Clavaseptin

Main information

  • Trade name:
  • Clavaseptin 62.5mg Palatable tablets for dogs and cats
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clavaseptin 62.5mg Palatable tablets for dogs and cats
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amoxicillin and enzyme inhibitor
  • Therapeutic area:
  • Cats Non Food, Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0209/004
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0209/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:April2013

AN:00043/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Name Countries

Clavaseptin62.5mgPalatabletabletsfordogs

andcats Belgium, Bulgaria, Cyprus,

Greece, Czech Republic,

Hungary, Ireland, Latvia,

Lithuania,Netherlands,Poland,

Romania,Slovakia,Slovenia,

UK,Portugal,Spain

ClavaseptinP62.5mgTabletsfordogsandcats France,Luxembourg

Clavaseptin62.5mg –Tabletsfordogsandcats Austria,Germany,Italy

Clavaseptin50mg/12.5mgTabletsfordogsand

cats Denmark, Finland, Sweden,

Norway

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

Activeingredients:

Amoxicillin(asamoxicillintrihydrate)……………….……………..……….50.000mg

Clavulanicacid(aspotassiumclavulanate)…………………………..…

12.500mg

Excipients

Brownironoxide(E172)………………………………….…..…….….. 0.120mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Beigescoredtabletthatcanbedividedintohalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats

4.2 Indicationsforuse,specifyingthetargetspecies

Indogs:treatmentoradjunctivetreatmentofperiodontalinfectionscausedby

bacteriasusceptibletoamoxicillinincombinationwithclavulanicacidi.e.Pasteurella

spp,StreptococcussppandEscherichiacoli.

Incats:treatmentofskininfections(includingwoundsandabscesses)causedby

bacteriasusceptibletoamoxicillinincombinationwithclavulanicacidi.e.Pasteurella

spp,Staphylococcusspp,StreptococcussppandEscherichiacoli.

Issued:April2013

AN:00043/2012

Page2of6

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstances

oftheβ-lactamgroup.

Donotadministertogerbils,guineapigs,hamsters,rabbitsandchinchillas.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Inadditiontosection4.3contraindications:

Inanimalswithimpairedliverandkidneyfunction,theuseoftheproductshouldbe

subjecttoarisk/benefitevaluationbytheveterinarysurgeonandtheposology

evaluatedcarefully.

Cautionisadvisedintheuseinsmallherbivoresotherthanthosein4.3.

Useoftheproductshouldbebasedonsusceptibilitytesting.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistantto

amoxicillin/clavulanicacid.Useoftheproductshouldtakeintoaccountofficialand

localantimicrobialpolicies.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmaylead

tocrossreactionstocephalosporinsandviceversa.Allergicreactionstothese

substancesmayoccasionallybeserious.

1. Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeen

advisednottoworkwithsuchpreparations.

2. Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

3. Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshould

seekmedicaladviceandshowthedoctorthiswarning.

Swellingoftheface,lipsoreyesordifficultybreathingaremoreserious

symptomsandrequireurgentmedicalattention.

Washhandsafterhandlingthetablets.

4.6Adversereactions(frequencyandseriousness)

Vomitinganddiarrhoeamaybeobserved.Treatmentmaybediscontinueddepending

ontheseverityoftheundesirableeffectsandabenefit/riskevaluationbythe

veterinarysurgeon.

Hypersensitivityreactions(allergicskinreactions,anaphylaxis)maybeobserved.In

thesecases,administrationshouldbediscontinuedandasymptomatictreatment

given.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasnotbeenestablishedduringpregnancyandlactation.

Laboratorystudiesinratshavenotproducedanyevidenceofteratogenic,foetotoxic

Issued:April2013

AN:00043/2012

Page3of6

ormaternotoxiceffects.Usetheproductonlyaccordingtothebenefit/risk

assessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidalactivityofamoxicillinmaybereducedbythesimultaneoususeof

bacteriostaticsubstancessuchasmacrolides,tetracyclines,sulfonamidesand

chloramphenicol.

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddoseoftheproductis10mgamoxicillin/2.5mgclavulanicacid

perkgbodyweighttwiceadaybytheoralrouteindogsandcats,i.e.1tabletper5

kgbodyweightevery12h,accordingtothefollowingtable:

Bodyweight(kg) Numberoftabletstwicedaily

[1.0-2.5] ½

[2.6-5.0] 1

[5.1-7.5] 1½

[7.6-10.0] 2

Insevereinfections,thedosemaybedoubledto20mgamoxicillin/5mgclavulanic

acid/kgbodyweighttwicedaily.

Durationoftreatment:

-7daysforthetreatmentofperiodontalinfectionsindogs.

-7daysforthetreatmentofskininfectionsincats(includingwoundsand

abscesses).Theclinicalstatusofanimalsshouldbere-evaluatedafter7daysand

thetreatmentprolongedforafurther7daysifnecessary.Severecasesofskin

infectionmayrequireanevenlongerdurationoftreatmentandthisshouldbeatthe

discretionoftheresponsibleveterinarian.

Toensurethecorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunder-dosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Atthreetimestherecommendeddoseforaperiodof28days,adecreasein

cholesterolvaluesandepisodesofvomitingwereobservedincatsanddiarrhoea

wasobservedindogs.Intheeventofanoverdosesymptomatictreatmentisadvised.

4.11Withdrawalperiod(s)

Notapplicable.

Issued:April2013

AN:00043/2012

Page4of6

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:anti-infectiveforsystemicuse;amoxicillinandenzyme

inhibitor.

ATCVetcode:QJ01CR02

5.1Pharmacodynamicproperties

Amoxicillinisanaminobenzylpenicillinfromtheβ-lactampenicillinfamilywhich

preventsthebacterialcellwallformationbyinterferingwiththefinalstepof

peptidoglycansynthesis.

Clavulanicacidisanirreversibleinhibitorofintracellularandextracellularβ-

lactamaseswhichprotectsamoxicillinfrominactivationbymanyβ-lactamases.

Amoxicillin/clavulanatehasawiderangeofactivitywhichin cludesβ-lactamase

producingstrainsofbothGram-positiveandGram-negativeaerobes,facultative

anaerobesandobligateanaerobes.

Amoxicillin/clavulanicacidbreakpoints(NCCLS/2002):

Staphylococci:sensitive:MIC<4/2µg/ml,resistant:MIC>8/4µg/ml

Otherorganisms:sensitive:MIC<8/4µg/ml,resistant:MIC>32/16µg/ml

IndogperiodontalinfectionsinEurope(isolatesoftheyear2002fromFrance,

GermanyandBelgium)amoxicillin/clavulanicacidcombinationinaratio2/1showed

thefollowingdataonsensitivity:

Streptococcusspp.:MIC

:0.4/0.2µg/ml,

Pasteurellaceae:MIC

:0.4/0.2µg/ml,

Escherichiacoli:MIC

:5.3/2.6µg/ml,

IncatskininfectionsincludingwoundsandabscessesinEurope(isolatesoftheyear

2002fromFrance,GermanyandBelgium)amoxicillin/clavulanicacidcombinationin

aratio2/1showedthefollowingdataonsensitivity:

Pasteurellaceae:MIC

:0.66/0.3µg/ml,

Staphylococcaceae:MIC

:0.4/0.2µg/ml,

Streptococcaceae:MIC

:0.4/0.2µg/ml,

Escherichiacoli:MIC

:7.0/3.5µg/ml,

Only1.5%ofallisolatedstrainswereresistant.

Resistance toβ-lactamantibioticsismainlymediatedbyβ-lactamaseswhich

hydrolyzeantibioticssuchasamoxicillin.

Susceptibilityandresistancepatternscanvarywithgeographicalareaandbacterial

strain,andmaychangeovertime.

5.2 Pharmacokineticparticulars

Afteroraladministrationattherecommendeddoseindogsandcats,theabsorption

ofamoxicillinandclavulanicacidisfast.Indogs,themaximumplasmaconcentration

ofamoxicillinof8.5µg/mlisreachedin1.4handthemaximumplasmaconcentration

Issued:April2013

AN:00043/2012

Page5of6

ofclavulanicacidof0.9µg/mlisreachedin0.9h.Halflifeis1hourindogsforboth

substances.

Incats,themaximumplasmaconcentrationofamoxicillinof6.6µg/mlisreachedin

1.8handthemaximumplasmaconcentrationofclavulanicacidof3.7µg/mlis

reachedin0.75h.Halflifeis1to2hoursincatsforbothsubstances.

Eliminationisalsofast.12%oftheamoxicillinand17%ofclavulanicacidis

excretedintheurine.Theremainderisexcretedasinactivemetabolites.

Afterrepeatedoraladministrationoftherecommendeddoseindogsandcats,there

isnoaccumulationofamoxicillinorclavulanicacidandthesteadystateisreached

rapidlyafterfirstadministration.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

BrownironoxideE172

Crospovidone

PovidoneK25

Silicondioxide

Microcrystallinecellulose

Liveraroma

Yeastaroma,

Magnesiumstearate

Hypromellose

6.2Incompatibilities

Noneknown

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeafterfirstopeningtheimmediatepackaging:12hours.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

Returnanyhalvedtabletstotheopenedstrip-packandusewithin12hours.

6.5Natureandcompositionofimmediatepackaging

Aluminium/aluminiumstrippackwith10tablets/strip

Cardboardbox:Packsizesof10,100,250and500tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Issued:April2013

AN:00043/2012

Page6of6

7. MARKETINGAUTHORISATIONHOLDER

VetoquinolUKLtd

VetoquinolHouse

GreatSlade

BuckinghamIndustrialPark

Buckinghamshire

MK181PA

8. MARKETINGAUTHORISATIONNUMBER

Vm08007/4135

9. DATEOFFIRSTAUTHORISATION

17April2013

10. DATEOFREVISIONOFTHETEXT

April2013

Approved: 17/04/2013

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The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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

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

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

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

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

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

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

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

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

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

15-10-2018

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Health Canada's sampling and evaluation program has determined the Barrel-O-Slime toy does not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Active substance: Tofacitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7554 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004214/T/0015

Europe -DG Health and Food Safety

12-11-2018

Tracleer (Janssen-Cilag International NV)

Tracleer (Janssen-Cilag International NV)

Tracleer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7556 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000401/T/0088

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety