Agros Pro Glyfosat 480

Primær information

  • Handelsnavn:
  • Agros Pro Glyfosat 480 Vandopløseligt koncentrat
  • Lægemiddelform:
  • Vandopløseligt koncentrat
  • Sammensætning:
  • 480 g/l glyphosat
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

Lokation

  • Fås i:
  • Agros Pro Glyfosat 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.
  • Sidste ændring:
  • 22-07-2018

Indlægsseddel

Forsigtig

Brugsanvisningen skal følges nøje 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 at arbejde med og udsættelse for plantebeskyttelsesmidler.

Læs nærmere i det eventuelt lovpligtige sikkerhedsdatablad 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 1 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 parkeringspladser, veje, indkørsler, fortove, havegange, terrasser og udyrkede arealer.

Må ikke anvendes til: Ukrudtsbekæmpelse 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 og søer mv.) for at beskytte organismer,

der lever i vand. Må ikke anvendes nærmere end 5 m fra §3-områder for at beskytte vilde planter. Undgå

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

(P102) Opbevares utilgængeligt for børn. Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

DEKLARATION

Ukrudtsmiddel nr.: 823-6

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler

og plantebeskyttelsesforordningen 1107/2009

Aktivstof: Glyfosat 480 g/l (40% w/w)

Midlet er et vandopløseligt koncentrat

Holdbarhed: 2 år fra produktionsdato

Produktionsdato: Se print på dunken

Batch nr: Se print på dunken

Godkendelsesindehaver: Agros Pro, Olaf Ryes Gade 7K. 2, 6000 Kolding • tlf. 3013 2327 • E-mail: to@agros.d

GLYFOSAT 480

Ukrudtsmiddel

Må kun anvendes til visse former for ukrudtsbekæmpelse samt nedvisning. Dette plantebeskyttelses-

middel må kun købes af professionelle og anvendes erhvervsmæssigt og kræver gyldig autorisation.

Emballage:

20 liter

Førstehjælp:

Generelle anvisninger: Aftag forurenet tøj. Ved besvær gå til lægen og medbring etiketten

Indånding:

Ro, frisk luft og lægehjælp.

Hudkontakt:

Kommer midlet på huden vaskes straks med store mængder vand.

Øjenkontakt:

Kommer midlet i øjnene, skylles straks grundigt med vand.

Indtagelse:

Skyl munden grundigt og drik rigeligt vand. Undgå opkastning.

AGROS

Afgrøder, skadegører, dosering og sprøjtetidspunkt

Forårsanvendelse

Der kan behandles mod kvik og andet ukrudt før jordbearbejdning. Kvikken bør

normalt have 3-4 blade. Dosering til delvis udvintret korn: 0,75-1,125 l/ha. Dosering

til kvik: 2,25 -3,0 l/ha.

Korn før høst

Til bekæmpelse af kvik, andre græsser samt tokimbladet ukrudt, i alle kornarter og

sorter. Produktet må ikke anvendes i korn til udlæg og maltbyg. Kvikken bør være

i vækst på behandlingstidspunktet. Der behandles, når kernerne er hårde, og når

mærket efter en fingernegl kan ses blivende på kernen. Dosering: 1,5-2,25 l/ha.

Højeste dosering ved stor kvikmængde (> 25 skud/m2). Sprøjtefrist 10 dage før høst.

Æ rter og hestebønner før høst

Til bekæmpelse af kvik og tokimbladet ukrudt samt nedvisning. Ærterne behandles

når 70-75% af marken har skiftet farve fra gulgrøn til gulbrun. Det betyder, at ærterne

fra de øverste bælge skal være til at dele med fingrene. Ærternes vandindhold er ca.

30%. Dosering: 1,5-3,0 l/ha. Højeste dosering til nedvisning. Sprøjtefrist 10 dage før

høst.

Korsblomstrede før høst

Til bekæmpelse af kvik og tokimbladet ukrudt samt nedvisning. Der behandles, når

vandprocenten i afgrøden på den mindst modne del af marken er under 30%. Så

er størstedelen af skulperne i rapsen gulgrønne med gulbrune og enkelte sorte frø.

Behandlingstidspunktet er normalt 2-4 dage før normal skårlægningstidspunkt, og

14-21 dage før en direkte høst. Dosering: 2,25 l/ha. Sprøjtefrist 10 dage før høst.

Stubmarker

Til bekæmpelse af kvik og andre græsser, samt tokimbladet ukrudt. Kvikken skal

have 3-6 blade og være ca. 15-20 cm. høj. For at opnå det bedste resultat må halm

og lignende fjernes. Dosering til spildkorn og småt tokimbladet ukrudt: 1,125-1,5 l/

ha. Dosering til kvik: 2,25-3,0 l/ha. Laveste dosering ved gunstige betingelser: Høj

luftfugtighed, temperatur over 15 °C

Stubmarker efter frøgræs

Halmen og plantemateriale bør fjernes hurtigt efter høst, således at der kan komme

en god genvækst. Det behandles, når kvikken og græsserne har 3-6 blade. Dosering:

3-4,5 l/ha. Højeste dosering på rødsvingel, engrapgræs eller andre smalbladede

frøgræsarter.

Græs

Før sidste slæt sprøjtes når græs og kvik er 10-20 cm høj (3-6 blade). Sprøjt mindst 10

dage for sidste slæt tages. Græsset må anvendes til alle normale formål, umiddelbart

efter behandlings-fristens udløb. Dosering: 3,0 l/ha.

Grankulturer

I grankulturer af rødgran, normannsgran og kæmpegran kan produktet anvendes

med 2,25-2,6 l/ha. Behandling foretages om efteråret, når strækningsvæksten er

afsluttet, og forårsskuddene er modne og

endeknopperne er dannet. Tidligst når

granerne er groet fast på blivende sted.

Frugtplantager og andre trækulturer

Der behandles med 2,25-4,0 l/ha på ukrudt i god vækst, senest en måned før

frugthøst eller efter.

Kulturen må ikke rammes, og der anvendes skærmet behandling, ram ikke rodskud.

Stødbehandling af fældede træer

Anvendes mod genvækst og rodskud, dosering 0,15 l pr. 0,80 l vand. Der behandles

umiddelbart efter fældning på træets snitflade med pensel eller rygsprøjte.

Behandlingen foretages, når træernes saftstrøm er nedadgående, d.v.s. fra oktober

til slutningen af februar. Bemærk at der kan være risiko for rodsammenfletninger, og

dermed mulighed for skade på nabotræer.

Utilplantede arealer og udyrkede arealer.

Disse arealer kan behandles med 3,0-4,5 l/ha for at fjerne uønsket plantevækst.

Højeste dosering anvendes mod flerårigt ukrudt så som følfod, mælkebøtte,

brændenælde og kvik. Behandl når ukrudtet er i god vækst.

Tilberedning af sprøjtevæske

Sprøjtetanken fyldes 3/4 med vand, og Agros Pro Glyfosat 480 tilsættes under

omrøring mens tanken fyldes op med vand.

Sprøjteteknik

Det er vigtigt, at sprøjteudstyret er rent ved påbegyndelse af sprøjtningen. Der

anvendes vandmængder fra 100 til 200 liter pr ha. Anvend lowdrift dyser, hvor der er

risiko for afdrift.

Resistens

Produktet tilhører resistensklasse G (glycin-virkemåde)

Ved ensidig anvendelse af produkter med samme resistensklasse kan resistens

dannes.

For at forhindre udvikling af resistens bør følgende følges:

· Undgå ensidig anvendelse af glyphosatholdige produkter

· Integrer mekanisk bekæmpelse i det omfang det er praktisk muligt.

· Undgå indslæbning af ukrudtsfrø som er resistente.

Sprøjteteknik

Dyse

Km/time

l/ha

02/025

02/025

02/025

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 Agros Pro Glyfosat

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

produktet i fyldestationen.

Rygsprøjte

Anvendes til ukrudtsbekæmpelse på mindre arealer såsom hegn, omkring buske

o.l. Sprøjt kun på det, der ønskes bekæmpet og vær opmærksom på vinddrift i

forbindelse med udsprøjtningen.

Dosering: 0,2-0,225 l pr. 10-15 l vand.

Rengøring af sprøjteudstyr

Indvendig rengøring af marksprøjter med præparatfyldeudstyr: Restsprøjtevæsken

og skyllevandet udsprøjtes eller anvendes på det behandlede areal uanset

fyldeudstyr. Skyllevandstankens kapacitet skal være så stor, at restsprøjtevæsken

kan fortyndes mindst 50 gange. Ved hjælp af de indvendige spuledyser vaskes

sprøjtetanken straks efter endt sprøjtning med vand fra skyllevandstanken.

Skyllevandet fordeles så indvendig vask og udsprøjtning kan foregå ad 2-3 gange

for at opnå den krævede fortyndingsgrad. Skyllevandet udsprøjtes på marken under

kørsel.

Ved rengøring af sprøjter med direkte injektion gennemskylles og rengøres systemet.

Vaskevandet udsprøjtes under kørsel på det behandlede areal

Udvendig: Rengøring af marksprøjten og traktor skal ske på det behandlede areal

eller på en vaskeplads med opsamling til gyllebeholder eller anden beholder.

Rengøring på det behandlede areal forudsætter, at marksprøjten er monteret med

udstyr hertil, samt skyllevandskapaciteten er tilstrækkelig.

Bortskaffelse af tom emballage.

Indholdet/beholderen bortskaffes i overensstemmelse med kommunale regler for

affaldshåndtering (P501): Rester skal afleveres til den kommunale affaldsordning for

farligt affald. Tomme beholdere kan bortskaffes med dagrenovationen. Den tomme

beholder bør skylles inde bortskaffelse. Skyllevandet hældes op i sprøjtevæsken.

Emballagen må ikke genbruges.

Tankblanding

Agros Pro Glyfosat 480 kan blandes med

de mest gængse produkter, som bruges

på behandlings-tidspunktet. Læs altid

blandingspartnerens brugsanvisning nøje.

Brugsanvisning GLYFOSAT 480

Generelt

Agros Pro Glyfosat 480 anvendes til bekæmpelse af kvik og andre græsser, tokimbladet ukrudt og til nedvisning af korn, græs, korsblomstrede afgrøder, ærter,

hestebønner, på stubmarker, i frugtplantager, i havebrugs-, planteskole- og skovkulturer, samt på udyrkede arealer.

Jordbehandling kan påbegyndes 10 dage efter sprøjtning.

Agros Pro Glyfosat 480 anbefales ikke i afgrøder til frø og såsæd. Produktet optages gennem bladene og fordeler sig med

plantens saftstrøm rundt i hele planten også rodsystemet. Effekten vil normalt kunne ses efter 10-14 dage.

AGROS

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Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

28-9-2018

Drug agency from China visits Denmark

Drug agency from China visits Denmark

A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen r...

Danish Medicines Agency

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-9-2018

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm's operations. No illnesses related to the water have been reported to the state.

FDA - U.S. Food and Drug Administration

25-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

2-10-2018

Zavesca (Janssen-Cilag International NV)

Zavesca (Janssen-Cilag International NV)

Zavesca (Active substance: Miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5472 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000435/T/0063

Europe -DG Health and Food Safety

2-10-2018

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Active substance: Parecoxib ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6471 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000381/T/0073

Europe -DG Health and Food Safety

2-10-2018

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Active substance: epoetin zeta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6481 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/872/T/86

Europe -DG Health and Food Safety

2-10-2018

HALAVEN (Eisai GmbH)

HALAVEN (Eisai GmbH)

HALAVEN (Active substance: eribulin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6457 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2084/T/46

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

2-10-2018

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6480 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety

1-10-2018

Verzenios (Eli Lilly Nederland B.V.)

Verzenios (Eli Lilly Nederland B.V.)

Verzenios (Active substance: abemaciclib) - Centralised - Authorisation - Commission Decision (2018)6405 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4302

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

1-10-2018

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Active substance: gefitinib) - Centralised - Authorisation - Commission Decision (2018)6406 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4826

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

26-9-2018

Comfortis (Elanco GmbH)

Comfortis (Elanco GmbH)

Comfortis (Active substance: Spinosad) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6323 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2233/T/18

Europe -DG Health and Food Safety

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

25-9-2018

Udenyca (ERA Consulting GmbH)

Udenyca (ERA Consulting GmbH)

Udenyca (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6290 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004413/0000

Europe -DG Health and Food Safety

25-9-2018

Inovelon (Eisai GmbH)

Inovelon (Eisai GmbH)

Inovelon (Active substance: Rufinamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6283 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/T/48

Europe -DG Health and Food Safety

25-9-2018

Zonegran (Eisai GmbH)

Zonegran (Eisai GmbH)

Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Brilique (AstraZeneca AB)

Brilique (AstraZeneca AB)

Brilique (Active substance: ticagrelor) - PSUSA - Modification - Commission Decision (2018)6282 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1241/PSUSA/2948/201712

Europe -DG Health and Food Safety

25-9-2018

Fycompa (Eisai GmbH)

Fycompa (Eisai GmbH)

Fycompa (Active substance: Perampanel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6280 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002434/T/0040

Europe -DG Health and Food Safety

25-9-2018

Opsumit (Janssen-Cilag International NV)

Opsumit (Janssen-Cilag International NV)

Opsumit (Active substance: macitentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6279 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002697/T/0028

Europe -DG Health and Food Safety

25-9-2018

Imfinzi (AstraZeneca AB)

Imfinzi (AstraZeneca AB)

Imfinzi (Active substance: durvalumab) - Centralised - Authorisation - Commission Decision (2018)6289 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004771/0000

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety