Volqer 400 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Volqer 400 mg tablete s produljenim oslobađanjem
  • Doziranje:
  • 400 mg
  • Farmaceutski oblik:
  • tableta s produljenim oslobađanjem
  • Sastav:
  • Urbroj: jedna tableta s produljenim oslobađanjem sadrži 400 mg kvetiapina (u obliku kvetiapinfumarata)
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Salutas Pharma GmbH, Barleben, Njemačka; Pharmathen International S.A., Rodopi, Grčka; Pharmathen S.A., Pallini Attikis, Atena

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Volqer 400 mg tablete s produljenim oslobađanjem
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-847509442-01]; 30 tableta u blisteru, u kutiji [HR-H-847509442-02]; 50 tableta u blisteru, u kutiji [HR-H-847509442-03]; 56 tableta u blisteru, u kutiji [HR-H-847509442-04]; 60 tableta u blisteru, u kutiji [HR-H-847509442-05]; 100 tableta u blisteru, u kutiji [HR-H-847509442-06]; 60 tableta u bočici, u kutiji [HR-H-847509442-07]; 120 tableta u bočici, u kutiji [HR-H-847509442-08] Urbroj: 381-12-01/70-15-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-847509442
  • Datum autorizacije:
  • 30-10-2015
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku: sastav, indikacije, doziranje, nuspojave, interakcija, trudnoća, dojenje

Uputa o lijeku: Informacije za korisnika

Volqer 50 mg tablete s produljenim oslobaĎanjem

Volqer 200 mg tablete s produljenim oslobaĎanjem

Volqer 300 mg tablete s produljenim oslobaĎanjem

Volqer 400 mg tablete s produljenim oslobaĎanjem

kvetiapin

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

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im štetiti, 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:

1. Što je Volqer i za što se koristi

2. Što morate znati prije nego počnete uzimati Volqer

3. Kako uzimati Volqer

4. Moguće nuspojave

5. Kako čuvati Volqer

6. Sadržaj pakiranja i druge informacije

1.

Što je Volqer i za što se koristi

Volqer sadrži djelatnu tvar kvetiapin. Ona pripada skupini lijekova koju nazivamo antipsihotici.

Volqer se može koristiti za liječenje različitih bolesti, kao što su:

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

kojem stalno možete osjećati tugu ili se možete osjećati potišteno, imati osjećaj krivnje,

nedostatak energije, gubitak apetita ili nesanicu.

manija: stanje u kojem se možete osjećati uzbuđeno, ushićeno, uznemireno, entuzijastično ili

hiperaktivno; ili možete imati poremećaj prosuđivanja što uključuje agresivno ili razorno

ponašanje.

shizofrenija: stanje u kojem možete 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 Volqer

koristi za liječenje velikih depresivnih epizoda u velikom depresivnom poremećaju,

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

Liječnik može nastaviti s propisivanjem Volqera čak i kada se osjećate bolje.

2.

Što morate znati prije nego počnete uzimati Volqer

Nemojte uzimati Volqer

ako ste alergični na kvetiapin ili bilo koji drugi sastojak ovog lijeka (navedeno u dijelu 6)

ako uzimate bilo koji od sljedećih lijekova:

neke lijekove za liječenje HIV infekcija

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lijekove iz skupine azola (za liječenje gljivičnih infekcija)

eritromicin ili klaritromicin (lijekovi za liječenje bakterijskih infekcija)

nefazodon (lijek za liječenje depresije).

Ako se bilo što od gore navedenog odnosi na Vas, nemojte uzimati Volqer. Ako niste sigurni, prije

uzimanja Volqera posavjetujte se sa svojim liječnikom ili ljekarnikom.

Upozorenja i mjere opreza

Prije uzimanja Volqera, obavijestite svog liječnika ako:

Vi, ili netko iz Vaše obitelji, ima ili je imao bilo kakve poteškoće sa srcem, na primjer

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

lijekove koji mogu utjecati na rad Vašeg srca.

imate nizak krvni tlak.

ste imali moždani udar, osobito ako ste starije životne dobi.

imate poteškoće s jetrom.

ste ikada imali napadaj (konvulzije).

imate šećernu bolest ili rizik da od nje obolite. Ako je tako, liječnik Vam može provjeravati

razinu šećera u krvi za vrijeme uzimanja Volqera.

Vam je poznato da ste u prošlosti imali sniženi broj bijelih krvnih stanica (što je moglo ili nije

moralo biti uzrokovano uzimanjem drugih lijekova).

ste starije životne dobi i imate demenciju (poremećaj funkcije mozga). U tom slučaju ne biste

trebali uzimati Volqer jer skupina lijekova kojoj pripada Volqer može povećati rizik od

moždanog udara, ili u nekim slučajevima rizik od smrtnog ishoda, u osoba starije životne dobi s

demencijom.

Vi, ili netko iz Vaše obitelji u povijesti bolesti ima podatak o pojavi krvnih ugrušaka, jer su

lijekovi poput ovog povezani sa stvaranjem 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 možete u potpunosti isprazniti svoj mjehur (zadržavanje

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

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

stanica kako bi se liječila određena medicinska stanja.

ako imate ili ste imali problema s alkoholom ili zlouporabom droga.

Odmah obavijestite svog liječnika ako nakon uzimanja Volqera primijetite bilo što od

navedenog:

kombinaciju vrućice, jake ukočenosti mišića, znojenja ili smanjenja stupnja svijesti (poremećaj

pod nazivom „neuroleptički maligni sindrom”). Možda će biti potrebno hitno medicinsko

liječenje.

nekontrolirane pokrete, uglavnom lica ili jezika.

omaglicu ili jaki osjećaj pospanosti. To može povećati rizik od ozljeda zbog nezgode (pad) u

starijih bolesnika.

napadaje (konvulzije).

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 može biti posljedica

vrlo niskog broja bijelih krvnih stanica, zbog čega ćete možda morati prestati uzimati Volqer i/ili

primiti liječenje.

zatvor praćen bolovima u trbuhu koji ne prolaze, ili zatvor koji ne odgovara na liječenje jer to

može dovesti do ozbiljnije blokade crijeva.

Misli o samoubojstvu i pogoršanje Vaše depresije

Ako ste depresivni, ponekad Vam se mogu pojaviti misli o samoozljeđivanju ili samoubojstvu. Do

toga češće može doći na početku liječenja, jer ovoj skupini lijekova treba određeno vrijeme da počnu

djelovati, obično oko dva tjedna, ali ponekad i dulje.

Ove misli mogu biti češće i pri naglom prestanku uzimanja lijeka. Također, mogu biti češće i kod

mlađih odraslih osoba. Informacije iz kliničkih ispitivanja pokazuju da se povećani rizik od pojave

misli o samoubojstvu i/ili suicidalnog ponašanja javlja u mlađih odraslih osoba u dobi ispod 25

godina, koje boluju od depresije.

Ako Vam se u bilo koje vrijeme pojave misli o samoozljeđivanju ili samoubojstvu, odmah se javite

svom liječniku ili otiđite u najbližu bolnicu. Možda će Vam biti od pomoći ako kažete rođaku ili

bliskom prijatelju da ste depresivni te ih zamolite da pročitaju ovu uputu. Također, možete ih zamoliti

da Vam kažu ako misle da se Vaša depresija pogoršava, ili ako su zabrinuti zbog promjena u Vašem

ponašanju.

Porast tjelesne težine

Porast tjelesne težine je opažen u bolesnika koji uzimaju Volqer. I Vi i Vaš liječnik trebate redovito

nadzirati Vašu tjelesnu težinu.

Djeca i adolescenti

Volqer se ne smije primjenjivati kod djece i adolescenata mlađih od 18 godina.

Drugi lijekovi i Volqer

Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli

ili biste mogli uzeti bilo koje

druge lijekove.

Ne uzimajte Volqer ako uzimate bilo koji od sljedećih lijekova:

neke lijekove za liječenje HIV infekcija.

lijekove iz skupine azola (za liječenje gljivičnih infekcija).

eritromicin ili klaritromicin (lijekovi za liječenje infekcija).

nefazodon (lijek za liječenje depresije).

Obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova:

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

lijekove za liječenje povišenog krvnog tlaka.

barbiturate (lijekovi za liječenje poremećaja spavanja).

tioridazin ili litij (također antipsihotici).

lijekove koji utječu na rad srca, na primjer, lijekove koji mogu uzrokovati neravnotežu elektrolita

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

antibiotici (lijekovi za liječenje infekcija).

lijekove koji mogu uzrokovati zatvor.

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

liječila određena medicinska stanja.

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

liječnikom.

Volqer s hranom, pićem i alkoholom

hrana može utjecati na Volqer i zbog toga morate uzeti svoje tablete najmanje jedan sat prije

obroka ili prije spavanja.

budite oprezni s količinom alkohola koju uzimate. Razlog je što Vas kombinirani utjecaj Volqera

i alkohola može učiniti pospanima.

nemojte piti sok od grejpa za vrijeme uzimanja Volqera. Sok od grejpa može utjecati na

djelovanje lijeka.

Trudnoća, dojenje i plodnost

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.

Ne smijete uzimati Volqer za vrijeme trudnoće, ukoliko to prethodno nije raspravljeno s Vašim

liječnikom. Volqer se ne smije uzimati ako dojite.

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

novorođenčadi majki koje su uzimale Volqer u zadnjem tromjesečju (zadnja tri mjeseca) trudnoće:

tresavica, ukočenost i/ili slabost mišića, pospanost, uznemirenost, poteškoće s disanjem i otežano

hranjenje. Ako Vaše dijete razvije bilo koji od tih simptoma, morate se javiti liječniku.

Upravljanje vozilima i strojevima

Vaše tablete Vas mogu učiniti pospanima. Ne vozite i ne rukujte alatima ili strojevima sve dok ne

utvrdite kako ove tablete djeluju na Vas.

Učinak na probirne testove na lijekove u urinu

Ukoliko ste podvrgnuti probirnim testovima na lijekove u urinu, uzimanje Volqera može uzrokovati

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

antidepresivi kada se koriste određene metode testiranja, iako Vi možda ne uzimate metadon ili

tricikličke antidepresive. Ako se to dogodi, može se koristiti specifičniji test.

Volqer sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite određene šećere, posavjetujte se s njim prije uzimanja

ovog lijeka.

3.

Kako uzimati Volqer

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik. Provjerite s Vašim

liječnikom ili ljekarnikom ako niste sigurni.

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

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

svoje tablete ćete uzimati jednom dnevno.

tablete ne smijete lomiti, žvakati ili drobiti.

tablete progutajte cijele, s nešto vode.

svoje tablete uzmite bez hrane (najmanje jedan sat prije obroka ili prije spavanja, liječnik će Vam

reći kada).

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tijekom liječenja Volqerom nemojte piti sok od grejpa, jer može utjecati na djelovanje lijeka u

organizmu.

čak i ako se osjećate bolje, nemojte prestati uzimati tablete sve dok Vam to ne preporuči liječnik.

Bolesnici s jetrenim tegobama

Ako imate jetrenih tegoba, liječnik Vam može promijeniti dozu.

Stariji bolesnici

Ako ste u starijoj životnoj dobi, liječnik Vam može dati nižu dozu.

Primjena u djece i adolescenata (mlađih od 18 godina)

Volqer se ne smije primjenjivati kod djece i adolescenata mlađih od 18 godina.

Ako uzmete više Volqera nego što ste trebali

Ako uzmete više Volqera nego što Vam je propisao liječnik, mogli biste osjetiti pospanost, omaglicu i

nepravilan rad srca. Odmah zatražite savjet liječnika ili najbliže bolnice. Ponesite Volqer tablete sa

sobom.

Ako ste zaboravili uzeti Volqer

Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite. Ako je uskoro vrijeme za sljedeću dozu,

pričekajte do tada. Ne uzimajte dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Volqer

Ako naglo prestanete uzimati Volqer, mogli biste osjetiti nesanicu, ili mučninu, ili biste mogli imati

glavobolju, proljev, povraćanje, omaglicu ili biti razdražljivi.

Liječnik Vam može savjetovati da postupno smanjujete dozu lijeka, prije potpunog prestanka

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 može uzrokovati nuspojave iako se one neće razviti kod svakoga.

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

omaglica (može dovesti do padova), glavobolja ili suha usta.

osjećaj pospanosti koji nastavkom uzimanja Volqera i tokom vremena može nestati (može dovesti

do padova).

simptomi ustezanja (simptomi koji se javljaju kod prekida uzimanja Volqera) uključuju

nemogućnost spavanja (nesanica), mučninu, glavobolju, proljev, povraćanje, omaglicu i

razdražljivost. Savjetuje se postupan prekid liječenja tijekom najmanje 1 do 2 tjedna.

dobivanje na težini.

abnormalni pokreti mišića. Oni uključuju otežano pokretanje mišića, tresavicu, osjećaj nemira ili

ukočenost mišića bez bolova.

promjene u količini određenih masnoća (triglicerida i ukupnog kolesterola).

Često (mogu se javiti kod 1 na 10 osoba):

ubrzani otkucaji srca.

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

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zatvor ili želučane tegobe (poremećaj probave).

osjećaj slabosti.

oticanje ruku ili nogu.

nizak krvni tlak prilikom ustajanja. Zbog toga možete imati osjećaj omaglice ili nesvjesticu (može

dovesti do padova).

porast razine šećera u krvi.

zamućen vid.

abnormalni snovi i noćne more.

pojačani osjećaj gladi.

osjećaj razdraženosti.

poremećaj u govoru i jeziku.

razmišljanje o samoubojstvu i pogoršanje Vaše depresije.

kratak dah (zaduha).

povraćanje (uglavnom kod starijih osoba).

vrućica.

promjene u količini hormona štitnjače u krvi.

smanjenja broja određenih 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 žena.

izostanak mjesečnica ili neredovite mjesečnice u žena.

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

napadaji.

alergijske reakcije koje mogu uključivati pojavu uzdignuća (oteklina) na koži, oticanje kože i

oticanje područja oko usta.

neugodan osjećaj u nogama (poznat i kao sindrom nemirnih nogu).

poteškoće s gutanjem.

nekontrolirani pokreti, osobito lica ili jezika.

spolna disfunkcija.

šećerna bolest.

promjena električne aktivnosti srca vidljiva na EKG-u (produljenje QT intervala)

sporiji otkucaji srca

što se može javiti na početku liječenja i može biti povezano s niskim krvnim

tlakom i nesvjesticom.

otežano mokrenje.

nesvjestica (može dovesti do padova).

začepljen nos.

smanjenje količine crvenih krvnih stanica.

smanjenje količine natrija u krvi.

pogoršanje postojeće šećerne bolesti.

Rijetko (mogu se javiti kod 1 na 1000 osoba):

kombinacija visoke tjelesne temperature (vrućica), znojenja, ukočenosti mišića, osjećaja izrazite

omamljenosti ili nesvjestice (poremećaj koji se zove „neuroleptički maligni sindrom“).

žutilo kože i očiju (žutica).

upala jetre (hepatitis).

dugotrajna i bolna erekcija (prijapizam).

oticanje dojki i neočekivano stvaranje mlijeka (galaktoreja).

menstrualni poremećaj.

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krvni ugrušci u venama, osobito u nogama (simptomi uključuju oticanje, bol i crvenilo nogu), koji

mogu putovati krvnim žilama do pluća uzrokujući bol u prsištu i otežano disanje. Ako primijetite

bilo koji od navedenih simptoma odmah potražite liječničku pomoć.

hodanje, govor, uzimanje hrane ili druge aktivnosti za vrijeme trajanja sna.

sniženje tjelesne temperature (hipotermija).

upala gušterače.

stanje koje se naziva „metaboličkim sindromom“, kod kojega možete 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.

kombinacija vrućice, simptoma nalik gripi, grlobolje ili bilo koja druga infekcija praćena vrlo

niskim brojem bijelih krvnih stanica - to stanje se naziva agranulocitoza.

blokada crijeva.

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

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

težak osip, mjehuri ili crvene mrlje na koži.

teška alergijska reakcija (nazvana anafilaksija), koja može uzrokovati otežano disanje ili izazvati

šok.

brzo oticanje kože, obično oko očiju, usana i u području ždrijela (angioedem).

ozbiljno stanje stvaranja mjehura na koži, ustima, očima i spolnim organima (Stevens-Johnsonov

sindrom).

neodgovarajuće izlučivanje hormona koji kontrolira volumen mokraće.

razgradnja mišićnih vlakana i bol u mišićima (rabdomioliza).

Nepoznato (učestalost se ne može procijeniti na osnovi dostupnih podataka):

osip kože s nepravilnim crvenim mrljama (multiformni eritem).

ozbiljna, iznenadna alergijska reakcija sa simptomima kao što su vrućica, mjehuri na koži i

ljuštenje kože (toksična epidermalna nekroliza).

simptomi ustezanja (prekida primjene lijeka) mogu nastupiti u novorođenčadi čije su majke

uzimale kvetiapin tijekom trudnoće

Lijekovi iz skupine kojoj pripada i Volqer mogu uzrokovati poremećaje srčanoga ritma, koji mogu

biti ozbiljni, a u teškim slučajevima i smrtonosni.

Pojedine nuspojave se mogu uočiti samo ako se učine krvne pretrage. To uključuje promjene razine

određenih masnoća (triglicerida i ukupnog kolesterola) ili šećera u krvi, promjene razine hormona

štitnjače u Vašoj krvi, povišene jetrene enzime, smanjenje broja određenih vrsta krvnih stanica,

smanjenje broja crvenih krvnih stanica, povišenje kreatin fosfokinaze (nalazi se u mišićima) u krvi,

smanjenje količine natrija u krvi i porast razine hormona prolaktina u krvi. U rijetkim slučajevima

porast hormona prolaktina može dovesti do sljedećeg:

oticanje dojki kod muškaraca i žena, te neočekivano stvaranje mlijeka.

izostanak mjesečnice ili neredovite mjesečnice kod žena.

Zbog toga Vaš liječnik može zatražiti da povremeno obavite pretrage krvi.

Nuspojave u djece i adolescenata

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

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

H A L M E D

13 - 03 - 2017

O D O B R E N O

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

porast razine hormona prolaktina u krvi. To u rijetkim slučajevima može dovesti do sljedećeg:

otok dojki kod dječaka i djevojčica, te neočekivano stvaranje mlijeka.

izostanak mjesečnice ili neredovite mjesečnice kod djevojčica.

povećani apetit.

povraćanje.

poremećaj mišićnih pokreta. To uključuje otežano započinjanje mišićnih pokreta, drhtanje, osjećaj

nemira ili bezbolnu ukočenost mišića.

porast krvnog tlaka.

Često (mogu se javiti kod 1 na 10 osoba):

osjećaj slabosti, nesvjestica (može dovesti do padova).

začepljen nos.

osjećaj razdražljivosti.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika. Ovo uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Volqer

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.

HDPE bočice: nakon prvog otvaranja upotrijebiti prije isteka roka valjanosti označenog na bočici iza

oznake „EXP“.

Ovaj lijek 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.

Sadržaj pakiranja i druge informacije

Što Volqer sadrži

Djelatna tvar je kvetiapin. Svaka Volqer tableta s produljenim oslobađanjem sadrži 50 mg,

200 mg, 300 mg ili 400 mg kvetiapina (u obliku kvetiapinfumarata).

Drugi sastojci su:

Jezgra tablete:

metakrilatna kiselina/etilakrilat kopolimer (1:1) vrste A, bezvodna laktoza,

magnezijev stearat, kristalična maltoza, talk.

Ovojnica tablete:

metakrilatna kiselina/etilakrilat kopolimer (1:1) vrste A, trietilcitrat.

H A L M E D

13 - 03 - 2017

O D O B R E N O

Kako Volqer izgleda i sadržaj pakiranja

Volqer 50 mg tablete s produljenim oslobađanjem: bijela do skoro bijela, okrugla bikonveksna

tableta, promjera 7,1 mm i debljine 3,2 mm, s utisnutim “50” na jednoj strani.

Volqer 200 mg tablete s produljenim oslobađanjem: bijela do skoro bijela, duguljasta

bikonveksna tableta, dužine 15,2 mm, širine 7,7 mm i debljine 4,8 mm, s utisnutim “200” na

jednoj strani.

Volqer 300 mg tablete s produljenim oslobađanjem: bijela do skoro bijela, duguljasta

bikonveksna tableta, dužine 18,2 mm, širine 8,2 mm i debljine 5,4 mm, s utisnutim “300” na

jednoj strani.

Volqer 400 mg tablete s produljenim oslobađanjem: bijela do skoro bijela, ovalna bikonveksna

tableta, dužine 20,7 mm, širine 10,2 mm i debljine 6,3 mm, s utisnutim “400” na jednoj strani.

Volqer tablete s produljenim oslobađanjem su dostupne u PVC/PCTFE-Al blisterima pakiranim

u kutiju.

Volqer tablete s produljenim oslobađanjem također su dostupne i u bijeloj, neprozirnoj, HDPE

bočici sa polipropilenskim navojnim sigurnosnim zatvaračem za djecu i indukcijski zavarenom

zaštitnom folijom.

Veličine pakiranja za blistere su: 10, 30, 50, 56, 60 i 100 tableta.

Veličina pakiranja za bočice su: 60 i 120 tableta.

Veličina pakiranja od 120 tableta ograničena je za bolničku primjenu.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja za stavljanje lijeka u promet

Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska

ProizvoĎač

Pharmathen International S.A, Sapes Industrial Park Block 5, Rodopi, 69300, Grčka

Pharmathen S.A, Dervenakion str. 6, Pallini, 15351 Attiki, Grčka

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Njemačka

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

sljedećim nazivima:

Država članica

Naziv lijeka

Danska

Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletter

Austrija

Quetiapin Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg –

Retardtabletten

Belgija

Quetibloxus 50 mg/150 mg/200 mg/300 mg/400 mg tabletten met

verlengde afgifte

Bugarska

Kvelux XR 50 mg/150 mg/200 mg/300 mg/400 mg prolonged release

tablet

Njemačka

Quetiapin HEXAL® 50/150/200/300/400 Retardtabletten

Grčka

Quetiapine /Sandoz

Finska

Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletti

Francuska

Quetiapin Sandoz LP 50 mg/150 mg/200 mg/300 mg/400 mg, comprimé

à libération prolongée

Mađarska

Quetiapine Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg retard tabletta

H A L M E D

13 - 03 - 2017

O D O B R E N O

Irska

Quetex XR 50 mg/200 mg/300 mg/400 mg Prolonged-release tablets

Island

Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg forðatöflur

Italija

Quetiapina Sandoz BV

Luksemburg

Quetibloxus 50 mg/150 mg/200 mg/300 mg/400 mg comprimés à

libération prolongée

Nizozemska

Quetiapine Sandoz SR 50 mg/150 mg/200 mg/300 mg/400 mg, tabletten

met verlengde afgifte

Poljska

Kvelux SR

Portugal

Quetiapina Sandoz

Rumunjska

Netiapin 50 mg/150 mg/200 mg/300 mg/400 mg comprimate cu eliberare

prelungită

Švedska

Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletter

Slovenija

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

sproščanjem

Slovačka

Quetiapin Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg

Velika Britanija

Psyquet XL 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-release

tablets

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u ožujku 2017.

H A L M E D

13 - 03 - 2017

O D O B R E N O

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

20-2-2019

Salmonella control in poultry flocks and its public health impact

Salmonella control in poultry flocks and its public health impact

Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2019

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

These tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

14-1-2019

Meer orgaan- en weefseltransplantaties in 2018

Meer orgaan- en weefseltransplantaties in 2018

In 2018 zijn in Nederland 815 orgaantransplantaties geweest en ruim 4000 patiënten geholpen met gedoneerd weefsel. Dit is een stijging van respectievelijk 15 en 18% in vergelijking met het jaar ervoor. Deze positieve jaarcijfers zijn gepubliceerd door de Nederlandse Transplantatie Stichting (NTS).

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

17-12-2018


Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

23-11-2018

ACT-Candesartan 4mg tablets (2018-11-23)

ACT-Candesartan 4mg tablets (2018-11-23)

Health Canada

6-3-2019

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more:  https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDev

Today @US_FDA made an update to a Safety Communication on the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure. Read more: https://go.usa.gov/xEfkX  #MedicalDevice #FDA pic.twitter.com/WZZjTq0BMX

FDA - U.S. Food and Drug Administration

1-3-2019

EU/3/15/1607 (TMC Pharma (EU) Limited)

EU/3/15/1607 (TMC Pharma (EU) Limited)

EU/3/15/1607 (Active substance: Entolimod) - Transfer of orphan designation - Commission Decision (2019)1738 of Fri, 01 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004004

Europe -DG Health and Food Safety

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

Europe - EMA - European Medicines Agency

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor (TBX-1400), decision type: , therapeutic area: , PIP number: P/0284/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency