Amicor H 10 mg 12 5

Glavna informacija

  • Trgovački naziv:
  • Amicor H 10 mg/12,5 mg tablete
  • Doziranje:
  • 10 mg + 12,5 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 10 mg lizinoprila u obliku lizinopril dihidrata i 12,5 mg hidroklorotiazida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Jadran Galenski laboratorij d.d., Rijeka, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Amicor H 10 mg/12,5 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 20 tableta u blisteru, u kutiji [HR-H-778899966-01]; 30 tableta u blisteru, u kutiji [HR-H-778899966-02] Urbroj: 381-12-01/70-15-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-778899966
  • Datum autorizacije:
  • 22-10-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Amicor H 10 mg/12,5 mg tablete

Amicor H 20 mg/12,5 mg tablete

lizinopril/hidroklorotiazid

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im štetiti, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To uključuje

i svaku moguću nuspojavu koja nije navedena u ovoj uputi, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što je Amicor H i za što se koristi?

Što morate znati prije nego počnete uzimati Amicor H?

Kako uzimati Amicor H?

Moguće nuspojave

Kako čuvati Amicor H?

Sadržaj pakiranja i druge informacije

1.

Što je Amicor H i za što se koristi?

Amicor H se koristi za liječenje visokog krvnog tlaka (hipertenzije). Sadrži dvije djelatne tvari koje se

zovu lizinopril i hidroklorotiazid.

Lizinopril pripada skupini lijekova koje nazivamo inhibitori konvertaze angiotenzina (ACE inhibitori)

i koji djeluje tako da pomaže širenju Vaših krvnih žila.

Hidroklorotiazid pripada skupini lijekova koju nazivamo diuretici (˝tablete za mokrenje˝). Pomaže

Vašem tijelu da se oslobodi viška vode i soli poput natrija u Vašoj mokraći.

Lizinopril i hidroklorotiazid zajedno pomažu u snižavanju krvnog tlaka.

2.

Što morate znati prije nego počnete uzimati Amicor H?

Nemojte uzimati Amicor H:

ako ste alergični na lizinopril, hidroklorotiazid ili bilo koji drugi sastojak ovog lijeka (naveden u

dijelu 6.),

ako ste alergični na druge ACE inhibitore ili sulfonamide. Pitajte svog liječnika ukoliko niste

sigurni,

ako ste prije imali oticanje ruku, nogu, zglobova, lica, usana, jezika ili grla, osobito tijekom

ranijeg liječenja s drugim lijekovima koji pripadaju skupini ACE inhibitora, pri čemu ste otežano

disali ili gutali,

ako imate dijagnozu nasljednog angioedema (stanje kod kojeg ste skloni oticanju kako je gore

opisano). Pitajte svog liječnika ukoliko niste sigurni da se to odnosi na Vas,

ako imate ozbiljnih problema s bubrezima,

ako ne mokrite,

ako imate tešku bolest jetre,

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ako ste trudni više od 3 mjeseca (izbjegavajte uzimanje lijeka Amicor H i u ranoj trudnoći,

pogledajte dio ˝Trudnoća i dojenje˝),

ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog

tlaka koji sadrži aliskiren.

Ako se nešto od gore navedenog odnosi na Vas, nemojte uzimati Amicor H. Ukoliko niste sigurni,

obratite se svome liječniku ili ljekarniku.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Amicor H:

ako imate suženje (stenozu) aorte (najveća krvna žila koja izlazi iz srca), srčanih zalistaka

(mitralni zalisci) ili bubrežnih arterija,

ako imate zadebljanje srčanog mišića (hipertrofičnu kardiomiopatiju),

ako imate problema s krvnim žilama (kolagena bolest krvnih žila),

ako imate nizak krvni tlak. Može se očitovati kao omaglica ili ošamućenost, posebice pri

ustajanju,

ako primijetite skup simptoma koji uključuju suha usta, žeđ, opću slabost, omamljenost, bolove,

grčeve i umor mišića, nizak krvni tlak, smanjeno mokrenje, ubrzani rad srca i poremećaje

probavnog sustava kao što su mučnina i povraćanje,

ako imate problema se bubrezima, odnosno idete na dijalizu ili imate presađen bubreg,

ako imate problema s jetrom,

ako imate šećernu bolest, tijekom prvog mjeseca liječenja ovim lijekom potrebno je češće mjeriti

razine glukoze u krvi,

ako ste nedavno imali proljev ili obilno povraćanje,

ako Vas je liječnik uputio da morate biti na dijeti sa smanjenim unosom soli,

ako primijetite dugotrajan suhi kašalj koji ne prestaje,

ako imate povišenu razinu kolesterola i idete na liječenje tzv. LDL aferezu,

ako imate sistemski eritemski lupus,

ako ste trudni ili biste mogli zatrudnjeti. Amicor H nije preporučen u ranoj trudnoći i ne smije se

uzimati ako ste trudni više od 3 mjeseca jer može ozbiljno naškoditi Vašem djetetu (vidjeti dio

„Trudnoća i dojenje“),

ako ste crne rase, jer Amicor H u Vas može biti manje djelotvoran. Također morate biti spremni

na veću učestalost nuspojave tzv. angioedema (teška alergijska reakcija koja se očituje oticanjem

ruku, nogu, zglobova, lica, usana, jezika ili grla)

Ako niste sigurni odnosi li se nešto od gore navedenog na Vas, obratite se svome liječniku ili

ljekarniku prije nego uzmete Amicor H.

Također, obratite se svom liječniku prije nego uzmete Amicor H:

ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog

tlaka:

blokator angiotenzin II receptora (ARB) (nazivaju se i sartanima – primjerice valsartan,

telmisartan, irbesartan), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.

aliskiren.

Liječnik Vam može provjeravati bubrežnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u krvi

u redovitim intervalima.

Vidjeti također informacije pod naslovom ˝Nemojte uzimati Amicor H˝.

Liječenje alergija na ubode insekata

Recite svom liječniku ukoliko idete ili namjeravate ići na postupak smanjenja alergijske reakcije npr.

na ubode insekata (postupak desenzibilizacije). Ako uzimate Amicor H tijekom postupka, može se

javiti teška alergijska reakcija.

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Operativni zahvat

Recite svom liječniku ili stomatologu ukoliko idete na neki operativni zahvat (uključujući i operacije u

usnoj šupljini) da uzimate Amicor H jer može doći do kratkotrajnog pada krvnog tlaka ako Vam bude

primijenjena lokalna ili opća anestezija.

Djeca i adolescenti

Amicor H nije namijenjen za liječenje djece i adolescenata jer sigurnost i djelotvornost primjene ovog

lijeka u ove skupine bolesnika nije utvrđena.

Drugi lijekovi i Amicor H

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

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

Amicor H može utjecati na učinak drugih lijekova te neki lijekovi mogu utjecati na učinak lijeka

Amicor H.

Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza ako uzimate:

neki

blokator

angiotenzin

receptora

(ARB)

aliskiren

(vidjeti

također

informacije

naslovima ˝Nemojte uzimati Amicor H˝ i ˝Upozorenja i mjere opreza˝),

druge lijekove za snižavanje krvnog tlaka, uključujući gliceriltrinitrat i sl.

˝tablete za mokrenje˝(diuretike),

nesteroidne protuupalne lijekove (NSAID) koji se koriste za liječenje bolova ili upale, npr.

indometacin, ibuprofen, acetilsalicilatna kiselina u dozi većoj od 3 g na dan, jer mogu umanjiti

učinak na snižavanje krvnog tlaka,

lijekove za liječenje depresije (uključujući tricikličke antidepresive, npr. amitriptilin, maprotilin),

lijekove za psihičke bolesti, uključujući litij,

lijekove koji povećavaju razinu kalija u krvi, poput nekih tableta za mokrenje (spironolakton,

epleronon, amilorid, triamteren) ili tableta kalija ili nadomjeske za sol koji sadrže kalij,

soli kalcija,

inzulin ili lijekove za liječenje šećerne bolesti koji se uzimaju kroz usta jer mogu povećati učinak

na snižavanje razine glukoze u krvi,

lijekove za liječenje astme,

lijekove za liječenje začepljenosti nosa ili sinusa ili ostale lijekove protiv simptoma prehlade

(uključujući i one koji se mogu kupiti bez recepta),

lijekove za suzbijanje imunološke reakcije organizma (imunosupresivi, kao što je ciklosporin),

alopurinol (lijek za liječenje gihta),

prokainamid (lijek za liječenje nepravilnog rada srca),

srčane glikozide (lijekovi za liječenje srčanih bolesti, npr. digoksin i metildigoksin),

lijekove koji sadrže zlato, uključujući natrijev aurotiomalat koji se primjenjuju u obliku injekcije,

amfotericin B (lijek za liječenje gljivičnih infekcija),

karbenoksolon (lijek za liječenje vrijeda (čira) jednjaka ili usta),

kortikosteroide (lijekovi koji utječu na upalni odgovor organizma),

kortikotropin (hormon),

lijekove za liječenje zatvora (laksativi),

kolestiramin

kolestipol

(lijekovi

sniženje

kolesterola

krvi,

sprečavanje

proljeva

ublažavanje svrbeža),

lijekove za opuštanje mišića (tubokurarin),

trimetoprim (antibakterijski lijek),

sotalol (beta- blokator, lijek za liječenje nepravilnog rada srca),

lovastatin (lijek za snižavanje kolesterola),

dekstran sulfat (koristi se u liječenju koje se zove LDL afereza, za sniženje kolesterola u krvi),

lijekove za liječenje zloćudnih bolesti (citostatike),

ostale lijekove koji mogu izazvati poremećaj rada srca poznat kao

torsades de pointes.

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Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Trudnoća

Morat reći svom liječniku ako mislite da ste trudni (ili planirate trudnoću). Vaš će vam liječnik obično

savjetovati da prestanete uzimati Amicor H prije nego što zatrudnite ili čim saznate da ste trudni te će

Vam savjetovati da uzmete neki drugi lijek umjesto Amicora H. Amicor H se ne preporučuje u ranoj

trudnoći i ne smijete ga uzimati ako ste trudni više od 3 mjeseca jer može ozbiljno naškoditi Vašem

djetetu ako ga koristite nakon trećeg mjeseca trudnoće.

Dojenje

Recite svom liječniku ako dojite ili planirate dojiti. Amicor H se ne preporučuje majkama koje doje te

Vaš

liječnik

može

odabrati

drugu

terapiju

želite

dojiti,

posebno

Vaše

dijete

novorođenče ili je prijevremeno rođeno.

Upravljanje vozilima i strojevima

Ovaj lijek može ponekad uzrokovati omaglicu i umor što može utjecati na upravljanje vozilom ili

strojem,

posebno

početku

liječenja,

tijekom

prilagodbe

doze

istodobnoj

primjeni

alkoholom. Ako se to dogodi, nemojte upravljati vozilom ili koristiti alate ili strojeve. Morate pričekati

da vidite kako ovaj lijek utječe na Vas prije nego počnete upravljati vozilom ili raditi sa strojem.

3.

Kako uzimati Amicor H?

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

ili ljekarnikom ako niste sigurni.

Kada jednom započnete uzimati ovaj lijek, Vaš će liječnik možda zatražiti da obavite krvne pretrage.

Liječnik će Vam prilagoditi dozu koju uzimate, kako biste uzeli odgovarajuću količinu ovog lijeka.

Doziranje kod odraslih osoba

Uobičajena doza

je jedna Amicor H tableta, jedanput dnevno.

Vaš liječnik će propisati jačinu lijeka koja Vam je potrebna.

Ako je potrebno, Vaš liječnik može povećati dozu na dvije tablete, primijenjene jedanput dnevno.

Način primjene

progutajte tabletu s dovoljnom količinom vode.

potrudite se da uzmete tabletu svaki dan u isto vrijeme. Nije važno uzimate li ovaj lijek prije ili

poslije jela.

nastavite uzimati ovaj lijek onoliko dugo koliko Vam je liječnik rekao. Radi se o dugotrajnom

liječenju i važno je uzeti ovaj lijek svaki dan.

tableta se može razdijeliti na jednake doze.

Uzimanje prve doze lijeka

budite osobito oprezni kada prvi puta uzimate ovaj lijek ili kad Vam se povećava Vaša doza.

Može doći do jačeg pada krvnog tlaka nego kasnije tijekom liječenja.

to se može očitovati kao vrtoglavica i ošamućenost, a ti se simptomi mogu smanjiti ako legnete.

Ukoliko Vas to zabrinjava, obratite se svom liječniku.

Primjena u djece i adolescenata

Ovaj lijek nije namijenjen za primjenu u djece i adolescenata.

Ako uzmete više Amicor H tableta nego što ste trebali

Ako uzmete više Amicor H tableta nego što Vam je propisao Vaš liječnik, odmah se javite svom

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liječniku ili otiđite u bolnicu. Sa sobom ponesite pakiranje lijeka ili ovu uputu kako bi zdravstveno

osoblje znalo koji ste lijek uzeli.

Ako ste zaboravili uzeti Amicor H tabletu

Ako ste zaboravili uzeti tabletu, uzmite je čim se sjetite, osim ako nije uskoro vrijeme za vašu sljedeću

dozu. U tom slučaju preskočite zaboravljenu tabletu. Nemojte uzeti dvostruku dozu kako biste

nadoknadili zaboravljenu tabletu.

Ako prestanete uzimati Amicor H

Nemojte prekinuti uzimati ovaj lijek, iako se osjećate bolje, prije nego što se posavjetujete sa svojim

liječnikom.

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

4.

Moguće nuspojave

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

Amicor H sadrži dva lijeka, lizinopril i hidroklorotiazid. Nuspojave navedene u nastavku zabilježene

su uz primjenu pojedinog lijeka. To znači da se također mogu pojaviti uz primjenu lijeka Amicor H.

Moguće nuspojave uz lizinopril

Teške alergijske reakcije

(rijetko, javljaju se u manje od 1 na 1000 osoba)

Ako imate tešku alergijsku reakciju,

prestanite uzimati Amicor H i odmah se javite liječniku

u bilo

kojem od sljedećih slučajeva:

ako Vam nateknu lice, usne, jezik i/ili grlo, zbog čega disanje ili gutanje može biti otežano,

ako Vam iznenada nateknu ruke, stopala ili gležnjevi,

otežano disanje,

jak svrbež kože (s uzdignutim kvržicama), ozbiljne promjene na koži ili osip. Simptomi

obuhvaćaju crvenilo, stvaranje mjehurića i ljuštenje kože, koji mogu brzo nastati i mogu

uključivati stvaranje mjehurića u ustima i nosu i drugim sluznicama.

Ozbiljni problemi s jetrom

(vrlo rijetko, javljaju se u manje od 1 na 10 000 osoba)

Znakovi mogu uključivati:

žutilo kože ili očiju, tamno obojana mokraća ili gubitak apetita.

Ako Vam se ovo dogodi,

odmah posjetite svog liječnika.

Ostale moguće nuspojave:

Česte

(javljaju se u manje od 1 na 10 osoba)

glavobolja,

osjećaj omaglice ili nesvjestice, pad krvnog tlaka osobito prilikom naglog ustajanja,

nesvjestica,

proljev,

povraćanje,

kašalj,

problemi s bubrezima (koji se vide pomoću krvne pretrage).

Manje česte

(javljaju se manje od 1 na 100 osoba)

promjene raspoloženja, osjećaj depresije,

osjećaj štipkanja poput 'bockanja i trnaca',

vrtoglavica,

promjene okusa,

problemi sa spavanjem,

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srčani ili moždani udar,

osjećaj lupanja srca, ubrzan rad srca,

promjene boje prstiju na rukama ili nogama,

curenje iz nosa,

mučnina, bol u želucu i loša probava,

promjene u krvnim pretragama koje služe za provjeru funkcije jetre,

osip, svrbež,

nemogućnost postizanja erekcije (impotencija),

opća slabost, umor,

povišena razina određenih tvari u Vašoj krvi (ureje, kreatinina, ili kalija).

Rijetke

(javljaju se u manje od 1 na 1000 osoba)

promjene nekih stanica ili drugih dijelova Vaše krvi; znakovi mogu obuhvaćati osjećaj umora

i bljedoću kože,

smetenost,

promjene u osjetu mirisa,

suhoća usta,

koprivnjača,

gubitak kose (alopecija),

psorijaza (problem s kožom),

infekcija krvi,

zatajenje bubrega,

povećanje dojki kod muškaraca,

sindrom

neprimjerenog

lučenja

antidiuretskog

hormona

(engl.

SIADH

Syndrome

of

Inappropriate Antidiuretic Secretion

niska

razina

natrija

krvi,

što

može

uzrokovati

slabost,

umor,

glavobolju,

mučninu,

povraćanje i grčeve.

Vrlo rijetke

(javljaju se u manje od 1 na 10 000 osoba)

problemi s koštanom srži ili smanjen broj krvnih stanica i/ili trombocita u Vašoj krvi. Možete

zamijetiti umor, infekciju (koja može biti ozbiljna), vrućicu, osjećaj nedostatka zraka ili lakšeg

dobivanja modrica ili lakšeg krvarenja.

otečene žlijezde (limfni čvorovi),

pojačani imunološki odgovor (autoimuna bolest),

niska razina šećera u krvi (hipoglikemija). Znakovi mogu obuhvaćati osjećaj gladi ili slabosti,

znojenje i ubrzan rad srca.

iznenadni osjećaj teškog disanja ili nedostatka zraka (bronhospazam),

upala pluća (zbog koje možete osjećati nedostatak zraka),

upala sinusa (osjećaj boli i punoće iza obraza i očiju),

eozinofilna upala pluća. Znakovi uključuju kombinaciju sljedećeg:

upala sinusa

osjećaj kao da imate gripu

osjećaj sve većeg nedostatka zraka

bol u području želuca ili crijeva

kožni osip

osjećaj ‘bockanja i trnaca’ ili obamrlosti ruku ili nogu.

upala gušterače. To uzrokuje umjerenu do jaku bol u trbuhu.

oticanje sluznice crijeva. To može uzrokovati iznenadnu bol u trbuhu, proljev ili Vam izazvati

mučninu (povraćanje).

znojenje,

smanjena količina mokraće (urina) nego uobičajeno ili prestanak mokrenja.

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Nepoznata učestalost

(ne može se procijeniti na temelju dostupnih podataka)

halucinacije

crvenilo kože praćeno osjećajem vrućine

Moguće nuspojave uz hidroklorotiazid (nepoznata učestalost)

upala žlijezde slinovnice,

smanjen broj krvnih stanica i/ili trombocita u Vašoj krvi. Možete zamijetiti umor, infekciju

(koja može biti ozbiljna), vrućicu, osjećaj nedostatka zraka ili lakšeg dobivanja modrica ili

lakšeg krvarenja.

gubitak apetita,

povećana količina šećera (glukoze) u Vašoj krvi,

šećer u Vašem urinu,

povećana količina mokraćne kiseline u Vašoj krvi,

promijenjene razine tvari u Vašoj krvi (na primjer niski natrij i kalij). Možete zamijetiti

mišićnu slabost, žeđ, ‘bockanje i trnce’, grčeve ili osjećaj mučnine.

povišene ili visoke razine masnoća u Vašoj krvi (uključujući kolesterol).

giht,

nemir,

depresija,

poteškoće sa spavanjem,

osjećaj štipkanja poput ‘bockanja i trnaca’,

ošamućenost,

promjene vida od kojih Vam stvari mogu izgledati žute,

kratkoročni problemi s vidom,

jaka bol u očima s crvenilom i iznenadno zamagljenim vidom. Ako iznenada imate bolno,

crveno oko odmah obavijestite svojeg liječnika; možda Vam je potrebno liječenje kako bi

izbjegli trajni gubitak vida.

vrtoglavica,

osjećaj nesvjestice (posebno kod ustajanja),

oštećenje krvnih žila što uzrokuje crvene ili ljubičaste mrlje po koži,

otežano disanje. Možete osjećati nedostatak zraka ako dobijete upalu pluća ili imate tekućinu

u plućima,

nadraženost želuca,

proljev,

zatvor,

upala gušterače. To uzrokuje umjerenu do jaku bol u trbuhu,

žutilo Vaše kože ili bjeloočnica očiju (žutica),

problemi s kožom koji obuhvaćaju osip uzrokovan osjetljivošću na svjetlost, osip, jaki osip

koji brzo nastaje, uz stvaranje mjehurića i ljuštenje kože te mogućeg stvaranja mjehurića u

ustima, aktivirajući ili pogoršavajući postojeći sistemski lupus ili pojave neobičnih reakcija na

koži.

alergijske reakcije,

grčevi mišića i slabost mišića,

problemi s bubrezima koji mogu biti ozbiljni (vidljivo u krvnim pretragama),

vrućica,

slabost.

Prijavljivanje nuspojava

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

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

nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

H A L M E D

22 - 10 - 2015

O D O B R E N O

5.

Kako čuvati Amicor H?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

EXP.

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

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

6.

Sadržaj pakiranja i druge informacije

Što Amicor H tablete sadrže?

Amicor H 10 mg/12,5 mg tablete

1 tableta sadrži 10 mg lizinoprila u obliku lizinopril dihidrata i 12,5 mg hidroklorotiazida.

Pomoćne tvari: kalcijev hidrogenfosfat dihidrat, manitol, kukuruzni škrob, škrob prethodno geliran,

magnezijev stearat, talk, silicijev dioksid, bezvodni, koloidni, željezov oksid, žuti (E 172).

Amicor H 20 mg/12,5 mg tablete

1 tableta sadrži 20 mg lizinoprila u obliku lizinopril dihidrata i 12,5 mg hidroklorotiazida.

Pomoćne tvari:

kalcijev hidrogenfosfat dihidrat, manitol, kukuruzni škrob, škrob prethodno geliran,

magnezijev stearat, talk, silicijev dioksid, bezvodni, koloidni, željezov oksid, žuti (E 172), željezov

oksid, crveni (E 172).

Kako Amicor H tablete izgledaju i sadržaj pakiranja?

Amicor H 10 mg/12,5 mg tableta je svijetlo žute do žute boje, šesterokutnog bikonveksnog oblika s

urezom u sredini tablete. Tableta se može razdijeliti na jednake doze.

Amicor H 20 mg/12,5 mg tableta je svijetlo ružičaste do ružičaste boje, šesterokutnog bikonveksnog

oblika s urezom u sredini tablete.

Tableta se može razdijeliti na jednake doze.

Pakiranja

20 (2x10) tableta u PVC/Al blisteru, u kutiji.

30 (3x10) tableta u PVC/Al blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

JADRAN-GALENSKI LABORATORIJ d.d., Svilno 20, 51000 Rijeka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji put revidirana u listopadu 2015.

H A L M E D

22 - 10 - 2015

O D O B R E N O

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

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

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

23-10-2018

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

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

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

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

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

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

13-9-2018

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

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

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

FDA - U.S. Food and Drug Administration

11-9-2018

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

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

Published on: Mon, 10 Sep 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 Greece for the pesticide active substance alpha‐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...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

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

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety