# en/humandocs/PDFs/EPAR/abilify/089304en1.xml.gz
# sl/humandocs/PDFs/EPAR/abilify/089304sl1.xml.gz
(src)="s1.1"> European Medicines Agency
(trg)="s1.1"> European Medicines Agency
(src)="s2.1"> EMEA/ H/ C/ 471
(trg)="s2.1"> EMEA/ H/ C/ 471
(src)="s3.1"> EUROPEAN PUBLIC ASSESSMENT REPORT ( EPAR )
(trg)="s3.1"> EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA ( EPAR )
(src)="s4.1"> ABILIFY
(trg)="s4.1"> ABILIFY
(src)="s5.1"> EPAR summary for the public
(trg)="s5.1"> Povzetek EPAR za javnost
(src)="s6.1"> This document is a summary of the European Public Assessment Report ( EPAR ) .
(trg)="s6.1"> Ta dokument je povzetek evropskega javnega poročila o oceni zdravila ( EPAR ) .
(src)="s6.2"> It explains how the Committee for Medicinal Products for Human Use ( CHMP ) assessed the studies performed , to reach their recommendations on how to use the medicine .
(trg)="s6.2"> Pojasnjuje , kako je Odbor za zdravila za uporabo v humani medicini ( CHMP ) ocenil opravljene študije , na podlagi katerih je oblikoval priporočila glede uporabe zdravila .
(src)="s6.3"> If you need more information about your medical condition or your treatment , read the Package Leaflet ( also part of the EPAR ) or contact your doctor or pharmacist .
(trg)="s6.3"> Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju , preberite navodilo za uporabo ( ki je prav tako del EPAR ) ali se posvetujte s svojim zdravnikom ali farmacevtom .
(src)="s6.4"> If you want more information on the basis of the CHMP recommendations , read the Scientific Discussion ( also part of the EPAR ) .
(trg)="s6.4"> Če želite več informacij , ki temeljijo na priporočilih CHMP , preberite znanstveno razpravo ( ki je prav tako del EPAR ) .
(src)="s7.1"> What is Abilify ?
(trg)="s7.1"> Kaj je zdravilo Abilify ?
(src)="s7.2"> Abilify is a medicine containing the active substance aripiprazole .
(trg)="s7.2"> Abilify je zdravilo , ki vsebuje zdravilno učinkovino aripiprazol .
(src)="s7.3"> It is available as 5 mg , 10 mg , 15 mg and 30 mg tablets , as 10 mg , 15 mg and 30 mg orodispersible tablets ( tablets that dissolve in the mouth ) , as an oral solution ( 1 mg/ ml ) and as a solution for injection ( 7.5 mg/ ml ) .
(trg)="s7.3"> Na voljo je v obliki 5 mg , 10 mg , 15 mg in 30 mg tablet ; v obliki 10 mg , 15 mg in 30 mg orodisperzibilnih tablet ( tablet , ki se raztopijo v ustih ) ter v obliki peroralne raztopine ( 1 mg/ ml ) in raztopine za injiciranje ( 7, 5 mg/ ml ) .
(src)="s8.1"> What is Abilify used for ?
(trg)="s8.1"> Za kaj se zdravilo Abilify uporablja ?
(src)="s8.2"> Abilify is used to treat adults with the following mental illnesses : • schizophrenia , a mental illness with a number of symptoms , including disorganised thinking and speech , hallucinations ( hearing or seeing things that are not there ) , suspiciousness and delusions ( mistaken beliefs ) ; • bipolar I disorder , a mental illness in which patients have manic episodes ( periods of abnormally high mood ) , alternating with periods of normal mood .
(trg)="s8.2"> Zdravilo Abilify se uporablja za zdravljenje odraslih bolnikov z naslednjimi duševnimi boleznimi : • shizofrenijo , duševno boleznijo s številnimi simptomi , ki vključujejo nepovezano razmišljanje in govor , halucinacije ( bolnik sliši ali vidi stvari , ki jih ni ) , sumničavost ter blodnje ( zmotna prepričanja ) ; • bipolarno I motnjo , duševno boleznijo , pri kateri bolniki doživljajo manične epizode ( obdobja nenormalno privzdignjenega razpoloženja ) , ki se izmenjujejo z obdobji normalnega razpoloženja .
(src)="s8.3"> They may also have episodes of depression .
(trg)="s8.3"> Doživljajo lahko tudi obdobja depresije .
(src)="s8.4"> Abilify is used to treat moderate to severe manic episodes and to prevent manic episodes in patients who have responded to the medicine in the past .
(trg)="s8.4"> Zdravilo Abilify se uporablja za zdravljenje zmernih do hudih maničnih epizod in preprečevanje maničnih epizod pri bolnikih , ki so v preteklosti bili odzivni na to zdravilo .
(src)="s8.5"> The solution for injection is used for the rapid control of agitation or disturbed behaviour when taking the medicine by mouth is not appropriate .
(trg)="s8.5"> Raztopina za injiciranje se uporablja za hitro vzpostavitev nadzora nad agitacijo ali vedenjskimi motnjami , kadar zaužitje peroralnih oblik zdravila ni primerno .
(src)="s8.6"> The medicine can only be obtained with a prescription .
(trg)="s8.6"> Zdravilo se dobi samo na recept .
(src)="s9.1"> How is Abilify used ?
(trg)="s9.1"> Kako se zdravilo Abilify uporablja ?
(src)="s9.2"> For schizophrenia , the recommended starting dose is 10 or 15 mg by mouth per day .
(trg)="s9.2"> Priporočeni začetni odmerek zdravila Abilify pri peroralni uporabi znaša 10 ali 15 mg na dan .
(src)="s9.3"> The maintenance dose is 15 mg once a day , but higher doses may benefit some patients .
(trg)="s9.3"> Vzdrževalni odmerek znaša 15 mg enkrat dnevno , nekateri bolniki pa bodo morda potrebovali večji odmerek .
(src)="s9.4"> For bipolar disorder , the recommended starting dose is 15 mg by mouth once a day , either on its own or in combination with other medicines .
(trg)="s9.4"> Pri bipolarni motnji je priporočeni začetni odmerek 15 mg zdravila dnevno , ki se ga zaužije peroralno bodisi samostojno ali v kombinaciji z drugimi zdravili .
(src)="s9.5"> Some patients may benefit from a higher dose .
(trg)="s9.5"> Nekateri bolniki bodo morda potrebovali večji odmerek .
(src)="s9.6"> To prevent manic episodes , the same dose should be continued .
(trg)="s9.6"> Za preprečitev maničnih epizod je zdravljenje treba nadaljevati z enakim odmerkom .
(src)="s9.7"> For both illnesses , the oral solution or orodispersible tablets can be used in patients who have difficulty swallowing tablets .
(trg)="s9.7"> Pri obeh boleznih se lahko pri bolnikih , ki težko pogoltnejo tableto , uporabi peroralna raztopina ali orodisperzibilne tablete .
(src)="s9.8"> The orodispersible tablets are taken by being placed on the tongue , where they disintegrate quickly in the saliva , or by mixing them in water before swallowing .
(trg)="s9.8"> Orodisperzibilno tableto zaužijemo tako , da jo položimo na jezik , kjer jo slina hitro razkroji , ali pa jo pred zaužitjem raztopimo v vodi .
(src)="s9.9"> The solution for injection is only for short-term use and should be replaced by tablets , orodispersible tablets or oral solution as soon as possible : the usual dose is 9.75 mg as a single injection into the upper arm or buttock muscle , but effective doses range between 5.25 and 15 mg .
(trg)="s9.9"> Raztopina za injiciranje je namenjena le kratkotrajni uporabi in jo je treba čim prej nadomestiti z jemanjem tablet , orodisperzibilnih tablet ali peroralne raztopine : običajni odmerek je 9, 75 mg na eno injiciranje v nadlaket ali zadnjico , učinkoviti
(src)="s9.11"> 7 Westferry Circus , Canary Wharf , London E14 4HB , UK Tel .
(trg)="s10.1"> 7 Westferry Circus , Canary Wharf , London , E14 4HB , UK Tel .
(src)="s9.12"> ( 44-20 ) 74 18 84 00 Fax ( 44-20 ) 74 18 84 16 E-mail : mail@emea . europa . eu http : / /www . emea . europa . eu
(trg)="s10.2"> ( 44- 20 ) 74 18 84 00 Fax ( 44- 20 ) 74 18 84 16 E- mail : mail@ emea. europa. eu http : // www. emea. europa. eu
(src)="s10.1"> © European Medicines Agency , 2008.
(trg)="s11.1"> © European Medicines Agency , 2008 .
(src)="s10.2"> Reproduction is authorised provided the source is acknowledged .
(trg)="s11.2"> Reproduction is authorised provided the source is acknowledged . odmerek pa znaša od 5, 25 do 15 mg .
(src)="s10.3"> Abilify can be taken with or without food .
(trg)="s11.3"> Če je potrebna še druga injekcija , se lahko ta vbrizga po dveh urah po prvi injekciji , vendar pa v 24- urnem obdobju ne smemo dati več kot treh injekcij .
(trg)="s11.4"> Zdravilo Abilify se jemlje s hrano ali brez nje .
(src)="s10.4"> The daily dose of Abilify should not exceed 30 mg , but this dose should be used with caution in patients who have severe problems with their liver .
(trg)="s11.5"> Dnevni odmerek zdravila Abilify ne sme preseči 30 mg .
(trg)="s11.6"> Ta odmerek je treba uporabljati previdno pri bolnikih s hudimi težavami z jetri .
(src)="s10.5"> The dose of Abilify should be adjusted in patients who are taking other medicines that are broken down in the same way as Abilify .
(trg)="s11.7"> Odmerek zdravila Abilify je treba prilagoditi pri bolnikih , ki jemljejo druga zdravila , ki se presnavljajo na enak način kot zdravilo Abilify .
(src)="s10.6"> Abilify has not been studied in children aged below 18 years or adults aged over 65 years .
(trg)="s11.8"> Zdravila Abilify niso preučevali pri otrocih , starih pod 18 let , ali odraslih , starih nad 65 let .
(src)="s10.7"> For more information , see the Package Leaflet .
(trg)="s11.9"> Za več informacij glejte navodilo za uporabo .
(src)="s11.1"> How does Abilify work ?
(trg)="s12.1"> Kako zdravilo Abilify deluje ?
(src)="s11.2"> The active substance in Abilify , aripiprazole , is an antipsychotic medicine .
(trg)="s12.2"> Zdravilna učinkovina zdravila Abilify , aripiprazol , je antipsihotično zdravilo .
(src)="s11.3"> Its exact mechanism of action is unknown , but it attaches to several different receptors on the surface of nerve cells in the brain .
(trg)="s12.3"> Natančen mehanizem njegovega delovanja zdravila ni znan , znano pa je , da se veže na več različnih vrst receptorjev na površini možganskih celic .
(src)="s11.4"> This disrupts signals transmitted between brain cells by ‘ neurotransmitters’ , chemicals that allow nerve cells to communicate with each other .
(trg)="s12.4"> S tem se zaustavijo signali , ki se prenašajo med možganskimi celicami s pomočjo „ živčnih prenašalcev “ , kemičnih spojin , ki jih živčne celice uporabljajo za medsebojno sporočanje .
(src)="s11.5"> Aripiprazole is thought to act mainly by being a ‘ partial agonist ’ for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine ( also called serotonin ) .
(trg)="s12.5"> Aripiprazol naj bi kot „ delni agonist “ deloval v glavnem na receptorje za živčna prenašalca dopamin in 5- hidroksitriptamin ( znan tudi kot serotonin ) .
(src)="s11.6"> This means that aripiprazole acts like 5-hydroxytryptamine and dopamine to activate the receptors , but to a lesser extent than the neurotransmitters .
(trg)="s12.6"> Delni agonist pomeni , da aripiprazol pri aktiviranju receptorjev deluje enako kot 5- hidroksitriptamin in dopamin , vendar v manjšem obsegu .
(src)="s11.7"> Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder , aripiprazole helps to normalise the activity of the brain , reducing psychotic or manic symptoms and preventing them from returning .
(trg)="s12.7"> Ker dopamin in 5- hidroksitriptamin sodelujeta v bolezenskem procesu shizofrenije in bipolarne motnje , aripiprazol pomaga normalizirati delovanje možganov , zmanjšati psihotične in manične simptome ter preprečiti njihov ponoven pojav .
(src)="s12.1"> How has Abilify been studied ?
(trg)="s13.1"> Kako je bilo zdravilo Abilify raziskano ?
(src)="s12.2"> For the treatment of schizophrenia , there were three main short-term studies of Abilify tablets lasting four to six weeks , which involved 1,203 patients and compared Abilify with placebo ( a dummy treatment ) .
(trg)="s13.2"> Pri zdravljenju shizofrenije so v treh večjih kratkoročnih študijah , ki so trajale od štiri do šest tednov in vključevale 1203 bolnikov , preučevali tablete Abilify in jih primerjali s placebom ( zdravilom brez zdravilne učinkovine ) .
(src)="s12.3"> The effectiveness of Abilify in preventing symptoms from returning was assessed in three studies lasting up to a year , two of which used haloperidol ( another antipsychotic medicine ) as a comparator .
(trg)="s13.3"> Učinkovitost zdravila Abilify pri preprečevanju ponovitve simptomov so ocenjevali v treh študijah , ki so trajale do enega leta , pri čemer so v dveh študijah kot primerjalno zdravilo uporabljali haloperidol ( drugo antipsihotično zdravilo ) .
(src)="s12.4"> The effectiveness of the solution for injection was compared with placebo over a period of two hours in two studies involving 805 patients with schizophrenia or related conditions who were experiencing symptoms of agitation .
(trg)="s13.4"> Učinkovitost raztopine za injiciranje v primerjavi s placebom v časovnem intervalu dveh ur so preučevali v dveh študijah , ki sta zajeli 805 bolnikov s shizofrenijo ali podobnimi boleznimi , ki so doživljali simptome agitacije .
(src)="s12.5"> All of the studies measured the change in the patient’ s symptoms using a standard scale for schizophrenia .
(trg)="s13.5"> V vseh študijah so merili spremembo bolnikovih simptomov na podlagi standardne ocenjevalne lestvice za shizofrenijo .
(src)="s12.6"> For the treatment of bipolar disorder , there were eight main studies looking at Abilify taken by mouth .
(trg)="s13.6"> Pri zdravljenju bipolarne motnje je bilo izvedenih osem večjih študij , ki so preučevale peroralno uživanje zdravila Abilify .
(src)="s12.7"> There were five short-term studies that compared the effectiveness of Abilify and placebo over three weeks in a total of 1,900 patients .
(trg)="s13.7"> V petih kratkoročnih študijah so v obdobju treh tednov pri skupno 1900 bolnikih primerjali učinkovitost zdravila Abilify s placebom .
(src)="s12.8"> Two of these studies used haloperidol and lithium ( another antipsychotic medicine ) as comparators and continued for a further nine weeks to look at the maintenance of the effect of the medicines .
(trg)="s13.8"> V dveh od teh študij so kot primerjalni zdravili uporabili haloperidol in litij ( drugo antipsihotično zdravilo ) , ki so ju bolnikom dajali devet tednov z namenom preučiti vzdrževanje učinka teh zdravil .
(src)="s12.9"> Another study compared Abilify with haloperidol over 12 weeks in 347 patients , and a further study compared the effectiveness of Abilify and placebo in preventing recurrence in 160 patients whose manic symptoms had already been stabilised using Abilify .
(trg)="s13.9"> V nadaljnji študiji so pri 347 bolnikih v obdobju 12 tednov primerjali zdravilo Abilify in haloperidol , v neki drugi študiji pa so primerjali učinkovitost zdravila Abilify in placeba pri preprečevanju ponovitve simptomov pri 160 bolnikih , pri katerih so manične simptome že uspeli stabilizirati z zdravilom Abilify .
(src)="s12.10"> The eighth study looked at the effect of adding Abilify or placebo to existing treatment with lithium or valproate ( another antipsychotic medicine ) in 384 patients .
(trg)="s13.10"> Osma študija je pri 384 bolnikih preučevala učinek dodajanja zdravila Abilify ali placeba obstoječemu zdravljenju z litijem ali valproatom ( drugim antipsihotičnim zdravilom ) .
(src)="s12.11"> The effectiveness of Abilify solution for injection was compared with that of lorazepam ( another antipsychotic medicine ) and of placebo over a period of two hours in one study involving 301 patients with bipolar disorder who were experiencing symptoms of agitation .
(trg)="s13.11"> V študiji , ki je vključevala 301 bolnika z bipolarno motnjo in simptomi agitacije , so učinkovitost zdravila Abilify v obliki raztopine za injiciranje primerjali z učinkovitostjo lorazepama ( drugega antipsihotičnega zdravila ) in placeba v obdobju dveh ur .
(src)="s12.12"> All of these studies looked at the change in symptoms using a standard scale for bipolar disorder or at the number of patients who responded to treatment .
(trg)="s13.12"> Vse te študije so preučevale spremembo simptomov na podlagi standardne ocenjevalne lestvice za bipolarno motnjo ali pa so beležile število bolnikov , ki so se odzvali na zdravljenje .
(src)="s12.13"> The company also carried out studies looking at the absorption of the orodispersible tablets and oral solution by the body .
(trg)="s13.13"> Družba je izvedla tudi študije , v katerih so preučevali absorpcijo orodisperzibilnih tablet in peroralne raztopine v telesu .
(src)="s13.1"> What benefit has Abilify shown during the studies ?
(trg)="s14.1"> Kakšne koristi je zdravilo Abilify izkazalo med študijami ?
(src)="s13.2"> When used to treat schizophrenia , Abilify was more effective than placebo in the short-term studies .
(trg)="s14.2"> V kratkoročnih študijah je bilo zdravilo Abilify pri zdravljenju shizofrenije učinkovitejše od placeba .
(src)="s13.3"> In the long-term studies , Abilify was more effective than placebo , and as effective as haloperidol , after up to a year of treatment .
(trg)="s14.3"> V dolgoročnih študijah je zdravilo Abilify po enem letu zdravljenja pokazalo večjo učinkovitost kot placebo in enako učinkovitost kot haloperidol .
(src)="s13.4"> In both studies of the solution for injection , patients receiving Abilify at doses of 5.25 , 9.75 or 15 mg had a significantly greater reduction in symptoms of agitation than those receiving placebo .
(trg)="s14.4"> V obeh študijah zdravila Abilify v obliki raztopine za injiciranje , je pri bolnikih , ki so prejemali zdravilo Abilify v odmerkih 5, 25 mg , 9, 75 mg ali 15 mg prišlo do znatno večjega zmanjšanja simptomov agitacije kot pri tistih , ki so prejemali placebo .
(src)="s13.5"> When used to treat bipolar disorder , Abilify was more effective than placebo at reducing manic symptoms in four of the five short-term studies .
(trg)="s14.5"> V štirih od petih kratkoročnih študij zdravljenja bipolarne motnje je bilo zdravilo Abilify učinkovitejše od placeba pri zmanjševanju maničnih simptomov .
(src)="s13.6"> Abilify also had a similar effect to haloperidol and to lithium over three weeks .
(trg)="s14.6"> Zdravilo Abilify je imelo v obdobju treh tednov podoben učinek kot haloperidol in litij .
(src)="s13.7"> This effect was maintained for up to 12 weeks .
(trg)="s14.7"> Ta učinek so lahko vzdrževali do 12 tednov .
(src)="s13.8"> Abilify was also more effective than placebo at preventing manic episodes returning in previously treated patients for up to 74 weeks , and when it was used as an add-on to existing treatment .
(trg)="s14.8"> Zdravilo Abilify je bilo učinkovitejše od placeba tudi pri preprečevanju ponovitve maničnih epizod v obdobju 74 2/ 3 tednov pri predhodno zdravljenih bolnikih in ob njegovi uporabi kot dodatek obstoječemu zdravljenju .
(src)="s13.9"> Injections of Abilify at doses of 10 or 15 mg were also more effective than placebo in reducing the symptoms of agitation , and were of similar effectiveness to lorazepam .
(trg)="s14.9"> Injekcije zdravila Abilify v odmerku 10 ali 15 mg so bile pri zmanjševanju simptomov agitacije prav tako učinkovitejše od placeba in podobno učinkovite kot lorazepam .
(src)="s14.1"> 2/ 3 What is the risk associated with Abilify ?
(trg)="s15.1"> Kakšna tveganja so povezana z zdravilom Abilify ?
(src)="s14.2"> The most common side effects when taking Abilify by mouth ( seen in between 1 and 10 patients in 100 ) are extrapyramidal disorder ( uncontrolled twitching or jerking ) , akathisia ( constant urge to move ) , tremor ( shaking ) , somnolence ( sleepiness ) , sedation ( drowsiness ) , headache , blurred vision , dyspepsia ( heartburn ) , vomiting , nausea ( feeling sick ) , constipation , salivary hypersecretion ( increased production of saliva ) , fatigue ( tiredness ) , restlessness , insomnia ( difficulty sleeping ) and anxiety .
(trg)="s15.2"> Najpogostejši neželeni učinki pri peroralnem jemanju zdravila Abilify ( opaženi pri 1 do 10 bolnikih izmed 100 ) so ekstrapiramidalne motnje ( nenadzorovano trzanje in sunkoviti gibi ) , akatizija ( neprestana potreba po gibanju ) , tremor ( tresavica ) , somnolenca ( zaspanost ) , sedacija ( dremavost ) , glavobol , zamegljen vid , dispepsija ( zgaga ) , bruhanje , slabost , zaprtje , prekomerno izločanje sline , utrujenost , nemirnost , nespečnost in tesnobnost .
(src)="s14.3"> Akathisia is more common in patients with bipolar disorder than in those with schizophrenia .
(trg)="s15.3"> Akatizija je pogostejša pri bolnikih z bipolarno motnjo kot pri bolnikih s shizofrenijo .
(src)="s14.4"> Between 1 and 10 patients in 100 receiving injections of Abilify experience somnolence , dizziness , headache , akathisia , nausea and vomiting .
(trg)="s15.4"> Pri 1 do 10 bolnikih izmed 100 , ki so prejemali injekcije zdravila Abilify , so opazili zaspanost , omotico , glavobol , akatizijo , slabost in bruhanje .
(src)="s14.5"> For the full list of all side effects reported with Abilify , see the Package Leaflet .
(trg)="s15.5"> Za celoten seznam neželenih učinkov , o katerih so poročali pri uporabi zdravila Abilify , glejte navodilo za uporabo .
(src)="s14.6"> Abilify should not be used in people who may be hypersensitive ( allergic ) to aripiprazole or any of the other ingredients .
(trg)="s15.6"> Zdravila Abilify ne smejo uporabljati osebe , ki utegnejo biti preobčutljive za ( alergične na ) aripiprazol ali katero koli drugo sestavino zdravila .
(src)="s15.1"> Why has Abilify been approved ?
(trg)="s16.1"> Zakaj je bilo zdravilo Abilify odobreno ?
(src)="s15.2"> The Committee for Medicinal Products for Human Use ( CHMP ) decided that Abilify’ s benefits are greater than its risks for the treatment of schizophrenia and of moderate to severe manic episodes in bipolar I disorder , and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment .
(trg)="s16.2"> Odbor za zdravila za uporabo v humani medicini ( CHMP ) je zaključil , da so koristi zdravila Abilify večje od z njim povezanih tveganj pri zdravljenju shizofrenije in zmernih do hudih maničnih epizod pri bipolarni I motnji ter preprečevanju novih maničnih epizod pri bolnikih , ki so doživljali pretežno manične epizode in so bili pri zdravljenju maničnih epizod odzivni na aripiprazol .
(src)="s15.3"> It also decided that the benefits of the solution for injection outweighed its risks for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in bipolar I disorder , when oral therapy is not appropriate .
(trg)="s16.3"> Odbor je tudi menil , da so koristi raztopine za injiciranje pri hitrem vzpostavljanju nadzora nad agitacijo in vedenjskimi motnjami pri bolnikih s shizofrenijo ali bolnikih z maničnimi epizodami pri bipolarni I motnji , kadar peroralno zdravljenje ni mogoče , večje od z njo povezanih tveganj .
(src)="s15.4"> The Committee recommended that Abilify be given marketing authorisation .
(trg)="s16.4"> Odbor je priporočil , da se za zdravilo Abilify odobri dovoljenje za promet .
(src)="s16.1"> Other information about Abilify :
(trg)="s17.1"> Druge informacije o zdravilu Abilify :
(src)="s16.2"> The European Commission granted a marketing authorisation valid throughout the European Union for Abilify to Otsuka Pharmaceutical Europe Ltd. on 4 June 2004.
(trg)="s17.2"> Evropska komisija je dovoljenje za promet z zdravilom Abilify , veljavno po vsej Evropski uniji , odobrila družbi Otsuka Pharmaceutical Europe Ltd . dne 4 . junija 2004 .
(src)="s17.1"> The full EPAR for Abilify can be found here .
(trg)="s18.1"> Celotno evropsko javno poročilo o oceni zdravila ( EPAR ) za zdravilo Abilify je na voljo tukaj .
(src)="s18.1"> This summary was last updated in 07-2008 .
(trg)="s19.1"> Povzetek je bil nazadnje posodobljen 07- 2008 .
(src)="s19.1"> 3/ 3
(trg)="s20.1"> 3/ 3
# en/humandocs/PDFs/EPAR/abilify/089304en2.xml.gz
# sl/humandocs/PDFs/EPAR/abilify/089304sl2.xml.gz
(src)="s1.1"> EU Number
(trg)="s1.1"> številka EU
(src)="s2.1"> Invented name
(trg)="s2.1"> ime
(src)="s3.1"> Strength
(trg)="s3.1"> jakost
(src)="s4.1"> Pharmaceutical Form
(trg)="s4.1"> farmacevtska oblika
(src)="s5.1"> Route of Administration
(trg)="s5.1"> pot uporabe
(src)="s6.1"> Packaging
(trg)="s6.1"> ovojnina
(src)="s7.1"> Content
(trg)="s7.1"> vsebina
(src)="s8.1"> Package size
(trg)="s8.1"> velikost pakiranja
(src)="s9.1"> EU/ 1/ 04/ 276/ 001
(trg)="s9.1"> EU/ 1/ 04/ 276/ 001
(src)="s10.1"> Abilify
(trg)="s10.1"> Abilify
(src)="s11.1"> 5 mg
(trg)="s11.1"> 5 mg
(src)="s12.1"> Tablet
(trg)="s12.1"> tableta
(src)="s13.1"> Oral use
(trg)="s13.1"> peroralna uporaba
(src)="s14.1"> unit dose perforated blister ( alu/ alu )
(trg)="s14.1"> enoodmerni perforiran pretisni omot ( alu/ alu )
(src)="s15.1"> 14 x 1
(trg)="s15.1"> 14 x 1
(src)="s16.1"> EU/ 1/ 04/ 276/ 002
(trg)="s16.1"> EU/ 1/ 04/ 276/ 002
(src)="s17.1"> Abilify
(trg)="s17.1"> Abilify
(src)="s18.1"> 5 mg
(trg)="s18.1"> 5 mg
(src)="s19.1"> Tablet
(trg)="s19.1"> tableta