Pursennid 12 mg

Hauptinformation

  • Handelsname:
  • Pursennid 12 mg - Dragees
  • Einheiten im Paket:
  • 20 Stück, Laufzeit: 60 Monate,40 Stück, Laufzeit: 60 Monate,100 Stück, Laufzeit: 60 Monate,200 Stück, Laufzeit: 60 Monate,5 x 20
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Pursennid 12 mg - Dragees
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Sennoside

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 6989
  • Letzte Änderung:
  • 29-08-2016

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Gebrauchsinformation:InformationfürPatienten

Pursennid12mg-Dragees

SennosideA+BinFormihrerKalziumsalze

LesenSiediegesamtePackungsbeilagesorgfältigdurch,bevorSiemitderEinnahme

diesesArzneimittelsbeginnen,dennsieenthältwichtigeInformationen.

NehmenSiediesesArzneimittelimmergenauwieindieserPackungsbeilagebeschrieben

bzw.genaunachAnweisungIhresArztesoderApothekersein.

HebenSiediePackungsbeilageauf.VielleichtmöchtenSiediesespäternochmalslesen.

FragenSieIhrenApotheker,wennSieweitereInformationenodereinenRatbenötigen.

WennSieNebenwirkungenbemerken,wendenSiesichanIhrenArztoderApotheker.

DiesgiltauchfürNebenwirkungen,dienichtindieserPackungsbeilageangegebensind.

WennSiesichnach14Tagennichtbesserodergarschlechterfühlen,wendenSiesich

anIhrenArzt.

WasindieserPackungsbeilagesteht

WasistPursennidundwofürwirdesangewendet?

WassolltenSievorderEinnahmevonPursennidbeachten?

WieistPursennideinzunehmen?

WelcheNebenwirkungensindmöglich?

WieistPursennidaufzubewahren?

InhaltderPackungundweitereInformationen

1. WasistPursennidundwofürwirdesangewendet?

Pursennid12mgDrageessindeinpflanzlichesArzneimittelzurkurzfristigenAnwendungbei

gelegentlichauftretenderVerstopfung.

WennSiesichnach14Tagennichtbesserodergarschlechterfühlen,wendenSiesichan

IhrenArzt.

2. WassolltenSievorderEinnahmevonPursennidbeachten?

Pursenniddarfnichteingenommenwerden,

wennSieallergischgegenSennosideodereinenderinAbschnitt6.genanntensonstigen

BestandteilediesesArzneimittelssind.

beiakut-entzündlichenErkrankungendesDarmes(MorbusCrohn,ulcerativeColitis).

beiDarmverschluss,Darmstenoseund-atonie.

beiBlinddarmentzündung

beiBauchschmerzenunbekannterUrsache

beischwerenStörungendesWasser-undElektrolythaushaltes(Hypokaliämie).

vonKindernunter12Jahren.

WarnhinweiseundVorsichtsmaßnahmen

Kinderunter12Jahren:

Kinderunter12JahrendürfenPursennid12mgDrageesnichteinnehmen(siehe4.3).

AufausreichendeFlüssigkeitszufuhrwährendderEinnahmeistzuachten.

DasAuftretenvonDurchfällenisteinZeichenvonÜberdosierung.

Patienten,dieHerzglykoside,AntiarrhythmikasowieArzneimitteln,diezueinerQT-

Verlängerungführenkönnen,Entwässerungsmittel,Adrenocorticosteroideoder

Süßholzwurzeleinnehmen,müssenvorderEinnahmevonPursennid12mgDrageesmit

ihremArztsprechen.

DaeinechronischeAnwendungzuvermeidenist,solltedasTherapiezieldieErreichungeiner

normalenVerdauungohneAbführmittelsein.EinemedikamentöseBehandlungder

Verstopfungsollnurerfolgen,wenneineentsprechendeballaststoffreicheErnährungnicht

zumZielführt.

FallsAbführmitteljedenTagbenötigtwerden,solltedieUrsachederVerstopfungermittelt

werden.EinelängerfristigeEinnahmevonAbführmitteln(längerals2Wochen)sollte

vermiedenwerden.

WennsichdieBeschwerdenverschlimmern,musseinArztaufgesuchtwerden.

DiesesArzneimitteldarfohneärztlicheVerordnungnichtübereinenlängerenZeitraum(mehr

alseinbiszweiWochen)eingenommenwerden.

WiealleAbführmittelsolltenPursennid12mgDrageesohneRücksprachemiteinemArzt

nichteingenommenwerdenvonPatienten,dieanKotstauung(Koprostase)und

undiagnostiziertenakutenoderanhaltendenMagen-Darm-Beschwerdenwiez.B.

Bauchschmerzen,ÜbelkeitundErbrechenleiden,weildieseSymptomeAnzeichenfüreinen

drohendenoderbestehendenDarmverschluss(Ileus)seinkönnen.

SofernPursennid12mgDrageesbeiinkontinentenErwachsenenangewendetwerden,sollten

PatientundPflegepersonaldarüberinformiertwerden,dieVorlageregelmäßigzuwechseln,

umeinenlängerenHautkontaktmitdemKotzuvermeiden.

LöstdieAnwendungvonPursennid12mgDrageesregelmäßigkrampfartige

Darmbeschwerdenaus,sohandeltessichvermutlichumeinekrampfartigeVerstopfung.Sie

solltenbeiSchmerzen,dieregelmäßigwährendderAnwendungvonAbführmittelnauftreten,

denArztaufzusuchen.

PatientenmitNierenerkrankungensolltenbesondersaufmöglicheStörungenim

Elektrolythaushaltachten.

Pursennid12mgDrageessindnichtzurReduktiondesKörpergewichtsgeeignet.

GewöhnungseffektesindbeikurzfristigerAnwendungnichtbekannt.

DerregelmäßigeGebrauchvonAbführmittelnkannaberdieEmpfindlichkeitder

Darmschleimhautsoweitherabsetzen,dassdergewünschteErfolgnurmehrübereine

Dosissteigerungerreichtwerdenkann.

EineVerfärbungdesHarnskannzurFehlinterpretationbeiHarnuntersuchungenführen.

EinnahmevonPursennidzusammenmitanderenArzneimitteln

InformierenSieIhrenArztoderApothekerwennSieandereArzneimittel

einnehmen/anwenden,kürzlichandereArzneimitteleingenommen/angewendethabenoder

beabsichtigenandereArzneimitteleinzunehmen/anzuwenden.

BeichronischemGebrauch/MissbrauchistdurchKaliummangeleineVerstärkungder

WirkungvonHerzglykosidensowieeineInteraktionmitAntiarrhythmika(Mittelzur

BehandlungvonHerzrhythmusstörungen)undArzneimitteln,diezurKardioversion

eingesetztwerden(z.B.Chinidin)sowiemitArzneimitteln,diezueinerQT-Verlängerung

führenkönnen,möglich.DieKaliumverlustekönnendurchdiegleichzeitigeAnwendungvon

Diuretika(Entwässerungsmittel),AdrenokortikoidenoderSüßholzwurzelverstärktwerden.

EinnahmevonPursennidzusammenmitNahrungsmittelnundGetränken

DieEinnahmevonSüßholzwurzelundPursennidkannmöglicherweiseIhrenSalzhaushalt

stören.

Schwangerschaft,StillzeitundZeugungs-/Gebärfähigkeit

WennSieschwangersindoderstillen,oderwennSievermuten,schwangerzuseinoder

beabsichtigen,schwangerzuwerden,fragenSievorderEinnahmediesesArzneimittelsIhren

ArztoderApothekerumRat.

Pursennid12mgDrageesdürfenwährendderSchwangerschaftundinderStillzeitnicht

eingenommenwerden.

VerkehrstüchtigkeitundFähigkeitzumBedienenvonMaschinen

PursennidhatkeinenEinflussaufIhreFahrtüchtigkeitunddasBedienenvonMaschinen.

PursennidenthältSaccharose,LaktoseundGlukose

JedesDrageeenthältca.40mgSaccharose,ca.27mgLaktose(Milchzucker)und1,25mg

Glukose.BittenehmenSiediesesArzneimittelerstnachRücksprachemitIhremArztein,

wennIhnenbekanntist,dassSieuntereinerZuckerunverträglichkeitleiden.

3. WieistPursennideinzunehmen?

NehmenSiediesesArzneimittelimmergenauwieindieserPackungsbeilagebeschrieben

bzw.genaunachdermitIhremArztoderApothekergetroffenenAbspracheein.FragenSie

beiIhremArztoderApothekernach,wennSiesichnichtsichersind.

DieempfohleneDosisbeträgt

ErwachseneundJugendlicheab12Jahren:1–2Drageesabends.

MaximaleTagesdosis:2Dragees.

AnwendungbeiKindernunter12Jahren

Kinderunter12JahrendürfenPursennid12mgDrageesnichteinnehmen(siehe4.3).

DieEinnahmeerfolgtnormalerweisevordemSchlafengehenmiteinemGlasWasser

(ca.1/4Liter).DieDarmentleerungerfolgt6bis12StundennachderEinnahme.

DiefüreinesichereWirkungnötigeDosiskannunterschiedlichsein.

EssollimmerdiekleinsteDosisverwendetwerden,diezueinemStuhlmitweicher,nicht

flüssigerKonsistenzführt.

Meistgenügtes,Pursennidnur2bis3-malproWocheanzuwenden.

WennsichdieBeschwerdenverschlimmerodernach1–2WochenkeineBesserungeintritt,

musseinArztaufgesuchtwerden.

EineAnwendunglängerals1-2WochensolltenurunterärztlicherAufsichterfolgen(siehe

Abschnitt4.4)

WennSieeinegrößereMengevonPursennideingenommenhaben,alsSiesollten

EssindkeineschwerenakutenFällevonÜberdosierungmitPursennid12mgDragees

bekannt.

EineAnwendunginhohenDosenoderübereinenlangenZeitraumkannzufolgenden

SymptomeneinerÜberdosierungführen.

AlsHauptsymptomebeiÜberdosierungoderMissbrauchkönnenschmerzhafteDarmkrämpfe

undschwereDurchfälleauftreten,mitderFolgevonWasser-undElektrolytverlusten,die

ersetztwerdensollten.

DurchfallkanninsbesondereKaliummangelverursachen.Kaliummangelkannzukardialen

FunktionsstörungenundMuskelasthenieführen,insbesonderebeigleichzeitigerEinnahmevon

Herzglykosiden,Diuretika(Entwässerungsmittel),AdenokortikosteroidenundSüßholzwurzel.

AlsunterstützendeBehandlungsolltengrößereFlüssigkeitsmengenaufgenommenwerden.

ChronischeÜberdosierungkannzutoxischerHepatitisführen.

WennSiedieEinnahmevonPursennidvergessenhaben

NehmenSienichtdiedoppelteMengeein,wennSiedievorherigeEinnahmevergessen

haben.

WennSieweitereFragenzurEinnahmediesesArzneimittelshaben,wendenSiesichanIhren

ArztoderApotheker.

4. WelcheNebenwirkungensindmöglich?

WiealleArzneimittelkannauchdiesesArzneimittelNebenwirkungenhaben,dieabernicht

beijedemauftretenmüssen.

ErkrankungendesMagen-DarmTrakts:

DieEinnahmekannzuBauchschmerzen,KrämpfenundDurchfallführen,insbesonderebei

PatientenmitReizDarm.DieseBeschwerdentretenaberimAllgemeinenalsFolgeeiner

individuellenÜberdosierungauf,sodassindiesenFälleneineDosisreduktionerforderlichist.

DesWeiterenkannbeinichtbestimmungsgemäßem,langdauerndenGebraucheine

PigmentierungderDarmschleimhaut(Pseudomelanosiscoli)auftreten,diesichnach

AbsetzendesPräparatesinderRegelzurückbildet.

ErkrankungenderHautunddesUnterhautzellgewebes

ÜberempfindlichkeitsreaktionenwieJuckreiz,Bläschenbildung,Hautausschlagund

IrritationeninderUmgebungdesDarmausgangeskönnenauftreten.

ErkrankungenderNierenundHarnwege

BeichronischemGebrauchkanneszuStörungendesWasser-undElektrolythaushaltesundzu

EiweißundBlutimHarnkommen.EineschwacheRotfärbungdesHarnsistohneBedeutung.

AngabenüberdieHäufigkeitdesAuftretensderNebenwirkungenkönnennichtgemacht

werden.

MeldungvonNebenwirkungen

WennSieNebenwirkungenbemerken,wendenSiesichanIhrenArztoderApotheker.Dies

giltauchfürNebenwirkungen,dienichtindieserPackungsbeilageangegebensind.

SiekönnenNebenwirkungenauchdirektüberdasnationaleMeldesystem(Detailssiehe

unten)anzeigen.

IndemSieNebenwirkungenmelden,könnenSiedazubeitragen,dassmehrInformationen

überdieSicherheitdiesesArzneimittelszurVerfügunggestelltwerden.

Österreich

BundesamtfürSicherheitimGesundheitswesen

Traisengasse5

1200WIEN

ÖSTERREICH

Fax:+43(0)5055536207

Website: http://www.basg.gv.at/

5. WieistPursennidaufzubewahren?

InderOriginalverpackungaufbewahren,umdenInhaltvorLichtzuschützen.

BewahrenSiediesesArzneimittelfürKinderunzugänglichauf.

SiedürfendiesesArzneimittelnachdemaufdemUmkartonnach"Verwendbarbis:"

angegebenenVerfalldatumnichtmehrverwenden.DasVerfalldatumbeziehtsichaufden

letztenTagdesangegebenenMonats.

EntsorgenSieArzneimittelnichtimAbwasseroderHaushaltsabfall.FragenSieIhren

Apotheker,wiedasArzneimittelzuentsorgenist,wennSieesnichtmehrverwenden.Sie

tragendamitzumSchutzderUmweltbei.

6. InhaltderPackungundweitereInformationen

WasPursennidenthält

DieWirkstoffesind:12mgSennosideA+BinFormihrerKalziumsalze

DiesonstigenBestandteilesind:Gelatine,Stearinsäure,Glukose,Talkum,

MaisstärkeLaktose-Monohydrat,Eisenoxidrot(E-172),Titandioxid(E-171),

hochdispersesSiliziumdioxid,Gummiarabicum,Sacharose,Carnaubawachs

WiePursennidaussiehtundInhaltderPackung

Arzneiform:ÜberzogeneTablette

DieTablettensindklein,bräunlich,rundundbeidseitiggewölbt.

DieBlisterPackungbestehtausPVC-Folie,Alu-FolieundHeißsiegellack.

Packungsgrößen:20,40,100,200und5x200(Bündelpackung)Stück.

EswerdenmöglicherweisenichtallePackungsgrößenindenVerkehrgebracht.

PharmazeutischerUnternehmerundHersteller

PharmazeutischerUnternehmer:NovartisConsumerHealth–GebroGmbH,A-6391

Fieberbrunn

Hersteller:NovartisFarma,TorreAnnunziata,Italien

Zul.Nr.:6989

DiesePackungsbeilagewurdezuletztüberarbeitetimJuni2014.

-----------------------------------------------------------------------------------------------------------------

DiefolgendenInformationensindfürmedizinischesFachpersonalbestimmt:

MagenspülungnurnachmassivenDosen.

SymptomatischeBehandlung:BeiKolikdesMagen-DarmtraktesVerabreichungvon

Spasmolytika; Überwachung des Herz-Kreislaufsystems sowie des Wasser-

Elektrolytgleichgewichts,insbesondereKalium.DiesistbesondersbeiälterenMenschen

wichtig.

BeiKolikdesMagen-DarmtrakteswirddieVerabreichungvonSpasmolytikaempfohlen.

BeistarkerDiarrhoeinfolgeakzidentellerÜberdosierunggenügtimAllgemeinenreichliche

Flüssigkeitssubstitutionoral.BesondersgeeignetsindFruchtsäfte.

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Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

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

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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

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...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

5-10-2018

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

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

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

13-12-2018

Valsartan comp.-CT 320 mg/12,5 - 25 mg

Rote - Liste

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Active substance: Tofacitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7554 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004214/T/0015

Europe -DG Health and Food Safety

12-11-2018

Tracleer (Janssen-Cilag International NV)

Tracleer (Janssen-Cilag International NV)

Tracleer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7556 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000401/T/0088

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

30-10-2018

SUTENT® 12,5/25/37,5/50 mg Hartkapseln

Rote - Liste

25-10-2018

Moventig® 12,5 mg/25 mg Filmtabletten

Rote - Liste

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

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

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration