Loquen XR 200 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Loquen XR 200 mg filmom obložene tablete s produljenim oslobađanjem
  • Doziranje:
  • 200 mg
  • Farmaceutski oblik:
  • filmom obložena tableta s produljenim oslobađanjem
  • Sastav:
  • Urbroj: svaka tableta sadrži 200 mg kvetiapina u obliku kvetiapinfumarata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Teva Pharma S.L.U., Zaragoza, Španjolska; Teva UK Ltd., East Sussex, Ujedinjeno Kraljevstvo; Teva Czech Industries s.r.o., Opa

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Loquen XR 200 mg filmom obložene tablete s produljenim oslobađanjem
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-324298177-01]; 20 tableta u blisteru, u kutiji [HR-H-324298177-02]; 30 tableta u blisteru, u kutiji [HR-H-324298177-03]; 50 tableta u blisteru, u kutiji [HR-H-324298177-04]; 50 tableta u perforiranom blisteru (bolničko pakiranje), u kutiji [HR-H-324298177-05]; 56 tableta u blisteru (kalendarsko pakiranje), u kutiji [HR-H-324298177-06]; 60 tableta u blisteru, u kutiji [HR-H-324298177-07]; 90 tableta u blisteru, u kutiji [HR-H-324298177-08]; 100 tableta u blisteru, u kutiji [HR-H-324298177-09]; 60 tableta u bočici, u kutiji [HR-H-324298177-10] Urbroj: 381-12-01/70-17-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-324298177
  • Datum autorizacije:
  • 27-03-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za korisnika

Loquen XR 50 mg filmom obloţene tablete s produljenim oslobaĎanjem

Loquen XR 150 mg filmom obloţene tablete s produljenim oslobaĎanjem

Loquen XR 200 mg filmom obloţene tablete s produljenim oslobaĎanjem

Loquen XR 300 mg filmom obloţene tablete s produljenim oslobaĎanjem

Loquen XR 400 mg filmom obloţene tablete s produljenim oslobaĎanjem

kvetiapin

Paţljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrţi Vama vaţne

podatke.

Sačuvajte ovu uputu. Moţda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite liječniku ili ljekarniku.

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 ili ljekarnika. To

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

Što se nalazi u ovoj uputi:

Što je Loquen XR i za što se koristi

Što morate znati prije nego počnete uzimati Loquen XR

Kako uzimati Loquen XR

Moguće nuspojave

Kako čuvati Loquen XR

Sadrţaj pakiranja i druge informacije

1.

Što je Loquen XR i za što se koristi

Loquen XR sadrţi djelatnu tvar kvetiapin. Ista pripada skupini lijekova koji se zovu antipsihotici.

Loquen XR se moţe koristiti u liječenju različitih bolesti kao što su:

Bipolarna depresija i velike depresivne epizode u velikom depresivnom poremećaju: stanje u

kojem ste tuţni. Isto tako, moţete se osjećati potišteno, imati osjećaj krivnje, nedostatak

energije, gubitak teka ili nesanicu.

Manija: stanje u kojem se moţete osjećati vrlo uzbuĎeno, ushićeno, uznemireno,

entuzijastično ili hiperaktivno; ili moţete biti u stanju poremećene prosudbe koje uključuje

agresivno ili razorno ponašanje.

Shizofrenija: stanje u kojem moţete čuti ili osjećati nešto što ne postoji, vjerovati u nešto što

nije istinito ili osjećati neobičnu sumnjičavost, tjeskobu, smetenost, krivnju, napetost ili

potištenost.

Kada se Loquen XR koristi za liječenje velikih depresivnih epizoda u velikom depresivnom

poremećaju, on se uzima kao dodatna terapija uz drugi lijek za liječenje ove bolesti.

Liječnik Vam moţe nastaviti davati Loquen XR, čak i kada se osjećate bolje.

2.

Što morate znati prije nego počnete uzimati Loquen XR

Nemojte uzimati Loquen XR:

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

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ako uzimate bilo koji od niţe navedenih lijekova:

neke lijekove kojima se liječi HIV

lijekove iz skupine azola (za suzbijanje gljivičnih infekcija)

eritromicin ili klaritromicin (za suzbijanje infekcija)

nefazodon (za liječenje depresije).

Nemojte uzimati Loquen XR ako se bilo što od gore navedenog odnosi na Vas. Imate li bilo kakvih

dvojbi, prije uzimanja Loquen XR obratite se svom liječniku ili ljekarniku.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Loquen XR:

ako Vi ili netko od članova Vaše obitelji, ima ili je imao bilo kakve srčane tegobe, primjerice

poremećaje srčanog ritma, slabljenje srčanog mišića ili upalu srca, ili ako uzimate bilo kakve

lijekove koji mogu utjecati na rad srca.

ako imate niski krvni tlak

ako ste preboljeli moţdani udar, posebice ukoliko ste u starijoj ţivotnoj dobi.

ako imate jetrenih tegoba.

ako ste ikada imali napadaje.

ako bolujete od šećerne bolesti ili postoji rizik da od nje obolite. U tom slučaju, tijekom

liječenja Loquenom XR liječnik Vam moţe provjeravati razinu šećera u krvi.

ako ste u prošlosti imali niske razine bijelih krvnih stanica (koje su mogle ili nisu morale biti

uzrokovane uzimanjem drugih lijekova).

ako ste u starijoj ţivotnoj dobi i bolujete od demencije (smanjenje moţdane funkcije). U tom

slučaju ne smijete uzimati Loquen XR. Razlog je taj što lijekovi iz skupine u koju spada i

Loquen XR mogu povećati rizik od moţdanog udara, a u nekim slučajevima i rizik od smrti u

starijih osoba s demencijom.

ako Vi ili netko od članova Vaše obitelji u povijesti bolesti ima krvne ugruške, obzirom da su

lijekovi poput ovog povezani s nastajanjem krvnih ugrušaka.

ako imate ili ste imali stanje kada ste prestali disati na kraće periode tijekom Vašeg

normalnog noćnog sna (tzv. „apneja u snu“) i uzimate lijekove koji usporavaju normalnu

aktivnost mozga („depresori“).

ako imate ili ste imali stanje kada ne moţete u potpunosti isprazniti svoj mjehur (zadrţavanje

urina), imate uvećanu prostatu, začepljenje crijeva ili povišen očni tlak. Ova stanja su

ponekad uzrokovana lijekovima (tzv. „antikolinergicima“) koji utječu na način funkcioniranja

ţivčanih stanica kako bi se liječila odreĎena medicinska stanja

Odmah recite svome liječniku ako osjetite nešto od sljedećeg nakon uzimanja Loquen XR:

kombinaciju visoke tjelesne temperature (vrućice), teške ukočenosti mišića, znojenja ili

smanjene razine svijesti (poremećaj koji se zove "neuroleptički maligni sindrom"). Moţe biti

potrebno hitno liječenje.

nekontrolirane kretnje, posebice Vašeg lica ili jezika.

omaglicu ili jaki osjećaj pospanosti. Ovo moţe povećati rizik ozljeda uslijed nezgode (pada)

kod starijih bolesnika.

napadaje.

dugotrajnu i bolnu erekciju (prijapizam).

Navedena stanja mogu biti uzrokovana ovom skupinom lijekova.

Što prije obavijestite svog liječnika ako imate:

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vrućicu, simptome nalik gripi, grlobolju ili bilo koju drugu infekciju jer to moţe biti

posljedica vrlo niskog broja bijelih krvnih stanica, zbog čega ćete moţda morati prestati

uzimati Loquen XR i/ili primiti liječenje.

zatvor praćen boli u trbuhu koja ne prolazi, ili zatvor koji ne odgovara na liječenje jer to moţe

dovesti do ozbiljnije blokade crijeva.

Misli o samoubojstvu i pogoršanje Vaše depresije

Ako patite od depresije, ponekad Vam se mogu javiti misli o samoozljeĎivanju ili samoubojstvu. Do

pojave takvih misli moţe češće doći na početku liječenja, s obzirom da ovoj skupini lijekova treba

odreĎeno vrijeme, obično oko dva tjedna, ali ponekad i dulje, da počnu djelovati. Ove misli mogu biti

češće i pri naglom prestanku uzimanja lijeka. TakoĎer, vjerojatnije je da ćete tako misliti ako ste

mlaĎa odrasla osoba. Podaci iz kliničkih ispitivanja su pokazali povećani rizik od pojave misli o

samoubojstvu i/ili suicidalnog ponašanja u odraslih osoba mlaĎih od 25 godina, koje boluju od

depresije.

Ako Vam se u bilo kojem trenutku jave misli o samoozljeĎivanju ili samoubojstvu, odmah se javite

svom liječniku ili otiĎite u najbliţu bolnicu. Moţda će Vam biti od pomoći ako kaţete roĎaku ili

bliskom prijatelju da ste depresivni te ih zamolite da pročitaju ovu uputu. TakoĎer, moţete ih i

zamoliti da Vam kaţu da li misle da se Vaša depresija pogoršava te da li su zabrinuti zbog promjena u

Vašem ponašanju.

Povećanje tjelesne teţine

Primijećeno je povećanje tjelesne teţine kod bolesnika koji uzimaju LoquenXR. Vi i Vaš liječnik

trebate redovito provjeravati Vašu tjelesnu teţinu.

Djeca i adolescenti

Loquen XR nije namijenjen za primjenu u djece i adolescenata mlaĎih od 18 godina.

Drugi lijekovi i Loquen XR

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

druge lijekove.

Nemojte uzimati Loquen XR ukoliko uzimate bilo koji od sljedećih lijekova:

neke lijekove za liječenje HIV-a.

lijekove iz skupine azola (za suzbijanje gljivičnih infekcija),

eritromicin ili klaritromicin (za suzbijanje infekcija),

nefazodon (za liječenje depresije).

Obavijestite svog liječnika ako uzimate bilo koji od navedenih lijekova:

lijekove za epilepsiju (kao što su fenitoin ili karbamazepin).

lijekove za liječenje povišenog krvnog tlaka.

barbiturate (zbog poteškoća sa spavanjem).

tioridazin ili litij (takoĎer antipsihotici).

lijekove koji utječu na rad srca, npr. lijekovi koji mogu uzrokovati neravnoteţu elektrolita

(niske razine kalija ili magnezija) kao što su diuretici (lijekovi za izmokravanje) te odreĎeni

antibiotici (lijekovi za liječenje infekcija).

lijekove koji mogu uzrokovati zatvor (konstipaciju).

lijekove (tzv. „antikolinergike“) koji utječu na način funkcioniranja ţivčanih stanica kako bi

se liječila odreĎena medicinska stanja.

Prije nego što prestanete uzimati bilo koji od lijekova koje inače uzimate, prvo razgovarajte sa svojim

liječnikom.

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Loquen XR s hranom, pićem i alkoholom

Hrana moţe utjecati na djelotvornost Loquen XR, te stoga ovaj lijek morate uzimati najmanje

jedan sat prije obroka ili prije spavanja.

Budite oprezni s količinom alkohola koju konzumirate. Razlog tome je što Vas kombinirani

učinak Loquen XR i alkohola moţe učiniti pospanima.

Tijekom liječenja Loquen XR nemojte piti sok od grejpa, jer isti moţe utjecati na način

djelovanja lijeka.

Trudnoća i dojenje

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

liječniku za savjet prije nego uzmete ovaj lijek. Ne smijete uzimati Loquen XR tijekom trudnoće

ukoliko to prethodno nije raspravljeno s Vašim liječnikom. Loquen XR se ne smije uzimati ukoliko

dojite.

Sljedeći simptomi, koji mogu biti znakovi ustezanja (prekida primjene lijeka), mogu se pojaviti kod

novoroĎenčadi majki koje su koristile Loquen XR u zadnjem trimestru (zadnja tri mjeseca trudnoće):

tresavica, ukočenost i/ili slabost mišića, pospanost, uznemirenost, problemi s disanjem i hranjenjem.

Ukoliko Vaše dijete ima bilo koji od ovih simptoma, morate se javiti liječniku.

Upravljanje vozilima i strojevima

Vaše tablete mogu Vas učiniti pospanima. Nemojte voziti i nemojte koristiti alate ili strojeve sve dok

ne utvrdite kako ove tablete utječu na Vas.

Učinak na probirne testove na lijekove u urinu

Ukoliko ste podvrgnuti probirnim testovima na lijekove u urinu, uzimanje Loquen XR moţe

uzrokovati pozitivne rezultate na metadon ili odreĎene lijekove protiv depresije koji se zovu triciklički

antidepresivi kada se koriste odreĎenje metode testiranja, iako Vi moţda ne uzimate metadon ili

tricikličke antidepresive. Ukoliko se ovo dogodi, moţe se koristiti test koji je više specifičan.

3.

Kako uzimati Loquen XR

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik. Provjerite s liječnikom ili

ljekarnikom ako niste sigurni.

O početnoj dozi lijeka odlučit će Vaš liječnik. Doza odrţavanja (dnevna doza) će ovisiti o Vašoj

bolesti i potrebama, no obično će se kretati izmeĎu 150 mg i 800 mg.

Svoje tablete uzimat ćete jednom dnevno.

Tablete nemojte lomiti, ţvakati niti mrviti.

Tablete progutajte cijele, s nešto vode.

Tablete uzimajte bez hrane (najmanje jedan sat prije obroka ili prije spavanja). Liječnik

će Vas uputiti o tome u koje vrijeme ćete uzimati tablete.

Tijekom liječenja Loquen XR nemojte piti sok od grejpa. Isti moţe utjecati na

djelovanje lijeka u organizmu.

Čak i ako se osjećate bolje, tablete nemojte prestati uzimati sve dok Vam to ne

preporuči liječnik.

Jetrene tegobe

Ukoliko imate jetrenih tegoba liječnik Vam moţe promijeniti dozu lijeka.

Stariji bolesnici

Ukoliko ste u starijoj ţivotnoj dobi liječnik Vam moţe promijeniti dozu lijeka.

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Primjena u djece i adolescenata

Loquen XR ne smiju koristiti djeca i adolescenti mlaĎi od 18 godina.

Ako uzmete više Loquen XR nego što ste trebali

Uzmete li više Loquen XR negoli Vam je propisao liječnik, moţete osjetiti pospanost, omaglicu i

nepravilne otkucaje srca. Odmah se obratite svome liječniku ili u najbliţu bolnicu. Tablete Loquen

XR ponesite sa sobom.

Ako ste zaboravili uzeti Loquen XR

Zaboravite li uzeti dozu lijeka, uzmite je čim se sjetite. Ukoliko se bliţi vrijeme uobičajenog uzimanja

slijedeće doze, pričekajte do tada. Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu

tabletu.

Ako prestanete uzimati Loquen XR

Prestanete li naglo uzimati Loquen XR, moţete patiti od nesanice, osjetiti mučninu, moţe se pojaviti

glavobolja, proljev, povraćanje te moţete imati omaglicu ili biti razdraţljivi. Liječnik Vam moţe

savjetovati da postupno smanjujete dozu lijeka, sve do potpunog prestanka njegova uzimanja.

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.

Ako primijetite bilo koju od sljedećih ozbiljnih nuspojava, prestanite uzimati Loquen XR i

odmah otiĎite Vašem liječniku ili u najbliţu bolnicu:

Često (mogu se javiti u do 1 na 10 osoba):

Razmišljanje o samoubojstvu i pogoršanje Vaše depresije.

Manje često (mogu se javiti u do 1 na 100 osoba):

Iznenadna vrućica pogotovo sa grloboljom i drugim simptomima nalik gripi. To mogu biti

znakovi abnormalno niske koncentracije bijelih krvnih stanica.

- Znakovi koţnih reakcija kao što su osip, koprivnjača, uzdignuća na koţi, crvenilo, svrbeţ,

moguće uz oticanje lica, očnih kapaka i usana. To moţe dodatno uzrokovati oteţano disanje,

omaglicu i šok.

Napadaji.

Nekontrolirani pokreti, uglavnom Vašeg lica ili jezika (tardivna diskinezija).

Osjećaj da Vaše srce jako lupa uz omaglicu ili nesvjesticu. To moţe biti znak ozbiljnih

problema s radom srca i kod teških slučajeva moţe biti smrtonosno.

Rijetko (mogu se javiti u do 1 na 1000 osoba):

Teška bol i/ili oticanje i crvenilo u jednoj od Vaših nogu; iznenadna jaka bol u prsima koja

se moţe proširiti do lijeve ruke ili iznenadni nedostatak zraka. To mogu biti znakovi

krvnih ugrušaka u venama.

Jaka bol u gornjem dijelu trbuha, koja se često osjeća i kao bol u leĎima, ponekad uz

mučninu i povraćanje. To moţe biti znak upale gušterače.

- Zatvor uz trajnu bol u trbuhu ili zatvor koji se ne smanjuje liječenjem, jer to moţe dovesti

do ozbiljnijeg začepljenja crijeva.

Ţuta boja koţe i očiju (ţutica), urin tamne boje, posebice zajedno s neuobičajenim umorom ili

vrućicom (znakovi hepatitisa).

Dugotrajna i bolna erekcija.

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Kombinacija vrućice, znojenja, krutih mišića, osjećaja omamljenosti ili nesvjestice

(poremećaj zvan"neuroleptički maligni sindrom").

Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba):

Teške koţne reakcije s osipom ili mjehurićima, nepravilne crvene mrlje ili pjege i/ili ljuštenje

koţe, moţda oko usta, očiju ili genitalija i često zajedno s iznenadnom vrućicom ili gripi

sličnim simptomima. Ove reakcije mogu se brzo razviti.

Neobjašnjiva bol u mišićima, osjetljivost na dodir ili slabost. To mogu biti rani znakovi

potencijalno teške degradacije mišića.

Ostale moguće nuspojave

Vrlo često (mogu se javiti u više od 1 na 10 osoba):

Omaglica (moţe dovesti do padova), glavobolja, suhoća usta.

Pospanost (koja s daljnjim uzimanjem Loquen XR moţe nestati) (moţe dovesti do padova).

Simptomi ustezanja (simptomi koji se pojavljuju kada prestanete uzimati Loquen XR). Ovi

simptomi uključuju: nemogućnost spavanja (nesanicu), mučninu, glavobolju, proljev,

povraćanje, omaglicu i razdraţljivost. Preporuča se postupno prekidanje uzimanja lijeka u

periodu od najmanje 1 do 2 tjedna.

Debljanje.

Abnormalni pokreti mišića. Oni uključuju oteţano pokretanje mišića, tresavicu, osjećaj

nemira ili ukočenost mišića bez boli.

Smanjena razina hemoglobina (proteina u crvenim krvnim stanicama koji nosi kisik)

Promjene u količini odreĎenih masnoća (triglicerida i ukupnog kolesterola).

Često (mogu se javiti u do 1 na 10 osoba):

Ubrzani otkucaji srca.

Osjećaj da Vaše srce lupa, vrlo brzo radi ili preskače otkucaje.

Zatvor, nadraţen ţeludac (probavne tegobe).

Osjećaj slabosti.

Oticanje ruku ili nogu.

Nizak krvni tlak pri ustajanju. Ovo moţe biti razlogom da osjećate omaglicu ili nesvjesticu

(moţe dovesti do padova).

Povišenje razine šećera u krvi.

Zamagljen vid.

Abnormalni snovi i noćne more.

Povećan osjećaj gladi.

Osjećaj razdraţljivosti.

Poremećaji u govoru i jeziku.

Nedostatak zraka.

Povraćanje (uglavnom kod starijih osoba).

Vrućica.

Promjene u količini hormona štitnjače u krvi.

Promjene broja odreĎenih vrsta krvnih stanica.

Povećanja količine jetrenih enzima u krvi.

Povećanja količine hormona prolaktina u krvi. Povećane količine hormona prolaktina mogu u

rijetkim slučajevima uzrokovati sljedeće:

oticanje dojki i neočekivano izlučivanje mlijeka iz dojki u muškaraca i ţena.

izostanak mjesečnica ili neredovite mjesečnice u ţena.

H A L M E D

15 - 01 - 2018

O D O B R E N O

Manje često (mogu se javiti u do 1 na 100 osoba):

Neugodan osjećaj u nogama (nazvan još i sindromom nemirnih nogu).

Poteškoće s gutanjem.

Spolna disfunkcija.

Šećerna bolest.

Sporiji puls (srčana frekvencija) nego obično, što se moţe javiti na početku liječenja i moţe

biti povezano s niskim krvnim tlakom i nesvjesticom.

Oteţano mokrenje.

Nesvjestica (moţe dovesti do padova).

Začepljen nos.

Smanjenje količine natrija u krvi.

Pogoršanje postojeće šećerne bolesti

Rijetko (mogu se javiti u do 1 na 1000 osoba):

Oticanje dojki i neočekivano izlučivanje mlijeka iz dojki (galaktoreja).

Menstrualni poremećaj.

Hodanje, govor, jedenje ili druge aktivnosti za vrijeme trajanja Vašeg sna.

Sniţena temperatura tijela (hipotermija).

Stanje koje se naziva „metaboličkim sindromom“, kod kojega moţete imati kombinaciju 3 ili

više od sljedećih faktora: povećanje masnog tkiva oko trbuha, smanjenje razine „dobrog“

(HDL) kolesterola, povišenje razine jedne vrste masnoća u krvi (triglicerida), visok krvni tlak

i povišenje razine šećera u krvi.

Povećana razina kreatin fosfokinaze u krvi (tvari iz mišića)..

Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba):

Neodgovarajuće izlučivanje hormona koji kontrolira volumen urina.

Nepoznato (učestalost se ne moţe procijeniti iz dostupnih podataka)

Simptomi ustezanja (prekida primjene lijeka) mogu nastupiti u novoroĎenčadi čije su majke

uzimale Loquen XR tijekom trudnoće.

Neke nuspojave mogu se uočiti samo ukoliko se učine krvne pretrage. Ovo uključuje promjene u

vrijednostima odreĎenih masnoća (triglicerida i ukupnog kolesterola) ili šećera u krvi, promjene

količine hormona štitnjače u Vašoj krvi, povišene jetrene enzime, smanjenje broja odreĎenih vrsta

krvnih stanica, smanjenje količine crvenih krvnih stanica, povišenje kreatin fosfokinaze (tvar iz

mišića) u krvi, smanjenje količine natrija u krvi i porast količine hormona prolaktina u krvi. U rijetkim

slučajevima porast hormona prolaktina moţe dovesti do slijedećeg:

Oticanje dojki i neočekivano izlučivanje mlijeka iz dojki kod muškaraca i ţena.

Izostanka mjesečnice ili neredovite mjesečnice kod ţena.

Vaš liječnik moţe zatraţiti da se povremeno podvrgnete pretragama krvi.

Dodatne nuspojave u djece i adolescenata

Iste nuspojave koje se mogu pojaviti u odraslih mogu se takoĎer pojaviti u djece i adolescenata.

Sljedeće nuspojave su uočene češće u djece i adolescenata, ili nisu bile uočene kod odraslih:

Vrlo često (mogu se javiti u više od 1 na 10 osoba):

Porast razine hormona prolaktina u krvi. U rijetkim slučajevima porast razine hormona

prolaktina moţe dovesti do slijedećeg:

Oticanje dojki i neočekivano izlučivanje mlijeka iz dojki kod dječaka i djevojčica.

Izostanka mjesečnice ili neredovite mjesečnice kod djevojčica.

H A L M E D

15 - 01 - 2018

O D O B R E N O

Povećani apetit.

Povraćanje

Abnormalni pokreti mišića. Oni uključuju oteţano pokretanje mišića, tresavicu, osjećaj

nemira ili ukočenost mišića bez boli.

Povećanje krvnog tlaka

Često (mogu se javiti u do 1 na 10 osoba):

Osjećaj slabosti, nesvjestica (moţe dovesti do padova).

Začepljen nos.

Razdraţljivost.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. 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 Loquen XR

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i blisteru iza

oznake “EXP“. Rok valjanosti odnosi se na zadnji dan navedenoga mjeseca.

Loquen XR ne zahtijeva posebne uvjete čuvanja.

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.

Sadrţaj pakiranja i druge informacije

Što Loquen XR sadrţi

Djelatna tvar je kvetiapin. Loquen XR tablete sadrţe 50 mg, 150 mg, 200 mg, 300 mg ili 400

mg kvetiapina (u obliku kvetiapinfumarata).

Drugi sastojci su:

Jezgra: hipromeloza, mikrokristalična celuloza, natrijev citrate, bezvodni, magnezijev stearat.

Ovojnica: titanijev dioksid (E171), hipromeloza, makrogol /PEG 400, polisorbat 80. Tablete od 50

mg, 200 mg i 300 mg sadrţe ţuti ţeljezov oksid (E172) i crveni ţeljezov oksid (E172). Tablete od 50

mg i 300 mg takoĎer sadrţe crni ţeljezov oksid (E172).

Kako Loquen XR izgleda i sadrţaj pakiranja

Loquen XR 50 mg tablete s produljenim oslobaĎanjem

SmeĎe, bikonveksne, duguljaste filmom obloţene tablete s utisnutim “Q50” na jednoj strani

Loquen XR 150 mg tablete s produljenim oslobaĎanjem

Bijele, bikonveksne, duguljaste filmom obloţene tablete s utisnutim “Q150” na jednoj strani

Loquen XR 200 mg tablete s produljenim oslobaĎanjem

Ţute, bikonveksne, duguljaste filmom obloţene tablete s utisnutim “Q200” na jednoj strani

Loquen XR 300 mg tablete s produljenim oslobaĎanjem

H A L M E D

15 - 01 - 2018

O D O B R E N O

Svijetlo ţute, bikonveksne, duguljaste filmom obloţene tablete s utisnutim “Q300” na jednoj strani

Loquen XR 400 mg tablete s produljenim oslobaĎanjem

Bijele, bikonveksne, duguljaste filmom obloţene tablete s utisnutim “Q400” na jednoj strani

Za sve jačine registrirana su pakiranja od 10, 20, 30, 50, 50x1 (perforirani blister djeljiv na jedinične

doze) (bolničko pakiranje), 56 (kalendarsko pakiranje), 60, 90 i 100 tableta. Na trţištu se ne moraju

nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja za stavljanje lijeka u promet:

PLIVA HRVATSKA d.o.o.

Prilaz baruna Filipovića 25

10 000 Zagreb

ProizvoĎači:

Teva Gyogyszergyar Zrt.

Pallagi út 13, 4042 Debrecen

MaĎarska

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG

Ujedinjeno Kraljevstvo

Pharmachemie B. V.

Swensweg 5, Haarlem, 2031 GA

Nizozemska

TEVA Czech Industries s.r.o.

Ostravska 29 c.p. 305, 7477 0 Opava-Komárov

Republika Češka

TEVA Operations Poland Sp. z.o.o.

ul. Mogilska 80, 31-546 Krakow

Poljska

TEVA Pharma S.L.U.

C/C, no.4, Poligono Industrial Malpica, 50016 Zaragoza

Španjolska

Merckle GmbH

Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Baden-Wuerttemberg

Njemačka

Samo za Loquen XR 50 mg, 200 mg, 300 mg, 400 mg:

Adamed Sp. z o.o.

Pieńków 149, 05-152, Czosnów

Poljska

H A L M E D

15 - 01 - 2018

O D O B R E N O

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

sljedećim nazivima:

Austrija

Quetiapin ratiopharm 50 mg Retardtabletten

Quetiapin ratiopharm 150 mg Retardtabletten

Quetiapin ratiopharm 200 mg Retardtabletten

Quetiapin ratiopharm 300 mg Retardtabletten

Quetiapin ratiopharm 400 mg Retardtabletten

Belgija

Quetiapine Teva 50/150/200/300/400 mg Tabletten met verlengde afgifte

Bugarska

EN: TEVAQUEL XR / BG: ТЕВАКВЕЛ XР

Češka

Quetiapine Teva 50 mg Retard

Quetiapine Teva 200 mg Retard

Quetiapine Teva 300 mg Retard

Quetiapine Teva 400 mg Retard

Njemačka

Quetiapin-ratiopharm 50/150/200/300/400 mg Retardtabletten

Danska

Quetiapine Teva

Estonija

Quetiapine Teva

Grčka

QUETIAPINE/TEVA XR

Španjolska

Quetiapina Teva 50 mg comprimidos de liberación prolongada EFG

Quetiapina Teva 150 mg comprimidos de liberación prolongada EFG

Quetiapina Teva 200 mg comprimidos de liberación prolongada EFG

Quetiapina Teva 300 mg comprimidos de liberación prolongada EFG

Finska

Quetiapin ratiopharm 50 mg depottabletti

Quetiapin ratiopharm 200 mg depottabletti

Quetiapin ratiopharm 300 mg depottabletti

Quetiapin ratiopharm 400 mg depottabletti

Francuska

Quetiapine Teva LP 50 mg, comprimé à libération prolongée

Quetiapine Teva LP 300 mg, comprimé à libération prolongée

Quetiapine Teva LP 400 mg, comprimé à libération prolongée

MaĎarska

Quetiapine-Teva 50/150/200/300/400 mg retard tabletta

Hrvatska

Loquen XR 50mg, 150mg, 200mg, 300mg, 400mg filmom obloţene tablete s

produljenim oslobaĎanjem

Irska

Tevaquel XL

Island

Quetiapin ratiopharm 50 mg/200mg/300 mg/400mg forðatöflur

Italija

Quetiapina Teva Italia

Luksemburg

Quetiapin-ratiopharm 50, 200, 300, 400 mg Retardtabletten

Nizozemska

Quetiapine Retard 50/150/200/300/400 mg Teva

Poljska

Kwetaplex XR

Portugal

Quetiapina Teva

Rumunjska

Quetiapină Teva 50/150/200/300/400 mg comprimate cu eliberare prelungită

Švedska

Quetiapine Teva 50 mg, 150 mg, 200 mg, 300 mg,400 mg depottablett

Slovenija

Loquen SR 50 mg/ 150 mg/ 200 mg/ 300 mg/ 400 mg tablete s podaljšanim

sproščanjem

Slovačka

Quetiapin Teva 50/200/300 mg

Ujedinjeno Kraljevstvo SONDATE XL

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u siječnju 2018.

H A L M E D

15 - 01 - 2018

O D O B R E N O

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

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 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 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 milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 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 napropamide. To assess the occurrence of napropamide 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 (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 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 fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 Aug 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 sintofen. To assess the occurrence of sintofen 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 ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 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 prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 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 levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 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 napropamide. To assess the occurrence of napropamide 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 (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 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 myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

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