Co-Articel

Glavna informacija

  • Trgovački naziv:
  • Co-Articel 5 mg / 1,25 mg filmom obložene tablete
  • Doziranje:
  • 5 mg + 1,25 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 5 mg perindopriltosilata i 1,25 mg indapamida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Pliva Hrvatska d.o.o., Zagreb, Republika Hrvatska; Teva Gyogyszergyar Zrt., Debrecen, Mađarska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Co-Articel 5 mg / 1,25 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u bočici, u kutiji [HR-H-954176708-01] Urbroj: 381-12-01/70-18-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-954176708
  • Datum autorizacije:
  • 11-01-2018
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Co-Articel 2,5 mg/0,625 mg filmom obložene tablete

Co-Articel 5 mg/1,25 mg filmom obložene tablete

perindopriltosilat, indapamid

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

podatke.

-

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

-

Ako imate dodatnih pitanja, obratite se Vašem 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 Vašeg 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 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?

Sadržaj pakiranja i druge informacije

1. Što je Co-Articel i za što se koristi?

Co-Articel sadrži dvije djelatne tvari: perindopriltosilat i indapamid.

Co-Articel je namijenjen za liječenje visokog krvnog tlaka (hipertenzije).

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

inhibitori). Tijekom liječenja perindoprilom krvne se žile šire, što olakšava srcu pumpanje krvi i dovodi

do sniženja krvnog tlaka.

Indapamid pripada skupini diuretika. Diuretici su lijekovi koji povećavaju količinu mokraće koju bubrezi

stvaraju. Indapamid, za razliku od nekih drugih diuretika, samo neznatno pojačava stvaranje mokraće.

Svaka od djelatnih tvari ovog lijeka smanjuje krvni tlak te zajednički doprinose kontroli Vašeg krvnog

tlaka.

2. Što morate znati prije nego počnete uzimati Co-Articel?

Nemojte uzimati Co-Articel

ako ste alergični na perindopril ili bilo koji drugi ACE inhibitor, na indapamid ili bilo koji drugi

sulfonamid, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6),

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

kožni osip tijekom prethodnog liječenja 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 bubrežnu funkciju i liječite se lijekom za snižavanje krvnog

tlaka koji sadrži aliskiren,

imate

tešku

bolest

jetre

bolujete

stanja

koje

zove

hepatička

encefalopatija

(degenerativna bolest mozga),

ako imate tešku bolest bubrega ili ste na dijalizi,

H A L M E D

11 - 01 - 2018

O D O B R E N O

ako imate nisku razinu kalija u krvi,

ako postoji sumnja da imate neliječeno dekompenzirano zatajenje srca (jako zadržavanje vode u

tijelu, otežano disanje),

ako ste trudni više od 3 mjeseca (takoĎer je bolje izbjegavati primjenu ovog lijeka u ranoj trudnoći,

vidjeti dio „Trudnoća i dojenje“),,

ako dojite

Upozorenja i mjere opreza

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

ako imate stenozu aorte (suženje glavne krvne žile koja izlazi iz srca) ili hipertrofičnu

kardiomiopatiju (bolest srčanog mišića) ili stenozu bubrežne arterije (suženje 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 (kožna bolest) kao što je sistemski lupus eritematosus ili sklerodermiju,

ako imate aterosklerozu (otvrdnjavanje arterija),

ako imate hiperparatireoidizam (previše aktivne paratireoidne žlijezde),

ako imate giht,

ako imate šećernu bolest (dijabetes),

ako ste na dijeti s ograničenim unosom soli ili koristite nadomjeske soli koji sadrže kalij,

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

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

ako ste osoba starije dobi,

ako imate reakcije fotoosjetljivosti

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

gutanje ili disanje (angioedem). To se može dogoditi bilo kada tijekom liječenja. Ako se kod Vas

jave ovi simptomi, odmah prestanite uzimati lijek i javite se 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 bubrežne tegobe povezane sa šećernom

bolešću,

aliskiren.

Liječnik Vam može provjeravati bubrežnu funkciju, krvni tlak i količinu elektrolita (npr.

kalija) u krvi u redovitim intervalima.

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

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

oticanje ispod kože u područjima poput grla):

racekadotril (primjenjuje se za liječenje proljeva).

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

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

ako ste pripadnik crne rase možete imati veći rizik od nastanka angioedema te ovaj lijek kod Vas

može biti i manje učinkovit u sniženju krvnog tlaka, nego kod osoba drugih rasa,

ako idete na hemodijalizu u kojoj se koriste visokopropusne membrane.

Angioedem

Angioedem (teška alergijska reakcija s oticanjem lica, usana, usta, jezika ili grla, što može uzrokovati

otežano gutanje ili disanje) zabilježena je kod bolesnika liječenih ACE inhbitorima, uključujući ovaj

lijek. To se može javiti bilo kada tijekom liječenja. Ukoliko se ti simptomi razviju kod Vas, odmah

prestanite uzimati ovaj lijek i javite se Vašem liječniku. Vidjeti takoĎer dio 4.

Obavezno recite Vašem liječniku ako mislite da ste trudni ili biste mogli zatrudnjeti. Ovaj lijek se ne

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

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

H A L M E D

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O D O B R E N O

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

ako ćete biti podvrgnuti anesteziji i/ili operativnom zahvatu,

ako ste nedavno imali proljev ili povraćali ili ste dehidrirali,

ako ćete biti podvrgnuti dijalizi ili LDL aferezi (uklanjanje kolesterola iz Vaše krvi pomoću ureĎaja),

ako ćete biti podvrgnuti tretmanu desenzibilizacije radi smanjivanja učinaka alergije na ubode pčela

ili osa,

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

koje sadrži jod (tvar koja omogućava da organi poput bubrega ili želuca budu vidljivi na rendgenu),

ako Vam se tijekom uzimanja ovog lijeka jave promjene vida ili bol u jednom ili oba oka. To može

biti znak da Vam se razvija glaukom, odnosno povišeni očni tlak. Trebate prestati uzimati ovaj lijek

što je brže moguće i potražiti savjet liječnika.

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

reakciju na doping testu.

Djeca i adolescenti

Djelotvornost i sigurnost primjene ovog lijeka u djece nije utvrĎena. Zbog toga ne smijete davati ovaj

lijek djeci.

Drugi lijekovi i Co-Articel

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

druge lijekove.

Trebate izbjegavati primjenu ovog lijeka s:

litijem (koristi se za liječenje manije ili depresije),

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

bubrezima,

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

estramustinom (koristi se u liječenju raka)

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

angiotenzinskih receptora.

Na djelotvornost liječenja ovim lijekom mogu utjecati drugi lijekovi. Liječnik će Vam možda morati

promijeniti dozu i/ili poduzeti druge mjere opreza. Ovo uključuje sljedeće lijekove:

ako uzimate neki blokator angiotenzin II receptora (ARB) ili aliskiren (vidjeti takoĎer informacije

pod naslovima „Nemojte uzimati Co-Articel“ i „Upozorenja i mjere opreza“)

diuretici (lijekovi koji povećavaju izlučivanje mokraće),

lijekovi 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 sadrže jod,

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

metadon (za liječenje ovisnosti),

prokainamid (za liječenje nepravilnosti otkucaja srca),

alopurinol (za liječenje 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 bolesti 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),

pentamidin (koristi se za liječenje upale pluća),

H A L M E D

11 - 01 - 2018

O D O B R E N O

zlato koje se daje u obliku injekcije (koristi se u liječenju reumatoidnog poliartritisa),

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

pamćenja),

bepridil (koristi se za liječenje angine pektoris),

sultoprid (koristi se u liječenju psihoza),

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

sotalol),

cisaprid, difemanil (koriste se za liječenje želučanih 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, metformin ili

gliptini,

kalcij, uključujući dodatke kalcija,

stimulirajući laksativi (npr. sena),

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

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

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

antidepresivi i neuroleptici:

amisulprid, sulpirid, tiaprid, haloperidol, droperidol),

tetrakozaktid (za liječenje Chronove bolesti),

ko-trimoksazol, koji je poznat i kao trimetoprim/sulfametoksazol (za liječenje infekcija),

vazodilatatori uključujući nitrate (lijekovi koji šire krvne žile),

heparin (sprečava zgrušavanje krvi),

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

adrenalin),

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

presaĎenih organa (sirolimus, everolimus, temsirolimus i drugi lijekovi koji pripadaju skupini koja se

naziva mTOR inhibitori). Vidjeti dio „Upozorenja i mjere opreza“.

Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Trudnoća

Vaš liječnik će Vam u pravilu savjetovati da prestanete uzimati ovaj lijek prije nego što zatrudnite ili čim

saznate da ste trudni i savjetovat će Vam da uzmete neki drugi lijek umjesto ovog lijeka.

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

može uzrokovati ozbiljna oštećenja kod Vašeg djeteta nakon trećeg mjeseca trudnoće.

Dojenje

Ovaj lijek ne smiju uzimati žene koje doje. Vaš liječnik može odabrati drugu terapiju za Vas ako želite

dojiti, osobito ako je Vaše dijete novoroĎenče ili je prijevremeno roĎeno.

Odmah se posavjetujte s liječnikom.

Upravljanje vozilima i strojevima

Ovaj lijek obično ne utječe na pozornost, meĎutim različite reakcije kao što su omaglica ili slabost,

povezane sa sniženjem krvnog tlaka, mogu se javiti kod odreĎenih bolesnika. Ako do toga doĎe, Vaša

sposobnost upravljanja vozilima i strojevima može biti oslabljena.

Co-Articel sadrži laktozu.

Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.

H A L M E D

11 - 01 - 2018

O D O B R E N O

3. Kako uzimati Co-Articel?

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

ljekarnikom ako niste sigurni.

Preporučena doza je 1 tableta na dan, ujutro prije doručka.

Progutajte tabletu uz čašu vode.

Liječnik će Vas obavijestiti o trajanju liječenja.

Ako imate probleme s bubrezima, liječnik može odlučiti o smanjenju doze ili prilagodbi doziranja.

Ako uzmete više Co-Articela nego što ste trebali

Ako ste uzeli previše tableta, odmah zatražite savjet liječnika ili hitne medicinske službe. Najčešći znak

predoziranja

krvnog

tlaka.

pojavi

znatno

niži

krvni

tlak

(povezan

mučninom,

povraćanjem, grčevima, omaglicom, pospanošću, zbunjenošću, promjenama u količini mokraće koju

proizvedu bubrezi), može pomoći ležanje s podignutim nogama.

Ako ste zaboravili uzeti Co-Articel

Važno je da svoj lijek uzimate svaki dan jer je redovito liječenje djelotvornije. MeĎutim, ako zaboravite

uzeti jednu dozu lijeka, uzmite sljedeću dozu u uobičajeno vrijeme. Nemojte uzeti dvostruku dozu kako

biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Co-Articel

S obzirom na to da je liječenje povišenog krvnog tlaka obično dugotrajno, obavezno se savjetujte s

Vašim 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 može uzrokovati nuspojave iako se one neće pojaviti kod svakoga.

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

liječniku:

teška omaglica ili nesvjestica zbog niskog krvnog tlaka (često - može se javiti u do 1 na 10 osoba)

bronhospazam (pritisak i stezanje u prsima, piskutavo disanje i kratkoća daha (manje često - može se

javiti u do 1 na 100 osoba)

oticanje lica, usana, usta, jezika ili grla, otežano disanje (angioedem) (vidjeti dio 2 „Upozorenja i

mjere opreza“) (manje često - može se javiti u do 1 na 100 osoba)

teške kožne reakcije, uključujući multiformni eritem (kožni osip koji često počinje s pojavom

crvenih mrlja na licu, rukama ili nogama koje jako svrbe) ili intenzivni kožni osip, koprivnjača,

crvenilo kože po cijelom tijelu, jak svrbež, pojava mjehura, ljuštenje i oticanje kože, upala sluznica

(Stevens-Johnsonov sindrom) ili ostale alergijske reakcije (vrlo rijetko - može se javiti u do 1 na 10

000 osoba)

poremećaji srca i krvnih žila (nepravilni otkucaji srca, angina pektoris (bol u prsima, čeljusti i leĎima

koja se javlja pri fizičkim naporima), srčani udar) (vrlo rijetko - može se javiti u do 1 na 10 000

osoba)

slabost ruku ili nogu, ili problemi s govorom koji mogu biti znak moždanog udara (vrlo rijetko -

može se javiti u do 1 na 10 000 osoba)

upala gušterače koja može uzrokovati jaku bol u trbuhu i leĎima, praćenu općim lošim osjećanjem

(vrlo rijetko - može se javiti u do 1 na 10 000 osoba)

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11 - 01 - 2018

O D O B R E N O

žuta boja kože ili očiju (žutica) koja može biti znak hepatitisa (upala jetre) (vrlo rijetko- može se

javiti u do 1 na 10 000 osoba)

nepravilni otkucaji srca koji su životno ugrožavajući (nepoznato-

učestalost se ne može procijeniti iz

dostupnih podataka)

bolest mozga uzrokovana bolešću jetre (hepatična encefalopatija) (nepoznato-

učestalost se ne može

procijeniti iz dostupnih podataka)

Zabilježene su i sljedeće nuspojave:

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

kožne reakcije preosjetljivosti kod osoba s predispozicijom za alergijske i astmatske 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, poremećaj okusa, dispepsija

ili loša probava, proljev, zatvor)

alergijske reakcije (poput kožnog osipa, svrbeža)

grčevi mišića,

opća slabost

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

promjene raspoloženja

poremećaji spavanja

koprivnjača

crvene točkice na koži (purpura)

pojava mjehurića na koži

problemi s bubrezima

poremećaj seksualne funkcije

prekomjerno znojenje

povišeni broj eozinofila (vrsta bijelih krvnih stanica)

promjene u laboratorisjkim nalazima: povišena razina kalija u krvi koja se normalizira nakon

prestanka uzimanja lijeka, snižena razina natrija u krvi

jaka pospanost

nesvjestica

osjećaj lupanja srca (palpitacije)

ubrzani srčani ritam (tahikardija)

snižene vrijednosti šećera u krvi (hipoglikemija) kod oboljelih od šećerne bolesti

upala krvnih žila (vaskulitis)

suhoća usta

reakcije fotoosjetljivosti (povećana osjetljivost kože na sunčevo svjetlo)

bol u zglobovima (artralgija)

bol u mišićima (mialgija)

bol u prsima

malaksalost

oticanje ruku i nogu (periferni edem)

vrućica

povišena razina ureje u krvi, povišena razina kreatinina u krvi

padovi

H A L M E D

11 - 01 - 2018

O D O B R E N O

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

pogoršanje psorijaze

promjene u laboratorijskim nalazima: povišena razina jetrenih enzima, povišena razina bilirubina

u serumu

umor

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

smetenost

eozinofilna upala pluća (rijetka vrsta upale pluća)

začepljenje ili curenje iz nosa (rinitis)

teške bolesti bubrega

promjene u krvnim pretragama poput sniženog broja bijelih i crvenih krvnih stanica, sniženog

hemoglobina, sniženog broja krvnih pločica (trombocita), povišene razine kalcija u krvi

poremećena jetrena funkcija

Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):

promjene u nalazima EKG-a,

promjene u krvnim nalazima: snižena razina kalija, povišena razina mokraćne kiseline i povišena

razina šećera u krvi

kratkovidnost (miopija)

zamućeni vid

oštećenje vida.

ako bolujete od sistemskog eritematoznog 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 možda uputiti na ispitivanje krvi kako bi kontrolirao Vaše stanje.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg 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 Co-Articel?

Ovaj 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.

Rok valjanosti nakon prvog otvaranja je 6 mjeseci uz čuvanje na temperaturi ispod 25°C.

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 Vašeg ljekarnika kako

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

6. Sadržaj pakiranja i druge informacije

Što Co-Articel sadrži?

-

Djelatne tvari su perindopriltosilat i indapamid.

H A L M E D

11 - 01 - 2018

O D O B R E N O

Jedna Co-Articel 2,5 mg/0,625 mg filmom obložena tableta sadrži 2,5 mg perindopriltosilata i 0,625

mg indapamida.

Jedna Co-Articel 5 mg/1,25 mg filmom obložena tableta sadrži 5 mg perindopriltosilata i 1,25 mg

indapamida.

-

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

kukuruzni škrob, povidon K30, magnezijev stearat, poli(vinilni alkohol) - djelomično hidroliziran,

titanijev dioksid (E171), makrogol/PEG 3350 i talk.

Kako Co-Articel izgleda i sadržaj pakiranja?

Co-Articel 2,5 mg/0,625 mg filmom obložene tablete su bijele, bikonveksne, filmom obložene tablete u

obliku kapsula, otprilike 4 mm široke i 8 mm dugačke, s urezom na jednoj strani i bez ikakvih oznaka na

drugoj strani.

Urez služi samo kako bi se olakšalo lomljenje radi lakšeg gutanja, a ne da bi se lijek podijelio na jednake

doze.

Co-Articel 5 mg/1,25 mg filmom obložene tablete su bijele, bikonveksne, filmom obložene tablete u

obliku kapsula, otprilike 5 mm široke i 10 mm dugačke, s oznakama "P" i "I" te urezom na jednoj strani i

bez ikakvih oznaka na drugoj strani.

Tableta se može razdijeliti na jednake doze.

Tablete su dostupne u pakiranju od 30 filmom obloženih tableta u bijeloj neprozirnoj PP bočici s bijelim

neprozirnim PE zatvaračem i sredstvom za sušenje, u kutiji.

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

PLIVA HRVATSKA d.o.o.

Prilaz baruna Filipovića 25

10 000 Zagreb

TEVA Gyógyszergyár Zrt.

Pallagi út 13, Debrecen, H-4042

MaĎarska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u siječnju 2018.

H A L M E D

11 - 01 - 2018

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