Frontect (til hunde 2-5 kg)

Primær information

  • Handelsnavn:
  • Frontect (til hunde 2-5 kg) 33,8+252,4 mg spot-on, opløsning
  • Dosering:
  • 33,8+252,4 mg
  • Lægemiddelform:
  • spot-on, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Frontect (til hunde 2-5 kg) 33,8+252,4 mg spot-on, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 52822
  • Sidste ændring:
  • 18-07-2018

Produktresumé

19. februar 2018

PRODUKTRESUMÉ

for

Frontect, spot-on, opløsning

0.

D.SP.NR.

28878

1.

VETERINÆRLÆGEMIDLETS NAVN

Frontect

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver pipette indeholder:

Aktive stoffer

Hjælpestoffer

Frontect spot-

on, opløsning

Indhold

pipette

(ml)

Fipronil

(mg)

Permethrin

(mg)

Butylhydroxytoluen

(E321) (mg)

Hund 2-5 kg

33,8

252,4

0,563

Hund 5-10 kg

67,6

504,8

1,125

Hund 10-20 kg

135,2

1009,6

2,250

Hund 20-40 kg

270,4

2019,2

4,500

Hund 40-60 kg

405,6

3028,8

6,750

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Spot-on, opløsning

Klar, farveløs til gulbrun opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hund

4.2

Terapeutiske indikationer

Behandling og forebyggelse af loppe- og/eller flåtangreb, hvor repellerende (anti-

blodsugende) virkning mod sandfluer, stikfluer og/eller myg er nødvendig.

52822_spc.docx

Side 1 af 7

Lopper

Behandling og forebyggelse af Ctenocephalides felis loppeangreb samt forebyggelse af

Ctenocephalides canis loppeangreb. En behandling forebygger nye loppeangreb i 4 uger.

Præparatet kan indgå som del af behandlingsstrategien for loppebetinget allergisk

dermatitis, hvor dette tidligere er diagnosticeret af en dyrlæge.

Flåter

Behandling og forebyggelse af flåtangreb (Dermacentor reticulatus, Ixodes ricinus,

Rhipicephalus sanguineus). En behandling dræber (Dermacentor reticulatus, Ixodes

ricinus, Rhipicephalus sanguineus) og repellerer (Ixodes ricinus, Rhipicephalus

sanguineus) flåter i 4 uger efter behandling, samt repellerer Dermacentor reticulatus fra 7

dage og op til 4 uger efter behandling.

Myg og sandfluer

Repellerer (anti-blodsugende virkning) sandfluer (Phlebotomus perniciosus) i 3 uger og

myg (Culex pipiens, Aedes albopictus) i 4 uger. Dræber sandfluer (Phlebotomus

perniciosus) og myg (Aedes albopictus) i 3 uger.

Stikfluer

Repellerer (anti-blodsugende virkning) og dræber stikfluer (Stomoxys calcitrans) i 5 uger.

4.3

Kontraindikationer

Må ikke anvendes til syge eller rekonvalescente dyr.

Præparatet er kun til hunde. Må ikke anvendes til katte eller kaniner, da dette kan forårsage

bivirkninger og muligvis dødsfald.

Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et

eller flere af hjælpestofferne (se også punkt 4.5 ”Særlige forsigtighedsregler for dyret”).

4.4

Særlige advarsler

Tilhæftning af enkelte flåter eller bid af enkelte myg eller sandfluer kan forekomme.

Derfor kan overførsel af patogener fra disse leddyr ikke helt udelukkes, hvis forholdene er

ugunstige. Enkelte flåter kan tilhæfte og give slip igen inden for de første 24 timer efter

infestation. Såfremt flåter er til stede allerede når præparatet påføres, vil alle flåter ikke

nødvendigvis dræbes inden for 48 timer efter behandling.

Præparatets virkning mod lopper påvirkes ikke selv om dyret af og til bliver vådt

(svømning, bad). Hunde skal dog ikke svømme eller vaskes med shampoo inden for 48

timer efter behandling. Undgå hyppig svømning eller shamponering af behandlede hunde,

da dette kan reducere præparatets virkningsvarighed.

For at mindske risikoen for nye loppeangreb anbefales det at behandle alle hunde i

husholdningen. Andre dyr i samme husholdning bør også behandles med et passende

præparat. For at reducere smittetrykket fra omgivelserne anbefales det, at omgivelserne

behandles med et passende middel, som virker mod voksne lopper og deres

udviklingsstadier.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Da der ikke foreligger specifikke studier, anbefales det, at man ikke anvender præparatet til

hunde, som er yngre end 8 uger eller som vejer under 2 kg.

Undgå at produktet kommer i kontakt med hundens øjne.

52822_spc.docx

Side 2 af 7

Vær omhyggelig med at påføre præparatet på et sted, hvor dyret ikke kan slikke det af, og

sørg for, at andre dyr ikke slikker på behandlingsstedet efter påføringen.

Præparatet kan fremkalde kramper hos katte, som kan være dødelige på grund af kattes

unikke fysiologi, der gør at de ikke kan metabolisere visse stoffer, heriblandt permethrin.

Ved utilsigtet hudeksponering vaskes katten med shampoo eller sæbe, og der søges hurtig

dyrlægehjælp. For at forhindre at katte eksponeres for præparatet, skal behandlede hunde

holdes adskilt fra katte, indtil påføringsstedet er tørt. Det er vigtigt at sørge for, at katte

ikke slikker på påføringsstedet på en hund, som er behandlet med dette præparat. Søg

straks dyrlægehjælp i tilfælde af denne type eksponering.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Præparatet kan forårsage hud- og øjenirritation, og det skal derfor undgås at præparatet

kommer i kontakt med hud og øjne. Pipetten skal ikke åbnes i nærheden eller i retning af

ansigtet. Skyl straks øjnene med rigeligt vand, hvis præparatet kommer i øjet, eller hvis

øjnene bliver irriterede under administrationen. Søg lægehjælp hvis øjenirritationen varer

ved. Vask straks huden med rigeligt vand og sæbe i tilfælde af hudeksponering, eller hvis

huden bliver irriteret under administrationen. Søg lægehjælp hvis hudirritationen varer ved

eller kommer igen.

Personer med kendt overfølsomhed over for fipronil og/eller permethrin skal undgå

kontakt med præparatet.

Præparatet er skadeligt, hvis det sluges. Undgå hånd-til-mund kontakt. Undgå at ryge, spise

eller drikke under påføringen. Vask hænder efter brug. Skyl munden hvis præparatet sluges

og søg læge, hvis du bliver utilpas.

Da hjælpestoffet N-methylpyrrolidon kan fremkalde føtotoxicitet og teratogenicitet efter

signifikant eksponering, skal gravide kvinder bruge beskyttelseshandsker for at undgå

kontakt med præparatet.

Behandlede dyr bør ikke håndteres, før påføringsstedet er tørt, og børn skal ikke gives lov

til at lege med behandlede dyr, før påføringsstedet er tørt. Det anbefales derfor, at man ikke

behandler dyr i løbet af dagen, men venter til tidligt på aftenen, og at nyligt behandlede dyr

ikke får lov at sove sammen med ejeren, især ikke med børn.

Opbevar pipetterne i original blisterpakning og bortskaf tomme pipetter på passende måde

straks efter anvendelsen for at forhindre yderligere adgang til dem.

Andre forsigtighedsregler

Præparatet kan være skadeligt for organismer, der lever i vand. Behandlede hunde skal

ikke gives lov til at bade i stillestående vand i 2 dage efter behandling.

4.6

Bivirkninger

Efter anvendelse er der i meget sjældne tilfælde set forbigående hudreaktioner på

påføringsstedet (misfarvning af huden, lokalt hårtab, kløe, rødmen) samt generel kløe og

hårtab. Udtalt savlen, reversible nervøse symptomer (øget følsomhed over for berøring,

hyperaktivitet, muskelrysten, depression, andre nervøse symptomer) eller opkastning er

ligeledes observeret efter anvendelse.

Hvis hunden slikker på påføringsstedet, kan der ses kraftig savlen og opkastning.

4.7

Drægtighed, diegivning eller æglægning

Laboratorieundersøgelser med fipronil eller permethrin har ikke afsløret teratogene

virkninger eller føtal toksicitet. Der er ikke udført undersøgelser af dette præparat hos

drægtige og diegivende dyr (se 4.5 ”Særlige forsigtighedsregler for dyret”).

52822_spc.docx

Side 3 af 7

N-methylpyrrolidon, et hjælpestof i veterinærpræparatet, har vist at være teratogent hos

laboratoriedyr efter gentagen eksponering ved høje doser.

Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-

benefit-forholdet.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Den anbefalede minimumsdosis er 6,76 mg fipronil/kg kropsvægt og 50,48 mg

permethrin/kg kropsvægt svarende til 0,1 ml spot-on opløsning pr. kg kropsvægt.

Brugen af præparatet skal baseres på en bekræftet infestation eller risiko for infestation

med lopper og/eller flåter, hvor repellerende (anti-blodsugende) virkning mod sandfluer

og/eller stikfluer og/eller myg også er nødvendig. Afhængig af ektoparasitforekomsten kan

gentaget behandling være indiceret. I sådanne tilfælde skal intervallet mellem to

behandlinger være mindst 4 uger.

Administrationsmåde

Vælg korrekt pipettestørrelse i henhold til hundens vægt. Til hunde over 60 kg anvendes

den kombination af to pipettestørrelser, som tilsammen passer bedst til kropsvægten.

Præparatet skal påføres på to steder, hvor hunden ikke kan slikke sig. Disse steder er lige

foran skulderbladene og i nakken midt mellem hoved og skulderblade.

Tag blisteret ud af pakningen og adskil 1 blister. Tag pipetten ud ved at klippe langs den

stiplede linie med en saks eller ved at rive folien af efter at have bøjet det markerede

hjørne. Hold pipetten lodret og væk fra ansigtet – den åbnes ved at klippe spidsen af med

en saks. Del pelsen i hundens nakke indtil huden er synlig. Placer pipettens spids på huden

og tryk på pipetten for at påføre ca. halvdelen af indholdet midt på nakken midt mellem

hoved og skulderblade. Gentag påføringen lige foran skulderbladene for at tømme pipetten.

Sørg for at præparatet påføres direkte på huden og ikke i pelsen for at opnå det bedste

resultat.

4.10

Overdosering

Sikkerheden er undersøgt hos raske voksne hunde med op til 5 gange den maksimale dosis

(behandlet op til 3 gange med månedlige intervaller), samt hos hvalpe (8-uger gamle

behandlet én gang). Kendte bivirkninger kan være lette neurologiske symptomer,

opkastning og diaré. Disse er forbigående og forsvinder normalt uden behandling i løbet af

1-2 dage.

Risikoen for bivirkninger (se punkt 4.6) kan forøges ved overdosering, derfor skal dyr altid

behandles med korrekt pipettestørrelse i henhold til deres kropsvægt.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: Ectoparasiticider til udvortes brug.

ATCvet-kode: QP 53 AX 65 (fipronil, kombination).

52822_spc.docx

Side 4 af 7

5.1

Farmakodynamiske egenskaber

Fipronil er et insekticid og acaricid hørende til phenylpyrazolfamilien. Fipronil og dets

metabolit fipronilsulfon virker ved at påvirke de ligand-styrede chloridkanaler, især de, der

styres af neurotransmitteren GABA (gamma-aminosmørsyre), såvel de desensibiliserende

(D) som de ikke-desensibiliserende (N) kanaler styret af glutamat (Glu, unikke invertebrat

ligand-styrede chloridkanaler), hvorved de blokerer den præ- og postsynaptiske overførsel

af chlorioner over cellemembraner. Dette resulterer i en ukontrolleret CNS-aktivitet med

deraf følgende drab af insekter og mider.

Permethrin tilhører type I klassen af pyrethroider. Pyrethroider er acaricider og insekticider

med repellerende virkning. Pyrethroider påvirker de elektrisk ladede natriumkanaler hos

hvirveldyr og hvirvelløse dyr. Pyrethroider er såkaldte "åben kanal-blokkere" som påvirker

natriumkanalen ved at forsinke både aktiverings- og inaktiveringsegenskaber og således

medføre hyperexcitabilitet og død hos parasitten. Permethrin i præparatet har

afskrækkende (anti-blodsugende) virkning mod sandfluer (> 80 % i 4 uger), myg og flåter.

I en eksperimentel undersøgelse havde præparatet hurtigere dræbende virkning på voksne

lopper end fipronil alene hhv. 7 og 14 dage efter behandling.

”Speed of kill”

Præparatet dræber nye lopper (C. canis, C. felis) inden for 6 timer fra 2 dage efter

behandling og i en hel måned. C. felis lopper, som allerede findes på hunden når

behandlingen påføres, dræbes inden for 24 timer. ”Speed of kill” på C. canis, som allerede

er til stede ved behandlingsstart, er ikke blevet evalueret.

Præparatet dræber nye flåter (R. sanguineus og I. ricinus) inden for 6 timer fra 2 dage efter

behandling og i en hel måned. Flåter (R. sanguineus, I. ricinus, D.reticulatus), som allerede

findes på hunden når behandlingen påføres, dræbes inden for 48 timer.

I en eksperimentel undersøgelse blev det vist, at præparatet indirekte reducerer risikoen for

overførsel af Babesia canis fra inficerede Dermacentor reticulatus flåter

fra 7 dage og op til

4 uger efter behandling. Derved reduceredes risikoen for babesiose hos de behandlede hunde i

denne undersøgelse.

I en eksperimentel undersøgelse blev det vist, at præparatet indirekte reducerer risikoen for

overførsel af Ehrlichia canis fra inficerede Rhipicephalus sanguineus flåter

fra 7 dage og

op til 4 uger efter behandling. Derved reduceredes risikoen for ehrlichiose hos de behandlede

hunde i denne undersøgelse.

Præparatets virkning med hensyn til at reducere overførsel af infektiøse agens efter naturlig

eksponering under feltforhold er imidlertid ikke undersøgt.

5.2

Farmakokinetiske egenskaber

Den farmakokinetiske profil af fipronil og permethrin i kombination blev undersøgt efter

udvortes påføring hos hund ved at måle koncentrationen i plasma og hår i 58 dage efter

behandling. Både permethrin og fipronil, sammen med hovedmetabolitten fipronilsulfon,

fordeles godt i hundens pels i løbet af den første dag efter påføringen. Koncentrationen af

fipronil, fipronilsulfon og permethrin i pelsen aftager over tid og kan påvises i minimum

58 dage efter påføringen.

Fipronil og permethrin virker topikalt ved kontakt med eksterne parasitter, og den lave

systemiske absorption af fipronil og permethrin er ikke relevant for den kliniske virkning.

Spot-on påføringen medførte ubetydelig systemisk absorption af permethrin med sporadisk

målbar koncentrationer af cis-permethrin mellem 11,4 ng/ml og 33,9 ng/ml observeret 5 til

48 timer efter behandling.

52822_spc.docx

Side 5 af 7

Gennemsnitlig maksimal plasmakoncentration (C

) på 30,1 ± 10,3 ng/ml fipronil og 58,5

± 20,7 ng/ml fipronilsulfon blev observeret mellem dag 2 og 5 (T

) efter påføring.

Fipronil plasmakoncentration aftager derefter med en gennemsnitlig halveringstid på 4,8 ±

1,4 dage.

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

N-methylpyrrolidon

Butylhydroxytoluen (E321)

Triglycerider, middelkædelængde

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

Pipette à 0,5 ml (33,8+252,4 mg, til hund 2-5 kg)

2 år.

Pipette à 1 ml (67,6+504,8 mg, til hund 5-10 kg)

30 måneder.

Pipette á 2 ml (135,2+1009,6 mg, til hund 10-20 kg)

30 måneder.

Pipette á 4 ml (270,4+2019,2 mg, til hund 20-40 kg)

30 måneder.

Pipette á 6 ml (405,6+3028,8 mg, til hund 40-60 kg)

30 måneder.

6.4

Særlige opbevaringsforhold

Opbevares i den originale blisterpakning.

Må ikke opbevares over 25

°C.

6.5

Emballage

Primærpakningen er en varmeformet film af polyethylen-ethylenvinylalkohol-

polyethylen/polypropylen.

Sekundærpakningen består af et plast/aluminiumblister med plast/aluminiumbagside.

Plastblisterkort med 1 pipette indeholdende 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml.

Æske med 3 eller 6 pipetter (som hver indeholder 0,5 ml, 1 ml, 2 ml, 4 ml eller 6 ml).

Kun én pipettestørrelse pr. æske.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

52822_spc.docx

Side 6 af 7

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Ikke anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale

retningslinjer.

Præparatet må ikke udledes i vandløb, da dette kan være farligt for fisk og andre

organismer i vandet.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Merial Norden A/S

Strødamvej 52

2100 København Ø

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

33,8+252,4 mg:

52822

67,6+504,8 mg:

52823

135,2+1009,6 mg: 52824

270,4+2019,2 mg: 52825

405,6+3028,8 mg: 52826

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

30. september 2014

10.

DATO FOR ÆNDRING AF TEKSTEN

19. februar 2018

11.

UDLEVERINGSBESTEMMELSE

52822_spc.docx

Side 7 af 7

  • 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.

    Anmode informationsbrochure for offentligheden.



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Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below.

FDA - U.S. Food and Drug Administration

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

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

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

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

25-10-2018

Nutrition Facts Label Reboot: A Tale of Two Labels

Nutrition Facts Label Reboot: A Tale of Two Labels

The Nutrition Facts Label (NFL) on packages consumers look at when they’re buying groceries or preparing a meal has undergone a makeover. The U.S. Food and Drug Administration (FDA) has changed it to reflect updated scientific findings and help consumers make better-informed choices about the foods their families eat. Until the deadlines, consumers may see two different versions on the products they buy: the original label they’ve been using, as well as the new label. The Consumer Update will emphasize...

FDA - U.S. Food and Drug Administration

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the 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 HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

25-9-2018

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

Whole Foods Market is voluntarily recalling 365 Everyday Value White Corn Tortilla Chips because the product may contain undeclared milk that was not listed on the product label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product

FDA - U.S. Food and Drug Administration

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin 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...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin 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 cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (...

FDA - U.S. Food and Drug Administration

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

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

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

31-7-2018

Heat wave: Retailers may refrain from selling non-prescription drugs

Heat wave: Retailers may refrain from selling non-prescription drugs

Due to the summer heat, the Danish Medicines Agency has given Danish retailers dispensation from the requirement to stock a basic selection of medicines if they are having trouble keeping the temperature in their store cool enough for proper storage of the drugs. This dispensation applies until 1 September.

Danish Medicines Agency

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

12-7-2018

Minimum service during 23 July - 3 August

Minimum service during 23 July - 3 August

Due to summer holidays minimum service level will be at the Icelandic Medicines Agency from 23 July till 3 August, both days included. Please note that the agency is closed on Monday 6 August due to a bank holiday.

IMA - Icelandic Medicines Agency

6-7-2018

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

29-6-2018

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling certain lots of Prescript-Assist, a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, dairy, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

25-6-2018

Ministers: voedselveiligheid verder versterken urgent

Ministers: voedselveiligheid verder versterken urgent

De Commissie Sorgdrager heeft een grondige analyse gemaakt van de wijze waarop de fipronilcrisis is afgehandeld en spreekt alle relevante actoren –het bedrijfsleven, de toezichthouders en departementen– aan op hun functioneren. Het beeld dat het rapport schetst is niet fraai. De pluimveehouders die nog steeds met de gevolgen van de crisis kampen, voelen het als geen ander.  De aanbevelingen om de voedselveiligheid verder te versterken worden opgevolgd. Dat schrijven de ministers Bruno Bruins en Carola Sc...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-6-2018

Commissie onderzoek fipronil in eieren: geef voedselveiligheid topprioriteit

Commissie onderzoek fipronil in eieren: geef voedselveiligheid topprioriteit

Bedrijven in de eierketen, de NVWA en de ministeries van VWS en LNV hebben onvoldoende voorrang gegeven aan voedselveiligheid. Bedrijven in de eierketen maken hun wettelijke verantwoordelijkheid niet waar. Bij de NVWA krijgt voedselveiligheid te weinig aandacht. Politiek en bestuur hebben een te beperkte opvatting over hun eigen rol ten aanzien van voedselveiligheid en komen pas in actie als zich een incident of crisis voordoet. Dat zijn de belangrijkste conclusies uit het rapport van de Commissie onderz...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

8-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

10-10-2018

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twi

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twi

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds >115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!! pic.twitter.com/Mhx4LNoJCr

FDA - U.S. Food and Drug Administration

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

29-8-2018

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Active substance: dinotefuran, pyriproxyfen, permethrin) - Centralised - Renewal - Commission Decision (2018)5783 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2555/R/9

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2069 (Professor Marjukka MyllArniemi)

EU/3/18/2069 (Professor Marjukka MyllArniemi)

EU/3/18/2069 (Active substance: Tilorone) - Orphan designation - Commission Decision (2018)5738 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/18

Europe -DG Health and Food Safety

22-8-2018

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed.  https://go.usa.gov/xUH4

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed. https://go.usa.gov/xUH4

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed. https://go.usa.gov/xUH4a  #GetAheadOfSepsis pic.twitter.com/7rut8Big03

FDA - U.S. Food and Drug Administration

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

Europe - EMA - European Medicines Agency

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

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety