Equest Pramox Vet.

Primær information

  • Handelsnavn:
  • Equest Pramox Vet. 19,5+121,7 mg oral gel
  • Dosering:
  • 19,5+121,7 mg
  • Lægemiddelform:
  • oral gel
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Equest Pramox Vet. 19,5+121,7 mg oral gel
    Danmark
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Hest

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 38864
  • Sidste ændring:
  • 16-07-2018

Produktresumé

24. november 2016

PRODUKTRESUMÉ

for

Equest Pramox Vet., oral gel

0.

D.SP.NR

23248

1.

VETERINÆRLÆGEMIDLETS NAVN

Equest Pramox Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 gram gel indeholder:

Aktive stoffer:

Moxidectin

19,5 mg

Praziquantel

121,7 mg

Hjælpestoffer:

Benzylalkohol (E1519)

220,0 mg

Butylhydroxytoluen (E321)

0,8 mg

Alle hjælpestoffer er anført under pkt. 6.1

3.

LÆGEMIDDELFORM

Oral gel.

Lysegul til orange/lyserød oral gel.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Heste.

4.2

Terapeutiske indikationer

Til behandling af blandingsinfestationer med bændelorm og rundorm eller leddyr

forårsaget af moxidectin- og praziquantelfølsomme stammer af:

Store strongylider:

Strongylus vulgaris (voksne stadier)

Strongylus edentatus (voksne stadier)

Triodontophorus brevicauda (voksne)

38864_spc.doc

Side 1 af 6

Triodontophorus serratus (voksne)

Triodontophorus tenuicollis (voksne)

Små strongylider (voksne og intraluminale larvestadier):

Cyathostomum spp.

Cylicocyclus spp.

Cylicostephanus spp.

Cylicodontophorus spp.

Gyalocephalus spp.

Ascarider:

Parascaris equorum (voksne)

Andre arter:

Oxyuris equi (voksne stadier)

Habronema muscae (voksne)

Gasterophilus intestinalis (L2, L3)

Gasterophilus nasalis (L2, L3)

Strongyloides westeri (voksne)

Trichostrongylus axei (voksne stadier)

Bændelorm (voksne):

Anoplocephala perfoliata

Anoplocephala magna

Paranoplocephala mammillana

Udskillelsen af æg fra små strongylider forhindres i 90 dage.

Produktet er effektivt over for (udviklende) intramucosale L4-stadier af små strongylider. 8

uger efter behandling elimineres tidlige (hypobiotiske) EL3 stadier af små strongylider.

4.3

Kontraindikationer

Bør ikke anvendes til føl under 6,5 måneder.

Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller

flere af hjælpestofferne.

Produktet er fremstillet udelukkende til brug hos heste. Hunde og katte kan få uønskede

virkninger af moxidectin-koncentrationen i dette produkt, hvis de indtager spildt gel eller

har adgang til brugte sprøjter.

4.4

Særlige advarsler

Vær særligt opmærksom på at undgå følgende praksis, da de kan medføre øget risiko for

udvikling af resistens og ultimativt medføre ineffektiv behandling:

For hyppig og gentagen brug af anthelmintika af samme klasse i en længere

periode.

Underdosering, der kan skyldes fejlvurdering af kropsvægt, fejladministration af

produktet eller manglende kalibrering af doseringsapparaturet (hvis et sådant

anvendes).

Mistanke om kliniske tilfælde af resistens over for anthelmintika skal undersøges

yderligere ved at anvende relevante undersøgelser (f. eks. Faecal Egg Count Reduction

Test). I tilfælde hvor testresultaterne kraftigt antyder resistens mod et specielt

38864_spc.doc

Side 2 af 6

anthelmintikum, skal der anvendes et anthelmintikum af en anden farmakologisk klasse og

med en anden virkningsmekanisme.

For at opnå bedst muligt kontrol af bremselarver, skal præparatet anvendes i efteråret efter

fluesæsonen og inden foråret, hvor larverne forpuppes og derfor er mindre følsomme for

behandlingen.

Hyppig og gentagende brug af anthelmintikum fra samme klasse kan føre til udvikling af

parasitær resistens. En dyrlæge bør fastsætte et passende doseringsprogram samt bestemme

hvor meget af midlet, man bør have på lager for at opnå tilstrækkelig kontrol med såvel

bændelorm som rundorm.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

For at forhindre overdosering bør man være omhyggelig med at dosere føl korrekt især

unge føl med lav kropsvægt eller ponyføl. Brug ikke den samme sprøjte til behandling af

mere end et dyr, medmindre hestene løber sammen eller er i direkte kontakt med hinanden.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Dette lægemiddel kan forårsage øjen- og hudirritation og øget følsomhed af huden.

Undgå direkte kontakt med hud og øjne.

Det anbefales at bruge handsker.

Vask hænder og andre eksponerede legemsdele efter anvendelse.

Undgå at ryge, spise eller drikke under håndtering af præparatet.

Hvis man får produktet i øjet, skal der straks skylles med rigeligt rent vand og søges læge.

Hvis produktet indtages uagtet, skal der søges lægehjælp og indlægssedlen bør vises til

lægen.

Andre forsigtighedsregler

For at begrænse moxidectins indvirkning på hestegødningen og på grund af utilstrækkelige

data for den miljømæssige risiko ved praziquantel bør hestene forblive i stalden i 3 dage

efter behandling.

4.6

Bivirkninger

Slaphed af underlæbe, ataksi og hævelse af mulen kan forekomme i sjældne tilfælde hos

unge dyr. Anoreksi og sløvhed er blevet rapporteret i meget sjældne tilfælde. Disse

bivirkninger er forbigående og forsvinder spontant. I tilfælde af alvorlige angreb af orm,

kan destruktionen af parasitterne forårsage let, forbigående kolik og tynd afføring hos de

behandlede heste.

Hyppigheden af bivirkninger er defineret som:

- Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en

behandling)

- Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr)

- Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr)

- Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr)

- Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)

4.7

Drægtighed, diegivning eller æglægning

Veterinærlægemidlet har vist sig at være sikkert at bruge til avlshopper samt drægtige og

lakterende hopper.

38864_spc.doc

Side 3 af 6

Administration af veterinærlægemidlet har ingen negativ indvirkning på hoppers fertilitet.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Moxidectin øger effekten af GABA-agonister.

4.9

Dosering og indgivelsesmåde

En enkelt oral dosis på 400 mikrogram moxidectin/kg legemsvægt og 2,5 mg

praziquantel /kg legemsvægt givet med den kalibrerede sprøjte, hvor en streg svarer til 25

kg legemsvægt.

For at sikre korrekt dosering bør legemsvægten bestemmes så præcist som muligt.

Doseringens præcision bør undersøges.

Det anbefales at bruge en vægt eller vægt-målebånd for at sikre en korrekt dosering

Hold sprøjten med den kapselklædte ende vendt mod venstre, så vægtinddelingen og de

små sorte streger kan ses. Hver streg svarer til 25 kg legemsvægt (1 enhed). Drej

doseringsringen frem indtil dens venstre side er ud for den sorte streg, som svarer til dyrets

vægt.

Indholdet af en sprøjte kan behandle 700 kg hest.

Ved behandling af bændelorm, er praziquantel-mængden i produktet valgt i den øvre ende

af doseringsintervallet. En dyrlæge bør fastsætte et passende doseringsprogram samt

bestemme hvor meget af midlet, man bør have på lager for at opnå tilstrækkelig

parasitkontrol.

4.10

Overdosering

Kortvarige bivirkninger kan optræde ved den anbefalede dosering ved brug hos føl. Hos

voksne heste kan der forekomme forbigående bivirkninger ved 3 gange anbefalet dosis.

Symptomerne er nedstemthed, manglende appetit, ataksi, og slapt hængende underlæbe i 8

til 24 timer efter behandling. Symptomatisk behandling er normalt ikke nødvendig og

komplet restitution indtræder som regel indenfor 24 til 72 timer. Der er ingen specifik

antidot.

4.11

Tilbageholdelsestid

Slagtning: 64 døgn.

Mælk: Må ikke anvendes til lakterende hopper, der producerer mælk til human konsum.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk klassifikation: antiparasitært middel, endektocid, moxidectin

kombinationer.

ATCvet-kode: QP 54 AB 52

5.1

Farmakodynamiske egenskaber

Moxidectin er et antiparasitært middel som er aktivt overfor et bredt spektrum af endo- og

ektoparasitter. Det er en andengenerations makrocyklisk lakton tilhørende milbemycin

familien.

38864_spc.doc

Side 4 af 6

Moxidectin interagerer med GABA receptorer og chloridkanaler. Nettoeffekten er at åbne

chloridkanalerne i de postsynaptiske overgange hvilket tillader indtrængning af

chloridioner og inducerer en irreversibel hviletilstand. Dette medfører paralyse og til sidst

død af de parasitter, der eksponeres for lægemidlet.

Praziquantel er et antiparasitært middel, der anvendes som ormemiddel til mange dyrearter.

Praziquantel absorberes hurtigt via parasittens overflade og fordeles jævnt indeni

parasitten. Det er vist både in vitro og in vivo, at større læsioner af parasittens overflade

fremkalder sammentrækning og paralyse af parasitten. Praziquantel ændrer

parasitmembranens permeabilitet for calciumioner, hvilket får parasittens metabolisme til

at gå i stå.

Produktet er effektivt overfor benzimidazolresistente stammer af cyathostominae.

5.2

Farmakokinetiske egenskaber

Moxidectin absorberes efter oral indgift, og maksimal koncentration i blodet opnås 6 til 8

timer efter administration. Lægemidlet fordeles i alle vævstyper, men pga. dets lipofile

egenskaber ophobes det selektivt i fedtvæv.

Halveringstiden er 11 dage.

Moxidectin gennemgår delvis biotransformation ved hydroxylering, og den eneste

signifikante udskillelsesvej er via fæces.

Praziquantel absorberes hurtigt og næsten fuldstændigt i kroppen, fordeles hurtigt til alle

organer. Halveringstiden er mindre end en time hos heste. Praziquantel metaboliseres

hurtigt i leveren. Det væsentligste nedbrydningsprodukt er en beslægtet 4-hydroxy-

cyclohexylforbindelse.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Benzylalkohol (E1519)

Butylhydroxytoluen (E321)

Colloidal silica, vandfri

Ethanol, vandfri

Polysorbat 80

Ethylcellulose,

Propylenglycoldicaprylat/-dicaprat

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

I salgspakning: 2 år.

Efter første åbning af den indre emballage: 6 måneder.

6.4

Særlige opbevaringsforhold

Må ikke opbevares over 25

38864_spc.doc

Side 5 af 6

6.5

Emballage

HDPE sprøjte indeholdende 14,4 gram gel med gradueret polypropylen pumpestempel og

hætte af LDPE pakket således:

Æske indeholdende 1 sprøjte.

Æske indeholdende 10 individuelt pakkede sprøjter.

Æske indeholdende 20 individuelt pakkede sprøjter.

Æske indeholdende 20 sprøjter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Produktet er toksisk for fisk og organismer, der lever i vand. Ikke anvendte veterinære

lægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinier.

Undgå at forurene damme, vandløb og grøfter med produktet eller brugte sprøjter.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Zoetis Finland Oy

Tietokuja 4

FI-00330 Helsinki

Finland

Repræsentant

Orion Pharma Animal Health A/S

Ørestads Boulevard 73

2300 København S

Danmark

8.

MARKEDSFØRINGSTILLADELSESNUMMER

38864

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

16. juni 2006

10.

DATO FOR ÆNDRING AF TEKSTEN

24. november 2016

11.

UDLEVERINGSBESTEMMELSE

38864_spc.doc

Side 6 af 6

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

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

27-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.

FDA - U.S. Food and Drug Administration

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

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

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

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

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

CVM Update describing FDA Dear Veterinarian Letter about the differences between FDA-approved Mirataz (mirtazapine transdermal ointment), an animal drug with demonstrated safety and effectiveness to manage undesired weight loss in cats, and compounded formulations of transdermal mirtazapine.

FDA - U.S. Food and Drug Administration

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

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

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

September 6, 2018: Cattle Company and Veterinarian Indicted for False Health Certificates on Livestock

September 6, 2018: Cattle Company and Veterinarian Indicted for False Health Certificates on Livestock

September 6, 2018: Cattle Company and Veterinarian Indicted for False Health Certificates on Livestock

FDA - U.S. Food and Drug Administration

31-8-2018

Danish Medicines Agency launches new concept for National Scientific Advice

Danish Medicines Agency launches new concept for National Scientific Advice

Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.

Danish Medicines Agency

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

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

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

28-6-2018

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

15-6-2018

Written Requests Issued

Written Requests Issued

Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies

FDA - U.S. Food and Drug Administration

30-5-2018

Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

In 2016, as part of the implementation of the Act "for the restoration of biodiversity, nature and landscapes” and as requested by the Ministries of Agriculture, Health and Ecology, ANSES initiated an assessment weighing up the risks and benefits of plant protection products containing neonicotinoids, compared with their chemical and non-chemical alternatives. Today, ANSES is publishing its final opinion. For most uses of plant protection products containing neonicotinoids, sufficiently effective and ope...

France - Agence Nationale du Médicament Vétérinaire

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

17-5-2018

FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products

FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products

FDA continued to take important steps to address youth use of e-cigarettes by sending official requests for information to four e-cigarette makers requiring them to submit important documents to better understand the youth appeal.

FDA - U.S. Food and Drug Administration

11-5-2018

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

FDA - U.S. Food and Drug Administration

8-5-2018

Veterinary Feed Directive (VFD)

Veterinary Feed Directive (VFD)

A VFD drug is intended for use in animal feeds, and such use of the VFD drug is permitted only under the professional supervision of a licensed veterinarian.

FDA - U.S. Food and Drug Administration

3-5-2018

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA approved a supplemental New Animal Drug Application submitted by AquaBounty Technologies, Inc. The supplemental NADA requested FDA approval to raise AquAdvantage Salmon at a land-based contained facility near Albany, Indiana.

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here:  https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgW5  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here:  https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgDd 

FDA - U.S. Food and Drug Administration

29-6-2018

BROADLINE (Merial)

BROADLINE (Merial)

BROADLINE (Active substance: Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel) - Centralised - Yearly update - Commission Decision (2018) 4164 of Fri, 29 Jun 2018

Europe -DG Health and Food Safety

7-6-2018

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

FDA - U.S. Food and Drug Administration

29-5-2018

Profender (Bayer Animal Health GmbH)

Profender (Bayer Animal Health GmbH)

Profender (Active substance: Emodepside / Praziquantel) - Centralised - Yearly update - Commission Decision (2018)3405 of Tue, 29 May 2018

Europe -DG Health and Food Safety

16-5-2018

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Active substance: fluralaner / moxidectin) - Centralised - Authorisation - Commission Decision (2018)3019 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4440

Europe -DG Health and Food Safety