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
    Austria
  • 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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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

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

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

29-8-2018

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

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

Published on: Tue, 28 Aug 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 sintofen. To assess the occurrence of sintofen 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 ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 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 prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 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 napropamide. To assess the occurrence of napropamide 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 (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 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 myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

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

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

19-7-2018

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

17-7-2018

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

Bells, TN – The Pictsweet Company has recalled 960 cases of Pictsweet Farms 12-ounce Steam’ables Baby Brussels Sprouts because they may contain undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy may run the risk of serious allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

30-5-2018

12 applications for allocation of special funds related to medicinal cannabis

12 applications for allocation of special funds related to medicinal cannabis

The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.

Danish Medicines Agency

19-4-2018

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

FDA - U.S. Food and Drug Administration

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

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

27-7-2018

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5043 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/158/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene) - Transfer of orphan designation - Commission Decision (2018)5062 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/014/12/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Active substance: tafamidis) - Transfer of orphan designation - Commission Decision (2018)5066 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/12/T/01

Europe -DG Health and Food Safety

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration

19-7-2018

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2018)4839 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/128/12/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/12/999 (Merck Sharp and Dohme B.V.)

EU/3/12/999 (Merck Sharp and Dohme B.V.)

EU/3/12/999 (Active substance: Letermovir) - Transfer of orphan designation - Commission Decision (2018)4104 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/12/T/02

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

2-6-2018

EU/3/12/1046 (Novartis Europharm Limited)

EU/3/12/1046 (Novartis Europharm Limited)

EU/3/12/1046 (Active substance: Mavoglurant) - Transfer of orphan designation - Commission Decision (2018)3631 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/059/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Active substance: Panobinostat) - Transfer of orphan designation - Commission Decision (2018)3041 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Active substance: Humanised monoclonal antibody against P-selectin) - Transfer of orphan designation - Commission Decision (2018)3040 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/12/T/02

Europe -DG Health and Food Safety

6-4-2018

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Active substance: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor) - Transfer of orphan designation - Commission Decision (2018)2008 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/11/T/01

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Active substance: Chimeric monoclonal antibody against claudin 6) - Transfer of orphan designation - Commission Decision (2018)2009 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/147/12/T/01

Europe -DG Health and Food Safety

5-3-2018

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Active substance: Carbetocin) - Transfer of orphan designation - Commission Decision (2018)1425 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/11/T/01

Europe -DG Health and Food Safety