Cyperb 100 EW

Primær information

  • Handelsnavn:
  • Cyperb 100 EW Olie i vand emulsion
  • Lægemiddelform:
  • Olie i vand emulsion
  • Sammensætning:
  • 100 g/l cypermethrin (cis:trans 40:60)
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

Lokation

  • Fås i:
  • Cyperb 100 EW Olie i vand emulsion
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Ikke længere markedsført
  • Autorisationsnummer:
  • Må ikke anvendes nærmere end 20 meter i byg, havre, hvede, rug, triticale, majs, græs og kløvergræs til afgræsning, kløvergræs til frøproduktion, frøgræs, raps, rybs, sennep, ærter, kartofler og bederoer fra vandmiljøet (vandløb, søer o.l.) for at beskytte organismer, der lever i vand. Må ikke anvendes nærmere end 30 meter i frilandsgrønsager fra vandmiljøet (vandløb, søer o.l.) for at beskytte organismer, der lever i vand. Må ikke anvendes nærmere end 30 meter ved sprøjtning af tømmerstokke og rodhalssprøj
  • Sidste ændring:
  • 22-07-2018

Indlægsseddel

Layout Guides Color : NO PRINT

SIDE 1 (FACING)

SIDE 2

SIDE 3

SIDE 4

CYPERB

®

Insektmiddel

Import: KLARSØ A/S

5 liter

CYPDK08.12-5.2

Førstehjælp

Indånding:

Bring vedkommende i frisk luft, søg læge ved fortsat ubehag.

Hud:

Fjern forurenet tøj. Kommer stoffet på huden vaskes straks med store mængder

vand.

Øjne:

Skyl omgående med rigeligt vand i mindst 15 min. og søg lægehjælp. Fjern

eventuelle kontaktlinser.

Indtagelse:

Ved indtagelse undgå at fremprovokere opkastning: kontakt omgående læge og

vis denne beholder eller etiket.

ADVARSEL

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

Irriterer huden.

Kan give overfølsomhed ved kontakt med huden.

Meget giftig for organismer, der lever i vand; kan forårsage uønskede langtidsvirkninger i

vandmiljøet.

Undgå indånding af aerosoltåger.

Undgå kontakt med huden.

Brug egnede beskyttelseshandsker under arbejdet.

Vask huden efter arbejdet.

Vær opmærksom på, at Arbejdstilsynet har regler for arbejde med og udsættelse for plantebe-

skyttelsesmidler. Læs nærmere i den eventuelt lovpligtige leverandørbrugsanvisning samt i

Arbejdstilsynets informationsmateriale om bekæmpelsesmidler.

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre straf:

Må kun anvendes til insektbekæmpelse i byg, havre, hvede, rug, triticale, majs, græs og

kløvergræs til afgræsning, kløvergræs til frøproduktion, frøgræs, raps, rybs og sennep,

ærter, kartofler, hovedsalat, persille, dild, savojkål, hvidkål, rødkål, broccoli, blomkål,

rosenkål, gulerødder, peberrod, persillerod, pastinak, skorzonerrod, knoldselleri, radise,

bederoer og væksthuskulturer af agurk, drueagurk, tomat, aubergine, pepino samt tøm-

merstokke og rodhalssprøjtning/dypning af nåletræer.

Må ikke anvendes mod andre skadevoldere og ikke i højere doseringer end de i brugsan-

visningen nævnte. Må i udendørsanvendelser kun anvendes 1 gang årligt, og i væksthuse

kun med 2 behandlinger pr. vækstsæson.

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

Må i kartofler, gulerødder, peberrod, persillerod, pastinak, skorzonerrod, knoldselleri,

radise, auberginer, agurker, drueagurk, hovedsalat, persille, dild, broccoli, blomkål, rosen-

kål, savojkål, hvidkål og rødkål ikke anvendes senere end 7 dage før høst.

Må i ærter m. bælg, ærter u. bælg og majs ikke anvendes senere end 14 dage før høst.

Må i byg, havre, hvede, rug og triticale ikke anvendes senere end 21 dage før høst.

Må i raps, rybs og sennep ikke anvendes senere end 28 dage før høst.

Må i bederoer ikke anvendes senere end 2 uger før høst.

Halm fra græs, kløvergræs og frøgræshalm til frøproduktion må ikke bruges til foder.

Kløverfrø behandlet med cypermethrin må ikke bruges til fodring.

For at beskytte bier og andre bestøvende insekter må dette produkt kun anvendes

udenfor biernes flyvetid – fra kl. 21.00 til kl. 03.00 (dansk sommertid).

Må ikke anvendes nærmere end 20 meter i byg, havre, hvede, rug, triticale, majs, græs

og kløvergræs til afgræsning, kløvergræs til frøproduktion, frøgræs, raps, rybs, sennep,

ærter, kartofler og bederoer fra vandmiljøet (vandløb, søer o.l.) for at beskytte organismer,

der lever i vand.

Må ikke anvendes nærmere end 30 meter i frilandsgrønsager fra vandmiljøet (vandløb,

søer o.l.) for at beskytte organismer, der lever i vand.

Må ikke anvendes nærmere end 30 meter ved sprøjtning af tømmerstokke og rod-

halssprøjtning/dypning af nåletræer fra vandmiljøet (vandløb, søer o.l.) for at beskytte

organismer, der lever i vand.

Undgå at forurene vandmiljøet med produktet eller med beholdere, der har indeholdt

produktet. Rens ikke sprøjteudstyr nær overfladevand/Undgå forurening via dræn fra

gårdspladser og veje.

Opbevares utilgængeligt for børn.

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

Må kun anvendes til insektbekæmpelse i byg, havre, hvede, rug, triticale, majs, græs og kløvergræs til afgræsning, kløvergræs til frøproduktion, frøgræs, raps, rybs og

sennep, ærter, kartofler, hovedsalat, persille, dild, savoykål, hvidkål, rødkål, broccoli, blomkål, rosenkål, gulerødder, peberrod, persillerod, pastinak, skorzonerrod,

knoldselleri, radise, bederoer og væksthuskulturer af agurk, drueagurk, tomat, aubergine, pepino samt tømmerstokke og rodhalssprøjtning/dypning af nåletræer.

Lokalirriterende

Miljøfarlig

FOR

BIER

FARLIG

Vandmængder

l/ha

Landbrug, grøntsager og friland

200-400

Afgrøde

Skadevolder

l/ha

Tidspunkt/kriterier

Byg, havre

Trips

0,20

Begyndende angreb - stadie 73 -

Ved forudgående varsel

Bladlus

0,25

Begyndende angreb - stadie 73 -

Ved forudgående varsel

Kornbladbiller

0,20

0,5-1,0 larve pr. aksbærende strå

Fritfluer

0,25

Stadie 12

Hvede, rug

triticale

Trips

0,20

Begyndende angreb - stadie 75

Bladlus

0,25

Begyndende angreb - stadie 75

Kornbladbiller

0,20

0,5-1,0 larve pr. aksbærende strå

Fritfluer

0,25

Stadie 12

Majs

Bladlus

0,25

Begyndende angreb

Fritfluer

0,25

Stadie 13

Græs og

kløvergræs

Bladrandbiller

0,20

10-20% planter med gnav i

tidlige vækststadier

Frøgræs

Bladlus

0,25

Begyndende angreb - Ved

forudgående varsel

Fritfluer

0,25

Ca. 8 dage efter slæt el. unge

planter på 2-3 bladstadiet sam-

menfaldende med fritfluernes

flyvning

Kløvergræs til

frøproduktion

Bladrandbiller

0,20

10-20% planter med gnav i

tidlige vækststadier

Kløversnudebiller

0,25

10-20% planter med gnav i

tidlige vækststadier

Raps*), rybs og

sennep

Kåltrips, jordlop-

per,

rapsjordlopper

0,20

Begyndende angreb

Kålbladlus

0,25

Begyndende angreb

Skulpesnudebiller,

0,25

6,0 bille pr. plante fra begyn-

dende blomstring

Skulpegalmyg

0,25

Ved varsling og ved kraftige

angreb

Glimmerbøsser

0,25

Tidlig knopstadium 1,0 bille pr.

plante - sent knopstadium 3,0

bille pr. plante

Ærter

Trips

0,20

Ved forudgående varsel/begyn-

dende angreb

Stribet

blandrandbille

0,20

Gennemsnitlig mere end 1 gnav/

plante i tidlige vækststadier

Ærtebladlus

0,25

15-20% angrebne planter.

Afblomstring og fuld bælglængde:

over 50% angrebne planter

Ærtevikler,

skyggevikler

0,25

5-10% sammenviklede topskud

Afgrøde

Skadevolder

l/ha

Tidspunkt/kriterier

Kartofler

Bladlus

0,25

10-20 bladlus pr. småblad

Coloradobiller

0,25

Begyndende angreb

Agerugler

0,25

Ved forudgående varsel

Cikader

0,25

Begyndende angreb. Randbe-

handling ofte tilstrækkelig

Bederoer

Trips, bedejordlop-

per, ådselbiller,

bedefluer

0,20

Inden bladfylden bliver så stor, at

skadedyrene ikke kan rammes

Agerugler,

bedeugler

0,25

Inden bladfylden bliver så stor, at

skadedyrene ikke kan rammes

Hvidkål, rødkål,

savoykål,

rosenkål

Trips, jordlopper

0,20

Begyndende angreb

Bladlus

0,25

Begyndende angreb

Stor- og lille

kålsommerfugl,

kålmøl

0,30

Begyndende angreb

Blomkål,

broccoli

Trips, jordlopper

0,20

Begyndende angreb

Bladlus

0,25

Begyndende angreb

Glimmerbøsser,

kålmøl, stor- og

lille kålsom-

merfugl

0,30

Begyndende angreb

Peberrod,

radise

Trips, jordlopper

0,20

Begyndende angreb

Bladlus

0,25

Begyndende angreb

Gulerod, persil-

lerod, pastinak,

skorzonerrod,

persille, dild,

knoldselleri

Agerugler

0,30

Begyndende angreb

Hovedsalat

Bladlus

0,25

Begyndende angreb

Væksthuskultu-

rer af agurk og

drueagurk

Væksthusmel-

lus, nelliketrips,

bladlus, larver af

målere,

viklere og møl

0,02%

styrke

Begyndende angreb

Væksthuskul-

turer af tomat,

aubergine og

pepino

Væksthusmel-

lus, nelliketrips,

tomatminerfluer,

bladlus, larver af

målere, viklere

og møl

0,02%

styrke

Begyndende angreb

Nåletræer

Nåletræssnude-

bille -

Opløsningen

anvendes til

nyplantede træer

som rodhals-

sprøjtning/dypning

6,0%

styrke

Dypning: Inden udplantning

Sprøjtning: Hurtigst muligt efter

udplantning

Tømmerstokke

Barkbiller/ved-

borere

2,0-

3,0%

styrke

Inden sværmning i april - fore-

byggende behandling

Forholdsregler ved brug

Udformet iht. Arbejdstilsynets vejledning.

Ved opblanding: Overtræksbukser/forklæde, ansigtsskærm + halvmaske eller helmaske, begge med filter

A2P2, beskyttelseshandsker og støvler.

Ved udsprøjtning: Med spredebom og traktor. Lukket eller åbent førerhus, bom mindre end 1 m. over

jordoverfladen og manometertryk under 3 bar: overtræksbukser, beskyttelseshandsker og støvler.

Ved dypning af nåletræer indendørs: Overtræksbukser/forklæde, halvmaske med filter A2P2, langskaftede

handsker og støvler.

Ved andre udbringningsmetoder henvises til vejledningen.

Sundhedsfarlige egenskaber

Indånding:

Kan fremkalde nysen og hoste ved irritation af luftvejene.

Hud:

Kan give prikken i huden, kløe og svien.

Øjne:

Kan give stærk irritation, rødme og smerter.

Indtagelse:

Utilpashed, kvalme, mavesmerter, sløvhed og diaré. Ingen kendt

langtidsvirkning.

Egenskaber ved brand

Kan danne giftige brandgasser.

Forholdsregler ved brand

Egnede slukningsmidler: Vand, kulsyre, skum eller pulver. Anvend åndedrætsværn mod brandgasser. Produktet

fjernes så vidt muligt fra brandstedet.

Uddannelseskrav

Sprøjtecertifikat iht. Miljøministeriets bekendtgørelse nr. 360 af 24.05.93. Iflg. Arbejdsministeriets bekendtgø-

relse nr. 524 af 19.06.92 om unges farlige arbejde må midlet som hovedregel ikke anvendes af unge under

18 år.

Virkning

Det aktive stof i Cyperb 100 EW er cypermethrin, som

er et bredtvirkende insektmiddel tilhørende gruppen af

pyrethroider (IRAC gruppe 3A). Cypermethrin virker som

kontakt- og mavegift, og har endvidere en afvisende

effekt overfor insekter. Cyperb 100 EW er ikke systemisk,

men bindes i planterners vokslag. En god fordeling af

sprøjtevæske er derfor vigtig for at opnå optimal effekt af

sprøjtningen.

Deklaration

Insektmiddel nr. 49-100

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og plantebeskyttelsesmiddelfor-

ordningen 1107/2009.

Udløbsdato: 2 år fra produktionsdato (batchnummer) som stemplet øverst på denne emballage.

Analyse: Cypermethrin (cis/trans: 40/60) 100 g/l (11% w/w).

Væske, 5 liter.

Godkendelsesindehaver:

Klarsø A/S

Søholm Park 1

2900 Hellerup

Anvendelsesbegrænsninger

Må i udendørsanvendelser kun anvendes 1 gang årligt, og i væksthuse kun med 2 behandlinger pr. vækstsæson.

Blandinger

Cyperb 100 EW kan tankblandes med de fleste bekæmpelsesmidler samt manganpræparater.

Resistens

Pyrethroider vurderes at have en lav risiko for udvikling af resistens i landbrugsafgrøder, mens risikoen for udvikling

af resistens i væksthuse er højere. I Danmark er der på mange lokaliteter konstateret resistens hos glimmerbøsser.

Her vil virkningen af Cyperb 100 EW og andre pyrethroider være utilstrækkelig, og der bør anvendes et middel med

anden virkningsmekanisme.

Risikoen for resistens stiger, når midler med samme virkemekanisme bruges ofte. For at mindske risikoen for

resistens anbefales det at skifte mellem midler med andre virkningsmekanismer, som har en god effekt overfor

de aktuelle arter.

*) I raps er der på mange lokaliteter konstateret nedsat eller manglende virkning af pyrethroider mod

glimmerbøsser pga. resistens. Her vil virkningen af Cyperb 100 EW og andre pyrethroider være utilstrækkelig,

og der bør anvendes et middel med anden virkningsmekanisme.

Antiresistensstrategi

Sprøjt kun efter behov. Det vil sige, når de vejledende bekæmpelsestærskler er overskredet.

Forenelighed med biologisk bekæmpelse

Cyperb 100 EW er ikke forenelig med biologisk bekæmpelse med nyttedyr i væksthuse.

Sprøjteteknik

Sprøjt under optimale vejrforhold. Vindhastigheden skal være lav (< 4m/s, vindstille) på behandlingstidspunktet.

Hvor det er muligt vælges low-drift dyser. Undgår overlapning i marken samt spild udenfor området. Vælg altid

en passende bomhøjde på behandlingstidspunktet, så der kan ske en jævn fordeling på afgrøden. Vandmængden

skal altid tilpasses opgaven, men en passende vandmængde vil i de fleste tilfælde være 200-400 l/ha. Den lave

mængde vælges ved lille bladmasse, hvor planterne er let våde af dug. Højeste vandmængde ved en tæt afgrøde

med stor bladmasse eller under tørre vejrforhold.

Tilberedning af sprøjtevæsken

Påfyldning af sprøjtevæske må kun ske på befæstet vaskeplads eller på det areal, som skal behandles. Inden sprøj-

ten fyldes skal den være omhyggelig rengjort med egnet rengøringsmiddel og efterset for eventuelle belægninger.

Det samme gælder for dyser, sier og filtre (se afsnit om rengøring).

Rengøring af sprøjteudstyr

Efter endt sprøjtning skal sprøjten og traktor rengøres enten i marken eller på vaskepladsen. Sprøjten skal være

monteret med tankspuledyser og en separat vandtank med tilstrækkelig kapacitet, som sikrer at tilstrækkelig

rengøring indvendig kan ske i den mark, der lige er behandlet.

Vaske- og skyllevandet opsamles i egnede beholdere og udbringes på omdriftsarealet på en sådan måde, at det

ikke udgør en risiko for miljø eller den efterfølgende afgrøde (se Miljøstyrelsens vejledning nr. 1 2009).

Bortskaffelse

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.

Import: KLARSØ A/S

5 liter

CYPDK08.12-5.2

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Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if...

FDA - U.S. Food and Drug Administration

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

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

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Kabinet investeert in eerste 1000 dagen kind

Kabinet investeert in eerste 1000 dagen kind

Van kinderwens tot 2-jarige peuter: de ontwikkeling die we in de eerste 1000 dagen als kind meemaken is cruciaal voor zowel een gezonde groei als de ontplooiing en kansen op latere leeftijd. Verreweg de meeste kinderen in Nederland groeien veilig en gezond op. Toch heeft ongeveer 14% van de kinderen in Nederland een ‘valse’ start door vroeggeboorte, een te laag geboortegewicht of een combinatie van beide. Minister Hugo de Jonge (VWS), gemeenten, partijen uit de geboortezorg en de jeugdgezondheidszorg (JG...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

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

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

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

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

12-6-2018

Ashley Furniture Industries , Inc. recalls Signature Design by Ashley Amnon Floor Lamp

Ashley Furniture Industries , Inc. recalls Signature Design by Ashley Amnon Floor Lamp

The lamp has incorrect lightbulb wattage information printed on a label on the sockets of the lamp. The incorrect labels indicate that each socket can support 40 W bulbs, however the product is only rated for each socket supporting a 25 W bulb. The use of lightbulbs with the incorrect wattage could potentially melt the power-switch, posing a burn hazard.

Health Canada

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% &amp; Pure Natural &amp; Body Slim capsules

Help 100% &amp; Pure Natural &amp; Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

25-9-2018

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

FDA - U.S. Food and Drug Administration

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

17-8-2018

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here:  https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

FDA - U.S. Food and Drug Administration

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety

7-6-2018

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

FDA - U.S. Food and Drug Administration

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

24-5-2018

Xarelto (Bayer AG)

Xarelto (Bayer AG)

Xarelto (Active substance: rivaroxaban) - Centralised - Renewal - Commission Decision (2018)3264 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/944/R/60

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety

3-5-2018

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Active substance: Clopidogrel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2776 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/975/T/60

Europe -DG Health and Food Safety