Milbemax

Main information

  • Trade name:
  • Milbemax tablets for Cats
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Milbemax tablets for Cats
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Milbemycin, combinations
  • Therapeutic area:
  • Cats

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0135/004
  • Authorization date:
  • 17-04-2011
  • EU code:
  • FR/V/0135/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

MILBEMAXCatsFinalSPCRENEWALJuly2007

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MILBEMAX ®

Film-coatedtabletsforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstances:

Milbemycinoxime

Praziquantel

16mg

40mg

Excipients:

Titaniumdioxide(E171)

Ironoxide(E172) 0.312mg

0.312mg

ExcipientsQSPonedivisabletabletof130mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Film-coatedtablet

Oblong shaped,darkred,withascoreononeside.Onesidebearstheimprint“KK”,

theotherside“NA”.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats

4.2 Indicationsforuse

Incats:treatmentofmixedinfectionsbyimmatureandadultcestodesand

nematodesofthefollowingspecies:

MILBEMAXCatsFinalSPCRENEWALJuly2007

-Cestodes:

Dipylidiumcaninum

Taeniaspp.

Echinococcusmultilocularis

-Nematodes:

Ancylostomatubaeforme

Toxocaracati

Preventionofheartwormdisease(Dirofilariaimmitis)ifconcomitanttreatmentagainst

cestodesisindicated

4.3 Contra-indications

Donotuseincatsweighinglessthan2kg

4.4 Specialwarnings

None

4.5 Specialprecautionsforuse,includingspecialprecautionstobetakenby

thepersonadministeringthemedicinalproducttoanimals

Specialprecautionsforuseinanimals

Aspergoodveterinarypractice,animalsshouldbeweighedtoensureaccurate

dosing

Echinococcosisrepresentsahazardforhumans.IncaseofEchinococcosis,specific

guidelinesonthetreatmentandfollowupandonthesafeguardofpersonshavetobe

followed.Expertsorinstitutesofparasitologyshouldbeconsulted.

Nostudieshavebeenperformedwithseverelydebilitatedcatsorindividualswith

seriouslycompromisedkidneyorliverfunction.Theproductisnotrecommendedfor

suchanimalsoronlyaccordingtoabenefit/riskassessmentbytheresponsible

veterinarian.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

producttoanimals

Washhandsafteruse.

Intheeventofaccidentalingestionofthetablets,particularlybyachild,seekmedical

adviceimmediatelyandshowthepackageleafletorthelabeltothedoctor.

4.6 Adversereactions(frequencyandseriousness)

Inveryrareoccasions,especiallyinyoungcats,systemicsigns(suchaslethargy),

neurologicalsigns(suchasataxiaandmuscletremors)and/orgastrointestinalsigns

MILBEMAXCatsFinalSPCRENEWALJuly2007

(suchasemesisanddiarrhoea.)havebeenobservedafteradministrationofthe

veterinarymedicinalproduct.

4.7 Useduringpregnancyandlactation

MILBEMAXcanbeusedinbreedingcatsincludingpregnantandlactatingqueens.

4.8 Interactionwithothermedicamentsandotherformsofinteraction

TheconcurrentuseofMILBEMAXwithselamectiniswelltolerated.Nointeractions

wereobservedwhentherecommendeddoseofthemacrocycliclactoneselamectin

wasadministeredduringtreatmentwithMILBEMAXattherecommendeddose.Inthe

absenceoffurtherstudies,cautionshouldbetakeninthecaseofconcurrentuseof

MILBEMAXandothermacrocycliclactones.Also,nosuchstudieshavebeen

performedwithreproducinganimals.

4.9 Amountstobeadministeredandadministrationroute

Minimumrecommendeddoserate:2mgofmilbemycinoximeand5mgof

praziquantelperkgaregivenonceorally.

Theproductshouldbeadministeredwithoraftersomefood.Doingsoensures

optimumprotectionagainstheartwormdisease.

Dependingonthebodyweightofthecat,thepracticaldosingisasfollows:

Weight Tablets

2-4kg ½tablet

>4 –8kg 1tablet

>8-12kg 1½tablets

MILBEMAXcanbeinsertedintoaprogrammeforpreventionofheartwormdiseaseif

atthesametimetreatmentagainsttapewormsisindicated.MILBEMAXhasa

durationofheartwormpreventionofonemonth.Forregularpreventionofheartworm

diseasetheuseofamonosubstanceispreferred.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdose,inadditiontosignsobservedattherecommendeddose(see

4.6),droolingwasobserved.Thissignwillusuallydisappearspontaneouslywithina

day.

4.11Withdrawalperiod(s)

Notapplicable.

MILBEMAXCatsFinalSPCRENEWALJuly2007

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiparasiticproducts,insecticidesandrepellants-

Endectocides

ATCvetCode:QP54AB51(Milbemycincombinations)

5.1. Pharmacodynamicproperties

Milbemycinoximebelongstothegroupofmacrocycliclactones,isolatedfromthe

fermentationofStreptomyceshygroscopicusvar.aureolacrimosus.Itisactiveagainst

mites,againstlarvalandadultstagesofnematodesaswellasagainstlarvaeof

Dirofilariaimmitis.

Theactivityofmilbemycinisrelatedtoitsactiononinvertebrateneurotransmission:

Milbemycinoxime,likeavermectinsandothermilbemycins,increasesnematodeand

insectmembranepermeabilitytochlorideionsviaglutamate-gatedchlorideion

channels(relatedtovertebrateGABA

andglycinereceptors).Thisleadsto

hyperpolarisationoftheneuromuscularmembraneandflaccidparalysisanddeathof

theparasite.

Praziquantelisanacylatedpyrazino-isoquinolinederivative.Praziquantelisactive

againstcestodesandtrematodes.Itmodifiesthepermeabilityforcalcium(influxof

Ca2+)inthemembranesoftheparasiteinducinganimbalanceinthemembrane

structures,leadingtomembranedepolarisationandalmostinstantaneouscontraction

ofthemusculature(tetany),rapidvacuolizationofthesyncytialtegumentand

subsequenttegumentaldisintegration(blebbing),resultingineasierexpulsionfrom

thegastrointestinaltractordeathoftheparasite.

5.2. Pharmacokineticproperties

Inthecat,praziquantelreachespeakplasmaconcentrationswithinanhourafteroral

administration.Thehalflifeofeliminationisaround3hours.

Inthedog,thereisrapidhepaticbiotransformation,prinicipallytomonohydroxylated

derivatives.Theprincipalrouteofeliminationinthedogisrenal.

Afteroraladministrationinthecat,milbemycinoximereachespeakplasma

concentrationswithin2hours.Thehalflifeofeliminationisaround13hours(

9

hours).

Intherat,metabolismappearstobecompletealthoughslow,sinceunchanged

milbemycinoximehasnotbeenfoundinurineorfeces.Mainmetabolitesintherat

aremonohydroxylatedderivatives,attributabletohepaticbiotransformation.In

additiontorelativelyhighliverconcentrations,thereissomeconcentrationinfat,

reflectingitslipophilicity.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Core:

Cellulose,microcristalline

MILBEMAXCatsFinalSPCRENEWALJuly2007

Croscarmellosesodium

Povidone

Lactosemonohydrate

Silica,colloidalanhydrous

Magnesiumstearate

Coat:

Hypromellose

Macrogol

Talc

Titaniumdioxide

Ironoxidered

6.2. Incompatibilities

Notapplicable

6.3. Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

3years

Shelf-lifeafterfirstopeningoftheimmediatepackaging:

6months

6.4. Specialprecautionsforstorage

Donotstoreabove30°C

Keepblisterintheoutercartontoprotectfromlight

6.5. Natureandcompositionofimmediatepackaging

PVC/PE/PVdC/aluminiumblister

Availablepacksizes:

Boxwith2tabletsinblister

Boxwith4tabletsinblister

Boxwith10tabletsinblister

Boxwith20tabletsinblister

Boxwith50tabletsinblister

Boxwith100tabletsinblister

Notallpacksizesmaybemarketed

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

MILBEMAXCatsFinalSPCRENEWALJuly2007

Theproductshouldnotcomeintocontactwith(IE'sproposal)watercoursesasthismay

bedangerousforfishandotheraquaticorganisms

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalHealthInc.

8. MARKETINGAUTHORISATIONNUMBER(S)

{NationalMANumber(s)}

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE AUTHORISATION

{DDMMMYYYY}

10. DATEOFREVISIONOFTHETEXT

{MMMYYYY}

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

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Europe - EFSA - European Food Safety Authority Publications

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

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– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

3-12-2018

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

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FDA - U.S. Food and Drug Administration

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

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Health Canada

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

20-11-2018

Pest categorisation of non‐EU Monochamus spp.

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Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

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Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

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Published on: Fri, 16 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Germany for the pesticide active substance clodinafop‐propargyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of clodinafop‐p...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

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Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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Europe - EFSA - European Food Safety Authority Publications

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

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Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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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

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Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

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Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

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FDA - U.S. Food and Drug Administration

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)

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Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

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Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

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The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

17-10-2018

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

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FDA - U.S. Food and Drug Administration

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

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Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

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Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

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Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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Europe - EFSA - European Food Safety Authority Publications

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

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FDA - U.S. Food and Drug Administration

28-9-2018

Avian influenza overview May – August 2018

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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

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

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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

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

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

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

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

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Enforcement Report for the Week of August 22, 2018

Enforcement Report for the Week of August 22, 2018

Recently Updated Records for the Week of August 22, 2018 Last Modified Date: Thursday, August 16, 2018

FDA - U.S. Food and Drug Administration

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

16-11-2018

Incruse Ellipta (Glaxo Group Ltd)

Incruse Ellipta (Glaxo Group Ltd)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)7676 of Fri, 16 Nov 2018

Europe -DG Health and Food Safety

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

16-11-2018

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7673 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3754/T/26

Europe -DG Health and Food Safety

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

16-11-2018

Emgality (Eli Lilly Nederland B.V.)

Emgality (Eli Lilly Nederland B.V.)

Emgality (Active substance: galcanezumab) - Centralised - Authorisation - Commission Decision (2018)7672 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4648/00

Europe -DG Health and Food Safety

16-11-2018

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Active substance: trastuzumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7553 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004323/T/0012

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Active substance: Afoxolaner / milbemycin oxime) - Centralised - 2-Monthly update - Commission Decision (2018)6977 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003842/WS1338/0015/G

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/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Active substance: Teriparatide) - Transfer of orphan designation - Commission Decision (2018)6987 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/031/16/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Active substance: Cholest-4-en-3-one, oxime) - Transfer of orphan designation - Commission Decision (2018)6995 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/081/04/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Active substance: Sirolimus) - Transfer of orphan designation - Commission Decision (2018)6988 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/045/16/T/01

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

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

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

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