Co-Dalneva

Glavna informacija

  • Trgovački naziv:
  • Co-Dalneva 4 mg/1,25 mg/10 mg tablete
  • Doziranje:
  • 4 mg + 1,25 mg + 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 4 mg perindopril-tert-butilamina što odgovara 3,34 mg perindoprila, 1,25 mg indapamida i 10 mg amlodipina u obliku amlodipinbesilata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo mesto, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Co-Dalneva 4 mg/1,25 mg/10 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-622847904-01]; 14 tableta u blisteru, u kutiji [HR-H-622847904-02]; 20 tableta u blisteru, u kutiji [HR-H-622847904-03]; 28 tableta u blisteru, u kutiji [HR-H-622847904-04]; 30 tableta u blisteru, u kutiji [HR-H-622847904-05]; 56 tableta u blisteru, u kutiji [HR-H-622847904-06]; 60 tableta u blisteru, u kutiji [HR-H-622847904-07]; 84 tablete u blisteru, u kutiji [HR-H-622847904-08]; 90 tableta u blisteru, u kutiji [HR-H-622847904-09] Urbroj: 381-12-01/14-17-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-622847904
  • Datum autorizacije:
  • 31-08-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Co-Dalneva 4 mg/1,25 mg/5 mg tablete

Co-Dalneva 4 mg/1,25 mg/10 mg tablete

Co-Dalneva 8 mg/2,5 mg/5 mg tablete

Co-Dalneva 8 mg/2,5 mg/10 mg tablete

perindopril-tert-butilamin/indapamid/amlodipin

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-Dalneva i za što se koristi?

Što morate znati prije nego počnete uzimati Co-Dalnevu?

Kako uzimati Co-Dalnevu?

Moguće nuspojave

Kako čuvati Co-Dalnevu?

Sadržaj pakiranja i druge informacije

1.

Što je Co-Dalneva i za što se koristi?

Co-Dalneva se propisuje za liječenje visokog krvnog tlaka (hipertenzije). Sve tri djelatne tvari pomažu

u kontroli visokog krvnog tlaka (hipertenzije). Bolesnici koji već uzimaju perindopril, indapamid i

amlodipin u odvojenim tabletama mogu umjesto toga uzimati jednu tabletu Co-Dalneve koja sadrži

sva tri sastojka.

Co-Dalneva sadrži tri djelatne tvari: perindopril, indapamid i amlodipin. Perindopril je ACE inhibitor

(inhibitor angiotenzin konvertirajućeg enzima). Amlodipin je antagonist kalcija (koji pripada klasi

lijekova nazvanoj dihidropiridini). Indapamid je diuretik.

U bolesnika s visokim krvnim tlakom perindopril i amlodipin djeluju opuštajući krvne žile, tako da krv

lakše prolazi kroz njih. Indapamid povećava količinu mokraće koju stvaraju bubrezi. Svaka od

djelatnih tvari snižava krvni tlak, te one zajedno djeluju kako bi kontrolirale krvni tlak.

2.

Što morate znati prije nego počnete uzimati Co-Dalnevu?

Nemojte uzimati Co-Dalnevu

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

druge sulfonamide, amlodipin ili bilo koje druge dihidropiridine, ili na neki drugi sastojak ovog

lijeka (naveden u dijelu 6.),

ako ste imali simptome poput piskanja, oticanja lica ili jezika, jakog svrbeža ili jakih kožnih

osipa uslijed prethodnog liječenja ACE inhibitorima ili ako ste Vi ili član Vaše obitelji imali ove

simptome u bilo kojim drugim okolnostima (stanje nazvano angioedem),

ako ste trudni duže od 3 mjeseca (takoĎer je bolje izbjegavati uzimanje Co-Dalneve u ranoj

trudnoći – vidjeti dio “Trudnoća i dojenje”),

ako dojite,

ako imate umjereno do tešku bolest bubrega ili idete na dijalizu,

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ako imate tešku bolest jetre ili stanje nazvano hepatička encefalopatija (degenerativna bolest

mozga uzrokovana bolešću jetre),

ako imate kardiogeni šok (kada srce nije u stanju opskrbljivati tijelo dovoljnom količinom krvi),

aortnu stenozu (suženje glavne krvne žile koja izlazi iz srca) ili nestabilnu anginu (bol u prsima

koja se može pojaviti pri odmaranju),

ako imate zatajenje srca (srce nije u mogućnosti pumpati krv na odgovarajući način što rezultira

nedostatkom zraka ili perifernim oteknućima kao što su oteknuća nogu, gležnjeva ili stopala)

nakon akutnog srčanog udara,

ako sumnjate da imate neliječeno dekompenzirano zatajenje srca (jako zadržavanje vode,

otežano disanje),

ako imate jako nizak krvni tlak (teška hipotenzija),

ako imate nisku ili visoku razinu kalija u krvi,

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

krvnog tlaka koji sadrži aliskiren.

Upozorenja i mjere opreza

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

ako ste nedavno imali srčani udar,

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

kardiomiopatiju (bolest srčanog mišića) ili stenozu bubrežne arterije (suženje arterije koja

bubreg opskrbljuje krvlju),

ako imate zatajenje srca,

ako imate bilo kakve druge probleme sa srcem ili probleme s bubrezima,

ako imate jako povišeni krvni tlak (hipertenzivna kriza),

ako imate problema s jetrom,

ako imate kolagenu bolest (kožna bolest) kao što je sistemski lupus eritematozus ili

skleroderma,

ako imate aterosklerozu (otvrdnuće arterija),

ako imate hiperparatireoidizam (prekomjerno aktivna paratireoidna žlijezda),

ako imate giht,

ako imate šećernu bolest,

ako ste na dijeti s ograničenim unosom soli ili koristite zamjenu za sol koja sadrži kalij,

ako uzimate litij ili diuretike koji štede kalij (spironolakton, triamteren) jer se njihova primjena s

Co-Dalnevom mora izbjegavati (vidjeti dio „Drugi lijekovi i Co-Dalneva“),

ako ste stariji i Vašu dozu treba povećati,

ako uzimate bilo koji od navedenih lijekova, povećan je rizik za nastanak angioedema:

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 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-Dalnevu”

Morate obavijestiti svog liječnika ako mislite da ste trudni (ili da biste mogli ostali trudni). Ne

preporučuje se primjena Co-Dalneve u ranoj trudnoći te se ne smije uzimati ako ste trudni duže od

3 mjeseca, jer može ozbiljno naškoditi Vašem djetetu ako se koristi u ovoj fazi trudnoće (vidjeti dio

„Trudnoća i dojenje“).

Pri uzimanju Co-Dalneve, takoĎer biste morali obavijestiti svog liječnika ili medicinsko osoblje:

ako ćete se podvrgnuti anesteziji i/ili operativnom zahvatu,

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ako ste nedavno imali proljev ili povraćali ili ste dehidrirali,

ako ćete se podvrgnuti dijalizi ili LDL aferezi (uklanjanje kolesterola iz krvi pomoću aparata),

ako se pripremate za desenzibilizacijsko liječenje kako bi smanjili učinke alergije na ubode

pčela ili osa,

ako ćete se podvrgnuti medicinskom testu koji zahtjeva ubrizgavanje jodnog kontrastnog

sredstva (tvar koja organe poput bubrega ili želuca čini vidljivim na rendgenu).

Sportaši moraju biti svjesni da Co-Dalneva sadrži djelatnu tvar (indapamid) koja može dati pozitivnu

reakciju u testovima na drogu.

Co-Dalneva se ne preporučuje za primjenu u djece i adolescenata.

Drugi lijekovi i Co-Dalneva

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

druge lijekove.

Potrebno je izbjegavati primjenu Co-Dalneve s:

litijem (koristi se u liječenju depresije),

diureticima koji štede kalij (spironolakton, triamteren), solima kalija,

estramustin (upotrebljava se u liječenju raka),

lijekovima koji se često primjenjuju u liječenju proljeva (racekadotril) ili za sprječavanje

odbacivanje presaĎenih organa (sirolimus, everolimus, temsirolimus i drugi lijekovi koji,

pripadaju skupini koja se naziva inhibitori mTOR-a). Vidjeti dio “Upozorenja i mjere opreza”.

Na liječenje s Co-Dalnevom mogu utjecati drugi lijekovi.

Pobrinite se da obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova jer će možda biti

potrebna posebna skrb:

druge lijekove za liječenje visokog krvnog tlaka (antihipertenzivi) uključujući neki blokator

angiotenzin II receptora (ARB) ili aliskiren (vidjeti takoĎer informacije pod naslovima

“Nemojte uzimati Co-Dalnevu” i “ Upozorenja i mjere opreza”),

prokainamid (za liječenje nepravilnih otkucaja srca),

alopurinol (za liječenje gihta),

terfenadin ili astemizol (antihistaminici za peludnu groznicu ili alergije),

kortikosteroide koji se koriste za liječenje različitih stanja uključujući tešku astmu i reumatoidni

artritis,

imunosupresive koji se koriste za liječenje autoimunih poremećaja ili nakon transplantacijskog

operativnog zahvata kako bi se spriječilo odbacivanje organa (npr. ciklosporin),

takrolimus (lijek koji kontrolira imunološki odgovor Vašeg organizma, omogućujući Vašem

tijelu prihvaćanje presaĎenog organa),

ritonavir, indinavir, nelfinavir (takozvani inhibitori proteaze koji se koriste za liječenje HIV-a),

lijekovi za liječenje raka,

ketokonazol, itrakonazol (lijekovi za liječenje gljivica),

rifampicin, eritromicin, klaritromicin (antibiotici),

halofantrin (koristi se za liječenje odreĎenih tipova malarije),

pentamidin (koristi se za liječenje upale pluća),

injekcijsko zlato (koristi se za liječenje reumatoidnog poliartritisa),

vinkamin (koristi se za liječenje simptomatskih kognitivnih poremećaja u starijih osoba,

uključujući i gubitak pamćenja),

bepridil, verapamil, diltiazem (lijekovi za srce),

sultoprid (za liječenje psihoza),

lijekove koji se koriste za probleme sa srčanim ritmom (npr. kinidin, hidrokinidin, dizopiramid,

amiodaron, sotalol),

digoksin ili druge srčane glikozide (za liječenje problema sa srcem),

baklofen (za liječenje ukočenosti mišića koja se javlja kod bolesti kao što je multipla skleroza),

lijekove za liječenje šećerne bolesti, kao što je inzulin ili metformin,

kalcij uključujući i nadomjestke kalcija,

stimulativne laksative (npr. sena),

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nesteroidne protuupalne lijekove (npr. ibuprofen) ili visoke doze salicilata (npr. aspirin),

amfotericin B putem injekcije (za liječenje teške gljivične bolesti),

lijekove za liječenje duševnih poremećaja kao što je depresija, tjeskoba, shizofrenija. (npr.

triciklički antidepresivi, neuroleptici),

tetrakosaktid (za liječenje Crohnove bolesti),

gospinu travu (Hypericum perforatum),

dantrolen (infuzija za jake poremećaje tjelesne temperature),

simvastatin (lijek za snižavanje kolesterola).

Co-Dalneva s hranom i pićem

Preporučuje se uzimati Co-Dalnevu prije obroka.

Bolesnici koji uzimaju Co-Dalnevu ne smiju konzumirati sok od grejpa ili grejp. Sok od grejpa i grejp

mogu uzrokovati porast vrijednosti djelatne tvari amlodipina u krvi, što može izazvati pojačano

djelovanje Co-Dalneve na snižavanje krvnog tlaka.

Trudnoća i dojenje

Obratite se Vašem liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.

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

Morate obavijestiti svog liječnika ako sumnjate da ste (ili ste možda ostali) trudni.

Liječnik će Vas obično savjetovati da prestanete uzimati Co-Dalnevu prije nego ostanete trudni ili čim

saznate da ste trudni te će Vam savjetovati uzimanje drugog lijeka umjesto Co-Dalneve. Co-Dalneva

se ne preporučuje u ranoj trudnoći te se ne smije uzimati ako ste trudni duže od 3 mjeseca jer može

ozbiljno naškoditi Vašem djetetu ako se koristi nakon trećeg mjeseca trudnoće.

Dojenje

Obavijestite svog liječnika ako dojite ili počinjete dojiti. Co-Dalneva je kontraindicirana za majke koje

doje te će liječnik možda odabrati drugo liječenje za Vas ako želite dojiti, posebno ako je Vaše dijete

novoroĎenče ili je prijevremeno roĎeno.

Odmah posjetite svog liječnika.

Upravljanje vozilima i strojevima

Co-Dalneva ne utječe na pozornost, ali Vam se može pojaviti omaglica ili slabost zbog niskog krvnog

tlaka što može utjecati na Vašu sposobnost upravljanja vozilima ili strojevima. Savjetuje Vam se da ne

upravljate vozilima ili strojevima dok ne znate kako Co-Dalneva na Vas djeluje.

3.

Kako uzimati Co-Dalnevu?

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

liječnikom ili ljekarnikom ako niste sigurni.

Uobičajena doza je jedna tableta jednom dnevno. Svoju tabletu po mogućnosti uzmite ujutro i prije

obroka. Progutajte tabletu uz čašu vode. Liječnik će odrediti ispravnu dozu za Vas. Co-Dalneva je

propisana bolesnicima koji već uzimaju perindopril, indapamid i amlodipin u zasebnim tabletama.

Ako uzmete više Co-Dalneve nego što ste trebali

Ako ste uzeli previše tableta, odmah se obratite svom liječniku ili najbližem odjelu za hitne slučajeve.

Najvjerojatniji učinak u slučaju predoziranja je nizak krvni tlak. Ako se pojavi izrazito nizak krvni tlak

(simptomi kao što su omaglica ili nesvjestica), ležanje s podignutim nogama može pomoći.

Ako ste zaboravili uzeti Co-Dalnevu

Važno je da svakog dana uzmete svoj lijek jer je redovito liječenje učinkovitije. MeĎutim, ako

zaboravite uzeti dozu Co-Dalneve, sljedeću dozu uzmite u uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

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Ako prestanete uzimati Co-Dalnevu

Budući da je liječenje visokog krvnog tlaka obično doživotno, trebali biste razgovarati sa svojim

liječnikom prije nego prestanete uzimati ovaj lijek.

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 Vam se pojavi bilo što od sljedećeg, odmah prestanite uzimati lijek i obavijestite svog

liječnika:

iznenadna pojava piskutavog disanja, bol u prsima, kratak dah ili tegobe s disanjem (manje

često, mogu se javiti u manje od 1 na 100 osoba)

simptomi alergijske reakcije kao što je oticanje lica, usana, usta, jezika ili grla, otežano disanje,

(manje često, mogu se javiti u manje od 1 na 100 osoba)

teške kožne reakcije koje uključuju intenzivni kožni osip, koprivnjaču, crvenilo po cijelom

tijelu, jaki svrbež, stvaranje mjehurića, guljenje i oticanje kože, upalu sluznice (Stevens

Johnsonov sindrom) ili druge alergijske reakcije (vrlo rijetko, mogu se javiti u manje od 1 na

10 000 osoba)

jača omaglica ili nesvjestica (često, mogu se javiti u manje od 1 na 10 osoba)

srčani udar (vrlo rijetko, mogu se javiti u manje od 1 na 10 000 osoba), neuobičajeno brzi ili

nepravilni otkucaji srca (nepoznato, učestalost se ne može procijeniti iz dostupnih podataka)

upala gušterače koja može uzrokovati jaku bol u trbuhu i leĎima, povezana s općim osjećajem

slabosti (vrlo rijetko, mogu se javiti u manje od 1 na 10 000 osoba).

U silaznom redoslijedu učestalosti, nuspojave mogu uključivati:

Vrlo često (mogu se javiti u više od 1 na 10 osoba):

edem (zadržavanje tekućine).

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

glavobolja, osjećaj omaglice, palpitacije (osjećaj lupanja srca), crvenilo uz osjećaj vrućine,

vrtoglavica, bockanje i trnci, somnolencija (pospanost), smetnje vida, ošamućenost zbog niskog

krvnog tlaka, tinitus (osjećaj šumova u ušima),

nizak krvni tlak, palpitacije (vrlo brzi otkucaji

srca), crvenilo uz osjećaj vrućine (osjećaj vrućine ili topline u Vašem licu), nedostatak zraka,

kašalj, probavni poremećaji (mučnina, bol u gornjem dijelu trbuha, gubitak teka, povraćanje, bol

u trbuhu, poremećaji okusa, suha usta, dispepsija ili otežana probava, proljev, zatvor, promjena

u pražnjenju crijeva), grčevi, oticanje gležnjeva (edem), slabost, osjećaj umora.

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

promjene raspoloženja, tjeskoba, poremećaj spavanja, depresija, drhtanje, koprivnjača,

nesvjestica, gubitak osjeta boli, nepravilni otkucaji srca, sinkopa (privremeni gubitak svijesti),

rinitis (začepljen nos ili curenje nosa), bronhospazam (stezanje u prsima, piskanje i nedostatak

zraka), promijenjene navike pražnjenja crijeva, angioedem (simptomi poput piskanja, oteknuća

lica ili jezika), koprivnjača, purpura (crvene točkice po koži), znojenje, opadanje kose, crvene ili

bezbojne mrlje na koži, bolovi u leĎima, mišićima ili zglobovima, problemi s bubrezima,

povećan nagon za mokrenjem naročito tijekom noći, impotencija, vrućica ili visoka temperatura,

osjećaj nelagode u dojkama ili povećanje dojki u muškaraca, bol u prsima, bol, opći osjećaj

slabosti, povećanje ili smanjenje tjelesne težine, prekomjeran broj bijelih krvnih stanica,

povišena razina kalija u krvi, hipoglikemija (vrlo niska razina šećera u krvi), niska razina natrija

u krvi, vaskulitis (upala stjenke krvnih ţila), fotosenzibilna reakcija (promjene u izgledu kože)

nakon izlaganja suncu ili umjetnim ultraljubičastim zrakama, nakupina mjehurića po koži,

oticanje ruku, gležnjeva ili stopala, povišene razine ureje i kreatinina u krvi, padovi, suha usta.

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O D O B R E N O

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

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

razina bilirubina u serumu i pogoršanje psorijaze.

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

smanjeni broj bijelih krvnih stanica, smanjeni broj trombocita što može dovesti do neuobičajene

pojava modrica ili lakog krvarenja (oštećenje crvenih krvnih stanica), anemija, kardiovaskularni

poremećaji (angina, srčani udar), eozinofilna upala pluća (rijetka vrsta upale pluća), oticanje

desni, periferna neuropatija (bolest koja uzrokuje gubitak osjeta, bol i nesposobnost kontrole

mišića), teške kožne reakcije uključujući jaki kožni osip, crvenilo kože po cijelom tijelu, jak

svrbež, mjehurići, ljuštenje i oticanje kože, multiformni eritem (crvenilo), poremećaj funkcije

jetre, upala jetre (hepatitis), žuto obojenje kože (žutica), nadutost (gastritis), poremećaj živaca

koji uzrokuje slabost, trnce ili utrnulost, pojačanu mišićnu napetost, hiperglikemija (vrlo visoka

razina šećera u krvi), visoka razina kalcija u krvi, moždani udar kao posljedica prekomjernog

pada krvnog tlaka.

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

u slučaju hepatičke insuficijencije (problemi s jetrom), postoji mogućnost nastanka hepatičke

encefalopatije (degenerativna bolest mozga), kratkovidnost (miopija), zamagljen vid,

poremećaji koji su kombinacija krutog držanja, nevoljnog drhtanja i /ili poremećaja pokreta.

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-Dalnevu?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 30

Čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage.

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

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

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-Dalneva sadrži?

Djelatne tvari su perindopril-tert-butilamin, indapamid i amlodipinbesilat.

Svaka tableta sadrži 4 mg perindopril-tert-butilamina što odgovara 3,34 mg perindoprila, 1,25 mg

indapamida i 5 mg amlodipina u obliku amlodipinbesilata.

Svaka tableta sadrži 4 mg perindopril-tert-butilamina što odgovara 3,34 mg perindoprila, 1,25 mg

indapamida i 10 mg amlodipina u obliku amlodipinbesilata.

Svaka tableta sadrži 8 mg perindopril-tert-butilamina što odgovara 6,68 mg perindoprila, 2,5 mg

indapamida i 5 mg amlodipina u obliku amlodipinbesilata.

Svaka tableta sadrži 8 mg perindopril-tert-butilamina što odgovara 6,68 mg perindoprila, 2,5 mg

indapamida i 10 mg amlodipina u obliku amlodipinbesilata.

Pomoćne tvari su: mikrokristalična celuloza, prethodno geliran škrob, natrijev škroboglikolat,

kalcijev klorid heksahidrat, natrijev hidrogenkarbonat, koloidni hidratizirani silicijev dioksid i

H A L M E D

31 - 08 - 2017

O D O B R E N O

magnezijev stearat.

Kako Co-Dalneva izgleda i sadržaj pakiranja?

Co-Dalneva 4 mg/1,25 mg/5 mg tablete su bijele do gotovo bijele, okrugle, blago bikonveksne, s

ukošenim rubovima, promjera 7 mm.

Co-Dalneva 4 mg/1,25 mg/10 mg tablete su bijele do gotovo bijele, ovalne, bikonveksne, s razdjelnim

urezom na jednoj strani, dužine 12 mm. Tableta se može razdijeliti na jednake doze.

Co-Dalneva 8 mg/2,5 mg/5 mg tablete su bijele do gotovo bijele, okrugle, bikonveksne, s ukošenim

rubovima, promjera 9 mm.

Co-Dalneva 8 mg/2,5 mg/10 mg tablete su bijele do gotovo bijele, okrugle, bikonveksne, s urezom na

jednoj strani i s ukošenim rubovima, promjera 9 mm. Tableta se može razdijeliti na jednake doze.

Co-Dalneva je dostupna u blisterima, a svaka kutija sadrži ukupno 10, 14, 20, 28, 30, 56, 60, 84 ili

90 tableta.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

HCS bvba, H. Kennisstraat 53, B 2650 Edegem, Belgija

Proizvođač:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u kolovozu 2017.

H A L M E D

31 - 08 - 2017

O D O B R E N O

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