Verria 200 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Verria 200 mg filmom obložene tablete
  • Doziranje:
  • 200 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 200 mg vorikonazola
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Medochemie Ltd., Limassol, Cipar

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Verria 200 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 2 tablete u blisteru, u kutiji [HR-H-476893358-01]; 10 tableta u blisteru, u kutiji [HR-H-476893358-02]; 14 tableta u blisteru, u kutiji [HR-H-476893358-03]; 20 tableta u blisteru, u kutiji [HR-H-476893358-04]; 28 tableta u blisteru, u kutiji [HR-H-476893358-05]; 30 tableta u blisteru, u kutiji [HR-H-476893358-06]; 50 tableta u blisteru, u kutiji [HR-H-476893358-07]; 56 tableta u blisteru, u kutiji [HR-H-476893358-08]; 100 tableta u blisteru, u kutiji [HR-H-476893358-09] Urbroj: 381-12-01/38-17-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-476893358
  • Datum autorizacije:
  • 07-12-2017
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

VERRIA 50 mg filmom obložene tablete

VERRIA 200 mg filmom obložene tablete

vorikonazol

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Moţda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Moţe im naškoditi, čak i ako

su njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku

sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je VERRIA i za što se koristi

Što morate znati prije nego počnete uzimati lijek VERRIA

Kako uzimati lijek VERRIA

Moguće nuspojave

Kako čuvati lijek VERRIA

Sadrţaj pakiranja i druge informacije

1. Što je VERRIA i za što se koristi

Lijek VERRIA sadrţi djelatnu tvar vorikonazol. VERRIA je lijek za liječenje gljivičnih infekcija.

Djeluje tako da uništava ili zaustavlja rast gljivica koje uzrokuju infekcije.

Koristi se za liječenje bolesnika (odraslih i djece starije od 2 godine) koji imaju:

invazivnu aspergilozu (vrstu gljivične infekcije uzrokovanu vrstama iz roda Aspergillus),

kandidemiju (drugu vrstu gljivične infekcije uzrokovanu vrstama iz roda Candida) u bolesnika

bez neutropenije (bolesnika koji nemaju neuobičajeno mali broj bijelih krvnih stanica),

ozbiljne invazivne infekcije uzrokovane vrstama iz roda Candida kada je gljivica otporna

na flukonazol (drugi lijek za liječenje gljivičnih infekcija),

ozbiljne gljivične infekcije uzrokovane vrstama iz rodova Scedosporium ili Fusarium (dva

različita roda gljivica).

Lijek VERRIA je namijenjen bolesnicima s gljivičnim infekcijama koje se pogoršavaju, a mogu biti

opasne po ţivot.

Prevencija gljivičnih infekcija u visokorizičnih primatelja transplantacije koštane srţi.

Ovaj se lijek smije uzimati samo pod nadzorom liječnika

2. Što morate znati prije nego počnete uzimati lijek VERRIA

Nemojte uzimati lijek VERRIA:

Ako ste alergični na vorikonazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).

Vrlo je vaţno da obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali neke

druge lijekove, uključujući i one koje ste nabavili bez recepta ili biljne lijekove.

Lijekovi navedeni u sljedećem popisu ne smiju se uzimati za vrijeme liječenja lijekom VERRIA:

terfenadin (koristi se za liječenje alergija)

astemizol (koristi se za liječenje alergija)

cisaprid (koristi se za ublaţavanje ţelučanih tegoba)

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pimozid (koristi se za liječenje duševnih bolesti)

kinidin (koristi se za liječenje nepravilnih otkucaja srca)

rifampicin (koristi se za liječenje tuberkuloze)

efavirenz (koristi se za liječenje HIV-a) u dozama od 400 mg i više jednom na dan

karbamazepin (koristi se za liječenje epileptičkih napadaja)

fenobarbital (koristi se kod teške nesanice i epileptičkih napadaja)

ergot alkaloidi (npr. ergotamin, dihidroergotamin; koriste se za liječenje migrene)

sirolimus (koristi se u bolesnika s presatkom organa)

ritonavir (koristi se za liječenje HIV-a) u dozama od 400 mg i više dva puta na dan

gospina trava (biljni pripravak)

Upozorenja i mjere opreza

Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek VERRIA ako:

ste imali alergijsku reakciju na druge azole.

trenutno imate ili ste ikada imali bolest jetre. Ako imate bolest jetre, liječnik će Vam moţda

propisati niţu dozu lijeka VERRIA. Za vrijeme liječenja lijekom VERRIA liječnik takoĎer

mora nadzirati funkciju Vaše jetre putem krvnih pretraga.

se zna da imate kardiomiopatiju, nepravilne otkucaje srca, usporen puls ili nepravilnost u

elektrokardiogramu (EKG) koja se naziva „sindrom produljenog QTc intervala“.

Tijekom liječenja morate izbjegavati sunčevu svjetlost i izlaganje suncu. Vaţno je da pokrijete

područja koţe izloţena suncu i koristite sredstvo za sunčanje s visokim faktorom zaštite od sunca

(SPF) jer moţe doći do pojačane osjetljivosti koţe na sunčeve UV zrake. Ove mjere opreza vrijede

takoĎer i za djecu.

Za vrijeme liječenja lijekom VERRIA:

odmah recite svom liječniku ako dobijete

opekline od sunca

teški osip ili mjehure na koţi

bol u kostima

Ako razvijete poremećaje koţe opisane u prethodnom tekstu, Vaš liječnik Vas moţe uputiti

dermatologu, koji nakon konzultacija moţe odlučiti da je vaţno da redovito dolazite na kontrole.

Postoji mala šansa od razvoja raka koţe uz dugoročnu primjenu lijeka VERRIA.

Vaš liječnik Vam mora nadzirati funkciju jetre i bubrega putem krvnih pretraga.

Djeca i adolescenti

VERRIA se ne smije davati djeci mlaĎoj od 2 godine.

Drugi lijekovi i VERRIA

Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove, uključujući i one koje ste nabavili bez recepta.

Kada se primjenjuju istodobno s lijekom VERRIA, neki lijekovi mogu utjecati na djelovanje lijeka

VERRIA, ali i VERRIA moţe utjecati na djelovanje drugih lijekova.

Obavijestite svog liječnika ako uzimate sljedeći lijek, jer treba izbjegavati istodobno liječenje

lijekom VERRIA ako je to moguće:

ritonavir (koristi se za liječenje HIV-a) u dozi od 100 mg dva puta na dan

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Obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova jer treba izbjegavati

istodobno liječenje lijekom VERRIA ako je to moguće, a moţda će biti potrebno prilagoditi dozu

vorikonazola:

rifabutin (koristi se za liječenje tuberkuloze). Ako već primate rifabutin, morat će se kontrolirati

krvna slika i nuspojave na rifabutin.

fenitoin (koristi se za liječenje epilepsije). Ako već primate fenitoin, za vrijeme liječenja

lijekom VERRIA morat će se pratiti koncentracija fenitoina u krvi i moţda prilagoditi doza

lijeka.

Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova, jer će moţda trebati prilagoditi

dozu lijeka ili provjeravati imaju li oni i/ili VERRIA i dalje ţeljeni učinak:

varfarin i ostale antikoagulanse (npr. fenprokumon, acenokumarol; primjenjuju se za

usporavanje zgrušavanja krvi)

ciklosporin (koristi se u bolesnika s presatkom organa)

takrolimus (koristi se u bolesnika s presatkom organa)

sulfonilureje (tj. tolbutamid, glipizid i gliburid) (koriste se za liječenje šećerne bolesti)

statine (npr. atorvastatin, simvastatin) (koriste se za sniţavanje razine kolesterola)

benzodiazepine (npr. midazolam, triazolam) (koriste se kod teške nesanice i stresa)

omeprazol (koristi se za liječenje vrijeda)

oralne kontraceptive (ako uzimate lijek VERRIA istodobno s oralnim kontraceptivima,

moţete imati nuspojave poput mučnine i poremećaja menstruacije)

vinka alkaloide (npr. vinkristin i vinblastin) (koriste se za liječenje raka)

indinavir i druge inhibitore HIV proteaze (koriste se za liječenje HIV-a)

nenukleozidne inhibitore reverzne transkriptaze (npr. efavirenz, delavirdin, nevirapin) (koriste

se za liječenje HIV-a) (neke doze efavirenza NE smiju se uzimati u isto vrijeme kad i lijek

VERRIA)

metadon (koristi se za liječenje ovisnosti o heroinu)

alfentanil, fentanil i ostale opijate kratkog djelovanja, kao što je sufentanil (lijekovi protiv

bolova koji se koriste za vrijeme kirurških zahvata)

oksikodon i ostale opijate dugog djelovanja, kao što je hidrokodon (koriste se za ublaţavanje

umjerene do jake boli)

nesteroidne protuupalne lijekove (npr. ibuprofen, diklofenak) (koriste se za liječenje boli i

upale)

flukonazol (koristi se za liječenje gljivičnih infekcija)

everolimus (koristi se za liječenje uznapredovalog raka bubrega i u bolesnika s presatkom

organa)

Trudnoća i dojenje

VERRIA se ne smije uzimati tijekom trudnoće osim ako Vaš liječnik nije tako odlučio. Ţene

reproduktivne dobi moraju koristiti učinkovitu kontracepciju. Odmah se javite svom liječniku ako

zatrudnite za vrijeme uzimanja lijeka VERRIA.

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Upravljanje vozilima i strojevima

VERRIA moţe uzrokovati zamagljen vid ili neugodnu preosjetljivost na svjetlost. Ako to osjećate,

nemojte voziti niti rukovati alatima ili strojevima. Javite se svom liječniku ako imate te nuspojave.

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VERRIA sadrži laktozu:

Ako vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja lijeka

VERRIA.

3.

Kako uzimati lijek VERRIA

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Provjerite sa svojim liječnikom

ili ljekarnikom ako niste sigurni.

Liječnik će odrediti dozu lijeka ovisno o Vašoj tjelesnoj teţini i vrsti infekcije koju imate.

Preporučena doza za odrasle (uključujući starije bolesnike) je kako slijedi:

Tablete

Bolesnici tjelesne teţine 40 kg i više

Bolesnici tjelesne teţine

manje od 40 kg

Doza tijekom

prva 24 sata

(udarna doza)

400 mg svakih 12 sati tijekom

prva 24 sata

200 mg svakih 12 sati

tijekom prva 24 sata

Doza nakon prva

24 sata

(doza odrţavanja)

200 mg dvaput na dan

100 mg dvaput na dan

Ovisno o Vašem odgovoru na liječenje, liječnik moţe povećati dnevnu dozu na 300 mg dva puta

na dan.

Liječnik će moţda odlučiti smanjiti dozu ako imate blagu do umjerenu cirozu jetre.

Primjena u djece i adolescenata

Preporučena doza za djecu i adolescente je kako slijedi:

Tablete

Djeca u dobi od 2 do nepunih

12 godina i adolescenti od 12

do 14 godina koji imaju

manje od 50 kg

Adolescenti od 12 do 14

godina koji imaju 50 kg i

više; i svi adolescenti

stariji od 14 godina

Doza tijekom

prva 24 sata

(udarna doza)

Liječenje će započeti

infuzijom

400 mg svakih 12 sati

tijekom prva 24 sata

Doza nakon

prva 24 sata

(doza odrţavanja)

9 mg/kg dvaput na dan

(najviša doza je 350 mg dvaput na

dan)

200 mg dvaput na dan

Ovisno o Vašem odgovoru na liječenje, liječnik moţe povećati ili smanjiti dnevnu dozu.

Tablete se smiju davati samo ako ih dijete moţe progutati.

Tablete uzimajte najmanje jedan sat prije ili jedan sat nakon jela. Progutajte cijelu tabletu s malo

vode.

Ako Vi ili Vaše dijete uzimate lijek VERRIA za prevenciju gljivičnih infekcija, liječnik Vam moţe

prestati davati lijek VERRIA ako Vi ili Vaše dijete razvijete povezane nuspojave.

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Ako uzmete više lijeka VERRIA nego što ste trebali

Ako uzmete više tableta nego Vam je propisano (ili ako netko drugi uzme Vaše tablete), morate

odmah zatraţiti savjet liječnika ili otići u hitnu sluţbu najbliţe bolnice. Ponesite sa sobom kutiju lijeka

VERRIA. Moţete osjetiti neuobičajeno nepodnošenje svjetlosti kao posljedicu uzimanja prevelike

količine lijeka VERRIA.

Ako ste zaboravili uzeti lijek VERRIA

Vaţno je da VERRIA tablete uzimate redovito, svakog dana u isto vrijeme. Ako zaboravite uzeti jednu

dozu, uzmite sljedeću dozu u predviĎeno vrijeme. Nemojte uzeti dvostruku dozu kako biste nadoknadili

zaboravljenu dozu.

Ako prestanete uzimati lijek VERRIA

Pokazalo se da se učinkovitost Vašeg lijeka moţe znatno povećati ako sve doze uzimate redovito i u

predviĎeno vrijeme. Stoga je, ako Vam liječnik nije rekao da prekinete liječenje, vaţno da lijek

VERRIA uzimate na pravilan način, kako je prethodno opisano.

Nastavite uzimati lijek VERRIA sve dok Vam liječnik ne kaţe da prestanete. Nemojte prerano prestati

s liječenjem jer infekcija moţda neće biti izliječena. Bolesnicima s oslabljenim imunološkim

sustavom ili onima s teškim infekcijama moţda će biti potrebno dulje liječenje kako bi se spriječio

povratak infekcije.

Kada liječnik odredi prekid liječenja lijekom VERRIA, ne biste trebali imati nikakvih nuspojava.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.

4. Moguće nuspojave

Kao i svi lijekovi, ovaj lijek moţe uzrokovati nuspojave iako se one neće javiti kod svakoga.

Pojave li se nuspojave, one će u većini slučajeva biti blage i prolazne. MeĎutim, neke od njih mogu biti

ozbiljne te zahtijevati liječničku pomoć.

Ozbiljne nuspojave - prestanite uzimati lijek VERRIA i odmah se javite liječniku

osip

ţutica; promjene u krvnim pretragama jetrene funkcije

pankreatitis

Druge nuspojave

Vrlo česte: mogu se javiti u više od 1 na 10 osoba

oštećenje vida (promjene vida koje uključuju zamagljeni vid, izmjene doţivljaja boja,

neuobičajenu netoleranciju na vizualnu percepciju svjetlosti, sljepoću za boje, poremećaje oka,

halo vid, noćnu sljepoću, ljuljajuću sliku, iskrenje pred očima, vizualnu auru, smanjenu oštrinu

vida, vizualnu svjetlinu, gubitak dijela uobičajenog vidnog polja, točke pred očima)

vrućica

osip

mučnina, povraćanje, proljev

glavobolja

oticanje udova

bolovi u trbuhu

oteţano disanje

povišeni jetreni enzimi

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Česte: mogu se javiti u do 1 na 10 osoba

upala sinusa, upala desni, zimica, slabost

smanjen (uključujući i značajno smanjen) broj nekih vrsta crvenih (katkad povezano s

imunitetom) i/ili bijelih krvnih stanica (katkad popraćeno temperaturom), niski broj stanica

koje se nazivaju trombociti i koje pomaţu u zgrušavanju krvi

nizak šećer u krvi, nizak kalij u krvi, nizak natrij u krvi

tjeskoba, depresija, smetenost, uznemirenost, nemogućnost spavanja, halucinacije

napadaji, nevoljno drhtanje ili nekontrolirani pokreti mišića, trnci ili neuobičajena

osjetljivost koţe, povećana napetost mišića, pospanost, omaglica

krvarenje u oku

problemi sa srčanim ritmom uključujući vrlo brze otkucaje srca, vrlo spore otkucaje srca,

nesvjestica

nizak krvni tlak, upala vene (moţe biti povezana sa stvaranjem krvnog ugruška)

akutno oteţano disanje, bol u prsima, oticanje lica (usne šupljine, usana i oko očiju),

nakupljanje tekućine u plućima

zatvor, loša probava, upala usana

ţutica, upala jetre i oštećenje jetre

koţni osipi koji mogu dovesti do jakog stvaranja mjehurića i ljuštenja koţe

karakterizirani ravnim, crvenim područjem koţe koje je prekriveno malim izraslinama

koje se spajaju, crvenilo koţe

svrbeţ

gubitak kose

bol u leĎima

zatajenje bubrega, krv u mokraći, promjene u testovima funkcije bubrega

Manje česte: mogu se javiti u do 1 na 100 osoba

simptomi nalik gripi, nadraţenost i upala probavnog trakta, upala probavnog trakta koja

uzrokuje proljev povezan uz antibiotike, upala limfnih ţila

upala tankog tkiva kojim je obloţena unutarnja stjenka trbuha i koja prekriva trbušne organe

povećani limfni čvorovi (ponekad bolni), zatajenje koštane srţi, povećani broj eozinofila

smanjena funkcija nadbubreţne ţlijezde, smanjena aktivnost štitnjače

poremećaj moţdane funkcije, simptomi slični Parkinsonovoj bolesti, ozljeda ţivca s

posljedičnom utrnulošću, boli, trncima ili ţarenjem u šakama ili stopalima

smetnje ravnoteţe ili koordinacije

oticanje mozga

dvoslike, ozbiljna stanja oka uključujući: bol i upalu očiju i vjeĎa, neuobičajeni očni pokreti,

oštećenje očnog ţivca s posljedičnim oštećenjem vida, oticanje optičkog diska

smanjen osjet dodira

poremećen osjet okusa

poteškoće sa sluhom, zvonjenje u ušima, vrtoglavica

upala odreĎenih unutarnjih organa – gušterače i dvanaesnika, oticanje i upala jezika

povećanje jetre, zatajenje jetre, bolest ţučnog mjehura, ţučni kamenci

upala zglobova, upala vena ispod koţe (što moţe biti povezano sa stvaranjem krvnog ugruška)

upala bubrega, proteini u mokraći, oštećenja bubrega

vrlo brz puls ili preskočeni otkucaji srca, katkad s nasumičnim električnim impulsima

poremećaj elektrokardiograma (EKG-a)

povišen kolesterol u krvi, povišena ureja u krvi

alergijske koţne reakcije (ponekad teške), uključujući koţna stanja opasna po ţivot koja

uzrokuju bolne mjehure i rane na koţi i sluzokoţi, posebice u ustima, upalu koţe, koprivnjaču,

opekline od sunca ili tešku koţnu reakciju uslijed izlaganja svjetlosti ili suncu, crvenilo i

nadraţenost koţe, crvenu ili ljubičastu promjenu boje koţe koja moţe biti prouzročena niskim

brojem trombocita, ekcem

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reakcija na mjestu infuzije

alergijska reakcija ili pretjerani imunološki odgovor

Rijetke: mogu se javiti u do 1 na 1000 osoba

prekomjerna aktivnost štitnjače

propadanje moţdane funkcije koje je ozbiljna komplikacija jetrene bolesti

gubitak većine vlakana vidnog ţivca, zamagljenje roţnice, neţeljeni pokreti oka

povećana osjetljivost na svjetlost popraćena mjehurićima

poremećaj u kojem imunosni sustav tijela napada dio perifernog ţivčanog sustava

problemi s ritmom ili provoĎenjem srca (ponekad opasni po ţivot)

alergijska reakcija opasna po ţivot

poremećaj u zgrušavanju krvi

alergijske reakcije koţe (katkad ozbiljne), uključujući brzo oticanje (edem) koţe, potkoţnog

tkiva, sluzokoţe i podsluzokoţe, svrab ili bolni dijelovi debele, crvene koţe sa srebrnastim

koţnim ljuskicama, nadraţenost koţe i sluzokoţe, koţna stanja opasna po ţivot koja uzrokuju

odvajanje velikih površina epidermisa, gornjeg sloja koţe, od donjih dijelova koţe

male suhe ljuskaste mrlje na koţi, katkad debele sa šiljcima ili "rogovima”

Nuspojave s nepoznatom učestalošću:

pjege i pigmentirane mrlje

Druge značajne nuspojave čija učestalost nije poznata, ali se moraju odmah prijaviti Vašem liječniku:

rak koţe

upala tkiva oko kosti

crvene, ljuskaste mrlje ili prstenasta oštećenja na koţi koji mogu biti simptomi autoimune

bolesti zvane koţni eritemski lupus

S obzirom da je poznato da VERRIA utječe na jetru i bubrege, liječnik Vam mora pratiti funkciju jetre i

bubrega putem krvnih pretraga. Obavijestite svog liječnika ako imate bolove u trbuhu ili ako se

promijeni uobičajena konzistencija stolice.

Prijavljen je rak koţe u bolesnika koji su liječeni lijekom VERRIA kroz duţi vremenski period.

Opekline od sunca ili teška koţna reakcija uslijed izlaganja svjetlosti ili suncu nastale su češće u djece.

Ako Vi ili Vaše dijete primijetite promjene na koţi, Vaš liječnik Vas moţe uputiti dermatologu, koji

nakon pregleda moţe ustanoviti da je vaţno da Vi ili Vaše dijete redovito dolazite na kontrolu.

Povišeni jetreni enzimi zabiljeţeni su češće kod djece.

Obavijestite svog liječnika ako bilo koja od navedenih nuspojava potraje ili postane zabrinjavajuća.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.

To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave moţete prijaviti

izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V. Prijavljivanjem

nuspojava moţete pridonijeti u procjeni sigurnosti ovog lijeka.

5. Kako čuvati lijek VERRIA

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. Rok valjanosti

odnosi se na zadnji dan navedenog mjeseca.

H A L M E D

07 - 12 - 2017

O D O B R E N O

Čuvati u originalnom pakiranju radi zaštite od vlage.

Lijek ne zahtijeva čuvanje na odreĎenoj temperaturi.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6. Sadržaj pakiranja i druge informacije

Što VERRIA sadrži

Djelatna tvar je vorikonazol. Svaka tableta sadrţi ili 50 mg vorikonazola (za VERRIA 50 mg

filmom obloţene tablete) ili 200 mg vorikonazola (za VERRIA 200 mg filmom obloţene

tablete).

Pomoćne tvari su laktoza hidrat, prethodno geliran škrob (kukuruzni škrob), umreţena

karmelozanatrij, povidon i magnezijev stearat u jezgri tablete i laktoza hidrat, hipromeloza

(E464), titanijev dioksid (E171) i triacetin u filmu za oblaganje.

Kako VERRIA izgleda i sadržaj pakiranja

VERRIA 50 mg filmom obloţene tablete su dostupne kao bijele do prljavo-bijele, okrugle filmom

obloţene tablete, promjera otprilike 7,2 mm.

VERRIA 200 mg filmom obloţene tablete su dostupne kao bijele do prljavo-bijele, filmom obloţene

tablete u obliku kapsule, veličine otprilike 15,9 x 8,0 mm.

VERRIA 50 mg filmom obloţene tablete i 200 mg filmom obloţene tablete su dostupne u pakiranjima

od 2, 10, 14, 20, 28, 30, 50, 56 i 100 tableta.

Na trţištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač:

Nositelj odobrenja:

Medochemie Ltd

1-10 Constantinoupoleos Street

3011 Limassol

Cipar

ProizvoĎač:

Medochemie Ltd

Factory AZ

2 Michael Erakleous Street

Agios Athanassios Industrial Area

Agios Athanassios

Limassol

4101

Cipar

Predstavnik nositelja odobrenja za Republiku Hrvatsku

Medicuspharma d.o.o.

Rokov perivoj 6/a

10000 Zagreb

Tel: 01/4920231

Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod

sljedećim nazivima:

Nizozemska - Verria 50 mg / 200 mg filmomhulde tabletten

H A L M E D

07 - 12 - 2017

O D O B R E N O

Bugarska - VERRIA 50 mg / 200 mg film coated tablets

Cipar - VERRIA 50 mg / 200 mg επικαλυμμένα με λεπηό υμένιο διζκία

Republika Češka - VERRIA

Estonija - VERRIA

Hrvatska - VERRIA 50 mg filmom obloţene tablete / VERRIA 200 mg filmom obloţene tablete

Litva - VERRIA 50 mg plėvele dengtos tabletės / VERRIA 200 mg plėvele dengtos tabletės

Malta - VERRIA 50 mg / 200 mg film coated tablets

Rumunjska - VERRIA 50 mg comprimate filmate / VERRIA 200 mg comprimate filmate

Slovačka - VERRIA 50 mg filmom obalené tablety / VERRIA 200 mg filmom obalené tablety

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u prosincu 2017.

H A L M E D

07 - 12 - 2017

O D O B R E N O

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Pest categorisation of non‐EU Monochamus spp.

Pest categorisation of non‐EU Monochamus spp.

Published on: Mon, 19 Nov 2018 The Panel on Plant Health performed a pest categorisation of non‐EU Monochamus spp., a well‐defined insect genus in the family Cerambycidae (Insecta: Coleoptera). Species can be identified using taxonomic keys at national and regional level, and DNA barcoding. Two online world catalogues exist for the genus. The genus includes about one hundred species and many subspecies colonising conifers and non‐conifer trees in many areas in the world. The non‐EU species are listed in...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen 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 validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

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

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

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

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

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

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

Health Canada

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

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

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

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

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

Health Canada

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

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

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

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

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

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

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

Health Canada

27-9-2018

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

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

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

18-9-2018

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

The hair dryer and power cord can overheat and catch on fire, posing fire, burn and electrical shock hazards.

Health Canada

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

Published on: Wed, 12 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 fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

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

Health Canada

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency