Co-Articel

Glavna informacija

  • Trgovački naziv:
  • Co-Articel 10 mg/2,5 mg filmom obložene tablete
  • Doziranje:
  • 10 mg + 2,5 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 10 mg perindopriltosilata, što odgovara 6,816 mg perindoprila, konvertiranog in situ u perindoprilnatrij i 2,5 mg indapamida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Teva UK Ltd., Eastbourne, East Sussex, Ujedinjeno Kraljevstvo; Merckle GmbH, Ulm, Njemačka; Teva Gyogyszergyar Zrt., Debrecen,

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Co-Articel 10 mg/2,5 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u spremniku, u kutiji [HR-H-054365653-01]; 50 tableta u spremniku, u kutiji [HR-H-054365653-02]; 90 tableta u spremniku, u kutiji [HR-H-054365653-03]; 100 tableta u spremniku, u kutiji [HR-H-054365653-04]; 60 tableta u spremniku, u kutiji [HR-H-054365653-05] Urbroj: 381-12-01/30-16-12

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-054365653
  • Datum autorizacije:
  • 26-10-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Co-Articel 10 mg/2,5 mg filmom obložene tablete

perindopriltosilat/indapamid

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

podatke.

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Sačuvajte ovu uputu. Moţda ćete je trebati ponovno pročitati.

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

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

njihovi znakovi bolesti jednaki Vašima.

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

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajtedio 4.

Što se nalazi u ovoj uputi:

Što je Co-Articel i za što se koristi

Što morate znati prije nego počnete uzimati Co-Articel

Kako uzimati Co-Articel

Moguće nuspojave

Kako čuvati Co-Articel

Sadrţaj pakiranja i druge informacije

1.

Što je Co-Articel i za što se koristi

Co-Articel je fiksna kombinacija dviju djelatnih tvari, perindoprila i indapamida. On je antihipertenziv i

koristi se za liječenje povišenog krvnog tlaka (hipertenzija).

Co-Articel se propisuje pacijentima koji već primaju 10 mg perindoprila i 2,5 mg indapamida u različitim

tabletama i koji umjesto toga mogu dobiti jednu tabletu lijeka Co-Articel koji sadrţi obje djelatne tvari.

Perindopril pripada skupini lijekova koji se nazivaju inhibitori angiotenzin-konvertirajućeg enzima (ACE

inhibitori). Djeluju tako da proširuju krvne ţile, što Vašem srcu olakšava pumpanje krvi kroz njih.Indapamid

je diuretik. Diuretici povećavaju količinu mokraće koju proizvode bubrezi. MeĎutim, indapamid se razlikuje

od drugih diuretika jer uzrokuje samo malo povećanje količine proizvedene mokraće. Svaka od djelatnih

tvari sniţava krvni tlak, a djelujući zajedno kontroliraju Vaš krvni tlak.

2.

Što morate znati prije nego počnete uzimati Co-Articel

Nemojte uzimati Co-Articel

ako ste alergični na perindopril, indapamid ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6),

ako ste alergični na bilo koji drugi ACE inhibitor ili bio koji drugi sulfonamid,

ako ste imali simptome poput piskanja pri disanju, oticanja lica ili jezika, intenzivan svrbeţ ili jak koţni

osip uz prethodno liječenje ACE inhibitorima ili ako ste Vi ili član Vaše obitelji imali ove simptome u

bilo kojim drugim okolnostima (stanje koje se naziva angioedem),

ako imate šećernu bolest ili oštećenu bubreţnu funkciju i liječite se lijekom za sniţavanje krvnog tlaka

koji sadrţi aliskiren,

ako imate tešku bolest jetre ili bolujete od stanja koje se zove hepatička encefalopatija (degenerativna

bolest mozga),

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ako imate tešku bolest bubrega ili ste na dijalizi,

ako imate nisku razinu kalija u krvi,

ako postoji sumnja da imate neliječeno dekompenzirano zatajenje srca (jako zadrţavanje vode, oteţano

disanje),

ako ste trudni više od 3 mjeseca (takoĎer je bolje je izbjegavati Co-Articel u ranoj trudnoći, vidjeti dio

„Trudnoća i dojenje“),,

ako dojite

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Co-Articel:

ako imate stenozu aorte (suţenje glavne krvne ţile koja izlazi iz srca) ili hipertrofičnu kardiomiopatiju

(bolest srčanog mišića) ili stenozu bubreţne arterije (suţenje arterije koja opskrbljuje bubreg krvlju),

ako imate zatajenje srca ili bilo koje druge probleme sa srcem,

ako imate probleme s bubrezima,

ako imate probleme s jetrom,

ako imate kolagensku bolest (koţna bolest) kao što je sistemski lupus eritematosus ili sklerodermiju,

ako imate aterosklerozu (otvrdnjavanje arterija),

ako imate hiperparatiroidizam (previše aktivne paratireoidne ţlijezde),

ako imate ulog (giht),

ako imate šećernu bolest (dijebetes),

ako ste na dijeti s ograničenim unosom soli ili koristite nadomjeske soli koje sadrţe kalij,

ako uzimate litij ili diuretike koji štede kalij (spironolakton, triamteren) ili nadomjeske kalija jer se

njihova primjena s lijekom Co-Articel treba izbjegavati (vidjeti dio „Drugi lijekovi i Co-Articel“)

ako ste osoba starije dobi,

ako ste imali fotosenzitivne reakcije

ako imate tešku alergijsku reakciju s oticanjem lica, usana, usta, jezika ili grla, što uzrokuje oteţano

gutanje ili disanje (angioedem). To se moţe desiti bilo kada tijekom liječenja. Ako se kod Vas jave ti

simptomi, prestanite uzimati lijek i odmah se javite liječniku.

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 bubreţne tegobe povezane sa šećernom bolešću,

aliskiren.

Liječnik Vam moţe provjeravati bubreţnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u

krvi u redovitim intervalima.

Vidjeti takoĎer informacije pod naslovom „Nemojte uzimati Co-Articel“.

ako uzimate bilo koji od navedenih lijekova, povećan je rizik od nastanka angioedema (brzo oticanje

potkoţnog tkiva u području poput grla):

racekadotril (primjenjuje se za liječenje proljeva).

sirolimus, everolimus, temsirolimus i ostale lijekove koji pripadaju skupini lijekova koji se

nazivaju inhibitori mTOR-a (primjenjuju se za sprječavanje odbacivanja presaĎenih organa).

ako ste pripadnik crne rase moţete imati veći rizik od angioedema te ovaj lijek kod Vas moţe biti i

manje učinkovit u sniţenju krvnog tlaka, nego što je to slučaj kod osoba koje nisu pripadnici crne rase,

ako ste podvrgnuti hemodijalizi s visokoprotočnim membranama.

Angioedem

Angioedem (teška alergijska reakcija s oticanjem lica, usana, usta, jezika ili grla, što uzrokuje oteţano

gutanje ili disanje) zabiljeţena je kod bolesnika liječenih ACE inhbitorima, uključujući Co-Articel. To se

moţe javiti bilo kada tijekom liječenja. Ukoliko se ti simptome razviju kod Vas, prestanite uzimati Co-

Articel i odmah se javite liječniku. Vidjeti takoĎer dio 4.

Obavezno recite svom liječniku ako mislite da ste trudni ili biste mogli zatrudnjeti. Co-Articel se ne

preporučuje u ranoj trudnoći i ne smije se uzimati ako ste trudni više od 3 mjeseca, jer moţe ozbiljno

naštetiti Vašem djetetu ako se primjenjuje u tom stadiju (vidjeti dio „Trudnoća i dojenje“).

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Kada uzimate ovaj lijek, obavezno obavijestite svog liječnika ili medicinsko osoblje:

ako ćete biti podvrgnuti anesteziji i/ili kirurškom zahvatu,

ako ste nedavno imali proljev ili povraćali ili ste dehidrirani,

ako ćete biti podvrgnuti dijalizi ili LDL aferezi (uklanjanje kolesterola iz Vašeg organizma pomoću

ureĎaja),

ako ćete biti podvrgnuti desenzibilizacijskom tretmanu radi smanjivanja učinaka alergije na ubod pčele

ili ose,

ako ćete biti podvrgnuti medicinskoj pretrazi koja zahtijeva primjenu injekcije kontrastnog sredstva koje

sadrţi jod (tvar koja omogućava da organi poput bubrega ili ţeluca budu vidljivi na rendgenu).,

ako tijekom uzimanja Co-Articela imate promjene vida ili bol u jednom ili oba oka. To moţe biti znak

da razvijate glaukom odnosno povišeni očni tlak. Trebate prestati uzimati Co-Articel i potraţiti savjet

liječnika.

Sportaši trebaju imati na umu da ovaj lijek sadrţi djelatnu tvar (indapamid) koja moţe dati pozitivnu

reakciju na doping testu.

Djeca i adolescenti

Co-Articel se ne smije davati djeci i adolescentima.

Drugi lijekovi i Co-Articel

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

lijekove.

Trebate izbjegavati primjenu lijeka Co-Articela s:

litijem (koristi se za liječenje manije ili depresije),

aliskirenom (za liječenje povišenog krvnog tlaka) ako nemate šećernu bolest ili probleme s bubrezima,

diureticima koji štede kalij (npr. triamteren, amilorid), kalijevim solima.

estramustinom (koristi se u liječenju karcinoma)

drugim lijekovima koji se koriste u liječenju povišenog krvnog tlaka: ACE inhibitori i blokatori

angiotenzinskih receptora.

Na liječenje Co-Articelom mogu utjecati drugi lijekovi. Liječnik će Vam moţda morati promijeniti dozu i/ili

poduzeti druge mjere opreza. Obavezno obavijestite svog liječnika ako uzimate bilo koji od sljedećih

lijekova, jer to moţe zahtijevati posebnu skrb:

drugi lijekovi za liječenje povišenog krvnog tlaka, uključujući blokatore angiotenzin II receptora (ARB)

ili aliskiren (vidjeti takoĎer informacije pod naslovima „Nemojte uzimati Co-Articel“ i „Upozorenja i

mjere opreza“) ili diuretici (lijekovi koji povećavaju količinu mokraće koju proizvode bubrezi),

diuretici koji štede kalij, koji se koriste u liječenju zatajenja srca: eplerenon i spironolakton u dozama od

12,5 mg do 50 mg na dan,

anestetici,

kontrastna sredstva koja sadrţe jod,

moksifloksacin, sparfloksacin (antibiotici: lijekovi koji se koriste u liječenju infekcija),

metadon (za liječenje ovisnosti),

prokainamid (za liječenje nepravilnosti otkucaja srca),

alopurinol (za liječenje uloga (gihta)),

mizolastin, terfenadin ili astemizol (antihistaminici koji se primjenjuju u liječenju peludne groznice ili

alergije),

kortikosteroidi koji se primjenjuju u liječenju različitih stanja uključujući tešku astmu i reumatoidni

artritis,

imunosupresivi koji se primjenjuju u liječenju autoimunih poremećaja ili nakon transplantacije kako bi

se spriječilo odbacivanja organa (npr. ciklosporin, takrolimus),

eritromicin koji se daje u obliku injekcije (antibiotik),

halofantrin (koristi se za liječenje odreĎenih vrsta malarije),

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pentamidin (koristi se za liječenje upale pluća),

zlato koje se daje u obliku injekcije, poznato kao natrijev aurotiomalat (koristi se u liječenju

reumatoidnog poliartritisa),

vinkamin (koristi se u liječenju kongenitivnih poremećaja u starijih osoba, uključujući gubitak pamćenja

u starijih),

bepridil (koristi se za liječenje angine pektoris),

sultoprid (koristi se u liječenju psihoza),

lijekovi za liječenje poremećaja srčanog ritma (npr. kinidin, hidrokinidin, disopiramid, amiodaron,

sotalol),

cisaprid, difemanil(koriste se za liječenje ţelučanih i probavnih problema)

digoksin ili drugi srčani glikozidi (za liječenje srčanih problema),

baklofen (za liječenje ukočenosti mišića koja se javlja u bolestima poput multiple skleroze),

lijekovi koji se koriste za liječenje šećerne bolesti (dijabetesa) kao što su inzulin ili metformin ili

gliptini,

kalcij, uključujući dodatke kalcija,

stimulirajuće laksative (npr. sena),

nesteroidni protuupalni lijekovi (npr. ibuprofen) ili visoke doze salicilata (npr. acetilsalicilatna kiselina),

amfotericin B koji se daje injekcijom (za liječenje teških gljivičnih bolesti),

lijekovi za liječenje mentalnih poremećaja poput depresije, tjeskobe, shizofrenije (npr. triciklički

antidepresivi i neuroleptici),

tetrakozaktid (za liječenje Crohnove bolesti),

trimetoprim i kotrimoksazol, koji je poznat i kao trimetoprim/sulfametoksazol (za liječenje infekcija),

vazodilatatori uključujući nitrate (lijekovi koji šire krvne ţile),

heparin (sprečava zgrušavanje krvi),

lijekovi koji se koriste u liječenju sniţenog krvnog tlaka, šoka ili astme (npr. efedrin, noradrenalin ili

adrenalin),

lijekovi, koji se najčešće koriste u liječenju proljeva (racekadotril) ili za sprečavanje odbacivanja

presaĎenih organa (sirolimus, everolimus, temsirolimus i drugi lijekovi koji pripadaju skupini tzv. mTor

inhibitora). Vidjeti dio „Upozorenja i mjere opreza“.

Trudnoća i dojenje

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.

Trudnoća

Liječnik će Vam u pravilu savjetovati da prestanete uzimati Co-Articel prije nego što zatrudnite ili čim

saznate da ste trudni te će Vam savjetovati da uzmete drugi lijek umjesto Co-Articel.

Ovaj lijek se ne preporučuje u ranoj trudnoći i ne smije se uzimati ako ste trudni više od 3 mjeseca, jer moţe

prouzročiti ozbiljna oštećenja u Vašeg djeteta ako se primjenjuje nakon trećeg mjeseca trudnoće.

Dojenje

Co-Articel 10 mg/2,5 mg NE SMIJU uzimati majke koje doje. Ako ţelite dojiti, liječnik će Vam odrediti

drugu terapiju, posebno ako je Vaše dijete tek roĎeno ili je roĎeno prije vremena.

Odmah posjetite liječnika.

Upravljanje vozilima i strojevima

Co-Articel obično ne utječe na budnost, meĎutim različite reakcije poput omaglice ili slabosti, povezane sa

sniţenjem krvnog tlaka mogu se javiti u odreĎenih bolesnika. Ako do toga doĎe, Vaša sposobnost

upravljanja vozilima i strojevima moţe biti oslabljena.

Co-Articel sadrži laktozu hidrat

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog

lijeka.

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3.

Kako uzimati Co-Articel

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

liječnikom ili ljekarnikom ako niste sigurni.

Preporučena doza je jedna tableta jednom dnevno. Preporuča se tabletu uzeti ujutro prije obroka. Progutajte

tabletu uz čašu vode.

Ako uzmete više Co-Articela nego što ste trebali

Ako uzmete previše tableta, odmah se javite svom liječniku ili hitnoj sluţbi najbliţe bolnice. Najvjerojatniji

učinak u slučaju predoziranja je nizak krvni tlak. Ako doĎe do značajnog pada krvnog tlaka (simptomi poput

mučnine, povraćanja, grčeva, omaglice, pospanosti, konfuznosti, promjena u količini mokraće koju stvaraju

bubrezi), moţe pomoći postavljanje u leţeći poloţaj s podignutim nogama.

Ako ste zaboravili uzeti Co-Articel

Vaţno je da svoj lijek uzimate svaki dan, jer je redovito liječenje učinkovitije. MeĎutim, ako zaboravite

uzeti jednu dozu Co-Articela, uzmite sljedeću dozu u uobičajeno vrijeme. Nemojte uzeti dvostruku dozu

kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Co-Articel

Budući da liječenje visokog krvnog tlaka obično traje cijeli ţivot, obavezno se savjetujte sa svojim

liječnikom prije prestanka uzimanja ovog lijeka.

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili ljekarniku.

4.

Moguće nuspojave

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

Ako se kod Vas javi neka od sljedećih nuspojava, odmah prestanite uzimati lijek i javite se svom

liječniku:

Teška omaglica ili nesvjestica zbog niskog krvnog tlaka (Često - moţe se javiti u manje od 1 na 10

osoba)

Bronhospazam (pritisak u prsima, piskutavo disanje i kratkoća daha (Manje često - moţe se javiti u

manje od 1 na 100 osoba)

Oticanje lica, usana, usta, jezika ili grla, oteţano disanje, (angioedem) (Vidjeti dio 2 „Upozorenja i

mjere opreza“) (Manje često - moţe se javiti u manje od 1 na 100 osoba)

Teške koţne reakcije uključujući multiformni eritem (koţni osip koji često počinje s pojavom crvenila

na koţi koja svrbe, a javljaju se na licu, rukama ili nogama) ili intenzivni rašireni koţni osip s pojavom

urtika i crvenilom, teškim svrbeţom, pojavom mjehura, ljuštenjem i oticanjem koţe te upalom sluznica

(Stevens-Johnson-ov sindrom) ili ostale alergijske reakcije (Vrlo rijetko - moţe se javiti u manje od 1 na

10 000 osoba)

Poremećaji srca i krvnih ţila (nepravilni otkucaji srca, angina pektoris (bol u prsima, čeljusti i leĎima,

čija je pojava vezana uz fizičke napore), srčani udar) (Vrlo rijetko - moţe se javiti u manje od 1 na 10

000 osoba)

Slabost ruku ili nogu, ili problemi s govorom koji mogu biti znak mogućeg moţdanog udara (Vrlo

rijetko - moţe se javiti u manje od 1 na 10 000 osoba)

Upala gušterače koja moţe uzrokovati jaku bol u trbuhu i leĎima, praćenu općim lošim osjećanjem (Vrlo

rijetko - moţe se javiti u manje od 1 na 10 000 osoba)

Ţuta boja koţe ili očiju (ţutica) koja moţe biti znak hepatitisa (Vrlo rijetko- moţe se javiti u manje od 1

na 10 000 osoba)

Nepravilni otkucaji srca koji su ţivotno ugroţavajući (Nepoznato)

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Poremećaj mozga uzrokovan bolešću jetre (hepatička encefalopatija) (Nepoznato)

Prema padajućem redoslijedu učestalosti, nuspojave mogu uključivati:

Često (mogu se javiti u manje od 1 na 10 osoba): koţne reakcije kod osoba s predispozicijom za

alergijske i asmatske reakcije, glavobolja, omaglica, vrtoglavica, osjećaj trnjenja i bockanja u nekom

dijelu tijela, poremećaji vida, zujanje u ušima (tinitus), kašalj, nedostatak zraka (dispneja), poremećaji

probavnog sustava (mučnina, povraćanje, bol u trbuhu, poremećaji okusa, dispepsija ili probavne

tegobe, proljev, zatvor), alergijske reakcije (poput koţnog osipa, svrbeţa), grčevi mišića, osjećaj umora.

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Manje često (mogu se javiti u manje od 1 na 100 osoba): promjene raspoloţenja, poremećaji spavanja,

urtikarija, crvene točkice na koţi (purpura), pojava mjehurića na koţi, problemi s bubrezima,

impotencija, znojenje, povišeni broj eozinofila (vrsta bijelih krvnih stanica), promjene u laboratorisjkim

nalazima: povišene vrijednosti kalija u krvi, koje se normaliziraju nakon prestanka uzimanja lijeka,

sniţene vrijednosti natrija u krvi, pospanost, omaglica, palpitacije (osjećaj lupanja srca), tahikardija

(ubrzani srčani ritam), hipoglikemija (sniţene vrijednosti šećera u krvi) kod oboljelih od šećerne bolesti,

vaskulitis (upala krvnih ţila), suha usta, fotosenzitivne reakcije (povećana osjetljivost koţe na sunce),

artralgija (bol u zglobovima), mialgija (bol u mišićima), bol u prsima, pobolijevanje, periferni edem,

vrućica, povišene vrijednosti ureje u krvi, povišene vrijednosti kreatinina, padovi.

-

Rijetko (mogu se javiti u manje od 1 na 1000 osoba): pogoršanje psorijaze, promjene u laboratorijskim

nalazima: povišene vrijednosti jetrenih enzima, povišene razine bilirubina u serumu, umor.

-

Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba): smetenost, eozinofilna pneumonija (rijetka

vrsta upale pluća), začepljenje ili curenje iz nosa (rinitis), teški problemi s bubrezima, promjene u

krvnim parametrima poput sniţenog broja bijelih i crvenih krvnih stanica, sniţenog hemoglobina,

sniţenog broja krvnih pločica, povišenih vrijednosti kalcija u krvi, abnormalna jetrena funkcija.

-

Nepoznato (učestalost se ne moţe procijeniti iz dostupnih podataka): promjene u nalazima EKG-a,

promjene u krvnim nalazima: sniţene vrijednosti kalija, povišene vrijednosti mokraćne kiseline i

povišene vrijednsoti šećera u krvi, kratkovidnost (miopija), zamućeni vid, oštećenje vida. Ako bolujete

od sistemskog eritemskog lupusa (vrsta kolagenske bolesti), moguće je njegovo pogoršanje.

Mogu se javiti poremećaji krvi, funkcije bubrega, jetre ili gušterače, a rezultati pretraga krvi mogu biti

promijenjeni. Vaš liječnik će Vas moţda uputiti na ispitivanje krvi kako bi kontrolirao Vaše stanje.

Prijavljivanje nuspojava

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

Ovo uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave moţete prijaviti

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

nuspojava moţete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Co-Articel

Lijek čuvajte izvan pogleda i dohvata djece.

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

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

Spremnik čuvati čvrsto zatvoren radi zaštite od vlage. Lijek ne zahtjeva posebne temperaturne uvjete

čuvanja.

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

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

H A L M E D

14 - 06 - 2017

O D O B R E N O

6.

Sadržaj pakiranja i druge informacije

Što Co-Articel sadrži

Djelatne tvari su perindopriltosilat i indapamid. Jedna filmom obloţena tableta sadrţi 10 mg

perindopriltosilata (što odgovara 6,816 mg perindoprila) i 2,5 mg indapamida.

Drugi sastojci su laktoza hidrat, kukuruzni škrob, natrijev hidrogenkarbonat, prethodno geliran

kukuruzni škrob, povidon, magnezijev stearat, poli(vinilni alkohol) – djelomično hidroliziran, titaninijev

dioksid E171, makrogol/PEG 3350 i talk.

Kako Co-Articel izgleda i sadržaj pakiranja

Co-Articel 10 mg/2,5 mg filmom obloţene tablete su bijele, okrugle i bikonveksne filmom obloţene tablete,

promjera pribliţno 10 mm, bez oznaka na obje strane tablete.

Tablete su dostupne u polipropilenskim spremnicima s polietilenskim zatvaračima, koji sadrţe 30, 50, 60

(2x30), 90 (3x30) ili 100 (2x50) tableta.

Na trţištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja za stavljanje lijeka u promet

PLIVA HRVATSKA d.o.o.

Prilaz baruna Filipovića 25

10 000 Zagreb

Proizvođač

TEVA Gyógyszergyár Zrt.

Pallagi út 13, Debrecen, H-4042

MaĎarska

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

Ujedinjeno Kraljevstvo

Pharmachemie B.V.

Swensweg 5, Haarlem

2031 GA

Nizozemska

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80., Krakow, 31-546

Poljska

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren, Baden-Wuerttemberg, 89143

Njemačka

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

nazivima:

Belgija

Coperindo 10 mg/2,5 mg filmomhulde tabletten /comprimés pelliculés /

H A L M E D

14 - 06 - 2017

O D O B R E N O

Češka

Estonija

Francuska

Irska

Italija

Litva

Latvija

Malta

Nizozemska

Poljska

Portugal

Rumunjska

Slovenija

Filmtabletten

Perindopril tosilate/Indapamid Teva 10 mg/2,5 mg

Perindopril/Indapamide Teva

Périndopril tosilate/ Indapamide TEVA 10/2,5 mg comprimé pelliculé

Perindopril tosilate/Indapamide Teva 10 mg/2.5 mg Film-coated Tablets

Perindopril e Indapamide Teva Italia

Perindopril/Indapamide Teva 10 mg/2,5 mg plėvele dengtos tabletės

Perindopril/Indapamide Teva 10 mg/2,5 mg apvalkotās tabletes

Perindopril tosilate/Indapamide Teva 10 mg/2.5 mg Film-coated Tablets

Perindopril Tosilaat/Indapamide Teva 10 mg/2,5 mg, filmomhulde tabletten

Indix Combi

Perindopril + Indapamida Mepha

PERINDOPRIL TOSILAT/INDAPAMIDĂ TEVA 10 mg/2,5 mg comprimate

filmate

Perivol Combo 10 mg/2,5 mg filmsko obloţene tablete

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u lipnju 2017.

H A L M E D

14 - 06 - 2017

O D O B R E N O

17-11-2018

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Published on: Fri, 16 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Germany for the pesticide active substance clodinafop‐propargyl 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 clodinafop‐p...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

4-10-2018

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

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

Published on: Wed, 03 Oct 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 Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos 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 ethopro...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 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 Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin 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 b...

Europe - EFSA - European Food Safety Authority Publications

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

31-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-5-2018

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3023 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

15-5-2018

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (Active substance: palivizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3064 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/257/T/116

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety