Epri 15 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Epri 15 mg filmom obložene tablete
  • Doziranje:
  • 15 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 15 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 15 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-368649981-01]; 30 tableta u blisteru, u kutiji [HR-H-368649981-02]; 56 tableta u blisteru, u kutiji [HR-H-368649981-03]; 98 tableta u blisteru, u kutiji [HR-H-368649981-04]; 100 tableta u blisteru, u kutiji [HR-H-368649981-05]; 30 tableta u bočici, u kutiji [HR-H-368649981-06]; 100 tableta u bočici, u kutiji [HR-H-368649981-07]; 90 tableta u blisteru, u kutiji [HR-H-368649981-08] 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-368649981
  • 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

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

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

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

Recently Updated Records for the Week of October 17, 2018 Last Modified Date: Monday, October 15, 2018

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-8-2018

Enforcement Report for the Week of August 15, 2018

Enforcement Report for the Week of August 15, 2018

Recently Updated Records for the Week of August 15, 2018 Last Modified Date: Monday, August 13, 2018

FDA - U.S. Food and Drug Administration

14-8-2018

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte neemt woensdagmiddag 15 augustus 2018 deel aan de herdenking van de capitulatie van Japan op 15 augustus 1945. De herdenking vindt plaats bij het Indisch Monument in Den Haag.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

18-7-2018

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Staatssecretaris Paul Blokhuis (VWS) wil het aantal zelfmoorden en zelfmoordpogingen terugdringen. Om dat te bereiken geeft hij structureel 2 miljoen per jaar extra instellingssubsidie aan 113Zelfmoordpreventie. Het jaarlijkse budget van de organisatie gaat daarmee fors omhoog, van 3,4 miljoen naar 5,4 miljoen euro. Daarnaast zijn er extra middelen voor andere lopende activiteiten zoals de lokale aanpakken suïcidepreventie en onderzoek. In totaal is daar 15 miljoen mee gemoeid.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

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

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

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

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety

29-6-2018

BROADLINE (Merial)

BROADLINE (Merial)

BROADLINE (Active substance: Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel) - Centralised - Yearly update - Commission Decision (2018) 4164 of Fri, 29 Jun 2018

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4080 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/287/14/T/01

Europe -DG Health and Food Safety