Effipro comp

Primær information

  • Handelsnavn:
  • Effipro comp 50 mg+60 mg spot-on, opløsning
  • Dosering:
  • 50 mg+60 mg
  • Lægemiddelform:
  • spot-on, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
  • 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.

Lokation

  • Fås i:
  • Effipro comp 50 mg+60 mg spot-on, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 54955
  • Sidste ændring:
  • 18-07-2018

Produktresumé: dosering, interaktioner, bivirkninger

27. juni 2017

PRODUKTRESUMÉ

for

Effipro comp, spot-on, opløsning 50/60 mg og 100/120 mg

0.

D.SP.NR.

29469

1.

VETERINÆRLÆGEMIDLETS NAVN

Effipro comp

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver pipette indeholder:

Effipro comp 50

mg/60 mg

Effipro comp 100

mg/120 mg

En pipette med 0,5

ml indeholder:

En pipette med 1 ml

indeholder:

Aktive stoffer:

Fipronil

Pyriproxyfen

50 mg

60 mg

100 mg

120 mg

Hjælpestoffer:

Butylhydroxyanisol

Butylhydroxytoluen

0,1 mg

0,05 mg

0,2 mg

0,1 mg

Alle hjælpestoffer er anført under pkt. 6.1

3.

LÆGEMIDDELFORM

Spot-on, opløsning.

Klar, farveløs til gullig opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Katte.

4.2

Terapeutiske indikationer

Til katte mod infestation af lopper alene eller samtidig med flåter.

54955_spc.docx

Side 1 af 7

Mod lopper

Forebyggelse og behandling af infestationer med lopper (Ctenocephalides felis). En

behandling forebygger re-infestation i 5 uger.

Forebygger i 12 uger efter behandling opformering af lopper ved at hindre, at loppeæg

udvikles til voksne lopper.

Præparatet kan anvendes som en del af en behandlingsstrategi i kontrollen af loppebetinget

allergisk dermatitis, der tidligere er diagnosticeret af en dyrlæge.

Mod flåter

Behandling af infestationer med flåter (Ixodes ricinus og Rhipicephalus turanicus).

En behandling har vedvarende acaricid virkning i en uge.

Hvis flåter er til stede på behandlingstidspunktet, er det ikke sikkert, at disse dræbes inden

for de første 48 timer.

4.3

Kontraindikationer

Må ikke anvendes til kaniner, da bivirkninger og også død kan forekomme.

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

eller flere af hjælpestofferne.

4.4

Særlige advarsler

Ved to laboratorieundersøgelser opblødtes pelsen med vand to timer inden påføring af

præparatet og to gange i løbet af den fastsatte virkningsperiode (med to ugers interval mod

voksne lopper og 4 ugers interval mod lopper i forskellige udviklingsstadier). Opblødning

af pelsen med vand som beskrevet nedsatte ikke præparates virkning.

Det er ikke undersøgt, hvordan brug af shampoo påvirker præparatets virkning. Hvis brug

af shampoo er nødvendig, anbefales det at gøre det inden behandling.

Kontrolforanstaltningerne ved loppeinfestation indledes med behandling af kattens kurv,

sove- og hvilesteder, som gulvtæpper og bløde møbler, med en egnet insektgift samt

regelmæssig støvsugning.

For at nedsætte belastningen med lopper fra omgivelserne skal alle dyr i husstanden også

behandles med et egnet loppemiddel.

Præparatet forhindrer ikke flåter i at hæfte sig på dyrene. Hvis dyret er behandlet inden det

udsættes for flåter, vil disse dø inden for 48 timer efter vedhæftning. Dette vil sædvanligvis

ske før flåten svulmer op, hvilket minimere, men ikke udelukker, risiko for overførsel af

sygdomme.

Døde flåter vil ofte falde af katten af sig selv. Tilbageværende flåter bør omhyggeligt

fjernes, mens det sikres at ingen munddele efterlades i huden.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Til anvendelse på huden. Må ikke gives via munden.

Dyr bør vejes nøjagtigt inden behandling.

Produktets sikkerhed er ikke fastlagt for katte yngre end 10 eller under 1 kg kropsvægt.

Undgå kontakt med dyrets øjne. I tilfælde af utilsigtet kontakt med dyrets øjne skylles

disse med vand.

Vær omhyggelig med korrekt påføring som beskrevet under pkt. 4.9. Undgå at anvende

præparatet på sår eller beskadiget hud. Det er vigtigt at sikre sig, at præparatet påføres

54955_spc.docx

Side 2 af 7

direkte på tør hud, på et sted, hvor dyret ikke har mulighed for at slikke det af, samt at

sørge for at behandlede dyr kan slikke hinanden.

Brugen af præparatet til syge og svækkede katte er ikke undersøgt, hvorfor anvendelse i

disse tilfælde alene bør baseres på den ansvarlige dyrlæges vurdering af fordele og

ulemper.

På grund af manglende yderligere sikkerhedsoplysninger bør behandlingen ikke gentages

med et interval under 4 uger.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Præparatet kan forårsage neurotoksicitet. Præparatet kan være skadeligt, hvis det indtages.

Undgå indtagelse, også via hånd-til-mund kontakt. Undgå kontakt med hud og mund.

Undlad at ryge, drikke eller spise under påføringen.

Vask hænderne efter brug. I tilfælde af selvindgivelse ved hændeligt uheld skal der straks

søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.

I tilfælde af kontakt med huden ved hændeligt uheld skylles med vand.

Børn bør ikke lege med behandlede dyr, og behandlede dyr bør ikke håndteres før

påføringsstedet er tørt. Det anbefales derfor, at dyrene ikke behandles i løbet af dagen, men

tidlig aften. Nyligt behandlede dyr bør ikke gives lov til at sove sammen med deres ejere,

især børn.

Opbevar pipetterne i original emballage indtil brug og smid brugte pipetter ud med det

samme.

Andre forsigtighedsregler

Præparatet kan have skadelig virkning på malede, lakerede eller andre overflader i

hjemmet, samt på møbler. Lad påføringsstedet tørre før der gives adgang til disse

materialer.

4.6

Bivirkninger

Forbigående kosmetiske effekter, som fugtigt udseende eller let skældannelse, kan

forekomme på påføringsstedet.

Ifølge den samlede erfaring med disse aktive stoffer i spot-on formuleringer, kan

forbigående hudreaktioner på påføringsstedet (skældannelse, lokalt hårtab, kløe, rødmen og

misfarvning af huden) samt generaliseret kløe eller hårtab ses efter brug. I meget sjældne

tilfælde kan øget spytsekretion, forbigående neurologiske symptomer (forstærket

berøringssans, nedstemthed, angstsymptomer), symptomer fra luftvejene eller opkast

forekomme.

4.7

Drægtighed, diegivning eller æglægning

Laboratorieundersøgelser af fipronil og pyriproxifen har ikke vist teratogen eller

embryotoksisk effekt. Der er ikke foretaget undersøgelser på drægtige og diegivende

hunkatte. Må kun anvendes til drægtige og diegivende dyr i overensstemmelse med den

ansvarlige dyrlæges vurdering af fordele og ulemper.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

54955_spc.docx

Side 3 af 7

4.9

Dosering og indgivelsesmåde

Spot-on anvendelse.

Dosering:

Afhængig af kropsvægten, som angivet i skemaet neden for, appliceres indholdet af 1

pipette på huden pr. kat, svt. en anbefalet minimumsdosering på 8,3 mg fipronil og 10 mg

pyriproxifen pr. kg. kropsvægt.

Kattens vægt

Mængde

Fipronil (mg)

Pyriproxyfen (mg)

1-6 kg

0,5 ml

>6-12 kg

1 ml

Til katte der vejer over 6 kg kan den anbefalede dosis på 1 ml også gives ved påføring af

indholdet fra to pipetter med hver 0,5 ml.

Administrationsmetode:

Pipetten fjernes fra sit hylster og holdes lodret. Slå på den øverste smalle del af pipetten for

at sikre, at indholdet er i den nedre tykke del. Knæk den øverste del af spot-on pipettens

spids af langs den markerede linje.

Skil kattens pels på nakken, så huden bliver synlig. Anbring toppen af pipetten direkte på

huden og klem flere gange for at tømme indholdet, så det er fordelt jævnt på et eller to

påføringssteder. Sørg for at opløsningen kun påføres rask hud. Undgå at opløsningen

havner i pelsen, eller at den løber af.

Dryp-frit system (indholdet frigives kun ved pres på pipettens brede del).

For at opnå optimal kontrol med loppe- og flåtangreb samt loppeopformering kan

behandlingsprogrammet baseres på den lokale epidemiologiske situation. På grund af

manglende yderligere sikkerhedsoplysninger bør behandlingen ikke gentages med et

interval under 4 uger (se pkt. 4.10).

4.10

Overdosering

Ingen alvorlige bivirkninger blev set ved sikkerhedsundersøgelser udført på 10 uger gamle

killinger, der fik op til 5 gange den maksimalt anbefalede dosis 3 gange med et interval på

4 uger samt den maksimalt anbefalede dosis 6 gange med et interval på 4 uger.

Risiko for bivirkninger (se pkt. 4.6) kan imidlertid øges ved overdosering, hvorfor dyret

altid skal behandles med den korrekte størrelse pipette i forhold til kropsvægt.

4.11

Tilbageholdelsestid

54955_spc.docx

Side 4 af 7

Ikke relevant.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: Ektoparasiticid til udvortes brug, fipronil, kombinationer.

ATCvet kode: QP 53 AX 65

5.1

Farmakodynamiske egenskaber

Fipronil er et insekticid og acaricid tilhørende phenylpyrazolfamilien. Fipronil og dets

metabolit fipronilsulfon virker på ligandregulerede chloridkanaler, særlig dem der styres af

neurotransmitteren gammaaminosmørsyre (GABA) samt de desensibiliserende (D) og non-

desensibiliserende (N) kanaler reguleret af glutamat (Glu, en ligandreguleret chloridkanal,

som er unik for invertebrater), hvorved den præ-og postsynaptiske passage af chloridioner

over cellemembranen blokeres. For insekter eller mider fører dette til en ukontrolleret

aktivitet i centralnervesystemet og døden.

Pyriproxyfen er en regulator af insekters vækst ((IGR) insect growth regulator), som

tilhører gruppen af stoffer kendt som juvenile hormonanaloger. Pyriproxifen steriliserer

voksne lopper og forhindrer udviklingen af immature stadier. Ved kontakt med molekylet

forhindres fremkomst af voksne insekter ved blokering af udviklingen af æg (ovicid

virkning), larver og pubber (larvicid virkning), som efterfølgende elimineres. Efter voksne

loppers kontakt med og/eller indtagelse af molekylet, virker det også ved at sterilisere æg

under deres modning og før de lægges. Molekylet forhindrer kontaminering af behandlede

dyrs omgivelser med immature loppestadier.

Kombinationen af fipronil og pyriproxifen har insekticid og acaricid virkning over for

lopper (Ctenocephalides felis), flåter (Rhipicephalus turanicus, Ixodes ricinus) og

forhindrer endvidere, at æg udvikler sig til voksne lopper.

Kombinationen giver integreret loppekontrol, som kan bruges mod infestationer med

lopper eller en kombination af lopper og flåter.

5.2

Farmakokinetiske egenskaber

Efter topikal applikation af præparatet, og ved normal brug, fordeles fipronil og

pyriproxifen godt over hele kattens pels inden for 24 timer.

Fipronils primære metabolit er fipronilsulfon, som også har insekticid og acaricid virkning.

Koncentrationerne af fipronil og pyriproxifen i hårlaget aftager over tid, men aktive stoffer

kan påvises mindst frem til 84 dage efter behandling (dvs. over grænsen for kvantificering

(LOQ); 100 ng/g for fipronil og 50 ng/g for pyriproxyfen).

Koncentrationen af fipronilsulfon forblev under grænsen for kvantificering (LOQ 100

ng/g) efter applikation.

Den maksimale plasmakoncentration for fipronil og pyriproxifen nås hurtigt, 1 dag efter

behandling. Plasmakoncentrationen af fipronil er kvantificerbar hos alle katte i op til 3

dage efter applikation (LOQ 1 ng/ml). Plasmakoncentrationen af pyriproxyfen er

kvantificerbar hos alle katte i op til 42 dage efter applikation (LOQ 0,2 ng/ml).

Plasmakoncentrationen af fipronilsulfon forblev under grænsen for kvantificering (LOQ 1

ng/ml) efter applikation.

5.3

Miljømæssige forhold

54955_spc.docx

Side 5 af 7

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Butylhydroxyanisol (E320)

Butylhydroxytoluen (E321)

Diethylenglycolmonoethylether

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

I salgspakning: 3 år.

6.4

Særlige opbevaringsforhold

Må ikke opbevares over 30

Opbevares tørt.

Opbevar hylster med pipetter i den ydre karton for at beskytte mod lys.

6.5

Emballage

Enkel-dosis pipette af flerlaget plastik indeholdende:

Effipro comp 50 mg/60 mg, spot-on, opløsning til katte:

0,5 ml

Effipro comp 100 mg/120 mg, spot-on, opløsning til store katte:

1 ml

Pipetterne fremstilles ved varmestøbning af en gennemsigtig flerlaget bund

(polyakrylnitril-methacrylat eller polyethylen-ethylen vinyl alkohol-polyethylen,

polypropylen, cyklisk olefin-copolymer, polypropylen) som lukkes ved varmeforsegling

med et flerlaget låg (polyakrylnitril-methacrylat eller polyethylen-ethylen vinyl alkohol-

polyethylen, aluminium, polyethylenterephthalat).

Pipetterne opbevares i et hylster af lagdelt polypropylen, cyklisk olefin-copolymer og

polypropylen lukket med et låg af lagdelt polyethylenterephthalat, aluminium,

polypropylen.

Æsker med 1, 4, 24 og 60 pipetter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Ikke anvendte veterinære lægemidler, samt affald heraf bør destrueres i henhold til lokale

retningslinjer.

Præparatet eller tomme beholdere må ikke udledes i damme, vandløb eller grøfter, da dette

kan være farligt for fisk og andre organismer i vandet.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Virbac

ère

avenue – 2065 m – L.I.D.

06516 Carros

Frankrig

54955_spc.docx

Side 6 af 7

Repræsentant

Virbac Danmark A/S

Profilvej 1

6000 Kolding

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

50 mg/60 mg:

54955

100 mg/120 mg:

54956

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

7. september 2015

10.

DATO FOR ÆNDRING AF TEKSTEN

27. juni 2017

11.

UDLEVERINGSBESTEMMELSE

54955_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.



  • Dokumenter på andre sprog er tilgængelige her

4-12-2018

Joint project on Benchmark Dose modelling with RIVM

Joint project on Benchmark Dose modelling with RIVM

Published on: Mon, 03 Dec 2018 A web application for PROAST, a software package for BMD modelling, was developed to make the use of the BMD approach significantly easier for toxicologists and risk assessors. In addition, model averaging was included in the software, for the most frequently occurring types of data in toxicological studies. The PROAST web application now allows for applying model averaging for the case of both quantal and continuous data, as well as for combined datasets (dose‐response da...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB 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 acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

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

25-9-2018

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding

FDA - U.S. Food and Drug Administration

18-9-2018

FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids

FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids

FDA launched new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids.

FDA - U.S. Food and Drug Administration

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

23-7-2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues making progress on bulk drug substances for compounding

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

6-6-2018

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

At the 35th French occupational medicine and health congress (CNMST) held in Marseille from 5 to 8 June 2018, ANSES presented for the very first time data on cancers of occupational origin collected by the National Network for Monitoring and Prevention of Occupational Diseases (RNV3P) coordinated by the Agency. These data are used to build up a comprehensive picture of the cancers associated with occupational exposure situations, in order toidentify the industry sectors and situations most at risk, with ...

France - Agence Nationale du Médicament Vétérinaire

5-6-2018

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

FDA - U.S. Food and Drug Administration

22-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

26-2-2016

New comprehensive list of euphoriant substances regulated in Denmark

New comprehensive list of euphoriant substances regulated in Denmark

You can now find a comprehensive list of euphoriant substances that are subject to control in Denmark via the executive order on euphoriant substances.

Danish Medicines Agency

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

11-9-2018

Agenda:  Agenda - COMP agenda of the 11-13 September 2018 meeting

Agenda: Agenda - COMP agenda of the 11-13 September 2018 meeting

Europe - EMA - European Medicines Agency

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

17-8-2018

 Minutes of the COMP meeting of 22-24 May 2018

Minutes of the COMP meeting of 22-24 May 2018

Europe - EMA - European Medicines Agency

17-8-2018

 Minutes of the COMP meeting of 19-21 June 2018

Minutes of the COMP meeting of 19-21 June 2018

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

17-7-2018

Agenda:  Agenda - COMP agenda of the 17-19 July 2018 meeting

Agenda: Agenda - COMP agenda of the 17-19 July 2018 meeting

Draft agenda for the meeting on 17-19 July 2018

Europe - EMA - European Medicines Agency

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK

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

28-6-2018

 Minutes of the COMP meeting of 17-19 April 2018

Minutes of the COMP meeting of 17-19 April 2018

Europe - EMA - European Medicines Agency

18-6-2018

Agenda:  Agenda - COMP agenda of the 19-21 June 2018 meeting

Agenda: Agenda - COMP agenda of the 19-21 June 2018 meeting

Committee for Orphan Medicinal Products (COMP) draft agenda for the meeting on 19-21 June 2018

Europe - EMA - European Medicines Agency

28-5-2018

 Minutes of the COMP meeting of 13-15 March 2018

Minutes of the COMP meeting of 13-15 March 2018

Europe - EMA - European Medicines Agency

22-5-2018

Agenda:  Agenda - COMP agenda of the 22-24 May 2018 meeting

Agenda: Agenda - COMP agenda of the 22-24 May 2018 meeting

Europe - EMA - European Medicines Agency

15-5-2018

 Minutes of the COMP meeting of 13-15 February 2018

Minutes of the COMP meeting of 13-15 February 2018

Europe - EMA - European Medicines Agency

30-4-2018

CERTIFECT (Merial)

CERTIFECT (Merial)

CERTIFECT (Active substance: (S)-Methoprene, Fipronil, Amitraz) - Withdrawal - Commission Decision (2018)2687 of Mon, 30 Apr 2018

Europe -DG Health and Food Safety