Agros Pro Clomazon

Primær information

  • Handelsnavn:
  • Agros Pro Clomazon Kapselsuspension
  • Lægemiddelform:
  • Kapselsuspension
  • Sammensætning:
  • 360 g/l clomazon
  • 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:
  • Agros Pro Clomazon Kapselsuspension
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • Ingen afstandskrav.
  • Sidste ændring:
  • 22-07-2018

Indlægsseddel

DEKLARATION

Ukrudtsmiddel: nr. 823-5

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler

og plantebeskyttelsesmiddelforordningen 1107/2009.

Aktivstof: Clomazon 360 g/l (33,6 % w/w)

Formulering: Flydende

Batchnummer: Se emballagen.

Produktionsdato: se andet sted på emballagen.

Holdbarhed: Producenten garanterer 2 år fra produktionsdato.

Midlet er en kapselsuspension

Registreringsindehaver: Agros Pro, Olaf Ryes Gade 7K. 2 • 6000 Kolding

Tlf. 3013 2327

E-mail: to@agros.dk

Emballage:

3 Liter

FORSIGTIG

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

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 fremhævede forskrifter kan medføre straf:

Må kun anvendes til ukrudtsbekæmpelse i raps og ikke senere end før fremspiring.

Brugsanvisningens doseringsangivelser må ikke overskrides. Den maksimale dosering er 0,25 L/ha, svarende til 90 g a.s. per ha.

Må ikke anvendes nærmere end 5 meter fra §3-områder for at beskytte vilde plandter (SPe3).

For at beskytte grundvandet må dette produkt maksimalt anvendes hvert tredje år.

Der må endvidere i samme periode ikke også anvendes andre produkter, der indeholder clomazon(Spe1).

Undgå forurening af vandmiljøet med produktet eller med beholdere, der har indeholdt produktet. Rens ikke sprøjteudsyr nær overfladevande (Sp1)

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

Førstehjælp:

Indånding: Sørg for at den tilskadekomne får frisk luft og ro. Søg læge ved vedvarende ubehag og medbring brugsanvisning.

Indtagelse: Skyl munden grundigt og drik mælk eller vand. Undgå opkastning. Søg læge og medbring brugsanvisning.

Hudkontakt: Fjern forurenet tøj og vask huden med rigelige mængder vand og sæbe. Søg læge ved ubehag og sygdomstegn. Medbring brugsanvisning.

Øjenkontakt: Skyl straks med vand, gerne fra en øjenskyller. Spil øjet godt op og fortsæt behandlingen i min. 20 minutter/indtil kemikaliet er skyllet væk. Fjern even-

tuelle kontaktlinser. Søg læge ved fortsat ubehag. Medbring brugsanvisning.

Yderlig information: Ingen specifik modgift eller symptomer.

Nødtelefon: (+45) 97 83 53 53 eller Giftlinjen på Bispebjerg Hospital (+45) 82 12 12 12

CLOMAZON

Ukrudtsmiddel

Må kun anvendes til ukrudtsbekæmpelse i raps. Dette plantebeskyttelsesmiddel

må kun købes af professionellle og anvendes erhvervsmæssigt og kræver gyldig autorisation.

AGROS

Agros Pro Clomazon 3 liter 2017.indd 1

04-06-2017 14:53:52

Afgrøder

Agros Pro Clomazon kan bruges mod ukrudt i vinterraps. Agros Pro Clomazon bekæmper en række

tokimbladede ukrudtsarter. Der er dog ingen effekt på rodukrudt.

Virkningsklasse

Agros Pro Clomazon tilhører resistens klasse F4: DOXP-syntese-hæmmer.

Virkemåder

Clomazon er et systemisk middel der efter udsprøjtning hurtigt optages gennem kimstænglen og

rødder i spiringsfasen. Midlet bliver bagefter transporteret i vedvævet (xylemet) nedefra og ud/op mod

blad- og skudspidserne. Fordelingen i bladene sker ved hjælp af diffusion. Agors Pro Clomazon har en

hæmmende/blokerende effekt på dannelsen af klorofyl i grønkornene og andre pigmenter involveret

i fotosyntesen, som derved blokeres. Agros Pro Clomazon udsprøjtes før ukrudtet er fremspiret. Under

ukrudtets fremspiring eller umiddelbart efter afbleges planterne og dør. Alt afhængig af vejret og jordtype

vil man ved normal dosering kunne regne med en virkningstid på 4-8 uger. Der frarådes at bruge Agros Pro

Clomazon på jorde med et højt humusindhold, da dette kan give en nedsat effekt.

Bemærkninger

Ved udsprøjtningen må afgrøden ikke være fremspiret, da dette kan medføre stærk afblegning og

svækkelse af afgrøden. Agros Pro Clomazon kan i vinterraps udsprøjtes fra såning og indtil 3 dage før

fremspiring. Der må i samme vækstår, som der behandles med Agros Pro Clomazon, ikke anvendes andre

produkter indeholdende clomazon. Når der sprøjtes ud på tør jord forbliver Agros pro Clomazon stabil og

inaktiv, men midlet aktiveres igen når jordoverfladen bliver fugtig.

I rapsrige sædskifter skal der minimum være 2 år, hvor den enkelte mark ikke behandles med clomazon

Efterfølgende afgrøder

Ved udvintring af vinterraps behandlet med Agros Pro Clomazon, kan man om foråret efter grundig

pløjning så om med korn, ærter, majs, kartofler, vårraps, gulerødder, løg og hør

Dosserings og anvendelsskema

Resistenshåndtering

Gentagen brug af samme middel eller midler med samme virkemekanisme kan resultere i dannelse

af resistens. For at dette ikke skal ske, anbefales det ind i mellem at anvende midler med anden

virkemekanisme enten i form af en tankblanding, eller ved at skifte middel med jævne mellemrum.

Producenten kan ikke drages til ansvar for manglende effekt ved en evt. resistensdannelse. Agros Pro

Clomazon tilhører gruppen af DOXP-syntese-hæmmer.

(Resistensklasse HRAC F4).

Sprøjteteknik

Agros Pro Clomozon udsprøjtes i 100-200 l vand/ha. Vindafdrift bør undgås til f.eks. til - stødende haver,

læhegn mv. Afdrift til marker med følsomme afgrøder eller til marker hvor såning af følsomme afgrøder

er planlagt skal undgås. Sprøjtevæsken skal gerne dække hele jordoverfladen og væskemængde bør

justeres så dette er muligt. Der skal tages højde for vejr- og vindforhold samt sprøjteudstyr ved valg af

væskemængde.

Under normale vindforhold anbefales det, at anvende en 02 eller 025 low drift dyse. I nedenstående tabel

ses en oversigt over disse dysers ydelser ved forskellig tryk og hastighed

Tilberedning af sprøjtevæsken

Sprøjtebeholderen skal være helt rengjort før Agros Pro Clomozon fyldes i. Fyld 75 % af den ønskede

vandmængde i beholderen, påfyld Agros Pro Clomozon, og tilsæt derefter resten af den ønskede

vandmængde. Sæt gang i returløb og omrøring. Skumdannelse ved påfyldningen kan mindskes ved at

nedsætte omrøringen. Ved påfyldning af marksprøjte bør der anvendes præperatfyldeudstyr eller udstyr

som er lavet til direkte injektion. Påfyldning af marksprøjte skal ske på vaskeplads med opsamling til

gyllebeholder eller anden beholder, som er godkendt hertil. Påfyldning kan også ske på et areal, hvor

Agros Pro Clomazon skal udbringes. I øvrigt henvises til Miljøstyrelsens vejledning angående påfyldning

og vask af sprøjter til udbringning af bekæmpelsesmidler, jf. Miljø- og Fødevareministeriets bekendtgørelse

nr. 906 af 24. juni 2016.

Rengøring af sprøjtemateriel

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 uden

at den maksimale dosering overskrides.

Optimale virkningsforhold

Bedst effekt opnås ved sprøjtning ved en god jordfugtighed.

Lagring

Agros Pro Clomazon skal opbevares frostfrit i uåbnet og ubeskadiget originalemballage beskyttet mod

direkte sollys og andre varmekilder.

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 inden bortskaffelse. Skyllevandet hældes op i

sprøjtevæsken. Emballagen må ikke genbruges.

Bemærk

Producenten påtager sig ikke noget ansvar for

følgerne af forkert anvendelse af produktet i strid

med de angivne instruktioner.

Sprøjteteknik

Ved udsprøjtning af Agros Clomozon bør midlet opblandes med en vandmængde på mellem 100

og 200 l vand/ha. Vindafdrift bør undgås til f.eks. til - stødende haver, læhegn mv. Afdrift til marker

med følsomme afgrøder eller til marker hvor såning af følsomme afgrøder er planlagt skal undgås.

Sprøjtevæsken skal gerne dække hele jordoverfladen og væskemængde bør justeres så dette er

muligt. Der skal tages højde for vejr- og vindforhold samt sprøjteudstyr ved valg af væskemængde.

Under normale vindforhold anbefales det, at anvende en 02 eller 025 low drift dyse. I

nedenstående tabel ses en oversigt over disse dysers ydelser ved forskellig tryk og hastighed.

Eksempler på vandmængder ved brug af 02 (gul) og 025 (lilla) dyser ved forskelligt tryk og kørehastighed.

Tilberedning af sprøjtevæsken

Sprøjtebeholderen skal være helt rengjort før Agros Clomozon fyldes i. Fyld 75 % af den ønskede

vandmængde i beholderen, påfyld Agros Clomozon, og tilsæt derefter resten af den ønskede

vandmængde. Sæt gang i returløb og omrøring. Skumdannelse ved påfyldningen kan mindskes

ved at nedsætte omrøringen. Ved påfyldning af marksprøjte

bør der anvendes præperatfyldeudstyr eller udstyr som er lavert til direkte injektion. Påfyldning af

marksprøjte skal ske på vaskeplads med opsamling til gyllebeholder eller anden beholder, som er

godkendt hertil. Påfyldning kan også ske på et areal, hvor Agros Clomazon skal

udbringes. I øvrigt henvises til Miljøstyrelsens vejledning angående påfyldning og vask af sprøjter

til udbringning af bekæmpelsesmidler, jf. Miljøministeriets bekendtgørelse nr. 268 af 31. marts

2009.

Rengøring af sprøjtemateriel

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.

Brugsanvisning CLOMAZON

AGROS

Afgrøde

Ukrudt

Udsprøjtning

Dosering

Vinterraps

God effekt: Hyrdetaske, Fuglegræs,

Burresnerre, Rød Tvetand.

Moderat effekt: Melde, Enårig

rapgræs, Vedbend og Storkronet

ærenpris.

Svag effekt: Vellugtende og Lugtløs

kamille Valmue, Agerstedmoder.

Produktet udsprøjtes jævnt og

direkte på jorden i et veltilberedt

såbed uden knolde og med god

jordfugtighed. Produktet må ikke

indarbejdes i jorden og tromling

frarådes. Frøene må ikke blive

eksponeret til produktet

0,25 l/ha.

Under stres-

sede forhold

reduceres til

0,2 l/ha

Agros Pro Clomazon 3 liter 2017.indd 2

04-06-2017 14:53:53

18-10-2018

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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...

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Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Shengan Natural Model contains hidden drug ingredient

Public Notification: Shengan Natural Model contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Shengan Natural Model, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: USA for Women contains hidden drug ingredient

Public Notification: USA for Women contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use USA for Women, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: In Shape contains hidden drug ingredient

Public Notification: In Shape contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use In Shape, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

Public Notification: ProSolution contains hidden drug ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Baschi Quick Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: V-Max contains hidden drug ingredient

Public Notification: V-Max contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use V-Max, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Strong Horses contains hidden drug ingredient

Public Notification: Strong Horses contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Strong Horses, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Green Lean Body Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Like Slim Coffee contains hidden drug ingredient

Public Notification: Like Slim Coffee contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Like Slim Coffee, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-9-2018

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

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

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