ATR Glyphosat 480

Primær information

  • Handelsnavn:
  • ATR Glyphosat 480 Vandopløseligt koncentrat
  • Lægemiddelform:
  • Vandopløseligt koncentrat
  • Sammensætning:
  • 480 g/l glyphosat
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for sundhedspersonale:
  • 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 sundhedspersonale.

Lokation

  • Fås i:
  • ATR Glyphosat 480 Vandopløseligt koncentrat
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • Må ikke anvendes nærmere end 2 meter fra vandmiljøet (vandløb, søer m.v.) for at beskytte organismer, der lever i vand (SPe3).
  • Sidste ændring:
  • 22-07-2018

Indlægsseddel

ATR GLYPHOSAT 480

Ukrudtsmiddel

Må kun anvendes til visse former for ukrudtsbekæmpelse samt nedvisning.

Dette plantebeskyttelsesmiddel må kun købes af professionelle og anvendes erhvervsmæssigt og

kræver gyldig autorisation.

Registreringsindehaver

Distributør

STEFES GmbH

ATR Landhandel GmbH & Co. KG

Wendenstr. 21b, 20097 Hamborg, Tyskland

Bahnhofsallee 44, 23909 Ratzeburg, Tyskland

Tlf.: +49 (0)40 5330 8330, E-mail: info@stefes.eu

Tlf.: +49 (0)4541 8060, E-mail: info@atr-landhandel.de

Læs først vedlagte brugsanvisning

DEKLARATION

Ukrudtsmiddel nr.: 826-15

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og plantebeskyttelsesmiddelforordningen 1107/2009

Aktivstof: Glyphosat 480 g/l (39.34% w/w) (svarende til glyphosat-dimethylaminsalt (DMA) 608 g/l (49.88% w/w)) ved 20°C

Midlet er et vandopløseligt koncentrat (SL).

Batchnummer og produktionsdato: Se emballagen

Holdbarhed: 2 år fra produktionsdato

Indhold: 20 Liter

BRUGSANVISNING

ATR Glyphosat

ATR Glyphosat 480 anvendes til:

Bekæmpelse af kvik, andet ukrudt samt ikke ønsket plantevækst før jordbearbejdning samt på stubmarker, udyrkede arealer,

gårdspladser, industriområder og lignende, i frugtplantager, havebrugs-, planteskole- og skovkulturer, omkring indhegning og

buske.

Nedvisning af korn, raps, ærter, hestebønner og fodergræs før høst. Nedvisning er ikke tilladt i afgrøder til udsæd samt maltbyg.

Virkemåde

ATR Glyphosat 480 optages gennem bladene og transporteres rundt i hele planten inklusiv rødder med plantens saftstrøm. I planten

hindres dannelsen af flere vigtige aminosyrer, hvilket resulterer i at planten dør. Effekten ses normalt 10-14 dage efter behandling.

Klimaforhold ved anvendelse

Optimal effekt af ATR GLYPHOSAT 480 opnås under følgende forhold: Planter i god vækst, høj luftfugtighed, fugtig jord, tørre planter

og gode temperaturforhold. Ved sprøjtning under andre betingelser, kan en langsommere effekt forventes.

Regnfasthed

ATR Glyphosat 480 er regnfast efter 6 timer.

Jordbearbejdning

Jordbearbejdning kan foretages når effekten ses på ukrudt, dog tidligst 10 dage efter behandling (7 dage om foråret). Direkte såning

kan ske 3 dage efter behandling af kvik og 1 dag efter behandling af andet ukrudt.

Jordtype

ATR Glyphosat 480 kan anvendes på alle jordtyper.

Sprøjteteknik og vandmængde

ATR Glyphosat 480 skal udbringes med en marksprøjte, som er kalibreret og lever op til de standarder

og specifikationer, som er givet af sprøjteproducenten. Anbefalet vandmængde ved behandling med

ATR Glyphosat 480 er 100 til 200 liter vand pr. hektar. Ved lave doseringer (<1,5 l/ha) anbefales maksimalt 150 liter vand pr. ha. For at

sikre god nedtrængning i tætte afgrøder anbefales lav hastighed (6-7 km/t) kombineret med højeste vandmængde.

Vejledende angivelse af væskemængde, dysevalg, tryk og kørehastighed

Vand (l/ha)

Dyse

Tryk (bar)

Hastighed (km/t)

100-200

ISO 025 eller 03

2,0 - 3,0

Eksempel på Sprøjteteknik

Grøn – ISO 015 (Lavdrift)

Gul – ISO 02 (Lavdrift)

Lilla ISO 025 (Lavdrift/fladsprede)

Tilberedning af sprøjtevæske

Sørg altid for, at sprøjten er korrekt rengjort samt efterset for belægninger inden tilberedningen af sprøjtevæsken startes. Dette gælder

især, hvis sprøjten har været anvendt til sprøjteopgaver i andre afgrøder.

Præparatfyldeudstyr:

Ved anvendelse af præparatfyldeudstyr fyldes stationen halvt med vand, hvorefter der påfyldes

den ønskede mængde ATR Glyphosat 480, som herefter suges op i sprøjtetanken samtidig med at rent vand tilsættes i fyldestationen.

Efterfølgende skylles præparatfyldeudstyret, samt evt. tomme dunke. Gentag proceduren med at åbne/lukke for bundventil til der ikke

er synlige spor af ATR Glyphosat 480 i fyldestationen.

Direkte injektion:

Ved skift og afslutning af sprøjteopgaver gennemføres en gennemskylning og rengøring af

systemet. Vaskevandet udsprøjtes under kørsel på det behandlede areal.

Personlige værnemidler

I henhold til Jordbrugets Arbejdsmiljøudvalg foreslås følgende:

Ved opblanding:

Anvend beskyttelsesbriller, -handsker og -støvler.

Ved udsprøjtning:

Med spredebom mindre end 1 meter over jordoverfladen monteret på traktor eller lign., samt

ved arbejde udenfor førerhus anvendes overtræksbukser, handsker og støvler. Under ophold i lukket førerhus (ventilationsanlæg skal

være slukket) skal der ikke anvendes særlige værnemidler. Ved andre udbringningsmetoder henvises til vejledning om personlige

værnemidler fra Jordbrugets Arbejdsmiljøudvalg.

Doserings- og anvendelsesområder

Laveste dosering anvendes under gode vækstforhold samt lavt ukrudtstryk. ATR Glyphosat 480 må ikke anvendes til nedvisning af

afgrøder til udsæd samt maltbyg.

Anvendelsesområde

Behandling/

skadegører

Dosering

(l/ha)

Tidspunkt

Behandlingsfrist

Udyrkede arealer

Dog ikke på offentlige

arealer i perioder, hvor der fin-

des spiselige bær og frugter på

arealet.

Uønsket plantevækst

3,0 - 4,5

Hele vækstsæsonen

Korn før høst

Kvikmængde <25

skud/m²

Når kernerne er vanskelige at dele

med en

fingernegl.

10 dage

Kvikmængde >25

skud/m²

2,25

Ærter før høst

Kvik

1,5 - 2,25

Når 70-75% af marken er

gulgrøn til gulbrun. På dette tids-

punkt kan ærterne fra de øverste

bælge deles med

fingrene. Vandindhold: <30%.

10 dage

Nedvisning

Anvendelsesområde

Behandling/

skadegører

Dosering

(l/ha)

Tidspunkt

Behandlingsfrist

Raps før høst

Nedvisning

2,25

Når vandindholdet er <30%.

Typisk når størstedelen af skul-

perne er gulgrønne

med gulbrune og enkelte sorte

frø. Ca. 2-4 dage før

skårlægningstidspunkt, eller 14-

21 dage før direkte høst.

10 dage

Hestebønner før høst

Kvik

2,25

Når 2/3–3/4 af bælgene har

skiftet farve. Ca. 10-14 dage før

høst.

10 dage

Nedvisning

Stubmarker

Spildkorn og småt

bredbladet ukrudt

1,125 - 1,5

Bedst effekt opnås hvis halmen

er fjernet. Ønskes effekt på kvik,

bør kvikken have 3-6 blade.

Kvik

2,25 - 3,0

Frøgræsstub

Græs og bredbladet

ukrudt

3,0 - 4,5

Behandles når græs og kvik har

3-6 blade. For at sikre god gen-

vækst, bør halmen

fjernes efter høst.

Fodergræs

Nedvisning

Når græs og kvik har 3-6 blade.

10 dage

Forårsanvendelse

Før jordbear-bejd-

ning

2,25 - 3,0

For at opnå effekt på kvik, bør

kvikken have 3-4 blade.

Omsåning af korn

0,75 - 1,125

Direkte såning

Nyfremspiret ukrudt

1,125

Bedst effekt opnås hvis halmen

er fjernet.

Ønskes effekt på kvik, bør

kvikken have 3-6 blade. Behand-

ling før fremspiring af afgrøde er

betinget af, at

frøene er godt dækkede.

Kvik

2,25 - 3,0

Anvendelsesområde

Behandling/

skadegører

Dosering

(l/ha)

Tidspunkt

Behandlingsfrist

Grankulturer

Rødgran,

nordmannsgran og

kæmpegran

Græs- og bredbladet

ukrudt

2,25-2,625

Anvendes om efteråret, når

strækningsvæksten

er afsluttet, forårsskuddene

er modne og endeknopperne

er dannet. Tidligst når

granerne er rodfæstet på bli-

vestedet.

Frugtplantager

Æbler, pærer, blommer

og kirsebær

Uønsket plantevækst

2,25 - 4,5

Når ukrudt er i god vækst. Kultu-

ren og rodskud må ikke

rammes. Anvend afskærmet

sprøjtning

for at undgå

vindafdrift

Frugtplantage:

30 dage

Andre trækulturer

Uønsket plantevækst

2,25 - 4,5

Stødbehandling af

fældede træer

Sikring mod gen-

vækst

og rodskud

0,15 l pr. 0,8 l vand

Oktober til ultimo februar når

træernes saftstrømme er

nedadgående.

ATR Glyphosat 480 pensles eller

sprøjtes på træets snitflade

umiddelbart efter

fældning.

BEMÆRK: Mellem

træer af samme art,

kan der forekomme

rodsammenfletninger og der-

med risiko for overførsel af ATR

Glyphosat 480 fra et behandlet

træ til et andet. Det samme gør

sig gældende ved behandling

af rodskud.

Pensling

Bjørneklo og hes-

tehov

0,15 l pr. 0,8 l vand

Påstryg kun de planter, der

ønskes bekæmpet. Andre plan-

ter der kommer i

berøring med

sprøjtevæsken, kan blive skadet.

Ryg- og håndholdt

sprøjte

Mindre arealer, fx

under hegn, omkring

buske o.l.

Uønsket plantevækst

0.15-0.225 l pr. 10-

15 l vand for

500m2

Sprøjt kun på det, der ønskes

bekæmpet.

Undgå vindafdrift ved

behandlingen.

Rengøring af sprøjteudstyr

Indvendig rengøring af sprøjteudstyr ved skift mellem/afslutning af sprøjteopgave

Bemærk! Skyllevandstankens kapacitet skal være så restsprøjtevæsken kan fortyndes mindst 50 gange. Vær meget opmærksom på at

få rengjort alle indvendige dele af sprøjten grundigt. Aktivér alle haner og ventiler samt hæv trykket så meget, at overtryksventilen fra

det selvrensende filter udløses. Dette gælder under alle rengøringsprocesser.

Husk at tømme sprøjten helt inden rengøring. Restsprøjtevæsken og skyllevandet skal udsprøjtes eller anvendes på det behan-

dlede areal.

Ved hjælp af de indvendige spuledyser vaskes sprøjtetank, slanger og bom straks efter endt sprøjtning med vand fra skyl-

levandstanken. Skyllevandet kan med fordel deles, så indvendig vask og udsprøjtning foregår af 2-3 gange.

Fyld vand i tanken - 10-15% af tankkapaciteten (100-150liter vand i en 1.000 liter tank) og tilsæt 0,5 liter rengøringsmiddel

(eks. None-ionisk sprede/klæbemiddel 15% + Monoethanolamin 8%) eller lignende produkt i anbefalet dosering pr. 100 liter

vand. Sprøjt lidt af vaskevandet ud gennem slanger, bom og dyser, så disse sættes i blød. Lad omrøring og tankspuledyse køre i

mindst 15 minutter. Tøm sprøjten gennem bom og dyser over et egnet areal f.eks. på marken under kørsel.

Dyser, filtre og sier afmonteres og renses i vand tilsat 50 ml rengøringsmiddel pr. 10 liter vand.

Skyl tanken og alle slanger grundigt i 5 min. med rent vand. Skyllevandet sprøjtes ud gennem bom og dyser.

Udvendig rengøring af sprøjteudstyr

Der henvises til Miljøstyrelsens vejledning angående påfyldning og vask af sprøjter til udbringning af bekæmpelsesmidler, jf. Miljømi-

nisteriets bekendtgørelse nr. 906 af 24. juni 2016.

Resistensstrategi

Produktnavn

Type

Aktivstof

HRAC gruppe

Risiko for ud-

vikling af resistens

ATR Glyphosat 480

Herbicid

Glyphosat

Producenten anbefaler en stærk anti-resistens strategi efter retningslinjerne udarbejdet af WRAG (Weed Resistance Action Group). For

at undgå resistensudvikling anbefaler producenten, at der generelt anvendes ukrudtsmidler med forskellige virkningsmekanismer i

sædskiftet. Det anbefales endvidere at have både vår- og vinterafgrøder i sædskiftet. Særligt i forbindelse med reduceret jordbehand-

ling bør disse anbefalinger følges nøje. Vær opmærksom på, at manglende effekt (hvis midlet ellers er anvendt korrekt) kan skyldes

begyndende resistensudvikling.

Sprøjt med omtanke

Overvej om det er nødvendigt at behandle og brug lavest mulige dosering. Tænk på vildtet og efterlad et usprøjtet bælte ved levende

hegn, skov og vandløb. Følg altid etikettens anvisninger og godt landmandskab.

Lagring

Opbevares tørt og frost frit.

Bortskaffelse

Indholdet/beholderen bortskaffes i overensstemmelse med kommunale regler (P501). Rester skal afleveres til den kommunale affald-

sordning for farligt affald. Tomme beholdere kan bortskaffes med dagrenovationen. Den tomme beholder bør skylles inden bortskaf-

felse. Skyllevandet hældes op i sprøjtevæsken. Emballagen må ikke genbruges.

Bemærk

Producenten fralægger sig ethvert ansvar for produktets skader og følgeskader, som er opstået i forbindelse med ikke forskriftsmæssig

brug eller opbevaring af produktet.

Vejrlig, sorter, resistens, behandlingsteknik og jordbundsforhold kan påvirke effekten.

ATR GLYPHOSAT 480

Ukrudtsmiddel

Må kun anvendes til visse former for ukrudtsbekæmpelse samt nedvisning.

Dette plantebeskyttelsesmiddel må kun købes af professionelle og anvendes erhvervsmæssigt og

kræver gyldig autorisation.

DEKLARATION

Ukrudtsmiddel nr.: 826-15

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og plantebeskyttelsesmiddelforordningen 1107/2009

Aktivstof: Glyphosat 480 g/l (39.34% w/w) (svarende til glyphosat-dimethylaminsalt (DMA) 608 g/l (49.88% w/w)) ved 20°C

Midlet er et vandopløseligt koncentrat (SL).

Batchnummer og produktionsdato: Se emballagen

Holdbarhed: 2 år fra produktionsdato

Indhold: 20 Liter

Registreringsindehaver

Distributør

STEFES GmbH

ATR Landhandel GmbH & Co. KG

Wendenstr. 21b, 20097 Hamborg, Tyskland

Bahnhofsallee 44, 23909 Ratzeburg, Tyskland

Tlf.: +49 (0)40 5330 8330, E-mail: info@stefes.eu

Tlf.: +49 (0)4541 8060, E-mail: info@atr-landhandel.de

ATR GLYPHOSAT 480

Glyphosat 480 g/l

Nettoindhold: 20 L

FORSIGTIG

Brugsanvisningen skal følges for ikke at bringe menneskers sundhed og miljøet i fare (EUH401).

Skadelig for vandlevende organismer, med langvarige virkninger (H412).

Vær opmærksom på, at Arbejdstilsynet har regler for arbejde med og udsættelse for plantebeskyttelsesmidler. Læs nærmere i det eventuelt lovplig

tige sikkerhetsdatablad samt i Arbejdstilsynets informationsmateriale om bekæmpelsesmidler.

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre straf:

Må kun anvendes til:

Ukrudtsbekæmpelse samt nedvisning i korn, korsblomstrede afgrøder, ærter, hestebønner og græs. Må ikke behandles senere end 10

dage før høst.

Ukrudtsbekæmpelse under frugttræer indtil en måned før høst og om efteråret efter høst.

Ukrudtsbekæmpelse efter såning og før fremspiring samt selektiv ukrudtsbekæmpelse i jordbrug ved hjælp af specielt udstyr.

Ukrudtsbekæmpelse i ikke spiselige havebrugs-, planteskole- og skovkulturer.

Ukrudtsbekæmpelse på parkeringsarealer, veje, indkørsler, fortove, havegange, terrasser og udyrkede arealer.

Må ikke anvendes til:

Ukrudtsbekæmpelser på offentlige arealer i perioder, hvor der findes spiselige bær og frugter på arealet.

Brugsanvisningens doseringsangivelser må ikke overskrides.

Må ikke anvendes nærmere end 2 m fra vandmiljøet (vandløb, søer mv.) for at beskyttet organismer, der lever i vand.

Må ikke anvendes nærmere end 5 m fra §3-områder for at beskyttet vilde planter.

Undgå forurening af vandmiljøet med produktet eller med beholdere, der har indeholdt produktet.

Opbevares utilgængeligt for børn (P102).

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

Førstehjælp:

Ved indtagelse:

Ved indtagelse, kontakt omgående læge og vis denne beholder eller etiket.

Øjenkontakt:

Kommer stoffet i øjnene, skylles straks grundigt med vand og læge kontaktes.

Hudkontakt:

Kommer stoffet på huden vaskes straks med store mængder vand.

Indånding:

Flyt patienten ud i frisk luft. Opsøg lægehjælp.

Registreringsindehaver: STEFES GmbH, Wendenstr. 21b, 20097 Hamborg, Tyskland • tlf. +49 40 5330 8330 • E-mail: info@stefes.eu

Distributør: ATR Landhandel GmbH & Co. KG, Bahnhofsallee 44, 23909 Ratzeburg, Tyskland • tlf. +49 4541 8060 • E-mail: info@atr-landhandel.de

12-9-2018

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Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

14-9-2018

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices:  http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

FDA - U.S. Food and Drug Administration

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

7-9-2018

 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019.

Europe - EMA - European Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

28-8-2018

 Minutes - PDCO minutes of the 24-27 July 2018 meeting

Minutes - PDCO minutes of the 24-27 July 2018 meeting

Paediatric Committee (PDCO) minutes of the meeting on 24-27 July 2018

Europe - EMA - European Medicines Agency

28-8-2018

Agenda:  Agenda - PDCO agenda of the 21-24 August 2018 meeting

Agenda: Agenda - PDCO agenda of the 21-24 August 2018 meeting

Paediatric Committee (PDCO) - Draft agenda for the written procedure 21-24 August 2018

Europe - EMA - European Medicines Agency

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

25-8-2018

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Active substance: anagrelide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5682 of Sat, 25 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/480/T/82

Europe -DG Health and Food Safety

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

14-8-2018

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at  https://go.usa.gov/xUF39   #Devices4Kid

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kid

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kids #MedicalDevice pic.twitter.com/XGwlpgopGn

FDA - U.S. Food and Drug Administration

14-8-2018

Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization.  https://go.usa.gov/xU6rg  #Devices4Kids #MedicalDevicepic.twitter.com/bMYgjX8CTX

Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization. https://go.usa.gov/xU6rg  #Devices4Kids #MedicalDevicepic.twitter.com/bMYgjX8CTX

Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization. https://go.usa.gov/xU6rg  #Devices4Kids #MedicalDevice pic.twitter.com/bMYgjX8CTX

FDA - U.S. Food and Drug Administration

14-8-2018

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting.  We look forward to continuing discussions around increasing medical device options for children today.  #Devices4Kids #M

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #M

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #MedicalDevice pic.twitter.com/7cXPFfvfif

FDA - U.S. Food and Drug Administration

14-8-2018

FDA Commissioner, @SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting  #devices4kids #FDA #MedicalDevicepic.twitter.com/0I1Poe9Yqn

FDA Commissioner, @SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting #devices4kids #FDA #MedicalDevicepic.twitter.com/0I1Poe9Yqn

FDA Commissioner, @SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting #devices4kids #FDA #MedicalDevice pic.twitter.com/0I1Poe9Yqn

FDA - U.S. Food and Drug Administration

13-8-2018

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevicepic.twitter.com/mzl

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevicepic.twitter.com/mzl

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevice pic.twitter.com/mzlmU6Nq9U

FDA - U.S. Food and Drug Administration

13-8-2018

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCertpic.twitter.com/X4wQbX0Tjc

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCertpic.twitter.com/X4wQbX0Tjc

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCert pic.twitter.com/X4wQbX0Tjc

FDA - U.S. Food and Drug Administration

13-8-2018

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation.  https://go.usa.gov/xU6rg 
#devices4kids #Pediatricspic.twitter

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatricspic.twitter

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatrics pic.twitter.com/3tXTgwPJPo

FDA - U.S. Food and Drug Administration

6-8-2018

Today is the last day to register to attend the Pediatric Medical Device Development public meeting in person. Click the link to learn more and register. #Pediatrics #medicaldevice  https://go.usa.gov/xUvBD pic.twitter.com/mWuQWK9MLk

Today is the last day to register to attend the Pediatric Medical Device Development public meeting in person. Click the link to learn more and register. #Pediatrics #medicaldevice https://go.usa.gov/xUvBD pic.twitter.com/mWuQWK9MLk

Today is the last day to register to attend the Pediatric Medical Device Development public meeting in person. Click the link to learn more and register. #Pediatrics #medicaldevice https://go.usa.gov/xUvBD  pic.twitter.com/mWuQWK9MLk

FDA - U.S. Food and Drug Administration

31-7-2018

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more.  https://go.usa.gov/xUvBD  #Pedi

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pedi

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/UzKDyAyER5

FDA - U.S. Food and Drug Administration

31-7-2018

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children.  https://go.usa.gov/xUvBD  #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/ZP3ImzNw2T

FDA - U.S. Food and Drug Administration

31-7-2018

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date.  Learn more about the PDC here:  https://go.usa.gov/xUvBC  #Pediatrics #Med

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date. Learn more about the PDC here: https://go.usa.gov/xUvBC  #Pediatrics #Med

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date. Learn more about the PDC here: https://go.usa.gov/xUvBC  #Pediatrics #MedicalDevice #FDA pic.twitter.com/HgMSCIbmra

FDA - U.S. Food and Drug Administration

31-7-2018

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here:  https://go.usa.gov/xUvZm 

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm 

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm  #Pediatrics #medicaldevice pic.twitter.com/c0cuVYtTLK

FDA - U.S. Food and Drug Administration

18-7-2018

EU/3/16/1686 (Mereo Biopharma Ireland Ltd)

EU/3/16/1686 (Mereo Biopharma Ireland Ltd)

EU/3/16/1686 (Active substance: Recombinant humanised monoclonal IgG2 lambda antibody against human sclerostin) - Transfer of orphan designation - Commission Decision (2018)4809 of Wed, 18 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/16/T/02

Europe -DG Health and Food Safety

18-7-2018

EU/3/16/1718 (Salzman Group Ltd)

EU/3/16/1718 (Salzman Group Ltd)

EU/3/16/1718 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4807 of Wed, 18 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/16/T/01

Europe -DG Health and Food Safety

17-7-2018

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register.  #Pediatrics  https://go.usa.gov/xUXHq  #MedicalDevicepic.twitter.c

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register. #Pediatrics https://go.usa.gov/xUXHq  #MedicalDevicepic.twitter.c

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register. #Pediatrics https://go.usa.gov/xUXHq  #MedicalDevice pic.twitter.com/hL7vawmOgR

FDA - U.S. Food and Drug Administration