Forthyron

Main information

  • Trade name:
  • Thyforon flavoured 200 microgram tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Thyforon flavoured 200 microgram tablets for dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • levothyroxine sodium
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0388/001
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0388/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised: December2011

AN:01146/2010

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forthyronflavoured200microgramtabletsfordogs

UK:Thyforonflavoured200microgramtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

200microgramlevothyroxinesodiumpertabletequivalentto194microgram

levothyroxine

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet

Offwhiteroundtabletwithbrownspots,quadrisectwithsidescores

Thetabletsmaybedividedintohalvesorquarters

4. CLINICALPARTICULARS

4.1. Targetspecies

Dogs.

4.2. Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofhypothyroidismindogs.

4.3. Contra-indications

Donotuseindogssufferingfromuncorrectedadrenalinsufficiency.

Donotuseincasesofknownhypersensitivitytolevothyroxinesodium.

4.4. Specialwarningsforeachtargetspecies

Thediagnosishypothyroidismshouldbeconfirmedwithappropriatetests.

4.5. Specialprecautionsforuse

Specialprecautionsforuseinanimals

Asuddenincreaseindemandforoxygendeliverytoperipheraltissues,plusthe

chronotropiceffectsoflevothyroxinesodium,mayplaceunduestressonapoorly

functioningheart,causingdecompensationandsignsofcongestiveheartfailure.

Hypothyroiddogssufferingfromhypoadrenocorticismhaveadecreasedabilityto

metaboliselevothyroxinesodiumandthereforeanincreasedriskofthyrotoxicosis.

Dogswithconcurrenthypoadrenocorticismandhypothyroidismshouldbestabilised

withglucocorticoidandmineralocorticoidtreatmentpriortotreatmentwithlevothyroxine

sodiumtoavoidprecipitatingahypoadrenocorticalcrisis.Afterthis,thyroidtests

shouldberepeated,thengradualintroductionoflevothyroxinetherapy,startingwith25%

Revised: December2011

AN:01146/2010

Page2of6

ofthenormaldose,increasingby25%incrementseveryfortnightuntiloptimal

stabilisationisachievedisrecommended.Gradualintroductionoftherapyisalso

recommendedfordogswithotherconcurrentillnesses;particularlyindogswithcardiac

disease,diabetesmellitusandrenalorhepaticdysfunction.

Specialprecautionstobetakenbythepersonadministeringthemedicinal

producttoanimals

Washhandsafteradministeringthetablets.Pregnantwomenshouldhandletheproduct

withcaution.Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.Note:thisproductcontainsahigh

concentrationofL-thyroxinesodiumandmaypresentarisktohumans,inparticular

children,ifingested.

4.6. Adversereactions(frequencyandseriousness)

Restorationofphysicalactivitymayunmaskorintensifyotherproblems,suchas

osteoarthrosis.Adversereactionsofthyroidhormonesaregenerallyassociatedwith

excessivedosageandcorrespondtothesymptomsofhyperthyroidism.Seealso

section4.10.

4.7. Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinpregnantor

lactatingbitches.However,levothyroxineisanendogenoussubstanceandthyroid

hormonesareessentialforthedevelopingfoetus,especiallyduringthefirstperiodof

gestation.Hypothyroidismduringpregnancymayresultinmajorcomplicationssuchas

foetaldeathandapoorperinataloutcome.Maintenancedoseoflevothyroxinesodium

mayneedadjustmentduringpregnancy.Pregnantbitchesshouldthereforebe

monitoredonaregularbasefromconceptionuntilseveralweeksafterdelivery.

4.8.Interactionswithothermedicinalproductsandotherformsofinteraction

Avarietyofdrugsmayimpairplasmaortissuebindingofthethyroidhormonesoralter

thyroidhormonemetabolism(eg.barbiturates,antacids,anabolicsteroids,diazepam,

furosemide,mitotane,phenylbutazone,phenytoin,propranolol,largedosesof

salicylates,andsulphonamides.).Whentreatingdogsthatarereceivingconcurrent

medicationthepropertiesofthesedrugsshouldbetakenintoconsideration.

Estrogensmayincreasethyroidrequirements.

Ketaminemaycausetachycardiaandhypertensionwhenusedinpatientsreceiving

thyroidhormones.Theeffectofcatecholaminesandsympaticomimeticsisincreasedby

levothyroxine.

Anincreaseinthedosageofdigitalismaybenecessaryinapatientthathadpreviously

compensatedcongestiveheartfailureandthatisplacedonthyroidhormone

supplementation.Followingtreatmentofhypothyroidismindogswithconcurrent

diabetes,carefulmonitoringofdiabeticcontrolisrecommended.

Mostdogsonchronichigh-dose,dailyglucocorticoidtherapywillhaveverylowor

Revised: December2011

AN:01146/2010

Page3of6

undetectableserumT

concentrations,aswellassubnormalT

values.

4.9 Amountstobeadministeredandadministrationroute

Therecommendedstartingdosageoflevothyroxinesodiumis10µg/kgbodyweight

orallyevery12hour.Becauseofvariabilityinabsorptionandmetabolism,thedosage

mayrequirealterationsbeforeacompleteclinicalresponseisobserved.Theinitial

dosageandfrequencyofadministrationaremerelyastartingpoint.Therapyhastobe

highlyindividualisedandtailoredtotherequirementsoftheindividualdog.When

initiatingdosingofdogsweighinglessthan5kgbodyweight,aquarterofone200μg

tabletshouldbeadministeredoncedaily.Suchcases

shouldbemonitoredcarefully.Inthedog,absorptionoflevothyroxinesodiummaybe

affectedbythepresenceoffood.Thetimingoftreatmentanditsrelationtofeeding

shouldthereforebekeptconsistentfromdaytoday.Toadequatelymonitortherapy,

troughvalues(justpriortotreatment)andpeakvalues(aboutthreehoursafterdosing)

ofplasmaT

canbemeasured.Inadequatelydoseddogspeakplasmaconcentration

ofT

shouldbeinthehigh-normalrange(approximately30to47nmol/l)andtrough

valuesshouldbeaboveapproximately19nmol/l.IfT

levelsareoutsidethisrangethe

levothyroxinedosecanbeadjustedin50to200µgincrementsuntilthepatientis

clinicallyeuthyroidandserumT

iswithinthereferencerange.PlasmaT

levelscanbe

retestedtwoweeksafterchangeofdosage,butclinicalimprovementisanequally

importantfactorindeterminingindividualdosageandthiswilltakefourtoeightweeks.

Whentheoptimumreplacementdosehasbeenattained,clinicalandbiochemical

monitoringmaybeperformedevery6 –12months.

Tobreakatabletaccuratelyandeasily,placethetabletscoreside

upandapplypressurewithyourthumb.

Tobreakthetabletintwoparts;holdonehalfofthetabletdownandpressdownthe

otherhalf.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Followingadministrationofoverdosesthyrotoxicosiscouldoccur.Thyrotoxicosisasa

sideeffectofmildoversupplementationisuncommonindogs,owingtothecanine

abilitytocatabolizeandexcretethyroidhormones.Incaseofaccidentalintakeoflarge

amountsoftheveterinarymedicinalproductabsorptioncanbedecreasedbyinduction

ofvomitingandoraladministrationofbothactivatedcharcoalandmagnesiumsulphate

once.

Overdosesofthreeuptosixtimeslabelrecommendedstartingdosefor4consecutive

weeksinhealthy,euthyroiddogsresultedinnosignificantclinicalsignsthatcouldbe

attributedtotreatment.Singleoverdoseupto3-6xtherecommendeddosedoesnot

poseathreattothedog,andnoactionsarenecessary.However,followingchronic

Revised: December2011

AN:01146/2010

Page4of6

over-supplementation,clinicalsignsofhyperthyroidismsuchaspolydipsia,polyuria,

panting,weightlosswithoutanorexia,andeitherorbothtachycardiaandnervousness

maytheoreticallyoccur.ThepresenceofthesesignsshouldresultinevaluationofT

serumconcentrationstoconfirmthediagnosis,andimmediatediscontinuanceofthe

supplementation.Oncethesignshaveabated(daystoweeks),thethyroiddosagehas

beenreviewed,andtheanimalhasfullyrecovered,alowerdosagemaybeinstituted,

withtheanimalbeingmonitoredclosely.

4.11.Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:syntheticthyroidhormones

ATCvetcode:QH03AA01.

5.1. Pharmacodynamicproperties

Pharmacologicallylevothyroxineisclassifiedasahormonalpreparationthatreplaces

deficientendogenoushormones.

LevothyroxineT

isconvertedtotriiodothyronineT

actsoncellularprocessesvia

specificligand-receptorinteractionswiththenucleus,themitochondria,andtheplasma

membrane.InteractionofT

withbindingsitesleadstoaugmentedtranscriptionofDNA

ormodulationofRNA,thusinfluencingproteinsynthesisandenzymeaction.

Thyroidhormonesactonmanydifferentcellularprocesses.Indevelopinganimalsand

humanbeings,theyarecrucialdeterminantsofnormaldevelopment,especiallyinthe

centralnervoussystem.Thyroidsupplementationincreasesbasalcellularmetabolism

andoxygenconsumptiontherebyaffectingthefunctionofvirtuallyallorgansystems.

5.2. Pharmacokineticparticulars

SomedogsappearedtoconsistentlyeitherabsorbL-thyroxinebetterand/oreliminateit

moreslowlythandootherdogs.Furthermoreabsorptionandeliminationrateis

influencedbydailyintakeoflevothyroxinesodium(highabsorption/loweliminationin

caseoflowintakeandviceversaincaseofhighintake).Thevariabilityin

pharmacokineticparametersbetweenindividualdogsisconsiderableand,althoughthe

presenceoffoodmayaffectabsorption,itisconsideredtohaveaminoreffectonthe

parametersoverall.Absorptionisrelativelyslowandincomplete:InmostcasesT

occursbetween1to5hoursafteroraladministration,meanC

variesmorethan3

foldbetweendogsonthesamedoses.Inadequatelydoseddogstheplasmapeak

approachesorslightlyexceedstheupperlimitofnormalplasmaT

levels,andbythe

endof12hoursafteroraladministration,plasmaT

usuallydeclinestothelowerhalfof

thenormalrange.TheratesofdisappearanceofT

fromtheplasmaareslowedin

hypothyroidism.Alargepartofthethyroxineistakenupbytheliver.L-thyroxineisbound

toplasma-proteinsandplasmalipoproteins.Partofadoseofthyroxineismetabolised

tothemorepotenttriiodothyronine(T

)bydeiodination.Theprocessofdeiodination

Revised: December2011

AN:01146/2010

Page5of6

continues.Thesefurtherdeiodinatedmetabolicproducts(otherthanT

andT

)donot

havethyromimeticactivity.Otherpathwaysofthyroidhormonemetabolisminclude

conjugationtoformsolubleglucuronidesandsulphatesforbiliaryorurinaryexcretionas

wellascleavageoftheetherlinkageoftheiodothyroninemolecule.Inthedog,over

50%oftheT

producedeachdayarelostinthefaeces.Theextrathyroidalbodystores

ofT

areeliminatedandreplacedinabout1day.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Calciumhydrogenphosphatedihydrate,

Cellulose,Microrcrystalline,

SodiumStarchGlycolate(typeA),

Magnesiumstearate.

Naturalmeatflavour

6.2. Incompatibilities

Notapplicable

6.3. Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeofremainingtabletparts:4days.

6.4. Specialprecautionsforstorage

Donotstoreabove25°C.

Returnanydividedtablettotheopenedblisterandusewithin4days.

6.5. Natureandcontentsofimmediatepackaging

Theproductispackagedinablister[Aluminium(20µm)-PVC/PE/PVDC(250/30/90)

white].

10Tabletsperblister,5or25blisterspercarton,50or250tabletspercarton.

Notallpacksizesmaybemarketed.

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerials,derivedfromtheuseofsuchproductsif

appropriate.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25,5531AEBladel

Revised: December2011

AN:01146/2010

Page6of6

TheNetherlands

8. MARKETINGAUTHORIZATIONNUMBER

Vm16849/4034

9. DATEOFFIRSTAUTHORISATION

22November2011

10. DATEOFREVISIONOFTHETEXT

December2011

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Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

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

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

20-10-2018

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

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

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

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

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

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

The hair dryer and power cord can overheat and catch on fire, posing fire, burn and electrical shock hazards.

Health Canada

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

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

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency