebatchrelease:

Name: LosanPharmaGmb

Address: OttoHahnstrasse13

79395Neuenberg

Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLAVUBACTIN50/12,5mgtabletsforcatsanddogs.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstancespertablet:

Amoxicillin(asamoxicillintrihydrate)50mg

Clavulanicacid(aspotassiumclavulanate) 12.5mg

Otheringredients

Microcrystallinecellulose,hypromellose,crospovidone,povidone,macrogol6000,stearicacid,

saccharinsodium,vanillaflavour,quinolineyellowlacquer(E104),titaniumdioxide(E171),

colloidalanhydroussilicaandmagnesiumstearate.

4. INDICATION(S)

Treatmentofinfectionsincatsanddogscausedbybacteriasensitivetoamoxicillinincombination

withclavulanicacid,particularly:

- Skininfections(includingsuperficialanddeeppyodermas)associatedwithStaphylococci(including

beta-lactamaseproducingstrains)andStreptococci.

- UrinarytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducingstrains),

Streptococci,Escherichiacoli(includingbeta-lactamaseproducingstrains),Fusobacterium

necrophorumandProteusspp.

- RespiratorytractinfectionsassociatedwithStaphylococci(includingbeta-lactamaseproducing

strains),StreptococciandPasteurellae.

- EnteritisassociatedwithEscherichiacoli(includingbeta-lactamaseproducingstrains)and

Proteusspp.

- Infectionsoftheoralcavity(mucousmembrane)associatedwithClostridia,Corynebacteria,

Staphylococci(includingbeta-lactamaseproducingstrains),Streptococci,Bacteroidesspp

(includingbeta-lactamaseproducingstrains),FusobacteriumnecrophorumandPasteurellae.

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensivitytopenicillinorothersubstancesofthebetalactam

group.

Donotuseinseriousdysfunctionofthekidneysaccompaniedbyanuriaandoliguria.

Donotuseinrabbits,guineapigs,hamstersorgerbils.

6. ADVERSEREACTIONS

Mildgastrointestinalsymptoms(diarrhea,nauseaandvomiting)mayoccurafteradministrationofthe

product.Allergicreactions(skinreactions,anaphylaxia)mayoccasionallyoccur.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogsandcats.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Posology

Fororaladministrationonly.

Dosage

Therecommendeddoseis12.5mgofcombinedactivesubstance(=10mgamoxicillinand2.5mg

clavulanicacid)perkgbodyweight,twicedaily.

Animalweight Dosage

Upto2.5kg 1

tabletClavubactin®50/12.5

2.5-5kg 1tabletClavubactin®50/12.5

5-7.5kg 1 1 /

tabletClavubactin®50/12.5

7.5-10kg 2tabletsClavubactin®50/12.5

10-12.5kg 1

tabletClavubactin®250/62.5or

tabletsofClavubactin®50/12.5

12.5-25kg 1tabletClavubactin®250/62.5

25-37.5kg 1 1 /

tabletClavubactin®250/62.5

37.5-50kg 1tabletClavubactin®500/125or

2tabletsofClavubactin®250/62.5

Inrefractorycasesofskininfections,adoubledoseisrecommended(25mgperkg

bodyweight,twicedaily).

Durationoftherapy

- Themajorityofroutinecasesrespondto5–10daysoftherapy.

- Inchroniccases,,alongercaseoftherapyisrecommendedasfollows:

Chronicskininfections 10-30daysorlongerinclinicalrefractorycasesorindeep

bacterialpyoderma(upto6-8weeks)dependingonclinical

response

Chroniccystitis 10-28days

9. ADVICEONCORRECTADMINISTRATION

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Donotstoreabove25°C.

Storeintheoriginalpackage.

Keepoutofthereachandsightofchildren.

Duringtherapytablethalvesshouldbestoredinadryplace(preferablyinthealuminium/aluminium

strip);nonusedhalvesaftertreatmentshouldbedisposed.

DonotuseaftertheexpirydatestatedonthecartonafterEXP.

12. SPECIALWARNING(S)

Specialprecautionsforuse

Nationalveterinaryguidelinesandpracticeswithrespecttotheuseofbroad-spectrumantibiotics

shouldbetakenintoaccount.

Donotuseincaseofbacteriasensitivetosmallspectrumpenicillinsortoamoxicillinassingle

substance.

Itisadvisedthatuponinitiatingtherapyappropriatesensitivitytestingisperformedandthattherapyis

continuedonlyaftersusceptibilitytothecombinationhasbeenestablished.

Inappropriateuseoftheproductmayincreasetheprevalenceofresistantbacteriaandmaydecrease

itseffectiveness.

Inanimalswithhepaticandrenalfailure,thedosingregimenshouldbecarefullyevaluated.

Specialprecautionsforuseinanimals

None.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivityreactions(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeserious.

- Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

- Whilehandlingtheproduct,avoidcontactwiththeskinandeyes.

- Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladvise

andshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

- Washhandsafteruse.

Useduringpregnancyandlactation

Laboratorystudiesinratsandmicehavenotproducedanyevidenceofteratogenicorfetotoxiceffects.

Nostudieshavebeenconductedinthepregnantandlactatingdogsandcats.Useonlyaccordingtothe

benefit/riskassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Chloramphenicol,macrolides,sulfonamides,andtetracyclinesmayinhibittheantibacterialeffectsof

penicillins.

Overdose(symptoms,emergencyprocedures,antidotes)

Mildgastrointestinalsymptoms(diarrhea,nauseaandvomiting)mayoccurmorefrequentlyafter

overdoseoftheproduct.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

24April2007

15. OTHERINFORMATION

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

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The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

Enforcement Report for the Week of December 12, 2018

Enforcement Report for the Week of December 12, 2018

Recently Updated Records for the Week of December 12, 2018 Last Modified Date: Wednesday, December 12, 2018

FDA - U.S. Food and Drug Administration

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

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


16th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, European Medicines Agency, London, UK, from 07/12/2018 to 07/12/2018

16th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, European Medicines Agency, London, UK, from 07/12/2018 to 07/12/2018

16th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, European Medicines Agency, London, UK, from 07/12/2018 to 07/12/2018

Europe - EMA - European Medicines Agency

4-12-2018


Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 December 2018, European Medicines Agency, London, UK, from 04/12/2018 to 06/12/2018

Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 December 2018, European Medicines Agency, London, UK, from 04/12/2018 to 06/12/2018

Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 December 2018, European Medicines Agency, London, UK, from 04/12/2018 to 06/12/2018

Europe - EMA - European Medicines Agency

3-12-2018

PMS-Amoxicillin (2018-12-03)

PMS-Amoxicillin (2018-12-03)

Health Canada

29-11-2018


Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Europe - EMA - European Medicines Agency

28-11-2018


European Medicines Agency EudraVigilance and signal management information day, Hilton Canary Wharf, London, UK, from 07/12/2018 to 07/12/2018

European Medicines Agency EudraVigilance and signal management information day, Hilton Canary Wharf, London, UK, from 07/12/2018 to 07/12/2018

European Medicines Agency EudraVigilance and signal management information day, Hilton Canary Wharf, London, UK, from 07/12/2018 to 07/12/2018

Europe - EMA - European Medicines Agency

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

18-12-2018


Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

17-12-2018


Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Adcetris,brentuximab vedotin,  13/12/2018,  Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trecondi,treosulfan,  13/12/2018,  Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Besremi,ropeginterferon alfa-2b,  13/12/2018,  Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Lusutrombopag Shionogi,lusutrombopag,  13/12/2018,  Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rapiscan,regadenoson,  13/12/2018,  Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Miglustat Dipharma,miglustat,  13/12/2018,  Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Tobramycin PARI,tobramycin,  13/12/2018,  Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide,  13/12/2018,  Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Simponi,golimumab,  13/12/2018,  Positive

Summary of opinion: Simponi,golimumab, 13/12/2018, Positive

Summary of opinion: Simponi,golimumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Sprycel,dasatinib,  13/12/2018,  Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rizmoic,naldemedine,  13/12/2018,  Positive

Summary of opinion: Rizmoic,naldemedine, 13/12/2018, Positive

Summary of opinion: Rizmoic,naldemedine, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rubraca,rucaparib,  13/12/2018,  Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Zirabev,bevacizumab,  13/12/2018,  Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004,  06/12/2018,  Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Kriptazen,halofuginone,  06/12/2018,  Positive

Summary of opinion: Kriptazen,halofuginone, 06/12/2018, Positive

Summary of opinion: Kriptazen,halofuginone, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated),  06/12/2018,  Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Europe - EMA - European Medicines Agency

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

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

26-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration