Ivabradine Accord

Glavna informacija

  • Trgovački naziv:
  • Ivabradine Accord
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ivabradine Accord
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Srčana terapija
  • Područje terapije:
  • Zastoj srca
  • Terapijske indikacije:
  • Simptomatsko liječenje kronične stabilne angine pektoris.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/004241
  • Datum autorizacije:
  • 22-05-2017
  • EMEA koda:
  • EMEA/H/C/004241
  • Zadnje ažuriranje:
  • 28-02-2018

Izvješće o ocjeni javnog

EMA/308752/2017

EMEA/H/C/004241

EPAR, sažetak za javnost

Ivabradine Accord

ivabradin

Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ivabradine Accord. Objašnjava

kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu

primjenu. Svrha sažetka nije davati praktične savjete o primjeni lijeka Ivabradine Accord.

Praktične informacije o primjeni lijeka Ivabradine Accord bolesnici trebaju pročitati u uputi o lijeku,

odnosno obratiti se svom liječniku ili ljekarniku.

Što je Ivabradine Accord i za što se koristi?

Ivabradine Accord je lijek za srce koji se koristi za liječenje dugotrajne stabilne angine (boli u prsima,

vilici ili leđima pri fizičkom naporu) u odraslih s bolešću koronarnih arterija (bolest srca u kojoj su

začepljene žile koje srce opskrbljuju krvlju). Lijek se koristi u bolesnika s normalnim srčanim ritmom

od barem 70 otkucaja u minuti. Koristi se u bolesnika koji ne mogu uzimati beta-blokatore (druga

vrsta lijeka za liječenje angine) ili u kombinaciji s beta-blokatorima u bolesnika čiju se bolest ne može

kontrolirati samo beta-blokatorima.

Ivabradine Accord također se koristi u bolesnika s dugoročnim zatajenjem srca (kad srce ne može

pumpati dovoljno krvi u ostatak tijela) i normalnim srčanim ritmom od barem 75 otkucaja u minuti.

Koristi se u kombinaciji sa standardnom terapijom koja uključuje beta-blokatore ili u bolesnika koje se

ne može liječiti beta-blokatorima.

Ivabradine Accord sadrži djelatnu tvar ivabradin. Riječ je o „generičkom lijeku”. To znači da Ivabradine

Accord sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u

Europskoj uniji (EU) pod nazivom Procoralan. Više informacija o generičkim lijekovima potražite u

dokumentu s pitanjima i odgovorima ovdje

Ivabradine Accord

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Kako se Ivabradine Accord koristi?

Ivabradine Accord je dostupan u obliku tableta (5 i 7,5 mg) te se izdaje samo na liječnički recept.

Preporučena početna doza je 5 mg dva puta dnevno uz obroke, što liječnik može povećati na 7,5 mg

dva puta dnevno ili smanjiti na 2,5 mg (polovicu tablete od 5 mg) dva puta dnevno, ovisno o pulsu i

simptomima bolesnika. U bolesnika starijih od 75 godina može se koristiti manja početna doza od 2,5

mg dva puta dnevno. Liječenje treba prekinuti ako je puls kontinuirano niži od 50 otkucaja u minuti ili

ako se nastave simptomi bradikardije (sporog pulsa). Pri liječenju angine terapiju treba prekinuti ako

se simptomi ne ublaže nakon tri mjeseca. Nadalje, liječnik će razmotriti prekid terapije ako lijek samo

ograničeno djeluje na ublažavanje simptoma i smanjenje pulsa.

Kako djeluje Ivabradine Accord?

Simptome angine uzrokuje stanje pri kojem srčani mišić ne prima dovoljno oksigenirane krvi. Pri

stabilnoj angini ti se simptomi javljaju za vrijeme fizičkog napora. Ivabradin, djelatna tvar u lijeku

Ivabradine Accord, blokira ‘I

struju’ u sinusnom čvoru, prirodnom elektrostimulatoru koji regulira puls.

Kada je ta struja blokirana, srčana se frekvencija smanjuje tako da srce mora manje raditi te treba

manje oksigenirane krvi. Stoga Ivabradine Accord ublažava ili sprječava simptome angine.

Do simptoma zatajenja srca dolazi kada srce ne opskrbljuje tijelo dovoljnom količinom krvi.

Snižavanjem srčane frekvencije, Ivabradine Accord ublažava napor za srce, te stoga usporava

napredak zatajenja srca i poboljšava simptome.

Kako je Ivabradine Accord ispitivan?

Ispitivanja o koristima i rizicima djelatne tvari pri odobrenim primjenama već su provedena za

referentni lijek Procoralan te ih ne treba ponavljati za lijek Ivabradine Accord.

Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Ivabradine Accord. Tvrtka je provela

i ispitivanje koje je pokazalo da je lijek „bioekvivalentan” referentnom lijeku. Dva su lijeka

bioekvivalentna kada u tijelu proizvode jednake razine djelatne tvari pa se stoga očekuje i da imaju

jednak učinak.

Koje su koristi i rizici od lijeka Ivabradine Accord?

Budući da je Ivabradine Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da

su njegove koristi i rizici isti kao i oni referentnog lijeka.

Zašto je Ivabradine Accord odobren?

Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je u skladu sa zahtjevima

EU-a potvrđeno da lijek Ivabradine Accord posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku

Procoralan. Stoga je stav CHMP-a da koristi nadmašuju utvrđene rizike, kao i kod lijeka Procoralan.

Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Ivabradine Accord u EU-u.

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Ivabradine Accord?

Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i

učinkovite primjene lijeka Ivabradine Accord nalaze se u sažetku opisa svojstava i u uputi o lijeku.

Ivabradine Accord

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Ostale informacije o lijeku Ivabradine Accord

Cjeloviti EPAR za lijek Ivabradine Accord nalazi se na internetskim stranicama

Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. Više

informacija o liječenju lijekom Ivabradine Accord pročitajte u uputi o lijeku (također dio EPAR-a),

odnosno obratite se svom liječniku ili ljekarniku.

Cjeloviti EPAR za referentni lijek također se nalazi na internetskim stranicama Agencije.

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacije za bolesnika

Ivabradin Accord 5 mg filmom obložene tablete

Ivabradin Accord 7,5 mg filmom obložene tablete

ivabradin

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.

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

ako su njihovi znakovi bolesti jednaki Vašima.

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

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

dio 4.

Što se nalazi u ovoj uputi:

Što je Ivabradin Accord i za što se koristi

Što morate znati prije nego počnete uzimati Ivabradin Accord

Kako uzimati Ivabradin Accord

Moguće nuspojave

5 Kako čuvati Ivabradin Accord

6. Sadržaj pakiranja i druge informacije

1.

Što je Ivabradin Accord i za što se koristi

Ivabradin Accord je lijek za srce koji se primjenjuje u liječenju:

Simptomatske stabilne angine pektoris (koja je karakterizirana pojavom bolova u prsnom košu)

u odraslih bolesnika koji imaju puls jednak ili veći od 70 otkucaja u minuti. Lijek se koristi kod

odraslih bolesnika koji ne podnose ili ne smiju uzimati lijekove za srce koji se zovu beta-

blokatori. Također se lijek koristi u kombinaciji s beta-blokatorima kod odraslih bolesnika čije

stanje nije u potpunosti kontrolirano s beta-blokatorima.

Kronično zatajenje srca kod odraslih bolesnika koji imaju puls veći ili jednak 75 otkucaja u

minuti. Lijek se koristi u kombinaciji sa standardnom terapijom, uključujući beta-blokatore ili

kada su beta-blokatori kontraindicirani ili se ne podnose.

O stabilnoj angini pektoris (koja se obično naziva “anginom”):

Stabilna angina pektoris jest bolest srca koja nastaje kada srce ne prima dovoljno kisika. Obično se

javlja u dobi između 40 i 50 godina. Najčešći simptom angine pektoris je pojava boli ili nelagode u

prsnom košu. Veća je vjerojatnost da će angina nastupiti kada srce radi brže u situacijama kao što je

fizički napor, emocije, izloženost hladnoći ili nakon jela. U ljudi koji boluju od angine, to povećanje

srčane frekvencije može uzrokovati bol u prsnom košu.

O kroničnom zatajenju srca:

Kronično zatajenje srca je bolest srca koja nastaje kada Vaše srce svojim radom ne može opskrbiti

Vaše tijelo dostatnom količinom krvi. Najčešći simptomi zatajenje srca su nedostatak zraka, opća

slabost, umor i oticanje gležnjeva.

Kako djeluje Ivabradin Accord?

Ivabradin Accord poglavito djeluje smanjivanjem srčane frekvencije za nekoliko otkucaja u minuti.

Time se smanjuje potreba srca za kisikom, osobito u situacijama kada postoji veća vjerojatnost da

će doći do napadaja angine. Na taj način, Ivabradin Accord pomaže u kontroliranju i smanjenju

broja napadaja angine. Nadalje, kako povišen broj otkucaja srca loše utječe na funkciju srca i

životnu prognozu bolesnika sa kroničnim zatajenjem srca, učinak ivabradina smanjivanjem srčane

frekvencije pomaže u poboljšanju rada srca kao i životnu prognozu kod ovih bolesnika.

2.

Što morate znati prije nego počnete uzimati Ivabradin Accord

Nemojte uzimati Ivabradin Accord

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

ako Vam je srčana frekvencija u mirovanju prije liječenja prespora (manje od 70

otkucaja u minuti);

ako bolujete od kardiogenog šoka (medicinsko stanje koje se liječi u bolnici);

ako bolujete od poremećaja srčanog ritma;

ako imate srčani udar;

ako imate niski krvni tlak;

ako imate nestabilnu anginu pektoris (težak oblik angine pektoris u kojoj se bolovi u

prsnom košu javljaju vrlo često uz napor, ali i bez napora);

ako imate zatajenje srca koje se nedavno pogoršalo;

ako imate elektrostimulator (pacemaker);

ako imate teške bolesti jetre;

ako uzimate lijekove za liječenje gljivičnih infekcija (kao što su ketokonazol, itrakonazol),

makrolidne antibiotike (kao što su jozamicin, klaritromicin, telitromicin ili eritromicin koji se

primjenjuju oralno), lijekove za liječenje infekcija HIV-om (kao što su nelfinavir, ritonavir) ili

nefazodon (lijek za liječenje depresije) ili diltiazem, verapamil (za liječenje visokog krvnog

tlaka ili angine pektoris);

ako ste žena koja može zatrudnijeti te ne koristite pouzdanu kontracepciju;

ako ste trudni ili pokušavate zatrudnijeti;

ako dojite.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Ivabradin Accord

ako bolujete od poremećaja srčanog ritma (kao nepravilni rad srca, osjećaj lupanja srca,

pojačana bol u prsnom košu) ili fibrilacije atrija (vrsta nepravilnog rada srca) ili

abnormalnosti u elektrokardiogramu (EKG) koje se nazivaju “sindrom dugog QT intervala”,

ako imate simptome kao što je umor, omaglica ili nedostatak zraka (to bi moglo značiti da

Vam srce radi presporo),

ako imate simptome fibrilacije atrija (puls u mirovanju neuobičajeno visok (iznad 110

otkucaja u minuti) ili nepravilan, bez jasnog razloga, što otežava njegovo mjerenje),

ako ste nedavno imali moždani udar,

ako imate blago ili umjereno niski krvni tlak,

ako bolujete od visokog krvnog tlaka koji nije dobro kontroliran, osobito nakon

promjene u terapiji

ako bolujete od teškog kroničnog srčanog zatajenja ili srčanog zatajenja s abnormalnošću

EKG-a koja se naziva „blok grane”,

ako imate kronične bolesti očne mrežnice,

ako imate umjereno oštećenje jetre,

ako imate teško oštećenje bubrega.

Ako se bilo što od gore navedenog odnosi na Vas, razgovarajte o tome s liječnikom prije nego što

počnete uzimati Ivabradin Accord, ili kada ga već uzimate.

Djeca

Ivabradin Accord nije namijenjen djeci ni adolescentima mlađima od 18 godina.

Drugi lijekovi i Ivabradin Accord

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

druge lijekove.

Ako uzimate neke od slijedećih lijekova, svakako o tome obavijestite svog liječnika koji bi trebao

prilagoditi dozu Ivabradin Accorda ili pratiti liječenje:

flukonazol (antifungik)

rifampicin (antibiotik)

barbiturati (za otežano spavanje ili epilepsiju)

fenitoin (za epilepsiju)

Hypericum perforatum ili Gospina trava (biljna terapija za depresiju)

lijekovi koji produljuju QT-interval i primjenjuju se za liječenje poremećaja srčanog ritma

ili drugih bolesti:

- kinidin, dizopiramid, ibutilid, sotalol, amiodaron (za liječenje poremećaja srčanog ritma)

bepridil (za liječenje angine pektoris)

lijekovi za liječenje anksioznosti, shizofrenije ili drugih psihoza (kao što su

pimozid, ziprasidon, sertindol)

antimalarici (kao npr. meflokin ili halofantrin)

intravenski eritromicin (antibiotik)

pentamidin (antiparazitik)

cisaprid (za liječenje gastro-ezofagealnog refluksa)

Neke vrste diuretika koji mogu uzrokovati sniženje razine kalija u krvi, poput

furosemida, hidroklorotiazida, indapamida (koriste se za liječenje edema, povišenog

krvnog tlaka).

Ivabradin Accord s hranom i pićem

Tijekom liječenja s Ivabradin Accordom izbjegavajte konzumiranje soka od grejpa.

Trudnoća i dojenje

Ne uzimajte Ivabradin Accord ako ste trudni ili planirate imati dijete (vidjeti “Nemojte uzimati

Ivabradin Accord”).

Ako ste trudni, a uzeli ste Ivabradin Accord, obratite se liječniku.

Nemojte uzimati Ivabradin Accord ako možete zatrudnijeti osim ako koristite pouzdanu

kontracepciju (vidjeti „Nemojte uzimati Ivabradin Accord”).

Ne uzimajte Ivabradin Accord ako dojite (vidjeti “Nemojte uzimati Ivabradin Accord”). Obavijestite

svog liječnika ukoliko dojite ili planirate dojiti budući da se dojenje treba obustaviti ukoliko uzimate

Ivabradin Accord.

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Upravljanje vozilima i strojevima

Ivabradin Accord može uzrokovati privremene vidne poremećaje (prolazna povećana svjetlost u

ograničenom dijelu vidnoga polja), (vidjeti dio 4 “Moguće nuspojave”). Ako se to dogodi Vama,

budite pažljivi kada upravljate vozilom ili radite za strojevima u vrijeme kada bi moglo doći do

iznenadnih promjena intenziteta svjetla, osobito tijekom upravljanja vozilom po noći.

Ivabradin Accord sadrži laktozu

Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati

ovaj lijek posavjetujete se sa svojim liječnikom.

3.

Kako uzimati Ivabradin Accord

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

ili ljekarnikom ako niste sigurni.

Ivabradin Accord treba uzimati tijekom obroka.

Ukoliko se liječite od stabilne angine pektoris

Početna doza ne smije prelaziti jednu tabletu Ivabradin Accord 5 mg dva puta na dan. Ukoliko i

dalje imate simptome angine i dobro podnosite dozu od 5 mg dva puta na dan, doza se može

povećati. Doza održavanja ne smije prelaziti 7,5 mg dva puta na dan. Liječnik će odrediti koja je

prava doza za Vas. Uobičajena doza je jedna tableta ujutro i jedna tableta uvečer. U nekim

slučajevima (npr. kod starijih osoba) postoji mogućnost da Vam liječnik propiše pola doze, t.j.

jednu polovicu tablete Ivabradin Accord 5 mg (što odgovara količini 2,5 mg ivabradina) ujutro i

jednu polovicu tablete Ivabradin Accord 5 mg uvečer.

Ukoliko se liječite od kroničnog zatajenja srca

Uobičajena doza je jedna tableta Ivabradin Accorda od 5 mg dva puta na dan, koja se, ako je

potrebno, povećava na jednu tabletu Ivabradin Accorda od 7,5 mg dva puta na dan. Liječnik će

odrediti koja je prava doza za Vas. Uobičajena doza je jedna tableta ujutro, a jedna tableta uvečer. U

nekim slučajevima (npr. kod starijih osoba) postoji mogućnost da Vam liječnik propiše pola doze,

t.j. polovicu tablete od Ivabradin Accorda 5 mg (što odgovara količini od 2,5 mg ivabradina) ujutro,

a drugu polovicu tablete od 5 mg uvečer.

Ako uzmete više Ivabradin Accorda nego što ste trebali:

Velika doza Ivabradin Accorda mogla bi djelovati tako da osjećate umor ili nedostatak zraka jer je

došlo do usporenja rada srca. Ako se to dogodi, odmah se obratite liječniku.

Ako ste zaboravili uzeti Ivabradin Accord:

Ako zaboravite uzeti jednu dozu Ivabradin Accorda, uzmite sljedeću dozu u uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Kalendar otisnut na blister pakiranju koje sadržava tablete, trebao bi Vam pomoći da zapamtite

kada ste zadnji put uzeli tabletu Ivabradin Accorda.

Ako prestanete uzimati Ivabradin Accord:

Liječenje angine ili kroničnog zatajenja srca obično je doživotno. Nemojte prekidati uzimanje

lijeka, a da se prethodno niste posavjetovali sa svojim liječnikom.

mislite

učinak

Ivabradin

Accorda

prejak

preslab,

razgovarajte

liječnikom

ljekarnikom.

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

4.

Moguće nuspojave

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

Učestalosti mogućih nuspojava mogu se svrstati prema sljedećoj podjeli:

vrlo često: mogu se javiti u više od 1 na 10 osoba

često: mogu se javiti u do 1 na 10 osoba

manje često: mogu se javiti u do 1 na 100 osoba

rijetko: mogu se javiti u do 1 na 1000 osoba

vrlo rijetko: mogu se javiti u do 1 na 10 000 osoba

nepoznato: učestalost se ne može procijeniti iz dostupnih podataka

Najčešće nuspojave zabilježene uz primjenu ovog lijeka su ovisne o dozi i povezane s

mehanizmom djelovanja lijeka:

Vrlo često:

Svjetlosni vidni fenomeni (kratki trenuci pojačane svjetlosti, najčešće uzrokovani iznenadnim

promjenama

intenziteta

svjetla).

Mogu

također

opisati

aureola,

raznobojni

bljeskovi,

rastavljanje slike ili višestruke slike. Obično se javljaju unutar prva dva mjeseca liječenja nakon

čega se mogu ponavljano javljati i nestati tijekom ili nakon liječenja.

Često:

Promjene u radu srca (simptomi su usporenje otkucaja srca). Osobito se javljaju unutar prva 2 ili 3

mjeseca od početka liječenja.

Druge nuspojave su također zabilježene:

Često:

Nepravilan, brzi rad srca, abnormalna percepcija rada srca, nekontrolirani krvni tlak, glavobolja,

omaglica i zamućen vid (zamagljen vid).

Manje često:

Osjećaj lupanja srca i neuobičajeni otkucaji srca, osjećaj slabosti (mučnina), zatvor, proljev, bol u

trbuhu, osjećaj vrtnje (vrtoglavica), poteškoće u disanju (dispneja), Spazmi mišića i promjene u

laboratorijskim pretragama: visoka razina mokraćne kiseline u krvi, prekomjeran broj eozinofila

(vrsta bijelih krvnih stanica) i povišena razina kreatinina u krvi (nastaje zbog raspada mišića), kožni

osip, angioedem (kao npr. oticanje lica, jezika ili grla, poteškoće u disanju ili gutanju), niski krvni

tlak, gubitak svijesti, osjećaj umora, osjećaj slabosti, abnormalni nalaz EKG-a, dvoslike, oštećen

vid.

Rijetko:

Urtikarija (koprivnjača), svrbež, crvenilo kože, opće loše osjećanje.

Vrlo rijetko:

Nepravilni otkucaji srca.

Prijavljivanje nuspojava

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

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

putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V. Prijavljivanjem

nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Ivabradin Accord

Lijek čuvajte izvan pogleda i dohvata djece.

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

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

Lijek ne zahtijeva posebne uvjete čuvanja.

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

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

6.

Sadržaj pakiranja i druge informacije

Što Ivabradin Accord sadrži

Djelatna tvar je ivabradin (u obliku ivabradinklorida).

Ivabradin Accord 5 mg: jedna filmom obložena tableta sadrži 5 mg ivabradina (u obliku

ivabradinklorida).

Ivabradin Accord 7,5 mg: jedna filmom obložena tableta sadrži 7,5 mg ivabradina (u obliku

ivabradinklorida).

Pomoćne tvari u jezgri tablete su: bezvodna laktoza, magnezijev stearat (E470b), prethodno

geliran škrob (kukuruzni), hidratizirani koloidni silicijev dioksid (E551); a u ovojnici tablete:

poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 4000, talk (E553b), žuti

željezov oksid (E172), crveni željezov oksid (E172).

Kako Ivabradin Accord izgleda i sadržaj pakiranja

Ivabradin Accord 5 mg filmom obložene tablete su duguljaste filmom obložene tablete boje lososa

s razdjelnom crtom na obje strane, s utisnutom oznakom „FK“ na jednoj strani i „2“ na drugoj

strani.

Ivabradin Accord 7,5 mg filmom obložene tablete su trokutaste filmom obložene tablete boje

lososa s utisnutom oznakom „FK“ na jednoj strani i „1“ na drugoj strani.

Tablete su dostupne u aluminij/aluminij perforiranim blisterima s jediničnim dozama u veličinama

pakiranja od 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 ili 112x1 tableta.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač:

Nositelj odobrenja:

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF

Ujedinjeno Kraljevstvo

Proizvođač:

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF

Ujedinjeno Kraljevstvo

Laboratori Fundacio Dau

C/ C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Španjolska

Wessling Hungary Kft.

Fóti út 56

1047 Budimpešta

Mađarska

Ova uputa je zadnji puta revidirana u MM/GGGG.

Ostali izvori informacija

Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za

lijekove: http://www.ema.europa.eu.

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 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 France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

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

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

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

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

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

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 pyraflufen‐ethyl

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

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

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

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

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

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

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

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

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

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety