Epri 30 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Epri 30 mg filmom obložene tablete
  • Doziranje:
  • 30 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 30 mg rosuvastatina (u obliku rosuvastatinkalcija)
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Pliva Hrvatska d.o.o., Zagreb, Republika Hrvatska; Merckle GmbH, Blaubeuren, Njemačka; Teva Operations Poland Sp. z o.o., Krak

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Epri 30 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-399406571-01]; 30 tableta u blisteru, u kutiji [HR-H-399406571-02]; 56 tableta u blisteru, u kutiji [HR-H-399406571-03]; 98 tableta u blisteru, u kutiji [HR-H-399406571-04]; 100 tableta u blisteru, u kutiji [HR-H-399406571-05]; 30 tableta u bočici, u kutiji [HR-H-399406571-06]; 100 tableta u bočici, u kutiji [HR-H-399406571-07]; 90 tableta u blisteru, u kutiji [HR-H-399406571-08] Urbroj: 381-12-01/30-16-10

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-399406571
  • Datum autorizacije:
  • 14-01-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za bolesnika

Epri 15 mg filmom obložene tablete

Epri 30 mg filmom obložene tablete

rosuvastatin

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

Sačuvajte ovu uputu. Moţda 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. Moţe 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 su Epri filmom obloţene tablete i za što se koriste

2. Što morate znati prije nego počnete uzimati Epri filmom obloţene tablete

3. Kako uzimati Epri filmom obloţene tablete

4. Moguće nuspojave

5. Kako čuvati Epri filmom obloţene tablete

6. Sadrţaj pakiranja i druge informacije

1.

Što su Epri filmom obložene tablete i za što se koriste

Epri filmom obloţene tablete pripadaju skupini lijekova koji se zovu statini.

Epri filmom obložene tablete propisane su Vam jer:

Imate visoku razinu kolesterola. To znači da ste izloţeni riziku od srčanog ili moţdanog udara. Epri

filmom obloţene tablete koriste se u odraslih, adolescenata i djece u dobi od 6 ili više godina za

liječenje povišenog kolesterola.

Statin Vam je propisan jer promjenom prehrane i tjelovjeţbom niste mogli dovoljno sniziti razinu kolesterola

u krvi. Potrebno je nastaviti s prehranom za smanjenje kolesterola i tjelovjeţbom dok uzimate Epri filmom

obloţene tablete.

Imate druge čimbenike koji povećavaju Vaš rizik od srčanog ili moţdanog udara ili s njima

povezanih zdravstvenih problema.

Srčani udar, moţdani udar i drugi problemi mogu biti uzrokovani bolešću koja se zove ateroskleroza.

Ateroskleroza je bolest u kojoj se masne naslage nakupljaju u arterijama.

Zašto je važno nastaviti uzimati Epri filmom obložene tablete?

Epri filmom obloţene tablete koriste se za sniţavanje razine masnoća u krvi koje se nazivaju lipidi i od kojih

je najčešći kolesterol.

U krvi se nalaze različite vrste kolesterola - tzv. „loš“ kolesterol (LDL) i „dobar“ kolesterol (HDL).

Rosuvastatin moţe sniziti razinu „lošeg“ i povisiti razinu „dobrog“ kolesterola.

Djeluje tako da pomaţe u sprječavanju nastanka „lošeg“ kolesterola u Vašem organizmu. Također,

poboljšava sposobnost organizma da ukloni „loš“ kolesterol iz krvi.

Većina ljudi ne osjeća povišenu razinu kolesterola jer ona ne uzrokuje pojavu simptoma. Međutim,

neliječena povišena razina kolesterola moţe dovesti do stvaranja masnih naslaga u stjenkama Vaših krvnih

ţila te uzrokovati njihovo suţenje.

Ponekad se suţene krvne ţile mogu začepiti što moţe prekinuti dovod krvi do srca ili mozga te time dovesti

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do srčanog ili moţdanog udara. Sniţavanjem razine kolesterola u krvi moţete smanjiti svoj rizik od srčanog

ili moţdanog udara ili s njima povezanih zdravstvenih problema.

Vaţno je nastaviti uzimati Epri filmom obložene tablete, čak i ako Vam se kolesterol smanjio na

prikladnu razinu, zato što sprječavaju ponovno povećanje razine kolesterola i nakupljanje masnih naslaga.

Međutim, morate ga prestati uzimati ako Vam je to savjetovao Vaš liječnik ili ako zatrudnite.

2.

Što morate znati prije nego počnete uzimati Epri filmom obložene tablete

Nemojte uzimati Epri filmom obložene tablete

Ako ste alergični na rosuvastatin ili na bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.)

Ako ste trudni ili dojite. Ako zatrudnite tijekom uzimanja Epri filmom obloţenih tableta, odmah

prekinite s njihovim uzimanjem i obavijestite svog liječnika. Ţene tijekom uzimanja Epri filmom

obloţenih tableta moraju izbjegavati trudnoću, štiteći se odgovarajućom metodom kontracepcije

Ako imate bolesti jetre

Ako imate teške bubrežne probleme

Ako imate ponavljajuće ili neobjašnjive bolove u mišićima

Ako uzimate lijek koji se zove ciklosporin (koristi se primjerice poslije presađivanja organa).

Ako se bilo što od ranije navedenog odnosi na Vas (ili sumnjate da se odnosi na Vas), molimo Vas da se

obratite svom liječniku.

Nadalje, nemojte uzimati Epri 30 mg ili višu dozu:

Ako imate umjerene probleme s bubrezima (ako sumnjate na njih, molimo Vas da se obratite svom

liječniku)

Ako imate poremećenu funkciju štitnjače

Ako ste imali učestale ili neobjašnjive bolove u mišićima, ako ste Vi ili članovi Vaše obitelji imali bilo

kakve probleme s mišićima ili ako ste prije, pri uzimanju lijekova za sniţavanje razine kolesterola, imali

problema s mišićima.

Ako redovito pijete veće količine alkohola

Ako ste podrijetlom azijat (Japanac, Kinez, Filipinac, Vijetnamac, Korejac i Indijac)

Ako uzimate druge lijekove za sniţavanje kolesterola koji se zovu fibrati.

Ako se bilo što od ranije navedenog odnosi na Vas (ili sumnjate da se na Vas odnosi), molimo Vas da se

obratite svom liječniku.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Epri filmom obloţene tablete.

Ako imate probleme s bubrezima

Ako imate probleme s jetrom

Ako ste imali ponavljajuće ili neobjašnjive bolove u mišićima, ako ste Vi ili članovi Vaše obitelji

imali bilo kakvih problema s mišićima ili ako ste prije, pri uzimanju lijekova za sniţavanje razine

kolesterola, imali problema s mišićima. Obavijestite odmah svog liječnika ako imate neobjašnjive bolove

u mišićima, posebno ako se osjećate loše ili imate vrućicu. Također, obavijestite svog liječnika ili

ljekarnika ako imate dugotrajnu mišićnu slabost.

Ako redovito pijete veće količine alkohola

Ako imate poremećenu funkciju štitnjače

Ako uzimate druge lijekove za sniţavanje razine kolesterola koji se zovu fibrati. Molimo Vas da ovu

uputu paţljivo pročitate, čak i ako ste prije uzimali druge lijekove za povišen kolesterol

Ako uzimate lijekove za liječenje HIV infekcije , npr. ritonavir s lopinavirom i/ili atazanavirom,

molimo Vas da pročitate odlomak Drugi lijekovi i Epri filmom obložene tablete.

Ako uzimate ili ste u posljednjih 7 dana uzimali lijekove koji sadrže fusidatnu kiselinu, (lijek za

liječenje bakterijske infekcije) kroz usta ili primijenjeno injekcijom. Kombinacija fusidatne kiseline i

Epri filmom obloţenih tableta moţe dovesti do ozbiljnih problema s mišićima (rabdomioliza).

Ako imate više od 70 godina (Vaš liječnik mora odrediti točnu početnu dozu Epri filmom obloţenih

tableta koja Vama odgovara).

Ako imate teško zatajenje dišnog sustava

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Ako ste podrijetlom azijat (Japanac, Kinez, Filipinac, Vijetnamac, Korejac ili Indijac), Vaš liječnik

mora odrediti točnu početnu dozu Epri filmom obloţenih tableta koja Vama odgovara.

Ako se bilo što od ranije navedenog odnosi na Vas (ili ako niste sigurni odnosi li se na Vas):

Nemojte uzimati Epri 30 mg ili višu dozu i razgovarajte sa svojim liječnikom ili ljekarnikom prije

početka uzimanja bilo koje doze Epri filmom obloženih tableta.

U manjeg broja ljudi statini mogu utjecati na funkciju jetre. To se moţe utvrditi jednostavnim pretragama

koje otkrivaju povišenu razinu jetrenih enzima u krvi. Zbog toga će Vaš liječnik obično traţiti krvne pretrage

(pretrage jetrene funkcije) prije početka kao i tijekom liječenja Epri filmom obloţenim tabletama.

Tijekom liječenja ovim lijekom Vaš će liječnik paţljivo nadzirati imate li šećernu bolest ili rizik od pojave

šećerne bolesti. Veća je vjerojatnost rizika od pojave šećerne bolesti ako imate povišenu razinu šećera i

masnoća u krvi, prekomjernu tjelesnu teţinu i visoki krvni tlak.

Djeca i adolescenti

Ako je bolesnik mlaĎi od 6 godina: Epri filmom obloţene tablete ne smiju se davati djeci mlađoj od 6

godina.

Ako je bolesnik mlaĎi od 18 godina: Epri 30 mg ili više doze nisu primjerene za liječenje djece i

adolescenata u dobi ispod 18 godina.

Drugi lijekovi i Epri filmom obložene tablete

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

lijekove.

Obavijestite svog liječnika ako uzimate bilo što od slijedećeg:

ciklosporin (koristi se, primjerice, poslije presađivanja organa)

varfarin ili klopidogrel (ili bilo koji drugi lijek protiv zgrušavanja krvi)

fibrate (kao što su gemfibrozil i fenofibrat) ili neki drugi lijek koji se koristi za sniţavanje razine

kolesterola (kao što je ezetimib)

lijekove protiv probavnih smetnji (koji se koriste za neutraliziranje kiseline u ţelucu)

eritromicin (antibiotik)

fusidatnu kiselinu (antibiotik – molimo vidjeti Upozorenja i mjere opreza). Ako morate uzimati

fusidatnu kiselinu kroz usta (oralno) zbog liječenja bakterijske infekcije, morat ćete privremeno

prestati uzimati ovaj lijek. Vaš liječnik će Vam reći kada je sigurno ponovno započeti terapiju

lijekom Epri filmom obložene tablete. Istovremena primjena Epri filmom obloženih tableta i

fusidatne kiseline može u rijetkim slučajevima dovesti do mišićne slabosti, mišićne boli ili

osjetljivosti mišića (rabdomioliza).Više informacija o rabdomiolizi pročitajte u dijelu 4.

oralne kontraceptive (kontracepcijsku pilulu)

hormonsku nadomjesnu terapiju

antivirusni lijekovi kao što je ritonavir s lopinavirom i/ili atazanavirom ili simeprevir (koriste se za

liječenje infekcija, uključujući HIV ili hepatitis C infekciju – pogledajte odlomak Upozorenja i mjere

opreza).

Epri filmom obloţene tablete mogu promijeniti učinak tih lijekova ili bi oni mogli promijeniti učinak Epri

filmom obloţenih tableta.

Trudnoća i dojenje

Ne uzimajte Epri filmom obložene tablete ako ste trudni ili ako dojite. Ako zatrudnite tijekom uzimanja

Epri filmom obloţenih tableta,odmah prekinite s njihovim uzimanjem i obavijestite svog liječnika. Ţene

tijekom uzimanja Epri filmom obloţenih tableta moraju izbjegavati trudnoću, štiteći se odgovarajućom

metodom kontracepcije.

Obratite se za savjet svom liječniku ili ljekarniku prije uzimanja bilo kojeg lijeka.

Upravljanje vozilima i strojevima

Većina ljudi moţe upravljati vozilima i strojevima tijekom uzimanja Epri filmom obloţenih tableta jer one

neće utjecati na njihove sposobnosti. Međutim, neki ljudi mogu osjetiti omaglicu tijekom liječenja Epri

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filmom obloţenim tabletama. Ako osjetite omaglicu, obratite se svom liječniku prije voţnje ili upravljanja

strojevima.

Epri filmom obložene tablete sadrže laktozu.

Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja ovoga

lijeka.

3.

Kako uzimati Epri filmom obložene tablete

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

ljekarnikom ako niste sigurni.

Uobičajene doze za odrasle

Ako uzimate Epri filmom obložene tablete zbog povišenog kolesterola:

Početna doza

Vaše liječenje Epri filmom obloţenim tabletama mora početi s dozom od 5 mg ili 10 mg, čak i ako ste ranije

uzimali veće doze drugog statina. Izbor Vaše početne doze ovisi o:

razini Vašeg kolesterola

razini Vašeg rizika od nastanka srčanog ili moţdanog udara

postojanju nekog čimbenika koji Vas mogu učiniti osjetljivijima na moguće nuspojave.

Molimo Vas da sa svojim liječnikom ili ljekarnikom provjerite koja Vam početna doza Epri filmom

obloţenih tableta najbolje odgovara.

Liječnik Vam moţe propisati najniţu dozu (5 mg) ako:

ste podrijetlom azijat (Japanac, Kinez, Filipinac, Vijetnamac, Korejac ili Indijac)

ste stariji od 70 godina

imate umjerene probleme s bubrezima

ste izloţeni riziku od bolova u mišićima (miopatija).

Za doziranja za koja ove jačine nisu prikladne, dostupne su i druge jačine ovog lijeka.

Povećanje doze i najviša dnevna doza

Vaš liječnik moţe odlučiti povećati Vašu dozu kako bi osigurao da uzimate odgovarajuću dozu Epri filmom

obloţenih tableta. Ako počnete s dozom od 5 mg, Vaš liječnik moţe odlučiti, na primjer, udvostručiti ovu

dozu na 10 mg, potom na20 mg te na 40 mg ako je to potrebno. Ako počnete s dozom od 10 mg, Vaš liječnik

moţe odlučiti udvostručiti ovu dozu na 20 mg te potom na 40 mg ako je to potrebno. Između svake

prilagodbe doza moraju proći četiri tjedna.

Najviša dnevna doza Epri filmom obloţenih tableta je 40 mg. Ona se propisuje samo bolesnicima s visokom

razinom kolesterola i s visokim rizikom od srčanog ili moţdanog udara u kojih s dozom od 20 mg nije

postignuto dovoljno sniţenje razine kolesterola.

Ako uzimate Epri filmom obložene tablete za snižavanje rizika od srčanog udara, moždanog udara ili

s njima povezanih zdravstvenih problema:

Preporučena dnevna doza je 20 mg. Vaš liječnik moţe odlučiti smanjiti ovu dozu ako imate neki od

čimbenika spomenutih u ranijem tekstu.

Primjena u djece i adolescenata u dobi od 6 do 17 godina

Uobičajena početna doza je 5 mg. Vaš liječnik moţe povećati Vašu dozu kako bi odredio odgovarajuću dozu

Epri filmom obloţenih tableta za Vas. Najviša dnevna doza Epri filmom obloţenih tableta je 10 mg u djece u

dobi od 6 do 9 godina te 20 mg u djece u dobi od 10 do 17 godina. Dozu uzimajte jednom dnevno. Epri 30

mg ili više doze ne smiju se koristiti u djece.

Uzimanje tableta

Progutajte cijelu tabletu s čašom vode.

Uzimajte Epri filmom obložene tablete samo jedanput dnevno. Moţete ih uzimati u bilo koje doba dana,

s hranom ili bez nje.

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Uzimajte tabletu svaki dan u isto vrijeme kako biste lakše zapamtili uzeti lijek.

Redovita kontrola razine kolesterola

Vaţno je da se obratite liječniku za redovite kontrole kolesterola kako biste bili sigurni da Vam je kolesterol

reguliran i odrţan na odgovarajućoj razini.

Vaš liječnik moţe Vam propisati veću dozu kako bi osigurao uzimanje odgovarajuće količine Epri filmom

obloţenih tableta.

Ako uzmete više Epri filmom obloženih tableta nego što ste trebali

Obratite se svom liječniku ili najbliţoj bolnici za savjet.

Ako odete u bolnicu ili se u bolnici liječite zbog nekog drugog razloga, obavijestite medicinsko osoblje da

uzimate Epri filmom obloţene tablete.

Ako ste zaboravili uzeti Epri filmom obložene tablete

Ne brinite već uzmite sljedeću dozu u točno vrijeme. Nemojte uzeti dvostruku dozu kako biste nadoknadili

zaboravljenu dozu.

Ako prestanete uzimati Epri filmom obložene tablete

Obavijestite svog liječnika ako ţelite prestati uzimati Epri filmom obloţene tablete. Ako prestanete uzimati

Epri filmom obloţene tablete, razina kolesterola moţe se ponovno povećati.

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 razviti kod svakoga.

Vaţno je znati koje su moguće nuspojave. One su obično blage i nestaju nakon kratkog vremena.

Ako imate bilo koju od sljedećih alergijskih reakcija, odmah prestanite uzimati Epri filmom obložene

tablete i potražite medicinsku pomoć:

oteţano disanje, praćeno oticanjem lica, usana, jezika i/ili grla ili bez oticanja

oticanje lica, usana, jezika i/ili grla koje moţe uzrokovati oteţano gutanje

jak svrbeţ koţe (s uzdignućima na koţi).

Nadalje, prestanite uzimati Epri filmom obložene tablete i odmah se obratite svom liječniku u slučaju

bilo koje neuobičajene boli u mišićima koja traje dulje nego što je očekivano. Mišićni simptomi se javljaju

češće u djece i adolescenata nego u odraslih. Kao i kod drugih statina, u vrlo malog broja ljudi mogu se javiti

neugodni učinci lijeka na mišiće, koji rijetko prelaze u oštećenje mišića moguće opasno po ţivot koje se

naziva rabdomioliza.

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

glavobolja

bol u ţelucu

zatvor

mučnina

bol u mišićima

osjećaj slabosti

omaglica

povećanje količine proteina u urinu – obično se vraća unutar normalnih vrijednosti spontano, bez potrebe

za prestankom uzimanja Epri filmom obloţenih tableta (samo za dozu od 40 mg)

šećerna bolest. Veća je vjerojatnost za pojavu šećerene bolesti ako imate visoku razinu šećera i masnoća

u krvi, prekomjernu tjelesnu teţinu i visoki krvni tlak. Vaš liječnik će Vas nadzirati dok uzimate ovaj

lijek.

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

osip, svrbeţ ili druge reakcije na koţi

povećanje količine proteina u urinu – obično se vraća unutar normalnih vrijednosti spontano, bez potrebe

za prestankom uzimanja Epri filmom obloţenih tablete (samo za doze od 5 mg, 10 mg i 20 mg).

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

jake alergijske reakcije – znakovi uključuju oticanje lica, usana, jezika i/ili grla, oteţano gutanje i disanje,

jaki svrbeţ koţe (s uzdignućima na koţi). Ako mislite da imate alergijsku reakciju, prestanite

uzimati Epri filmom obložene tablete i odmah potraţite medicinsku pomoć

oštećenje mišića u odraslih - kao mjeru opreza prestanite uzimati Epri filmom obložene tablete i

odmah se obratite svom liječniku u slučaju bilo koje neuobičajene boli u mišićima koja traje dulje

nego što je očekivano

jaka bol u trbuhu (upala gušterače)

povećanje razine jetrenih enzima u krvi

neočekivano krvarenje i nastanak modrica (trombocitopenija)

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

ţutica (ţuta koţa i oči)

hepatitis (upala jetre)

tragovi krvi u urinu

oštećenje ţivaca nogu i ruku (kao što je primjerice utrnulost)

bol u zglobovima

gubitak pamćenja

povećanje dojki u muškaraca (ginekomastija)

Nuspojave nepoznate učestalosti mogu uključivati:

proljev (meke stolice)

Stevens-Johnsonov sindrom (ozbiljno stanje pri kojem se pojavljuju mjehurići na koţi, ustima, očima i

genitalijama)

kašalj

nedostatak zraka

edeme (oticanje)

poremećaje spavanja, uključujući nesanicu i noćne more

poremećaj seksualne funkcije

depresiju

poteškoće s disanjem, uključujući stalni kašalj i/ili nedostatak zraka ili vrućicu

ozljede tetiva

mišićna slabost koja je dugotrajna.

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 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 Epri filmom obložene tablete

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza „Rok valjanosti“/

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

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.

H A L M E D

06 - 03 - 2018

O D O B R E N O

6.

Sadržaj pakiranja i druge informacije

Što Epri filmom obložene tablete sadrže

Djelatna tvar je rosuvastatin.

Svaka filmom obloţena tableta sadrţi 15 mg rosuvastatina (u obliku rosuvastatinkalcija).

Svaka filmom obloţena tableta sadrţi 30 mg rosuvastatina (u obliku rosuvastatinkalcija).

Drugi sastojci su

Jezgra tablete:

mikrokristalična celuloza

laktoza hidrat

krospovidon (tip B)

hidroksipropilceluloza

natrijev hidrogenkarbonat

magnezijev stearat

Ovojnica tablete:

laktoza hidrat

hipromeloza 6 Cp

titanijev dioksid (E 171)

triacetin

ţuti ţeljezov oksid (E172)

Kako Epri filmom obložene tablete izgledaju i sadržaj pakiranja

Epri 15 mg filmom obloţene tablete: okrugla, konveksna, ţuta tableta.

Epri 30 mg filmom obloţene tablete: okrugla, konveksna, ţuta tableta s razdjelnim urezom na jednoj strani.

Epri 15 i 30 mg filmom obloţene tablete pakirane su u blistere s 28, 30, 56, 90, 98 i 100 filmom obloţenih

tableta i u bočice od polietilena visoke gustoće (HDPE) s 30 i 100 filmom obloţenih tableta.

Bočica mo

e sadr

avati zasebni spremnik za sredstvo za sušenje sa silikagelom. NEMOJTE ga ukloniti iz

bočice. NEMOJTE jesti spremnik koji sadr

i silikagel.

Na trţištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja:

PLIVA HRVATSKA d.o.o.

Prilaz baruna Filipovića 25

10 000 Zagreb

ProizvoĎač:

PLIVA HRVATSKA d.o.o.

Prilaz baruna Filipovića 25, 10 000 Zagreb

Hrvatska

MerckleGmbH

Ludwig-Merckle-Straße 3, Blaubeuren, 89143

Njemačka

HBM Pharma s.r.o

Sklabinská 30, Martin 036 80

H A L M E D

06 - 03 - 2018

O D O B R E N O

Slovačka

Teva Operations Poland Sp. z o.o.

Mogilska 80, 31-546 Krakow

Poljska

Teva Pharma B.V

Swensweg 5, 2031 GA, Haarlem

Nizozemska

TEVA PHARMA S.L.U.

C/ C, n

4, Poligono Industrial Malpica, 50016 Zaragoza

Španjolska

Ovaj je lijek odobren u državama članicama EGP-a pod sljedećim nazivima:

Danska

Austrija

Belgija

Finska

Hrvatska

Mađarska

Poljska

Portugal

Rovanta

Rosuvastatinratiopharm 15 mg, 30 mg Filmtabletten

Rosuvastatine Teva 15 mg, 30 mg

filmomhuldetabletten/compriméspelliculés/Filmtabletten

Rosuvastatinratiopharm 15 mg, 30 mg tabletti, kalvopäällysteinen

Epri 15 mg, 30 mg filmom obloţene tablete

Rozuva-Teva 15 mg, 30 mg filmtabletta

Rosuvastatin Teva

Rosuvastatina Ratiopharm

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

06 - 03 - 2018

O D O B R E N O

15-11-2018

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018.

FDA - U.S. Food and Drug Administration

7-11-2018

Reactie op berichtgeving over nota Waarborgfonds

Reactie op berichtgeving over nota Waarborgfonds

Op dinsdag 30 oktober heeft minister Bruno Bruins een feitenrelaas rondom het faillissement van de MC Groep naar de Tweede Kamer gestuurd.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

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

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

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

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

6-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

31-7-2018

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration

5-9-2018

 Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted

Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Europe - EMA - European Medicines Agency

30-8-2018

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Active substance: ertugliflozin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5789 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4315/T/2

Europe -DG Health and Food Safety

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety

3-8-2018

Scandonest and associated names

Scandonest and associated names

Scandonest and associated names (Active substance: mepivacaine) - Community Referrals - Art 30 - Commission Decision (2018)5380 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-30/1455

Europe -DG Health and Food Safety

1-8-2018

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Active substance: sugammadex) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5213 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/885/T/30

Europe -DG Health and Food Safety

30-7-2018

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Active substance: nitisinone) - Centralised - Authorisation - Commission Decision (2018)5446 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4582

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety

30-7-2018

Aimovig (Novartis Europharm Limited)

Aimovig (Novartis Europharm Limited)

Aimovig (Active substance: erenumab) - Centralised - Authorisation - Commission Decision (2018)5102 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4447

Europe -DG Health and Food Safety

30-7-2018

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Active substance: inotuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5104 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4119/T/7

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Invokana (Janssen-Cilag International NV)

Invokana (Janssen-Cilag International NV)

Invokana (Active substance: canagliflozin) - Centralised - Renewal - Commission Decision (2018)5105 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2649/R/37

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

30-7-2018

Hyrimoz (Sandoz GmbH)

Hyrimoz (Sandoz GmbH)

Hyrimoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5097 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4320

Europe -DG Health and Food Safety

30-7-2018

Halimatoz (Sandoz GmbH)

Halimatoz (Sandoz GmbH)

Halimatoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5098 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4866

Europe -DG Health and Food Safety

30-7-2018

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Active substance: rasagiline) - Centralised - Yearly update - Commission Decision (2018)5108 of Mon, 30 Jul 2018

Europe -DG Health and Food Safety

30-7-2018

Hefiya (Sandoz GmbH)

Hefiya (Sandoz GmbH)

Hefiya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5099 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4865

Europe -DG Health and Food Safety

30-7-2018

Alsitek (AB Science)

Alsitek (AB Science)

Alsitek (Active substance: masitinib) - Refusal of authorisation - Commission Decision (2018)5109 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4398

Europe -DG Health and Food Safety

30-7-2018

UBAC (Laboratorios Hipra, S.A.)

UBAC (Laboratorios Hipra, S.A.)

UBAC (Active substance: Streptococcus uberis vaccine (inactivated)) - Centralised - Authorisation - Commission Decision (2018)5152 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4595

Europe -DG Health and Food Safety

30-7-2018

Apoquel (Zoetis Belgium S.A.)

Apoquel (Zoetis Belgium S.A.)

Apoquel (Active substance: Oclacitinib maleate) - Centralised - Renewal - Commission Decision (2018)5153 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2688/R/13

Europe -DG Health and Food Safety

30-7-2018

Ofev (Boehringer Ingelheim International GmbH)

Ofev (Boehringer Ingelheim International GmbH)

Ofev (Active substance: Nintedanib) - PSUSA - Modification - Commission Decision (2018)5115 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10319/201710

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

30-7-2018

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)5095 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4463

Europe -DG Health and Food Safety

30-7-2018

RXULTI (Otsuka Pharmaceutical Europe Ltd)

RXULTI (Otsuka Pharmaceutical Europe Ltd)

RXULTI (Active substance: brexpiprazole) - Centralised - Authorisation - Commission Decision (2018)5088 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3841

Europe -DG Health and Food Safety

24-7-2018

ACV meeting statement, Meeting 8, 30 May 2018

ACV meeting statement, Meeting 8, 30 May 2018

Advisory Committee on Vaccines meeting statement

Therapeutic Goods Administration - Australia