Co-Diovan

Glavna informacija

  • Trgovački naziv:
  • Co-Diovan 320 mg/ 12,5 mg filmom obložene tablete
  • Doziranje:
  • 320 mg + 12,5 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 320 mg valsartana i 12,5 mg hidroklorotiazida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Novartis Pharma GmbH, Nürnberg, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Co-Diovan 320 mg/ 12,5 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 7 tableta u blisteru, u kutiji [HR-H-174157013-01]; 14 tableta u blisteru, u kutiji [HR-H-174157013-02]; 28 tableta u blisteru (kalendarsko pakiranje), u kutiji [HR-H-174157013-03]; 56 tableta u blisteru, u kutiji [HR-H-174157013-04]; 98 tableta u blisteru (kalendarsko pakiranje), u kutiji [HR-H-174157013-05]; 280 tableta u blisteru, u kutiji [HR-H-174157013-06]; 56 tableta u perforiranom blisteru, u kutiji [HR-H-174157013-07]; 98 tableta u perforiranom blisteru, u kutiji [HR-H-174157013-08]; 280 tableta u perforiranom blisteru, u kutiji [HR-H-174157013-09] Urbroj: 381-12-01/30-16-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-174157013
  • Datum autorizacije:
  • 09-02-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za korisnika

Co-Diovan 80 mg/12,5 mg filmom obložene tablete

Co-Diovan 160 mg/12,5 mg filmom obložene tablete

Co-Diovan 160 mg/25 mg filmom obložene tablete

Co-Diovan 320 mg/12,5 mg filmom obložene tablete

Co-Diovan 320 mg/25 mg filmom obložene tablete

valsartan, hidroklorotiazid

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

Sačuvajte ovu uputu. Možda ćete ju trebati ponovno pročitati.

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

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

znakovi bolesti jednaki Vašima.

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

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Co-Diovan i za što se koristi

Što morate znati prije nego počnete uzimati Co-Diovan

Kako uzimati Co-Diovan

Moguće nuspojave

Kako čuvati Co-Diovan

Sadržaj pakiranja i druge informacije

1.

Što je Co-Diovan i za što se koristi

Co-Diovan filmom obložene tablete sadrže dvije djelatne tvari zvane valsartan i hidroklorotiazid. Obje

tvari pomažu u kontroli povišenog krvnog tlaka (hipertenzije).

Valsartan

pripada skupini lijekova poznatoj kao „antagonisti angiotenzin II receptora“, koji

pomažu u kontroli povišenog krvnog tlaka. Angiotenzin II je tvar koja sužava krvne žile u tijelu,

čime uzrokuje povišenje krvnog tlaka. Valsartan djeluje tako da sprječava djelovanje angiotenzina

II. To dovodi do toga da se krvne žile šire, a krvni tlak pada.

Hidroklorotiazid

pripada skupini lijekova koji se nazivaju tiazidni diuretici (također poznati kao

„tablete za mokrenje“). Hidroklorotiazid povećava izlučivanje mokraće, čime se također snižava

krvni tlak.

Co-Diovan se koristi za liječenje povišenog krvnog tlaka koji se ne može odgovarajuće kontrolirati samo

jednom djelatnom tvari.

Povišeni krvni tlak povećava opterećenje na srce i arterije. Ako se to ne liječi mogu se oštetiti krvne žile u

mozgu, srcu i bubrezima, što može dovesti do moždanog udara, zatajenja srca ili zatajenja bubrega.

Povišeni krvni tlak povećava rizik od srčanog udara. Snižavanje krvnog tlaka na normalnu razinu

smanjuje rizik od razvoja ovih bolesti.

2.

Što morate znati prije nego počnete uzimati Co-Diovan

Nemojte uzimati Co-Diovan:

ako ste alergični (preosjetljivi) na valsartan, hidroklorotiazid, derivate sulfonamida (tvari kemijski

srodne hidroklorotiazidu) ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).

ako ste

trudni više od 3 mjeseca

(također je bolje izbjegavati Co-Diovan u ranoj trudnoći -

vidjeti dio Trudnoća).

H A L M E D

09-02-2016

O D O B R E N O

ako imate

tešku

bolest jetre, uništenje malih žučnih vodova unutar jetre (bilijarna ciroza) koje

vodi do nakupljanja žuči u jetri (kolestaza).

ako imate

tešku

bolest bubrega.

ako Vaše tijelo ne može stvarati mokraću (anurija).

ako ste na dijalizi.

ako je razina kalija ili natrija u Vašoj krvi niža od normalne, ili ako je razina kalcija u Vašoj krvi

viša od normalne unatoč liječenju.

ako imate giht.

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

tlaka koji sadrži aliskiren.

Ako se bilo što od gore navedenog odnosi na Vas, obavijestite svog liječnika i nemojte uzimati Co-

Diovan.

Upozorenja i mjere opreza

Obavijestite Vašeg liječnika

ako uzimate lijekove koji štede kalij, nadomjestke kalija, zamjene za sol koje sadrže kalij ili

druge lijekove koji povećavaju količinu kalija u Vašoj krvi poput heparina. Vaš liječnik će možda

trebati redovito kontrolirati količinu kalija u Vašoj krvi.

ako imate niske razine kalija u krvi.

ako imate proljev ili jako povraćate.

ako uzimate visoke doze tableta za mokrenje (diuretika).

ako imate tešku srčanu bolest.

ako bolujete od zatajenja srca ili ste imali srčani udar. Pažljivo slijedite upute Vašeg liječnika o

početnoj dozi. Vaš će liječnik možda provjeriti funkciju Vaših bubrega.

ako bolujete od suženja bubrežne arterije.

ako ste nedavno primili novi bubreg.

ako bolujete od hiperaldosteronizma. To je bolest kod koje Vaše nadbubrežne žlijezde stvaraju

previše hormona aldosterona. Ako se to odnosi na Vas, primjena Co-Diovana se ne preporučuje.

ako imate bolest jetre ili bubrega.

ako ste tijekom uzimanja drugih lijekova (uključujući ACE inhibitore) iskusili oticanje jezika i

lica uzrokovano alergijskom reakcijom koja se zove angioedem, obavijestite svog liječnika. Ako

se navedeni simptomi pojave tijekom uzimanja Co-Diovana, odmah prestanite uzimati Co-

Diovan i nemojte ga više nikad uzimati. Također pogledajte dio 4. Moguće nuspojave.

ako imate vrućicu, osip i bol u zglobovima, koji bi mogli biti znakovi sistemskog eritemskog

lupusa (SLE, takozvana autoimuna bolest).

ako imate šećernu bolest, giht, visoke razine kolesterola ili triglicerida u krvi.

ako ste imali alergijske reakcije prilikom primjene drugih lijekova za sniženje krvnog tlaka ove

skupine (antagonisti angiotenzin II receptora) ili ako imate alergiju ili astmu.

ako osjetite slabljenje vida ili bol u oku. To bi mogli biti simptomi povećanja tlaka u Vašem oku i

može se dogoditi u roku od nekoliko sati do jednog tjedna od uzimanja Co-Diovana. Ako se ne

liječi, to može dovesti do trajnog gubitka vida. Ako ste ranije imali alergiju na penicilin ili na

sulfonamid, kod Vas može postojati veći rizik od razvoja takvog stanja.

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

krvnog tlaka:

ACE inhibitore (primjerice enalapril, lizinopril, ramipril), osobito ako imate bubrežne

tegobe povezane sa šećernom bolešću.

aliskiren.

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

redovitim intervalima.

Vidjeti također informacije pod naslovom „Nemojte uzimati Co-Diovan”.

H A L M E D

09-02-2016

O D O B R E N O

Co-Diovan može izazvati povećanu osjetljivost kože na sunce.

Primjena Co-Diovana u djece i adolescenata (ispod 18 godina starosti) se ne preporučuje.

Obavezno obavijestite svog liječnika ako mislite da ste trudni (ili planirate trudnoću

). Co-Diovan se ne

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

štetiti Vašem djetetu ako se koristi u toj fazi (vidjeti dio Trudnoća).

Drugi lijekovi i Co-Diovan

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

druge lijekove.

Uzimanje Co-Diovana s nekim drugim lijekovima može utjecati na terapijski učinak. Može biti potrebno

promijeniti dozu, poduzeti druge mjere opreza ili u nekim slučajevima prestati uzimati jedan od lijekova.

To se posebno odnosi na sljedeće lijekove:

litij, lijek koji se koristi za liječenje nekih vrsta psihijatrijskih bolesti.

lijekove ili tvari koje bi mogle povećati količinu kalija u Vašoj krvi. Oni uključuju dodatke kalija ili

zamjene za sol koje sadrže kalij, lijekove koji štede kalij i heparin.

lijekove koji bi mogli smanjiti količinu kalija u Vašoj krvi, kao što su diuretici (tablete za mokrenje),

kortikosteroidi, laksativi, karbenoksolon, amfotericin ili penicillin G.

neki antibiotici (rifamicinska skupina antibiotika), lijekovi koji se primjenjuju za sprečavanje

odbacivanja organa nakon transplatacije (ciklosporin) ili antivirusni lijekovi koji se koriste za liječenje

HIV infekcije/AIDS-a (ritonavir). Ovi lijekovi mogu pojačati učinak Co-Diovana.

lijekove

koji bi mogli uzrokovati “torsades de pointes” (nepravilne otkucaje srca), kao što su

antiaritmici (lijekovi koji se primjenjuju za liječenje srčanih tegoba) i neki antipsihotici.

lijekove koji bi mogli smanjiti količinu natrija u Vašoj krvi, kao što su antidepresivi, antipsihotici,

antiepileptici.

lijekove za liječenje gihta poput alopurinola, probenecida, sulfinpirazona.

terapijske nadomjestke vitamina D i kalcija.

lijekove za liječenje šećerne bolesti (oralni lijekovi kao što su metformin ili inzulini)

druge lijekove za snižavanje krvnog tlaka uključujući metildopu, ACE inhibitore (poput enalaprila,

lizinoprila, itd.) ili aliskiren (vidjeti također informacije pod naslovom „Nemojte uzimati Co-Diovan“ i

„Upozorenja i mjere opreza”).

lijekove za povišenje krvnog tlaka, poput noradrenalina ili adrenalina.

digoksin ili druge glikozide digitalisa (lijekove za liječenje srčanih tegoba).

lijekove koji mogu povisiti razine šećera u krvi poput diazoksida ili beta blokatora.

citotoksične lijekove (koriste se za liječenje maligne bolesti) poput metotreksata ili ciklofosfamida.

lijekove protiv bolova kao što su nesteoridni protuupalni lijekovi (NSAID, od engl. non-steroidal anti-

inflammatory medicines), uključujući selektivne inhibitore ciklooksigenaze-2 (Cox-2 inhibitore) i

acetilsalicilatnu kiselinu > 3 g.

lijekove za opuštanje mišića poput tubokurarina

antikolinergike (lijekovi za liječenje raznih poremećaja kao što su grčevi probavnog sustava, grč

mokraćnog mjehura, astma, morska bolest, mišićni spazmi, Parkinsonova bolest te kao pomoć

anesteziji).

amantadin (lijek koji se koristi za liječenje Parkinsonove bolesti te za liječenje ili sprečavanje

određenih bolesti uzrokovanih virusima)

kolestiramin i kolestipol (lijekovi koji se uglavnom koriste za liječenje visokih razina lipida u krvi)

ciklosporin, lijek koji se koristi kod presađivanja organa kako bi se izbjeglo odbacivanje organa

alkohol, lijekove za spavanje i anestetike (lijekove s učinkom uspavljivanja ili smanjivanja boli koji se

koriste, primjerice, tijekom operacije).

kontrastna sredstva koja sadrže jod (tvari koje se koriste za preglede snimanjem).

H A L M E D

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O D O B R E N O

Co-Diovan s hranom, pićem i alkoholom

Izbjegavajte uzimanje alkohola prije nego porazgovarate s Vašim liječnikom. Alkohol može izazvati veći

pad krvnog tlaka i/ili povećati rizik od omaglice ili nesvjestice.

Trudnoća i dojenje

Obavezno obavijestite svog liječnika ako mislite da ste trudni (ili planirate trudnoću)

Vaš liječnik će Vas u pravilu savjetovati da prestanete uzimati Co-Diovan prije trudnoće ili čim saznate

da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Co-Diovana. Co-Diovan se ne

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

štetiti Vašem djetetu ako se koristi nakon trećeg mjeseca trudnoće.

Obavijestite svog liječnika ako dojite ili planirate dojiti

Co-Diovan se ne preporučuje majkama koje doje, a ako želite dojiti liječnik Vam može odabrati drugu

terapiju, posebno ako je Vaše dijete novorođenče ili je prijevremeno rođeno.

Upravljanje vozilima i strojevima

Prije

nego

počnete

voziti

automobil,

koristiti

alate

strojeve

obavljati

druge

aktivnosti

koje

zahtijevaju koncentraciju, svakako morate znati kako Co-Diovan utječe na Vas. Kao i mnogi drugi

lijekovi za liječenje povišenog krvnog tlaka, i Co-Diovan u rijetkim slučajevima može uzrokovati

omaglicu i utjecati na sposobnost koncentracije.

3.

Kako uzimati Co-Diovan

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. To će Vam pomoći u postizanju

najboljih rezultata i smanjenju rizika od nuspojava. Provjerite s Vašim liječnikom ili ljekarnikom ako

niste sigurni.

Osobe s povišenim krvnim tlakom često ne osjećaju nikakve znakove ovog problema. Mnogi se osjećaju

kao i obično. Stoga je još važnije da obavljate planirane posjete liječniku, čak i ako se dobro osjećate.

Vaš liječnik će Vam točno reći koliko tableta Co-Diovana trebate uzimati. Ovisno o tome kako reagirate

na liječenje, Vaš liječnik može predložiti višu ili nižu dozu.

Preporučena doza Co-Diovana je jedna tableta na dan.

Nemojte mijenjati dozu ili prestati uzimati tablete bez savjetovanja s Vašim liječnikom.

Ovaj lijek se treba uzimati svaki dan u isto vrijeme, uglavnom ujutro.

Co-Diovan možete uzimati zajedno s hranom ili bez nje.

Tabletu popijte s čašom vode.

Ako uzmete više Co-Diovana nego što ste trebali

Kod teške omaglice i/ili nesvjestice, legnite i odmah se obratite svom liječniku. Ako ste slučajno uzeli

previše tableta, obratite se liječniku, ljekarniku ili se javite u bolnicu.

Ako ste zaboravili uzeti Co-Diovan

Ako ste zaboravili uzeti dozu, uzmite ju čim se sjetite. Međutim, ako je uskoro vrijeme za Vašu sljedeću

dozu, preskočite propuštenu dozu.

Ne udvostručujte dozu kako biste nadoknadili propuštenu dozu.

Ako prestanete uzimati Co-Diovan

Prekid liječenja Co-Diovanom može pogoršati Vaš povišeni krvni tlak. Ne prekidajte s uzimanjem lijeka,

osim ako Vam to ne kaže Vaš liječnik.

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

liječniku ili ljekarniku.

H A L M E D

09-02-2016

O D O B R E N O

4.

Moguće nuspojave

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

Neke nuspojave mogu biti ozbiljne i zahtijevaju hitnu liječničku pomoć:

Odmah morate otići liječniku, ako osjetite simptome angioedema, poput:

oticanja lica, jezika ili ždrijela

otežanog gutanja

koprivnjače i otežanog disanja.

teška kožna bolest koja uzrokuje osip, crvenilo kože, mjehure na usnama, očima ili u ustima,

ljuštenje kože, vrućicu (toksična epidermalna nekroliza)

slabljenje vida ili bol u očima uzrokovan visokim tlakom (mogući znakovi akutnog glaukoma

zatvorenog kuta)

vrućica, grlobolja, učestalije infekcije (agranulocitoza)

Ove nuspojave su vrlo rijetke ili nepoznate učestalosti.

Ako osjetite bilo koji od navedenih simptoma, odmah prekinite uzimati Co-Diovan i javite se svom

liječniku (također vidjeti dio 2. „Upozorenja i mjere opreza“)

Ostale nuspojave uključuju:

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

kašalj

sniženi krvni tlak

ošamućenost

dehidracija (sa simptomima žeđi, suhih usta i jezika, rijetkog mokrenja, tamno obojene

mokraće, suhe kože)

bolovi u mišićima

umor

trnci ili utrnutost

zamagljen vid

šumovi (npr. pištanje, zvonjenje) u ušima

Vrlo rijetko

mogu se javiti u do 1 na 10 000 bolesnika):

omaglica

proljev

bolovi u zglobovima

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

otežano disanje

jako smanjeno mokrenje

sniženje razine natrija u krvi (što može dovesti do umora, smetenosti, trzanja mišića i/ili

konvulzija u težim slučajevima)

sniženje razine kalija u krvi (ponekad sa slabošću mišića, grčevima mišića, nenormalnim

srčanim ritmom)

sniženje razine leukocita u krvi (sa simptomima poput vrućice, infekcija kože, grlobolje ili

čireva u ustima zbog infekcija, slabosti)

povišenje razine bilirubina u krvi (što može u težim slučajevima izazvati žutilo kože i

očiju)

povišenje

razine

dušika

uree

krvi

kreatinina

krvi

(što

može

ukazivati

poremećenu funkciju bubrega)

povišenje razine mokraćne kiseline u krvi (što može u težim slučajevima izazvati giht)

H A L M E D

09-02-2016

O D O B R E N O

sinkopa (nesvjestica)

Sljedeće nuspojave su bile zabilježene samo s valsartanom ili hidroklorotiazidom:

Valsartan

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

osjećaj da Vam se vrti

bol u trbuhu

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

stvaranje mjehura na koži (znak buloznog dermatitisa)

kožni osip sa ili bez svrbeža zajedno s nekim od sljedećih znakova ili simptoma: vrućica,

bol u zglobovima, bol u mišićima, otečeni limfni čvorovi i/ili simptomi nalik gripi

osip, ljubičasto-crvene pjege, vrućica, svrbež (simptomi upale krvnih žila)

sniženje razine trombocita u krvi (ponekad s neuobičajenim krvarenjem ili modricama)

povišenje razine kalija u krvi (ponekad s grčevima mišića, nepravilnim srčanim ritmom)

alergijske reakcije (sa simptomima poput osipa, svrbeža, urtikarije, otežanog disanja ili

gutanja, omaglice)

oticanje uglavnom lica i grla, osip, svrbež

porast vrijednosti pokazatelja jetrene funkcije

sniženje razine hemoglobina i sniženje udjela eritrocita u krvi (što oboje može u težim

slučajevima dovesti do anemije)

zatajenje bubrega

niska razina natrija u krvi (što može dovesti do umora, smetenosti, trzanja mišića i/ili

konvulzija u težim slučajevima)

Hidroklorotiazid

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

niska razina kalija u krvi

povišenje lipida u krvi

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

niska razina natrija u krvi

niska razina magnezija u krvi

visoka razina mokraćne kiseline u krvi

osip sa svrbežom i druge vrste osipa

smanjeni apetit

blaga mučnina i povraćanje

omaglica, nesvjestica pri ustajanju

nemogućnost postizanja ili održavanja erekcije

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

oticanje i plikovi na koži (zbog povećane osjetljivosti na sunce)

visoka razina kalcija u krvi

visoka razina šećera u krvi

šećer u mokraći

pogoršanje dijabetičkog metaboličkog stanja

zatvor, proljev, nelagoda u trbuhu ili crijevima, poremećaji jetre koji se mogu pojaviti

zajedno sa žutilom kože i očiju

nepravilni otkucaji srca

glavobolja

poremećaji sna

tužno raspoloženje (depresija)

sniženje razine trombocita u krvi (ponekad s krvarenjem ili modricama pod kožom)

H A L M E D

09-02-2016

O D O B R E N O

omaglica

trnci ili obamrlost

poremećaj vida

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

upala krvnih žila sa simptomima poput osipa, ljubičasto-crvenih pjega, vrućice (vaskulitis)

osip,

svrbež,

koprivnača,

poteškoće

disanju

gutanju,

omaglica

(reakcije

preosjetljivosti)

osip na licu, bolovi u zglobovima, mišićni poremećaj, vrućica (eritemski lupus)

teški bolovi u gornjem dijelu trbuha (pankreatitis)

otežano

disanje

vrućicom,

kašljanje,

piskanje,

gubitak

daha

(respiratorni

distres

uključujući pneumonitis i plućni edem)

bljedilo kože, umor, nedostatak zraka pri disanju, tamna mokraća (hemolitička anemija)

vrućica, grlobolja ili ulceracija u ustima zbog infekcija (leukopenija)

zbunjenost, umor, trzanje mišića i spazam, ubrzano disanje (hipokloremijska alkaloza)

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

slabost, podljevi i učestale infekcije (aplastična anemija)

uvelike smanjeno stvaranje mokraće (mogući znakovi poremećaja ili zatajenja bubrega)

osip, crvenilo kože, mjehuri na usnama, očima ili u ustima, ljuštenje kože, vrućica (mogući znakovi

multiformnog eritema)

mišićni spazam

vrućica (pireksija)

slabost (astenija)

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

Prijavljivanje nuspojava

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

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

nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V. Prijavljivanjem nuspojava možete

pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Co-Diovan

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji. Rok valjanosti

odnosi se na zadnji dan navedenog mjeseca.

Ne čuvati na temperaturi iznad 30°C. Čuvati u originalnom pakiranju radi zaštite od vlage.

Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili su na njemu vidljivi

znakovi otvaranja.

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

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

6.

Sadržaj pakiranja i druge informacije

Što Co-Diovan sadrži

Djelatne tvari su valsartan i hidroklorotiazid. Svaka filmom obložena tableta sadrži 80 mg, 160 mg

ili 320 mg valsartana i 12,5 mg ili 25 mg hidroklorotiazida.

Jezgra tablete sadrži mikrokristaličnu celulozu, bezvodni koloidni silicijev dioksid, krospovidon,

magnezijev stearat.

Ovojnica tablete sadrži

hipromelozu, makrogol 8000 (samo 80 mg/12,5 mg i 160 mg/12,5 mg),

makrogol 4000 (samo 160 mg/25 mg, 320 mg/12,5 mg i 320 mg/25 mg), talk, crveni željezov oksid

H A L M E D

09-02-2016

O D O B R E N O

(E172,

320 mg/25 mg),

žuti

željezov

oksid

(E172,

samo

80 mg/12,5 mg,

160 mg/25 mg

320 mg/25 mg),

crni

željezov

oksid

(E172,

samo

160 mg/25 mg

320 mg/12,5 mg),

titanijev

dioksid (E171).

Kako Co-Diovan izgleda i sadržaj pakiranja

Co-Diovan 80 mg/12,5 mg je svijetlonarančasta, ovalna tableta, s utisnutom oznakom „HGH“ na jednoj

strani i „CG“ na drugoj strani.

Co-Diovan 160 mg/12,5 mg je tamnocrvena, ovalna tableta, s utisnutom oznakom „HHH“ na jednoj strani

i „CG“ na drugoj strani.

Co-Diovan 160 mg/25 mg je smeđa, ovalna tableta, s utisnutom oznakom „HXH“ na jednoj strani i

„NVR“ na drugoj strani.

Co-Diovan 320 mg/12,5 mg je ružičasta, ovalna tableta kosih rubova, s utisnutom oznakom „NVR“ na

jednoj strani i „HIL“ na drugoj strani.

Co-Diovan 320 mg/25 mg je žuta, ovalna tableta kosih rubova, s utisnutom oznakom „NVR“ na jednoj

strani i „CTI“ na drugoj strani.

Tablete su dostupne u blisteru od 7 tableta (samo Co-Diovan 320 mg/12,5 mg i

320 mg/25 mg), 14 tableta, 28 tableta u kalendarskom pakiranju, 30 tableta (samo za Co-Diovan

80 mg/12,5 mg), 56 tableta, 98 tableta u kalendarskom blisteru ili 280 tableta. Perforirani blisteri djeljivi

na jedinične doze od 56x1, 98x1 ili 280x1 tableta su također dostupni.Na tržištu se ne moraju nalaziti sve

veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

Novartis Hrvatska d.o.o.

Radnička cesta 37b

10 000 Zagreb

Tel. +385 1 6274 220

Faks +385 1 6274 255

Proizvođač

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni

Ovaj lijek je odobren u državama članicama Europskog ekonomskog prostora (EEA) pod sljedećim

nazivima:

Danska, Finska, Island, Norveška, Švedska

Diovan Comp

Austrija, Bugarska, Cipar, Češka Republika, Estonija, Grčka,

Hrvatska , Irska, Latvija, Litva, Malta, Nizozemska, Njemačka,

Poljska, Portugal, Rumunjska, Slovačka Republika, Slovenija,

Španjolska, Velika Britanija

Co-Diovan

Austrija, Njemačka, Portugal, Španjolska

Co-Diovan forte

Austrija

Co-Diovan fortissimum

Belgija, Luksemburg

Co-Diovane

Francuska, Italija

Co-Tareg

Mađarska

Diovan HCT

Ova uputa je zadnji puta revidirana u veljači 2016.

H A L M E D

09-02-2016

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