Floxabactin

Main information

  • Trade name:
  • Floxabactin
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Floxabactin
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0135/001
  • Authorization date:
  • 08-01-2011
  • EU code:
  • NL/V/0135/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floxabactin15 mgtabletsforcatsanddogs

FloxabactinVet.(DK)

FloxabactinVet.15 mgtabletsforcatsanddogs(SE,NO, FI)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Enrofloxacin 15.0 mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Aslightlyyellow,round,convexsnap-tabtabletfororaladministrationto dogsandcats.

Thetabletcanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats

4.2 Indicationsforuse, specifyingthetargetspecies

Incats:

treatmentofupperrespiratorytractinfections

Indogs:

-treatmentoflowerurinarytractinfections(associatedornotwithprostatitis)andupper

urinarytractinfectionscausedbyEscherichiacoliorProteusmirabilis.

-Treatmentofsuperficialanddeep pyoderma.

4.3 Contraindications

Donotuseinyoungorgrowingdogs(dogsagedlessthan12months(smallbreed)orless

than18months(largebreed))astheproductmaycauseepiphysealcartilagealterationsin

growingpuppies.

Donotuseinyoung,growingcats,becauseofthepossibilityofthedevelopmentofcartilage

lesions.(catsagedlessthan3 monthsorweighinglessthan1kg).

Donotuseincatsordogshavingseizuredisorders,sinceenrofloxacinmaycauseCNS

stimulation.

Donotuseincatsordogswithknownhypersensitivitytofluoroquinolonesortoanyofthe

excipientsoftheproduct.

Donotuseincaseofresistancetoquinolones,asthereexistsalmostcompletecrossresistance

to otherquinolonesandcompletecrossresistancetootherfluoroquinolones.

Donotusewithtetracyclines,phenicolsormacrolidesbecauseofpotentialantagonistic

effects.

Pregnantandlactatinganimals,pleaseseesection4.7.

4.4 Specialwarningsforeachtargetspecies

Retinotoxiceffects,includingblindness,canoccurincatswhentherecommendeddoseis

exceeded.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itisprudenttoreservethefluoroquinolonesforthetreatmentofclinicalconditionsthathave

respondedpoorly,orareexpectedtorespondpoorly,tootherclassesofantibiotics.Whenever

possible,fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.Officialand

localantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.Useofthe

productdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttofluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwith

otherquinolonesduetothepotentialcrossresistance.

Usetheproductwithcautionincatsordogswithsevererenalorhepaticimpairment.

Pyodermaismostlysecondarytoanunderlyingdisease.Itisadvisabletodeterminethe

underlyingcauseandto treattheanimalaccordingly.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletto

thephysician.

Washhandsafterhandlingtheproduct.

Incaseofcontactwiththeeyes,rinseimmediatelywithplentyofwater.

Donothandletheproductincaseofknownhypersensitivitytotheproduct

4.6Adversereactions(frequencyandseriousness)

-Hypersensitivityreactions

-AlterationsinCentralNervousSystem

Cats:

Vomitingordiarrheamayappearduringthetreatment.Thesesignsregressspontaneouslyand

generallydo notrequiretreatmentdiscontinuation.

Dogs:

Possiblejointcartilagealterationsingrowingpuppies(see4.3 contraindications).

Inrarecasesvomitingandanorexiaareobserved.

4.7Useduringpregnancy,lactationorlay

Useduringpregnancy:

Studiesinlaboratoryanimals(rat,chinchilla)havenotproducedanyevidenceofa

teratogenic,foetotoxic,maternotoxiceffect.Useonlyaccordingtothebenefit/riskassessment

bytheresponsibleveterinarian.

Useduringlactation:

Asenrofloxacinpassesintothematernalmilk,theuseisnotrecommendedduringlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofflunixinshouldbeundercarefulveterinarymonitoring,astheinteractions

betweenthesedrugsmayleadtoadverseeventsrelatedto delayedelimination.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserumlevelsof

theophyllinemayincrease.

Concurrentuseofmagnesiumoraluminiumcontainingsubstances(suchasantacidsor

sucralfate)mayreduceabsorptionofenrofloxacin.Thesedrugsshouldbeadministeredtwo

hoursapart.

Donotadministersimultaneouslywithtetracyclines,phenicolsormacrolidesbecauseof

potentialantagonisticaffects.

Donotadministersimultaneouslywithnon-steroidalantiinflamatorydrugs,convulsionscan

occur

4.9 Amountstobeadministeredandadministrationroute

Oraluse

Dogs:

5 mgofenrofloxacin/kg/dayasasingledailydosing,i.e.onetabletfor3kgdailyfor:

-10 daysinlowerurinarytractinfections

-15daysinupperurinarytractinfectionsandlowerurinarytractinfectionsassociated

withprostatitis

-Upto 21 daysinsuperficialpyodermadependingonclinicalresponse

-Upto 49 daysindeep pyodermadependingonclinicalresponse

Cats

5 mgofenrofloxacin/kgbodyweightoncedailyfor5 to 10 consecutivedays.

-Either1 tabletfor3 kgbodyweightasasingledailydosing

-Or½ tabletfor1.5 kgbodyweightasasingledailydosing

Thetreatmentshouldbeconsideredincaseoflackofclinicalimprovementathalfofthe

treatmentduration.

Thetabletsmaybeadministereddirectlyinthemouthofthedogorcatorsimultaneously

withfoodifnecessary.

Donotexceedtherecommendedtreatmentdose.

Afterbreakingatablet,usetheremainingtablethalveforthenextdose.Storethetablethalve

intheoriginalblisterpocket

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosingcancausevomitingandnervoussigns(muscletremor,incoordinationand

convlusions)whichmayrequiretreatmentdiscontinuation.

Intheabsenceofanyknownantidote,applydrugeliminationmethodsandsymptomatic

treatment.

Ifnecessary,administrationofaluminium-ormagnesium-containingantacidsoractivated

carboncanbeusedtoreduceabsorptionofenrofloxacin.

Accordingtoliterature,signsofoverdosagewithenrofloxacinindogssuchasinappetence

andgastrointestinaldisturbancewereobservedatapproximately10timestherecommended

dosewhenadministeredfortwoweeks.Nosignsofintolerancewereobservedindogs

administered5 timestherecommendeddoseforamonths.

Inlaboratorystudies,ocularadverseeffectsincatshavebeenobservedfrom20 mg/kg.

Thetoxiceffectsontheretinacausedbyoverdosingmaybesuchthattheyleadtoirreversible

blindnessinthecat.

4.11Withdrawalperiod(s)

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Fluoroquinoloneantibiotics

ATCvetcode:QJ01MA90

5.1 Pharmacodynamicproperties

Enrofloxacinisasyntheticfluoroquinoloneantibioticthatexertsitsactivitybyinhibiting

topoisomeraseII,anenzymeinvolvedinthemechanismofbacterialreplication.

Enrofloxacinexertsbactericidalactivityconcentration-dependantwithsimilarvaluesof

minimalinhibitconcentrationandminimalbactericideconcentrations.Italsopossesses

activityagainstbacteriainthestationaryphasebyanalterationofthepermeabilityofthe

outermembranephospholipidcellwall.

Ingeneral,enrofloxacinexhibitsgoodactivityagainstmostgram-negativebacteria,especially

thoseoftheENterobacteriacea.Escherichiacoli,Klebsiellaspp.,Proteusspp.,and

Enterobacterspp.Aregenerallysusceptible.

Pseudomonasaeruginosaisvariablysusceptibleand,whenitissusceptible,usuallyhasa

higherMICthanothersusceptibleorganisms.

StaphylococcusaureusandStaphylococcusintermediususuallyaresusceptible.

Streptococci,enterococci,anaerobicbacteriacangenerallybeconsideredresistant.

Inductionofresistanceagainstquinolonescandevelopbymutationsinthegyrasegeneof

bacteriaandbychangesincellpermeabilitytowardsquinolones.

5.2 Pharmacokineticparticulars

Enrofloxacinisapproximately100%bioavailableafteroraladministration.Itisunaffectedby

food.Enrofloxacinisrapidlymetabolizedtoformanactivecompound,ciprofloxacin.

Afteradoseof5mg/kgbodyweight,maximumplasmalevelsofapproximately1.5µg/mLin

dogsandapproximately2.5 µg/mLincatsarereachedafter0.5 to 2.0 hours.

Enrofloxacinisprimarilyexcretedviathekidneys.Amajorportionoftheparentdrugandits

metabolitesisrecoveredinurine.

Enrofloxaciniswidelydistributedinthebody.Thetissueconcentrationsareoftenhigherthan

theserumconcentrations.Enrofloxacincrossestheblood-brainbarrier.Thedegreeofprotein

bindinginserumis14%indogsand8%incats.Thehalf-lifeliesbetween3.0and6.8hours

fordogsandcats,respectively.

Approximately25%ofthedoseofenrofloxacinisexcretedintheurineand75%viathe

faeces.Approximately60%(dogs)or15%(cats)ofthedoseisexcretedasunchanged

enrofloxacinintheurineandtheremainderasmetabolites,amongstothersciprofloxacin.The

totalclearanceisapproximately9 mL/minute/kgbodyweight.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Maizestarch

PovidoneK25

Cellulose,powdered

Croscarmellosesodium

Crospovidone

Colloidalanhydroussilica

Magnesiumstearate

6.2Incompatibilities

Notapplicable

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale: 3 years

Shelflifeofdividedtablets:24 hours

Anydividedtabletportionsremainingafter24 hoursshouldbediscarded.

6.4.Specialprecautionsforstorage

Veterinarymedicinalproductaspackagedforsale:No specialprecautionsforstorage.

Dividedtablets:Storebelow25°C.Dividedtabletsshouldbestoredintheblisterpack.

6.5Natureandcompositionofimmediatepackaging

Alu-PVC/PE/PVDCblisterorAlu-PVC/PVDCblisterwith10 tablets;

Boxwith1 blister(10tablets);

Boxwith2 blisters(20tablets);

Boxwith3 blisters(30tablets);

Boxwith5 blisters(50tablets);

Boxwith6 blisters(60tablets);

Boxwith10 blisters(100tablets);

Boxwith15 blisters(150tablets).

Notallpack sizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements

7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRST

10. DATEOFREVISIONOFTHETEXT

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Carton

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floxabactin15 mgtabletsforcatsanddogs

Enrofloxacin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachtabletcontains:

Enrofloxacin 15.0 mg

3. PHARMACEUTICALFORM

Tablets

4. PACKAGESIZE

10/20/30/50/60/100/150tablets

5. TARGETSPECIES

DogsandCats

6. INDICATIONS

7. METHODANDROUTE(S)OFADMINISTRATION

Fororaladministration.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNING(S),IFNECESSARY

Retinotoxiceffects,includingblindness,canoccurincatswhentherecommendeddoseis

exceeded.

10.EXPIRYDATE

EXP:(month/year)

11.SPECIALSTORAGECONDITIONS

Veterinarymedicinalproductaspackagedforsale:No specialprecautionsforstorage.

Dividedtablets:Storebelow25 0 C.

Dividedtabletsshouldbestoredintheblisterpack.

Anydividedtabletportionsremainingafter24 hoursshouldbediscarded.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONS

ORRESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly–to besuppliedonlyonveterinaryprescription..

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

{xxxxx}

17.MANUFACTURER’SBATCHNUMBER

Lot:

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

BLISTERS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floxabactin15mgtabletsforcatsanddogs

enrofloxacin

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

LeVet

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Lot{number}

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly–to besuppliedonlyonveterinaryprescription.

PACKAGELEAFLET

Floxabactin15 mgtabletsforcatsanddogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

Manufacturerforthebatchrelease:

ArtesanPharmaGmbH&Co KG

Wendlandstrasse1

29439 Lüchow

Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floxabactin15 mgtabletsforcatsanddogsEnrofloxacin

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

INGREDIENT(S)

Floxabactin15mgisaslightlyyellow,round,convexsnap-tabtabletfororaladministration

to dogsandcats.

Thetabletcanbedividedintoequalhalves.

Eachtabletcontains:

Activesubstance: Enrofloxacin15.0 mg

4. INDICATION(S)

Incats:

treatmentofupperrespiratorytractinfections

Indogs:

-treatmentoflowerurinarytractinfections(associatedornotwithprostatitis)andupper

urinarytractinfectionscausedbyEscherichiacoliorProteusmirabilis.

-Treatmentofsuperficialanddeep pyoderma.

5. CONTRAINDICATIONS

Donotuseinyoungorgrowingdogs(dogsagedlessthan12months(smallbreed)orless

than18months(largebreed))astheproductmaycauseepiphysealcartilagealterationsin

growingpuppies.

Donotuseinyoung,growingcats,becauseofthepossibilityofthedevelopmentofcartilage

lesions.(catsagedlessthan3 monthsorweighinglessthan1kg).

Donotuseincatsordogshavingseizuredisorders,sinceenrofloxacinmaycauseCNS

stimulation.

Donotuseincatsordogswithknownhypersensitivitytofluoroquinolonesortoanyofthe

excipientsoftheproduct.

Donotuseincaseofresistancetoquinolones,asthereexistsalmostcompletecrossresistance

to otherquinolonesandcompletecrossresistancetootherfluoroquinolones.

Donotusewithtetracyclines,phenicolsormacrolidesbecauseofpotentialantagonistic

effects.

6. ADVERSEREACTIONS

-Hypersensitivityreactions

-AlterationsinCentralNervousSystem

Cats:

Vomitingordiarrheamayappearduringthetreatment.Thesesignsregressspontaneouslyand

generallydo notrequiretreatmentdiscontinuation.

Dogs:

Possiblejointcartilagealterationsingrowingpuppies(see4.3 contraindications).

Inrarecasesvomitingandanorexiaareobserved.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthispackageleaflet,please

informyourveterinarysurgeon

7. TARGETSPECIES

DogsandCats

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

ADMINISTRATION

Oraluse

Dogs:

5mgofenrofloxacin/kg/dayasasingledailydosing,i.e.onetabletfor3kgdailyfor:

-10 daysinlowerurinarytractinfections

-15daysinupperurinarytractinfectionsandlowerurinarytractinfectionsassociated

withprostatitis

-Upto 21 daysinsuperficialpyodermadependingonclinicalresponse

-Upto 49 daysindeep pyodermadependingonclinicalresponse

Cats

5 mgofenrofloxacin/kgbodyweightoncedailyfor5 to 10 consecutivedays.

-Either1 tabletfor3 kgbodyweightasasingledailydosing

-Or½ tabletfor1.5 kgbodyweightasasingledailydosing

Thetreatmentshouldbeconsideredincaseoflackofclinicalimprovementathalfofthe

treatmentduration.

Thetabletsmaybeadministereddirectlyinthemouthofthedogorcatorsimultaneously

withfoodifnecessary.

Donotexceedtherecommendedtreatmentdose.

9. ADVICEONCORRECTADMINISTRATION

Afterbreakingatablet,usetheremainingtablethalveforthenextdose.Storethetablethalve

intheoriginalblisterpocket

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

DonotuseaftertheexpirydatestatedontheblisterandcartonafterEXP.

Veterinarymedicinalproductaspackagedforsale:No specialprecautionsforstorage.

Dividedtablets:Storebelow25°C.

Dividedtabletsshouldbestoredintheblisterpack

Anydividedtabletportionsremainingafter24 hoursshouldbediscarded

12. SPECIALWARNING(S)

Retinotoxiceffects,includingblindness,canoccurincatswhentherecommendeddoseis

exceeded.

Specialprecautionsforuseinanimals

Itisprudenttoreservethefluoroquinolonesforthetreatmentofclinicalconditionsthathave

respondedpoorly,orareexpectedtorespondpoorly,tootherclassesofantibiotics.Whenever

possible,fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.Officialand

localantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.Useofthe

productdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttofluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwith

otherquinolonesduetothepotentialcrossresistance.

Usetheproductwithcautionincatsordogswithsevererenalorhepaticimpairment.

Pyodermaismostlysecondarytoanunderlyingdisease.Itisadvisabletodeterminethe

underlyingcauseandto treattheanimalaccordingly.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletto

thephysician.

Washhandsafterhandlingtheproduct.

Incaseofcontactwiththeeyes,rinseimmediatelywithplentyofwater.

Donothandletheproductincaseofknownhypersensitivitytotheproduct

Useduringpregnancy,lactationorlay

Useduringpregnancy:

Studiesinlaboratoryanimals(rat,chinchilla)havenotproducedanyevidenceofa

teratogenic,foetotoxic,maternotoxiceffect.Useonlyaccordingtothebenefit/riskassessment

bytheresponsibleveterinarian.

Useduringlactation:

Asenrofloxacinpassesintothematernalmilk,theuseisnotrecommendedduringlactation.

Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofflunixinshouldbeundercarefulveterinarymonitoring,astheinteractions

betweenthesedrugsmayleadto adverseeventsrelatedto delayedelimination.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserumlevelsof

theophyllinemayincrease.

Concurrentuseofmagnesiumoraluminiumcontainingsubstances(suchasantacidsor

sucralfate)mayreduceabsorptionofenrofloxacin.Thesedrugsshouldbeadministeredtwo

hoursapart.

Donotadministersimultaneouslywithtetracyclines,phenicolsormacrolidesbecauseof

potentialantagonisticaffects.

Donotadministersimultaneouslywithnon-steroidalantiinflamatorydrugs,convulsionscan

occur

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Overdosingcancausevomitingandnervoussigns(muscletremor,incoordinationand

convlusions)whichmayrequiretreatmentdiscontinuation.

Intheabsenceofanyknownantidote,applydrugeliminationmethodsandsymptomatic

treatment.

Ifnecessary,administrationofaluminium-ormagnesium-containingantacidsoractivated

carboncanbeusedtoreduceabsorptionofenrofloxacin.

Accordingtoliterature,signsofoverdosagewithenrofloxacinindogssuchasinappetence

andgastrointestinaldisturbancewereobservedatapproximately10timestherecommended

dosewhenadministeredfortwoweeks.Nosignsofintolerancewereobservedindogs

administered5 timestherecommendeddoseforamonths.

Inlaboratorystudies,ocularadverseeffectsincatshavebeenobservedfrom20 mg/kg.

Thetoxiceffectsontheretinacausedbyoverdosingmaybesuchthattheyleadtoirreversible

blindnessinthecat.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<MM/JJJJ>

15. OTHERINFORMATION

Alu-PVC/PE/PVDCblisterorAlu-PVC/PVDCblisterwith10 tablets;

Boxwith1 blister(10tablets);

Boxwith2 blisters(20tablets);

Boxwith3 blisters(30tablets);

Boxwith5 blisters(50tablets);

Boxwith6 blisters(60tablets);

Boxwith10 blisters(100tablets);

Boxwith15 blisters(150tablets);

Notallpack sizesmaybemarketed.

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Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

Recently Updated Records for the Week of October 17, 2018 Last Modified Date: Monday, October 15, 2018

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

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

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-8-2018

Enforcement Report for the Week of August 15, 2018

Enforcement Report for the Week of August 15, 2018

Recently Updated Records for the Week of August 15, 2018 Last Modified Date: Monday, August 13, 2018

FDA - U.S. Food and Drug Administration

14-8-2018

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte neemt woensdagmiddag 15 augustus 2018 deel aan de herdenking van de capitulatie van Japan op 15 augustus 1945. De herdenking vindt plaats bij het Indisch Monument in Den Haag.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

18-7-2018

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Staatssecretaris Paul Blokhuis (VWS) wil het aantal zelfmoorden en zelfmoordpogingen terugdringen. Om dat te bereiken geeft hij structureel 2 miljoen per jaar extra instellingssubsidie aan 113Zelfmoordpreventie. Het jaarlijkse budget van de organisatie gaat daarmee fors omhoog, van 3,4 miljoen naar 5,4 miljoen euro. Daarnaast zijn er extra middelen voor andere lopende activiteiten zoals de lokale aanpakken suïcidepreventie en onderzoek. In totaal is daar 15 miljoen mee gemoeid.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

15-11-2018

Benepali (Samsung Bioepis NL B.V.)

Benepali (Samsung Bioepis NL B.V.)

Benepali (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018) 7557 of Thu, 15 Nov 2018

Europe -DG Health and Food Safety

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety