Euparen Multi

Primær information

  • Handelsnavn:
  • Euparen Multi Pulver
  • Lægemiddelform:
  • Pulver
  • Sammensætning:
  • 500 g/kg tolylfluanid
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

Lokation

  • Fås i:
  • Euparen Multi Pulver
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Udgået
  • Autorisationsnummer:
  • Må i æbler og pærer (tidligt stadium) ikke anvendes nærmere end 30 meter fra vandmiljøet (vandløb, søer m.v.). Må i æbler og pærer (sent stadium) ikke anvendes nærmere end 20 meter fra vandmiljøet (vandløb, søer m.v.). Må i frugtbuske ikke anvendes nærmere end 20 meter fra vandmiljøet (vandløb og søer m.v.). Må i jordbær ikke anvendes nærmere end 10 meter fra vandmiljøet (vandløb, søer m.v.).
  • Sidste ændring:
  • 23-07-2018

Indlægsseddel

Brugsanvisning

Euparen Multi er et vandopløseligt granulat til bekæmpelse af svampesygdomme på jordbær,

æbler, pærer, frugtbuske, prydplanter på friland samt prydplanter og tomat i væksthus.

Sprøjteteknik:

Frugt- og bæravl

Doseringerne er nævnt under de enkelte kulturer.

Vandmængde 200 - 400 liter anvendes.

Udsprøjtningen kan f.eks. foretages med Schauman sprøjte med luftforstøvning:

Markkulturer

Der anvendes væskemængder på mellem 150 og 400 liter vand pr. ha, der kan udbringes med

marksprøjte:

En bedre dækning kan i jordbær opnås ved at anvende 3 – 5 dyser pr. række. Der anbefales dyse ISO 80

02 med et tryk på 4 – 5 bar, og en hastighed på 3 – 4 km/t der giver en vandmængde på 400 - 800 ltr/ha.

Lavest vandmængde ved åbne / lave afgrøder højest vandmængde ved tætte/høje afgrøder

Æbler og pærer

2,0 kg Euparen Multi pr. ha anvendes på nedenstående tidspunkter:

Euparen Multi har en god og langvarig virk-

ning mod skurv 3-7 døgn forebyggende.

Euparen Multi har samtidig en vis sideeffekt

mod Gloeosporium. Den angivne dosering

virker tillige mod æblebladgalmider (rustmi-

der).

Særlige forhold:

”Effektiv bekæmpelse af ovennævnte skadevoldere i æbler vil medføre en bedre farvesortering for gule

og røde sorter samt glattere skal”.

Buskfrugt

Dosering: 3,0 kg pr. ha. Euparen Multi anvendes mod gråskimmel i hindbær, brombær, solbær og ribs.

Anvendelsestidspunkt: Mod gråskimmel sprøjtes i åben blomst.

Jordbær

Dosering: 3,0 kg pr. ha. Euparen Multi anvendes mod gråskimmel og jordbærsortråd. Der benyttes 300

liter vand pr. ha, som udbringes med en dysekombination af 3 dyser pr. række.

Anvendelsestidspunkt: Mod gråskimmel behandles ved begyndende blomstring, 20%, 50% og 80%

blomstring. Afstanden mellem sprøjtningerne bør ikke overstige 5 - 7 dage. I år med lang blomstrings-

periode skal der derfor sprøjtes flere gange end de nævnte 4. Virkningen mod jordbærsortråd forbedres

ved også at sprøjte lige inden blomstringen og på udløberne lige efter plukning. Det øger virkningen mod

gråskimmel at veksle med Teldor WG 50 og lagerholdbarheden øges tillige, når Teldor WG 50 anvendes

til sidst.

I skemaet er angivet en strategi der kan anvendes i jordbær.

Behandlingsplan i jordbær

Prydplanter:

Dosering: 0,5% styrke (500 g pr. 100 liter vand) i roser, øvrige kulturer 0,25%. Euparen Multi virker

mod rosens stråleplet og meldug. Mod meldug og gråskimmel på chrysanthemum, hortensia, bego-

nia, cyclamen m.fl. samt på hvid chrysanthemumrust.

Browallia speciosa tåler ikke Euparen Multi.

Anvendelsestidspunkt: Euparen Multi anvendes forebyggende ved infektionsrisiko og med 8-10

dages mellemrum. Blomstrende planter behandles almindeligvis ikke.

Udbringning: I væksthus kan det ske med hydraulisk sprøjte til begyndende afdrypning, hvilket

normalt svarer til ca. 200 ml pr. m2. Ved anvendelse af varm og koldtågesprøjter anvendes 300 g

Euparen Multi opløst 10 liter vand pr. 1.000 m2 væksthus.

Tomat

Dosering: 0,15 % styrke (125 g pr. 100 liter vand) mod gråskimmel og meldug. Mod gråskimmel

anvendes Euparen Multi forebyggende, ved at starte behandlingen i det tidlige forår, når tomaterne

har udviklet anden blomsterklase. Behandlingen kan gentages med 1 til 2 ugers mellemrum, så

længe risiko for angreb forekommer, eller efter behov. Mod meldug behandles så snart angreb

konstateres.

Udbringning: I væksthus kan det ske med hydraulisk sprøjte til begyndende afdrypning, hvilket

normalt svarer til ca. 200 ml pr. m

. Ved anvendelse af varm og koldtågesprøjter anvendes 150 g

Euparen Multi opløst 6 liter vand pr. 1.000 m

væksthus.

Anvendelse af højere kon-

centrationer, end de angiv-

nedsætte

tålsom-

heden

overfor

kulturen.

Der anvendes den laveste

dosering

under

vækst

skud,

roserne

dette

tids

punkt

mest

følsomme. Se i øvrigt under

tålsomhed.

Tålsomhed

Sortsfølsomhed: Da der ikke er udført tålsomhedsforsøg i samtlige arter og sorter, kan Bayer ikke

påtage sig nogen almen garanti for tålsomhed. Det anbefales derfor at prøvebehandle et mindre

parti på et aktuelt udviklingstrin, 14 dage før hele kulturen eventuelt behandles. I væksthus er plan-

terne særligt følsomme. Undgå at sprøjte i solskin. Lave vandmængder kan nedsætte følsomheden

over for kulturen.

Virker mod:

Chrysanthemumrust, Hvid (Puccinia horiana)

Gloeosporium spp.- sideeffekt

Gråskimmel (Botrytis cinerea)

Jordbærsortråd (Colletotrichum acutatum)

Rosenmeldug (Erysiphe spp.)

Rosenstråleplet (Diplocarpon rosae)

Skurv (Venturia spp.)

Æblebladgalmider (rustmider) (Aculus schlechtendali)

Virkningsforhold:

Da Euparen Multi er et ikke-systemisk middel, er det vigtigt at dække ny vækst ved gentagne

sprøjtninger. Derfor anvendes en vandmængde og sprøjteteknik, der tilgodeser at sprøjtevæsken

fordeles så alle dele af planten bliver dækket.

Optimale virkningsbetingelser

Der er også virkning, selv

om de optimale virknings-

betingelser ikke er tilstede,

men det begrænser mulig-

heden for at anvende ned-

satte doseringer.

Tankblanding

Euparen Multi kan blandes med Baycor 25 WP. Uafprøvede blandinger kan resulteret i skader. For

Euparen kendes til kraftige skader, hvor der har været blandet med midlet af emulsionstypen.

Fremstilling af sprøjtevæske

Sprøjtebeholderen fyldes

med vand. Omrøring startes og midlet hældes direkte i beholderen,

uden anvendelse af si, hvorefter den manglende vandmængde tilsættes.

Rester og tom emballage

Rester skal afleveres til den kommunale affaldsordning for farligt affald. Tomme beholdere kan

bortskaffes med dagrenovationen. Den tomme beholder bør skylles inden bortskaffelse. Skyl-

levandet hældes op i sprøjtevæsken.

Kvalitet

Euparen Multi er testet med hensyn til effekt og påvirkninger efter regler for godkendelse. Da

midlet anvendes under biologiske forhold, vil der optræde naturlige udsving i virkningen. Det kan

ikke udelukkes, at der også kan komme større udsving end de omfattende afprøvninger har vist.

Bayer hæfter kun for midlets kvalitet og ensartethed.

Opbevaring

Tørt og køligt

6.2006

Uddrag af Leverandørbrugsanvisningen

Forholdsregner ved brug

Undgå kontakt med huden

Ved opblanding: Åndedrætsværn med filter A

, forklæde, støvler og handsker.

Sprøjtning indendørs med rifler, lanser på traktor el. lign:

Helmaske med filter A

, overtræksdragt med hætte, briller, støvler og handsker. Ifølge Arbejds-

tilsynets regler om unge menneskers farlige arbejde, må midlet ikke anvendes af unge under 18 år.

Sundhedsfarlige egenskaber

Indtagelse: Lav akut giftighed.

Hud: Kommer stof på huden vaskes straks med store mængder vand. (S28)

Øjne: Svagt irriterende.

Førstehjælp

Øjne: Skyl straks med rigeligt vand i mindst 15 minutter.

Hud: Forurenet tøj fjernes straks, og forurenet hud vaskes med vand og sæbe.

Indtagelse: Fremkald opkastning hos personer ved bevisthed. Bevistløse må ikke tvinges til at

kaste op.

Egenskaber ved opvarmning og brand

Ved opvarmning og brand kan der udvikles farlige røggasser.

Forholdsregler ved brand

Produktet bør så vidt muligt fjernes fra brandstedet. Vand, pulver, skum eller

kan anvendes som slukningsmiddel.

ADVARSEL

For at nedsætte risikoen for mennesker og miljø skal brugsanvisningen følges nøje.

Irriterer øjnene. (R36)

Kan give overfølsomhed ved kontakt med huden (R43)

Meget giftig for organismer der lever i vand. (R50)

Vær opmærksom på, at Arbejdstilsynet har regler for anvendelsen. Læs nærmere i den eventuelt lovplig-

tige leverandørbrugsanvisning samt i Arbejdstilsynets informationsmateriale om bekæmpelsesmidler.

Undgå kontakt med huden. (S24)

Brug egnede beskyttelseshandsker under arbejdet. (S37)

Vask huden efter arbejdet.

Overtrædelse af nedenstående særligt fremhævede

forskrifter kan medføre straf:

Må kun anvendes til bekæmpelse af svampesygdomme

i æbler, pærer, ribs, solbær, brombær, hindbær, jordbær,

tomater og prydplanter.

Der må ikke sprøjtes mod andre skadevoldere end de i brugsanvisningen nævnte og brugsanvisningens

doseringsangivelser må ikke overskrides.

Må i æbler, pærer, hindbær, brombær, solbær og ribs ikke anvendes senere end 14 dage før høst.

Må i jordbær ikke anvendes senere end 7 dage før høst.

Må i tomater ikke anvendes senere end 3 dage før høst.

Må i æbler og pærer (tidligt stadium - under blomstring) ikke anvendes nærmere end 30 meter fra vandmil-

jøet (vandløb og søer mv.).

Må i æbler og pærer (sent stadium - efter blomstring) ikke anvendes nærmere end 20 meter fra vandmiljøet

(vandløb og søer mv.).

Må i frugtbuske ikke anvendes nærmere end 20 meter fra vandmiljøet (vandløb og søer mv.).

Må i jordbær ikke anvendes nærmere end 10 meter fra vandmiljøet (vandløb og søer mv.).

Opbevares utilgængeligt for børn. (S2)

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer. (S13)

Svampemiddel nr. 18-329

Omfattet af Miljøministeriets

bekendtgørelse om bekæmpelsesmidler

Analyse

Tolylfluanid ……………….50%

NETTO 5 KG

Pulver

Euparen

Multi

Euparen

Multi

Vand pr. ha

Dyse-

Svir-

Række

km/h

Væske-

Luft-

med 14 dyser

plade

afstand

tryk

tryk

200 liter

1,5 mm

400 liter

1,7 mm

Afgrøde

Dyse

Tryk

Hastighed

Vandmængde

Åbne/lave

ISO 110-025 (lilla)

2,6 bar

7,3 km/t

150 ltr/ha

Tætte/høje

ISO 110 0,40 (rød)

2,5 bar

5,8 km/t

300 ltr/ha

Udvikling

Grøn spids

Æble-/pæreskurv

Fuld blomst

Æble-/pæreskurv

Blomsterfald

Æble-/pæreskurv

August

Æble-/pæreskurv

14 dage før høst

Æble-/pæreskurv

Bladfald

Tidspunkt

Middel

kg/ha

Umiddelbart før blomstring

Euparen

Jordbærsortråd

Beg. blomstring

Euparen

Gråskimmel, Jordbærsortråd

20% blomstring

Teldor

Gråskimmel

50% blomstring

Euparen

Gråskimmel, Jordbærsortråd

80% blomstring

Teldor

Gråskimmel

Efter plukning på udløberne

Euparen

Jordbærsortråd

Bayer A/S

Bayer CropScience

Nørgaardsvej 32 · 2800 Kgs. Lyngby

Tlf. 45 23 50 00

www.bayercropscience.dk

Afgrøde

Skadegører

Dosering

Roser

Rosenstråleplet

0,25 - 0,5 % styrke 1)

Rosenmeldug

0,25 - 0,5 % styrke 1)

Andre prydplanter

Gråskimmel

0,25 % styrke

Meldug

0,25 % styrke

Hvid chrysantemumrust

0,25 % styrke

Tomater

Meldug

0,15 % styrke

Gråskimmel

0,15 % styrke

Temperatur

20° C, minimum 10° C

Luftfugtighed

Over 90%

Skadegører, udvikling

Før svampesporen trænger ind

Virkningstid

1 uge

Tørvejr efter sprøjtningen

2 timer

Lokalirriterende

Miljøfarlig

® = Bayer CropScience

Svampemiddel

Må kun anvendes til bekæmpelse af svampesyg-

domme i æbler, pærer, ribs, solbær, brombær,

hindbær, jordbær, tomater og prydplanter.

UN 3077

5 kg

Euparen Multi

Euparen Multi

PMR:

Form.:

Artwork:

Job no.:

Bayer CropScience DK

Date:

Country:

Colour: CMYK

Use only for corrections

Print Ready PDF for

upload to Server

720x380 mm

5486a

26-3309

07-08-2006

DK06107507A

DK06107507A

Afgrøde

Max antal beh. pr. år

Æbler, pærer, hindbær, brombær

Solbær, ribs

Jordbær

Prydplanter

Tomater

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

9-10-2018

Notice of call for expressions of interest - Multiplex serologie

Notice of call for expressions of interest - Multiplex serologie

France - Agence Nationale du Médicament Vétérinaire

1-10-2018

Minister Bruno Bruins naar ministeriële G20-bijeenkomst over gezondheid

Minister Bruno Bruins naar ministeriële G20-bijeenkomst over gezondheid

Op woensdag 3 en donderdag 4 oktober is minister Bruno Bruins (Medische Zorg) namens Nederland aanwezig bij de G20-bijeenkomst over gezondheid. Tijdens deze bijeenkomst in Argentinië komen alle gezondheidsministers van de grootste economieën van de wereld samen. Op de agenda staat onder andere de gezamenlijke strijd tegen antibioticaresistentie. Onderdeel hiervan is een crisissimulatie over een internationale infectieziekte-uitbraak met een multiresistente bacterie. Ook wordt er gesproken over het verste...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA - U.S. Food and Drug Administration

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically, the child-resistant mechanism may not work properly.

Health Canada

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

Outbreak of Salmonella Enteritidis Linked to Shell Eggs

FDA - U.S. Food and Drug Administration

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Minister Bruno Bruins (Medische Zorg) heeft met succes onderhandeld over de prijs van het middel daratumumab in twee verschillende combinatietherapieën voor de vervolgbehandeling van de ziekte van Kahler (multipel myeloom). Bij deze ziekte is er sprake van kwaadaardige woekering van plasmacellen in het beenmerg. Daratumumab was al beschikbaar als zogenaamde monotherapie voor patiënten die al eerder zijn behandeld. Door de prijsafspraken wordt het middel vanaf 1 september voor deze patiënten ook vergoed u...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

2-8-2018

Orphan designation:  Pomalidomide,  for the: Treatment of multiple myeloma

Orphan designation: Pomalidomide, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

26-7-2018

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

21-7-2018

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, is investigating a multi-state outbreak of Salmonella Sandiego illnesses linked to Spring Pasta Salad sold at Hy-Vee locations in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Thalidomide,  for the: Treatment of multiple myeloma

Orphan designation: Thalidomide, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

14-7-2018

FDA Investigates Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s

FDA Investigates Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s

The FDA confirms the presence of Cyclospora in Fresh Express salad mix through new laboratory method; Fresh Express recalls expired products containing romaine lettuce.

FDA - U.S. Food and Drug Administration

26-6-2018

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically the lighters:

Health Canada

16-6-2018

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement.

FDA - U.S. Food and Drug Administration

16-6-2018

FDA Investigates Multistate Outbreak of Cyclospora illnesses linked to Del Monte Vegetable Trays

FDA Investigates Multistate Outbreak of Cyclospora illnesses linked to Del Monte Vegetable Trays

The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local officials have been investigating a cluster of cyclosporiasis illnesses associated with recalled Del Monte vegetable trays from Kwik Trip/Kwik Star locations in the United States.

FDA - U.S. Food and Drug Administration

15-6-2018

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

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

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

FDA - U.S. Food and Drug Administration

15-6-2018

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Mbandaka illnesses that may be linked to Kellogg’s Honey Smacks cereal.

FDA - U.S. Food and Drug Administration

9-6-2018

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Adelaide illnesses that may be linked to cut melons.

FDA - U.S. Food and Drug Administration

29-5-2018

Orphan designation:  Panobinostat,  for the: Treatment of multiple myeloma

Orphan designation: Panobinostat, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

29-5-2018

Orphan designation:  Venetoclax,  for the: Treatment of multiple myeloma

Orphan designation: Venetoclax, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

11-5-2018

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients

FDA - U.S. Food and Drug Administration

10-5-2018

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, also commonly called B. cepacia, in three states: California (2), Pennsylvania (7), and New Jersey (1). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been linked to the Medline product, Remedy Essentials No-Rinse Cleansing Foam.

FDA - U.S. Food and Drug Administration

9-5-2018

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA - U.S. Food and Drug Administration

19-4-2018

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

FDA - U.S. Food and Drug Administration

16-3-2018

"Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risks

"Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risks

Health Canada is advising Canadians that "Beyond Yourself Multi Athlete" multivitamin and unauthorized "Multi-Vitamines" sold in bulk were seized from several Shop Santé stores in Quebec because they may pose serious health risks.

Health Canada

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

9-7-2013

Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

Danish Medicines Agency

27-6-2011

Danish Pharmacovigilance Update, 16 June 2011

Danish Pharmacovigilance Update, 16 June 2011

Among the articles in this issue of Danish Pharmacovigilance Update, you can read about the removal of contraindication for Velcade® (bortezomib) used for the treatment of multiple myeloma.

Danish Medicines Agency

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted

Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted

Critical Path Global Ltd.’s Critical Path for Parkinson’s (CPP) is a multinational consortium of the Critical Path Institute supported by Parkinson’s UK and industry. This broad collaboration of pharmaceutical companies, government agencies, academic institutions, and charities aims to accelerate the development of therapies for Parkinson’s disease (PD).

Europe - EMA - European Medicines Agency