Admiral 10 EC

Primær information

  • Handelsnavn:
  • Admiral 10 EC Emulsionskoncentrat
  • Lægemiddelform:
  • Emulsionskoncentrat
  • Sammensætning:
  • 100 g/l pyriproxyfen
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

Lokation

  • Fås i:
  • Admiral 10 EC Emulsionskoncentrat
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • Ingen afstandskrav til vandmiljø (indendørs anvendelse).
  • Sidste ændring:
  • 22-07-2018

Indlægsseddel

Admiral

®

10 EC

Insektmiddel

Insektmiddel, nr. 526-5.

Omfattet af Miljøministeriets bekendtgørelse om

bekæmpelsesmidler og plantebeskyttelsesmiddelforordningen 1107/2009.

Analyse: Pyriproxyfen 100 g/l (10,9 % w/w). Indeholder solvent naphta (petroleum).

Midlet er et emulgerbart koncentrat fra Sumitomo Chemical Agro Europe S.A.,

Parc d’Affaires de Crecy, Rue C. Chappe 2, 69370 Saint-Didier-au-Mont-d'Or, Frankrig

Distribution:

Nordisk Alkali

Anemonevænget 2 - 4330 Hvalsø

Tlf.

4649 1171 - www.nordiskalkali.dk

2014.10

INDHOLD:

250 ml

FARE

Brugsanvisningen skal følges for ikke at

bringe menneskers sundhed og miljøet

i fare (EUH401).

Kan være livsfarligt, hvis det indtages og

kommer i luftvejene (H304).

Forårsager hudirritation (H315).

Meget giftig med langvarige virkninger for

vandlevende organismer (H410).

Bær beskyttelseshandsker (P280).

Vær opmærksom på, at Arbejdstilsynet har

regler for arbejde med og udsættelse for

plantebeskyttelsesmidler. Læs nærmere i det

eventuelt lovpligtige sikkerhedsdatablad.

Overtrædelse af nedenstående særligt frem-

hævede forskrifter kan medføre straf:

Må kun anvendes til bekæmpelse af insekter i pryd-

planter samt agurk, courgetter, asier og drueagurk

dyrket i væksthus.

Må ikke anvendes mod andre skadevoldere og ikke i

højere doseringer end de i brugsanvisningen nævnte.

Må i agurk, courgette, asier og drueagurk dyrket i

væksthus ikke anvendes senere end 3 dage før høst.

Højst 2 behandlinger og 10 dage mellem hver

behandling.

Undgå forurening af vandmiljøet med produktet eller

med beholdere, der har indeholdt produktet. Undgå

forurening via dræn fra gårdspladser og veje (SP1).

Opbevares under lås og utilgængeligt for børn

(P102+P405).

Må ikke opbevares sammen med fødevarer, drikke-

varer og foderstoffer.

Førstehjælp

I TILFÆLDE AF INDTAGELSE:

Ring omgående til en

GIFTINFORMATION eller en

læge. Fremkald IKKE opkast-

ning (P301+P310+P331).

VED KONTAKT MED HUDEN: Vask med rigeligt sæbe og vand. (P302+P352).

Forurenet tøj tages af og vaskes, før det bruges igen (P362). Ved hudirritation:

Søg lægehjælp (P332+P313).

VED INDÅNDING: Flyt personen til et sted med frisk luft. Søg lægehjælp hvis

ubehag fortsætter.

VED KONTAKT MED ØJNENE: Skyl grundigt med vand.

Fjern eventuelle kontaktlinser, hvis dette kan gøres let.

Søg lægehjælp hvis irritation opstår.

Hvis der er brug for lægehjælp, medbring da

beholderen eller etiketten (P101).

Holdbar i mindst 2 år efter produktions-

datoen som sammen med batchnummer

findes stemplet på emballagen.

® Varemærke registreret af Sumitomo Chemical.

Må kun anvendes til bekæmpelse af insekter i prydplanter samt agurk, courgetter, asier og drueagurk dyrket i væksthus.

Gældende fra 26. november 2015:

Dette plantebeskyttelsesmiddel

må kun købes af professionelle

og anvendes erhvervsmæssigt

og kræver gyldig autorisation.

Læs vedlagte

brugsanvisning

ADMIRAL

®

10 EC

BRUGSANVISNING

Generel information

ADMIRAL

selektivt

insektmiddel

bekæmpelse/kontrol af mellus i væksthuse. ADMIRAL

virker

“forstyrre”

insektets

naturlige

væksthormon

(juvenilhormonet),

hvorved

hudskiftet

mellem

forskellige

udviklingsstadier

påvirkes.

ADMIRAL

10 EC kan endvidere virke “steriliserende” på

nogle insektarter, f.eks. mellus.

ADMIRAL

10 EC hindrer skadedyrene i at udvikle sig til

deres voksenstadium. Ved behandling af veletablerede

angreb vil antallet af skadedyr gradvis blive reduceret,

idet de voksne individer efterhånden forsvinder samtidig

med, at der ikke opformeres nye skadedyr. Insekternes

følsomhed og reaktion over for ADMIRAL

10 EC er

meget

forskellig

art,

hvilket

gør

produktet

velegnet

anvendelse

forbindelse

biologisk

bekæmpelse.

ADMIRAL

10 EC bør anvendes før et angreb bliver

veletableret,

f.eks.

begyndende

indflyvning

eller

æglægning, da effekten er størst ved behandling i de

tidlige

stadier.

ADMIRAL

langtidsvirkning, men den er afhængig af doseringens

størrelse,

sprøjtevæskens

dækning

planterne,

planternes tilvækstform samt insektarten og dens adfærd.

Effekt

ADMIRAL

10 EC bekæmper/kontrollerer bomuldsmellus

væksthusmellus.

desuden

sideeffekt

bladlus.

ANVENDELSE

Prydplanter i væksthus

Bomuldsmellus, væksthusmellus: ADMIRAL

10 EC har

især god effekt ved behandling på ægstadiet og de første

nymfestadier (larvestadier), mens der ingen direkte effekt

er at observere på voksenstadiet. Det skal bemærkes, at

nymfestadierne fortsætter deres normale udvikling helt

frem til puppestadiet. Virkningen ses ved, at pupperne

ikke klækkes. Behandling foretages så snart de første

mellus konstateres. Der behandles 2 gange med 7-14

dages interval.

Dosering: 0,0025-0,005 % (2,5-5 ml i 100 liter vand).

Prydplanters tålsomhed

ADMIRAL

10 EC er testet på nedenstående kulturer

med 3 behandlinger med 1 uges interval i doseringerne

0,025 og 0,10 %. På grund af det store antal arter og

sorter samt især forskelle i dyrkningsforhold, giver dette

ingen garanti for, at skader ikke kan opstå. Derfor bør den

enkelte

bruger

altid

først

afprøve

følsomheden

mindre

antal

planter

under

aktuelle

forhold.

Vær

opmærksom

på,

også

forekomme

årstidsvariationer.

Admiral

blevet

testet

følgende

kulturer

uden

blad/blomsterskader:

Dendranthema indicum-hybrid, Gerbera jamsonii, Ficus

pumila, Hibiscus rosa-sinensis, Rosa-hybrid.

Admiral

blevet

testet

følgende

kulturer

uden

blad/blomsterskader,

mulig

risiko

blomsterskader:

Begonia

elatior-hybrid,

Euphorbia

pulcherrima

(Grojii),

Impatiens Ny Guinea-hybrid, Saintpaulia ionantha.

Admiral

blevet

testet

følgende

kulturer

uden

blad/blomsterskader, men med mulig vækstretardering:

Kalanchoë blossfeldiana.

Sprøjtning på kulturer i blomst bør undlades af hensyn til

svidningsfare.

Agurk, courgetter, asier og drueagurk i væksthus

Bomuldsmellus, væksthusmellus: ADMIRAL

10 EC har

især god effekt ved behandling på ægstadiet og de første

nymfestadier (larvestadier), mens der ingen direkte effekt

er at observere på voksenstadiet. Det skal bemærkes, at

nymfestadierne fortsætter deres normale udvikling helt

frem til puppestadiet. Virkningen ses ved, at pupperne

ikke klækkes. Behandling foretages så snart de første

mellus konstateres. Der behandles 2 gange med 10-14

dages interval, behandlingsfrist på 3 dage.

Dosering: 0,0025-0,005 % (2,5-5 ml i 100 liter vand).

Ved anvendelse af humlebier i dyrkningen:

Humlebiernes

stader

skal

overdækkes

under

sprøjtningen. Overdækning fjernes først, når væsken er

tørret ind.

Biologisk bekæmpelse

ADMIRAL

10 EC er generelt forenelig med anvendelse

af biologiske bekæmpelsesmetoder. I visse tilfælde kan

der blive tale om forbigående hæmning af kort varighed.

Resistens

Aktivstoffet i ADMIRAL

10 EC, pyriproxyfen, hører til

gruppen

juvenil

hormoner

(IRAC

gruppe

7C).

Når

insektmidler med samme virkemåde anvendes i samme

væksthus flere gange i træk, kan der ske en udvælgelse

evt.

naturligt

forekommende

resistente

skadegører.

Disse kan opformeres og blive dominerende. Derfor skal

almindelig resistensforebyggelse foretages. D.v.s. at der

skal veksles med midler med anden virkemekanisme,

men med samme effekt over for skadegøreren.

ADMIRAL

®

10 EC

Væskemængde

agurk

anvendes

200-300

vand

1.000

prydplanter anvendes normalt op til 200 l vand pr. 1.000

. Det er vigtigt, at der sørges for en så optimal dækning

af planterne som muligt - både over- og underside.

Blandinger

Blandinger inden for gartneriområdet frarådes normalt på

grund af det store antal arter og sorter samt forskelle i

dyrkningsforholdene.

Fremstilling af sprøjtevæsken

Påfyldning skal ske på plads med opsamling. Start altid

sprøjtearbejdet med en ren sprøjte. Fyld tanken 3/4 med

vand, start omrøring, tilsæt ADMIRAL

10 EC, fyld efter

vand.

Fortsæt

omrøring,

indtil

udsprøjtningen

afsluttet.

Rengøring af sprøjteudstyr

Straks efter endt udsprøjtning af ADMIRAL

10 EC skal

sprøjtemateriellet

rengøres

grundigt,

også

selv

sprøjtningen

fortsættes

næste

dag.

Restsprøjtevæske

fortyndes

minimum

gange

udsprøjtes på den behandlede kultur. Husk vask med

rengøringsmiddel

indvendigt

flere

gange

skylning af alle indvendige dele. For yderligere regler

vedrørende

fyldning,

tømning

rengøring

sprøjteudstyret

henvises

Bekendtgørelse

1355

14/12/2012.

Forholdsregler

ved

adgang

til

eller

håndtering

af

behandlede planter

Adgang

behandlet

område

ikke

før

sprøjtevæsken er tørret ind, og der er foretaget en god

ventilation/gennemluftning af området. Ved håndtering af

planter anvendes der handsker de første 3 døgn efter

behandlingen.

Opbevaring

Opbevares tørt og køligt, men frostfrit.

Bortskaffelse af tom emballage

Indholdet/beholderen

bortskaffes

overensstemmelse

kommunale

regler

affaldshåndtering

(P501):

Rester skal afleveres til den kommunale affaldsordning

for farligt affald. Tomme beholdere kan bortskaffes med

dagrenovationen. Den tomme beholder bør skylles inden

bortskaffelse. Skyllevandet hældes op i sprøjtevæsken.

Emballagen må ikke genbruges.

OBS:

Producenten

fralægger

ethvert

ansvar

produktets

skader

følgeskader,

opstået

forbindelse

ikke

forskriftsmæssig

brug

eller

opbevaring af produktet.

Distribution:

Nordisk Alkali

Anemonevænget 2

4330 Hvalsø

Tlf. 4649 1171

www.nordiskalkali.dk

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

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

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Pending EC decision:  Inflacam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Inflacam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  NexGard, afoxolaner, Opinion date: 13-Sep-2018

Pending EC decision: NexGard, afoxolaner, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety