Effipro comp

Primær information

  • Handelsnavn:
  • Effipro comp 67 mg+20 mg spot-on, opløsning
  • Dosering:
  • 67 mg+20 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.


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Lokation

  • Fås i:
  • Effipro comp 67 mg+20 mg spot-on, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 54811
  • Sidste ændring:
  • 18-07-2018

Produktresumé

27. juni 2017

PRODUKTRESUMÉ

for

Effipro comp, spot-on, opløsning 67/20 mg, 134/40 mg, 268/80 mg og 402/120 mg

0.

D.SP.NR.

29469

1.

VETERINÆRLÆGEMIDLETS NAVN

Effipro comp

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver pipette indeholder:

Effipro

comp 67

mg/20 mg

Effipro

comp 134

mg/40 mg

Effipro

comp 268

mg/80 mg

Effipro

comp 402

mg/120 mg

En pipette

med 0,67 ml

indeholder:

En pipette

med 1,34 ml

indeholder:

En pipette

med 2,68 ml

indeholder:

En pipette

med 4,02 ml

indeholder:

Aktive stoffer:

Fipronil

Pyriproxyfen

67,0 mg

20,1 mg

134,0 mg

40,2 mg

268,0 mg

80,4 mg

402,0 mg

120,6 mg

Hjælpestoffer:

Butylhydroxyanisol

Butylhydroxytoluen

0,134 mg

0,067 mg

0,268 mg

0,134 mg

0,536 mg

0,268 mg

0,804 mg

0,402 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

Hunde.

4.2

Terapeutiske indikationer

54811_spc.docx

Side 1 af 7

Mod infestation af lopper alene eller sammen med flåter.

Mod lopper

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

behandling forebygger re-infestation i 7 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).

En behandling har vedvarende acaricid virkning i 2 uger over for Ixodes ricinus og i 4 uger

over for Dermacentor reticulatus og Rhipicephalus sanguineus.

Hvis flåter af arterne Dermacentor reticulatus eller Rhipicephalus sanguineus 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

Brug af shampoo eller badning af hunden umiddelbart efter behandling kan nedsætte

virkningstiden. Ved brug af shampoo en gang om måneden forbliver præparatet virksomt i

5 uger efter behandling. Hvis brug af shampoo er nødvendig, er det bedre at gøre det inden

behandling.

Badning gentaget to gange efter behandling havde ingen indflydelse på drabseffekten af

voksne lopper eller den præventive virkning på udviklingen af loppeæg til voksne lopper.

Det er ikke fastlagt, hvilken indflydelse brug af shampoo og badning af hunden har på

virkningen mod flåter.

Kontrolforanstaltningerne ved loppeinfestation indledes med behandling af hundens 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. Under uheldige omstændigheder

kan overførsel af smitsom sygdom med flåter derfor ikke helt udelukkes.

Der er påvist øjeblikkelig virkning på Ixodex ricinus, hvilket indikerer, at flåter af denne

art, sandsynligvis dræbes inden for 48 timer efter behandling. Hvis flåter af arterne

Dermacentor reticulatus eller Rhipicephalus sanguineus er til stede på

behandlingstidspunktet, er det ikke sikkert, at disse dræbes inden for de første 48 timer.

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

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

4.5

Særlige forsigtighedsregler vedrørende brugen

54811_spc.docx

Side 2 af 7

Særlige forsigtighedsregler for dyret

Til anvendelse på huden.

Dyr bør vejes nøjagtigt inden behandling.

På grund af manglende oplysninger om sikkerhed bør præparatet ikke anvendes til hvalpe

under 10 uger og/eller under 2 kg kropsvægt.

Undgå omhyggeligt at pipettens indhold kommer i kontakt med dyrets øjne eller mund.

Indtagelse ved slikken på behandlingsstedet bør undgås, både for den behandlede hund og

andre dyr, som den er i kontakt med.

Undgå at anvende præparatet på sår eller beskadiget hud.

På grund af manglende oplysninger om sikkerhed bør behandlingen ikke gentages med et

interval under 4 uger.

Brugen af præparatet til syge og svækkede hunde er ikke undersøgt.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Præparatet kan forårsage neurotoksicitet.

Præparatet kan være skadeligt, hvis det indtages.

Undgå kontakt med hud og mund.

Undgå indtagelse, også via hånd-til-mund kontakt.

Undlad at ryge, drikke eller spise under påføringen.

Vask hænderne efter brug.

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

påføringsstedet er tørt. Det anbefales derfor, at dyrene ikke behandles om 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.

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

I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges lægehjælp, og

indlægssedlen eller etiketten bør vises til lægen.

Andre forsigtighedsregler

Fipronil og pyriproxifen kan have skadelig virkning på vandlevende organismer. Hunde

må ikke have adgang til vandløb eller åer i 48 timer efter behandling (se også pkt. 6.6).

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

54811_spc.docx

Side 3 af 7

hunhunde. Må kun anvendes til drægtige og diegivende hunde 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

Spot-on anvendelse.

Dosering:

Afhængig af kropsvægten, som angivet i skemaet nedenfor, appliceres indholdet af 1

pipette på huden pr. hund, svt. en anbefalet dosering på 6,7 mg fipronil og 2 mg

pyriproxifen pr. kg. kropsvægt.

Mængde

Hundens vægt

Fipronil (mg)

Pyriproxyfen (mg)

0,67 ml

2-10 kg

20,1

1,34 ml

10-20 kg

40,2

2,68 ml

20-40 kg

80,4

4,02 ml

40-60 kg

120,6

Til hunde over 60 kg bør en relevant kombination af pipetter anvendes.

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.

Del hundens pels på nakken foran skulderbladene, så huden bliver synlig. Anbring toppen

af pipetten direkte på huden og klem blidt adskillige gange for at få indholdet ud. Særligt

på store hunde, kan det være nødvendigt at fordele pipettens indhold på yderligere et eller

to steder langs hundens ryg for at undgå, at opløsningen løber af eller fordeler sig

overfladisk i pelsen.

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

En pipette svarer til en behandling med mulighed for genbehandling en gang om måneden.

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

behandlingsprogrammet baseres på den lokale epidemiologiske situation.

54811_spc.docx

Side 4 af 7

4.10

Overdosering

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

hvalpe, 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

Ikke relevant.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe: Ektoparasiticider 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 stadier af lopper.

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

lopper (Ctenocephalides felis), flåter (Rhipicephalus sanguineus, Dermacentor reticulatus,

Ixodes ricinus) og forhindrer endvidere, at æg udvikler sig til voksne lopper.

5.2

Farmakokinetiske egenskaber

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

pyriproxifen godt over hele hundens hårlag inden for 24 timer.

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

Koncentrationerne af fipronil, fipronilsulfon og pyriproxifen i hårlaget aftager over tid,

men kan påvises mindst frem til 84 dage efter behandling.

Efter behandling nås den maksimale plasmakoncentration for fipronil efter 3-7 dage, for

fipronilsulfon efter 7-14 dage og for pyriproxifen efter 1-3 dage.

Plasmakoncentrationerne af fipronil og pyriproxifen aftager over tid og kan kvantificeres

op til 50 dage efter behandling.

5.3

Miljømæssige forhold

54811_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 et volumen på:

Effipro comp 67 mg/20 mg, spot-on, opløsning:

0,67 ml

Effipro comp 134 mg/40 mg, spot-on, opløsning:

1,35 ml

Effipro comp 268 mg/80 mg, spot-on, opløsning:

2,68 ml

Effipro comp 402 mg/120 mg, spot-on, opløsning:

4,02 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

alkoholpolyethylen, 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 veterinærlægemidler 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.

54811_spc.docx

Side 6 af 7

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

VIRBAC.

ère

avenue – 2065 m – L.I.D.

06516 Carros

Frankrig

Repræsentant

Virbac Danmark A/S

Profilvej 1

6000 Kolding

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

67 mg/20 mg:

54811

134 mg/40 mg:

54812

268 mg/80 mg:

54813

402 mg/120 mg:

54814

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

7. september 2015

10.

DATO FOR ÆNDRING AF TEKSTEN

27. juni 2017

11.

UDLEVERINGSBESTEMMELSE

54811_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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Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

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

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

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