# en/humandocs/PDFs/EPAR/abilify/089304en1.xml.gz
# et/humandocs/PDFs/EPAR/abilify/089304et1.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"> EUROOPA AVALIK HINDAMISARUANNE
(src)="s4.1"> ABILIFY
(trg)="s4.1"> ABILIFY
(src)="s5.1"> EPAR summary for the public
(trg)="s5.1"> Kokkuvõte üldsusele
(src)="s6.1"> This document is a summary of the European Public Assessment Report ( EPAR ) .
(trg)="s6.1"> Käesolev dokument on Euroopa avaliku hindamisaruande kokkuvõte .
(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"> Selles selgitatakse , kuidas inimravimite komitee hindas tehtud uuringuid , et koostada ravimi kasutamise soovitused .
(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"> Kui vajate oma haigusseisundi või ravi kohta asjakohast lisateavet , lugege palun pakendi infolehte ( mis on samuti Euroopa avaliku hindamisaruande osa ) või pöörduge oma arsti või apteekri poole .
(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"> Kui soovite lisateavet inimravimite komitee soovituste aluse kohta , lugege palun teadusliku arutelu kokkuvõtet ( samuti Euroopa avaliku hindamisaruande osa ) .
(src)="s7.1"> What is Abilify ?
(trg)="s7.1"> Mis on Abilify ?
(src)="s7.2"> Abilify is a medicine containing the active substance aripiprazole .
(trg)="s7.2"> Abilify on ravim , mille toimeaine on aripiprasool .
(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"> Seda turustatakse 5 mg , 10 mg , 15 mg ja 30 mg tablettidena või 10 mg , 15 mg ja 30 mg suus dispergeeruvate ( lahustuvate ) tablettidena , suukaudse lahusena ( 1 mg/ ml ) ja süstelahusena ( 7, 5 mg/ ml ) .
(src)="s8.1"> What is Abilify used for ?
(trg)="s8.1"> Milleks Abilifyt kasutatakse ?
(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"> Abilifyt kasutatakse järgmiste vaimuhaiguste raviks täiskasvanud patsientidel : • skisofreenia , mis on vaimuhaigus , millel on mitmesuguseid sümptomeid , sealhulgas mõtlemis - ja kõnehäired , hallutsinatsioonid ( ebareaalsete asjade nägemine või kuulmine ) , kahtlustamine ja pettekujutlused ; • I tüüpi bipolaarne meeleoluhäire , mis on vaimuhaigus , mille korral patsientide maaniaepisoodid ( meeleolu äärmuslik tõus ) vahelduvad normaalse tuju perioodidega .
(src)="s8.3"> They may also have episodes of depression .
(trg)="s8.3"> Patsientidel võib esineda ka meeleolu languse episoode .
(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"> Abilifyt kasutatakse mõõdukate ja raskete maaniaepisoodide raviks ja episoodide ennetamiseks patsientidel , kellel on varem tekkinud ravivastus .
(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"> Abilify süstelahust kasutatakse rahutuse ja käitumishäirete kiireks leevendamiseks skisofreeniaga patsientidel , kui ravimit ei saa manustada suu kaudu .
(src)="s8.6"> The medicine can only be obtained with a prescription .
(trg)="s8.6"> Seda ravimit saab üksnes retsepti alusel .
(src)="s9.1"> How is Abilify used ?
(trg)="s9.1"> Kuidas Abilifyt kasutatakse ?
(src)="s9.2"> For schizophrenia , the recommended starting dose is 10 or 15 mg by mouth per day .
(trg)="s9.2"> Abilify soovituslik algannus skisofreenia ravis suukaudsel manustamisel on 10 mg või 15 mg päevas .
(src)="s9.3"> The maintenance dose is 15 mg once a day , but higher doses may benefit some patients .
(trg)="s9.3"> Säilitusravi annus on 15 mg üks kord päevas , kuid mõnele patsientidele võib olla kasulik suurem annus .
(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"> Bipolaarse meeleoluhäire korral on soovitatav algannus suukaudsel manustamisel 15 mg päevas ainsa ravimina või koos teiste ravimitega .
(src)="s9.5"> Some patients may benefit from a higher dose .
(trg)="s9.5"> Mõnedele patsientidele võib olla kasulik suurem annus .
(src)="s9.6"> To prevent manic episodes , the same dose should be continued .
(trg)="s9.6"> Maaniaepisoodide ennetamiseks peab ravi jätkama sama annusega .
(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"> Mõlema haiguse korral võib suukaudset lahust või suus dispergeeruvaid tablette kasutada patsientidel , kellel on tablette raske neelata .
(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"> Suus dispergeeruvad tabletid asetatakse keelele , kus need süljes kiiresti lagunevad , või segatakse enne neelamist veega .
(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"> Süstelahust kasutatakse ainult lühiajaliselt ning see tuleb niipea kui võimalik asendada tablettide , suus dispergeeruvate tablettide või suukaudse lahusega .
(trg)="s9.10"> Kasutamisel on tavaline annus 9, 75 mg ühekordse intramuskulaarse süstina ( õlavarre - või tuharalihasesse ) .
(trg)="s9.11"> Olenevalt patsiendist võib efektiivne annus olla vahemikus 5, 25– 15 mg .
(src)="s9.10"> A second injection can be given from two hours after the first if necessary , but no more than three injections should be given in any 24-hour period .
(trg)="s9.12"> Teise süsti võib vajadusel teha alates 2 tunni möödumisest esimesest , kuid 24 tunni jooksul ei tohi teha rohkem kui kolm süsti .
(src)="s9.11"> 7 Westferry Circus , Canary Wharf , London E14 4HB , UK Tel .
(trg)="s9.13"> 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)="s9.14"> ( 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)="s10.1"> © European Medicines Agency , 2008 .
(src)="s10.2"> Reproduction is authorised provided the source is acknowledged .
(trg)="s10.2"> Reproduction is authorised provided the source is acknowledged .
(src)="s10.3"> Abilify can be taken with or without food .
(trg)="s10.3"> Abilifyt võetakse koos toiduga või ilma .
(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)="s10.4"> Abilify päevane annus ei tohi ületada 30 mg .
(trg)="s10.5"> Seda annust peab kasutama raske maksahaigusega patsientidel ettevaatlikult .
(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)="s10.6"> Abilify annust tuleb kohandada patsientidel , kes võtavad teisi ravimeid , mis lagunevad organismis samal viisil kui Abilify .
(src)="s10.6"> Abilify has not been studied in children aged below 18 years or adults aged over 65 years .
(trg)="s10.7"> Abilify kasutamist alla 18- aastastel lastel ja üle 65- aastastel täiskasvanutel ei ole uuritud .
(src)="s10.7"> For more information , see the Package Leaflet .
(trg)="s10.8"> Üksikasjalik teave on esitatud pakendi infolehel .
(src)="s11.1"> How does Abilify work ?
(trg)="s11.1"> Kuidas Abilify toimib ?
(src)="s11.2"> The active substance in Abilify , aripiprazole , is an antipsychotic medicine .
(trg)="s11.2"> Abilify toimeaine aripiprasool on antipsühhootikum .
(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)="s11.3"> Aine täpne toimemehhanism ei ole teada , kuid see seondub aju eri närvirakkude pinnaretseptoritega .
(src)="s11.4"> This disrupts signals transmitted between brain cells by ‘ neurotransmitters’ , chemicals that allow nerve cells to communicate with each other .
(trg)="s11.4"> See häirib neurotransmitterite ( keemilised ained , mille abil toimub närvirakkudevaheline signaalivahetus ) vahendatavaid närviimpulsse .
(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)="s11.5"> Arvatakse , et aripiprasool mõjub põhiliselt osalise agonistina neurotransmitterite dopamiini ja 5 - hüdroksütrüptamiini ( serotoniin ) retseptoritele .
(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)="s11.6"> „ Osaline agonist ” tähendab , et aripiprasool mõjub vähemal määral ka neid retseptoreid aktiveeriva ainena nagu 5- hüdroksütrüptamiin ja dopamiin .
(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)="s11.7"> Et 5 - hüdroksütrüptamiin ja dopamiin osalevad skisofreenia ja bipolaarse meeleoluhäire tekkimisel , aitab aripiprasool ajutalitlust normaliseerida , vähendades psühhootilisi ja maniakaalseid sümptomeid ning ennetades nende taasteket .
(src)="s12.1"> How has Abilify been studied ?
(trg)="s12.1"> Kuidas Abilifyt uuriti ?
(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)="s12.2"> Abilify tablettide kasutamise kohta skisofreenia ravis viidi läbi kolm lühiajalist ( 4– 6 nädalat ) põhiuuringut , milles osales 1203 patsienti ning milles Abilifyt võrreldi platseeboga ( näiva ravimiga ) .
(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)="s12.3"> Abilify efektiivsust sümptomite taastekke ennetamisel mõõdeti kolmes kuni üks aasta kestnud uuringus .
(trg)="s12.4"> Neist kahes kasutati võrdlusravimina haloperidooli ( samuti antipsühhootikum ) .
(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)="s12.5"> Süstelahuse efektiivsust võrreldi platseeboga kahes kahetunnises uuringus , milles osales 805 patsienti , kellel oli skisofreenia või sellega seotud seisund ja kellel olid tekkinud rahutuse sümptomid .
(src)="s12.5"> All of the studies measured the change in the patient’ s symptoms using a standard scale for schizophrenia .
(trg)="s12.6"> Kõikides uuringutes mõõdeti patsiendi sümptomite muutusi standardse skisofreeniasümptomite skaalaga .
(src)="s12.6"> For the treatment of bipolar disorder , there were eight main studies looking at Abilify taken by mouth .
(trg)="s12.7"> Abilfy suukaudse kasutamise kohta bipolaarse meeleoluhäire ravis viidi läbi kaheksa põhiuuringut .
(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)="s12.8"> Viies lühiajalises uuringus võrreldi Abilify efektiivsust platseebo efektiivsusega kolme nädala jooksul kokku 1900 patsiendil .
(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)="s12.9"> Neist kahes uuringus kasutati võrdlusravimina haloperidooli ja liitiumi ( samuti antipsühhootikum ) ning jälgiti veel üheksa nädala jooksul ravimite toime säilimist .
(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)="s12.10"> Ühes uuringus võrreldi Abilifyt haloperidooliga 12 nädala jooksul 347 patsiendil , ning täiendavas uuringus võrreldi Abilify ja platseebo efektiivsust maniakaalsete sümptomite taastekke ennetamisel 160 patsiendil , kelle haiguse sümptomeid õnnestus Abilifyga stabiliseerida .
(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)="s12.11"> Kaheksandas uuringus võrreldi Abilify või platseebo lisamist olemasolevale ravile liitiumi või valproaadiga ( samuti antipsühhootikum ) 384 patsiendil .
(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)="s12.12"> Abilify süstelahuse efektiivsust võrreldi lorasepaami ( samuti antipsühhootikum ) ja platseebo efektiivsusega kahe tunni jooksul ühes uuringus , milles osales 301 bipolaarse meeleoluhäirega patsienti , kellel olid tekkinud rahutuse sümptomid .
(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)="s12.13"> Kõikides uuringutes mõõdeti patsiendi sümptomite muutusi standardse bipolaarse meeleoluhäire skaalaga või patsientide arvuga , kellel tekkis ravivastus .
(src)="s12.13"> The company also carried out studies looking at the absorption of the orodispersible tablets and oral solution by the body .
(trg)="s12.14"> Ettevõte viis läbi ka uuringud suus dispergeeruvate tablettide ja suukaudse lahuse imendumise kohta organismis .
(src)="s13.1"> What benefit has Abilify shown during the studies ?
(trg)="s13.1"> Milles seisneb uuringute põhjal Abilify kasulikkus ?
(src)="s13.2"> When used to treat schizophrenia , Abilify was more effective than placebo in the short-term studies .
(trg)="s13.2"> Lühiajalistes uuringutes oli Abilify skisofreenia ravis platseebost efektiivsem .
(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)="s13.3"> Pikaajalised uuringud näitasid , et kuni aastase kestusega ravi Abilifyga on sama efektiivne kui ravi haloperidooliga ja efektiivsem kui ravi platseeboga .
(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 .
(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)="s13.4"> Mõlemas süstelahuse uuringus vähenesid patsientidel , kellele anti Abilifyt annustes 5, 25 mg , 9, 75 mg või 15 mg , rahutuse sümptomid oluliselt rohkem kui patsientidel , kellele süstiti platseebot Bipolaarse meeleoluhäire ravis oli Abilify neljas viiest lühiajalisest uuringust sümptomite vähendamisel platseebost efektiivsem .
(src)="s13.6"> Abilify also had a similar effect to haloperidol and to lithium over three weeks .
(trg)="s13.5"> Kasutamisel kolme nädala jooksul on Abilify toime samane haloperidooli ja liitiumi toimega .
(src)="s13.7"> This effect was maintained for up to 12 weeks .
(trg)="s13.6"> Toime säilis kuni 12 nädala jooksul .
(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)="s13.7"> Abilify oli efektiivsem kui platseebo maaniaepisoodide taastekke ennetamisel patsientidel , keda oli eelnevalt 74 nädala jooksul ravitud ning kui seda kasutati olemasolevale ravile täiendava ravimina .
(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)="s13.8"> Abilify süstelahus annuses 10 mg ja 15 mg oli rahutuse sümptomite vähendamisel efektiivsem kui platseebo ja sama efektiivne kui lorasepaam . .
(src)="s14.1"> 2/ 3 What is the risk associated with Abilify ?
(trg)="s14.1"> 2/ 3 Mis riskid Abilifyga kaasnevad ?
(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)="s14.2"> Abilify kõige sagedamad kõrvalnähud ravimi suukaudsel manustamisel ( esinenud ühel kuni kümnel patsiendil sajast ) on ekstrapüramidaalne häire ( tahtele allumatud tõmblused ) , akatiisia ( pidev liikumisvajadus ) , värin , unisus , uimasus , peavalu , nägemise ähmastumine , düspepsia ( kõrvetised ) , oksendamine , iiveldus , kõhukinnisus , süljevoolus , väsimus , rahutus , unetus ja ärevus .
(src)="s14.3"> Akathisia is more common in patients with bipolar disorder than in those with schizophrenia .
(trg)="s14.3"> Akatiisia esineb sagedamini bipolaarse häirega kui skisofreeniaga patsientidel .
(src)="s14.4"> Between 1 and 10 patients in 100 receiving injections of Abilify experience somnolence , dizziness , headache , akathisia , nausea and vomiting .
(trg)="s14.4"> Ühel kuni kümnel Abilify süste saanud patsiendil sajast tekkis unisus , peapööritus , peavalu , akatiisia , iiveldus ja oksendamine .
(src)="s14.5"> For the full list of all side effects reported with Abilify , see the Package Leaflet .
(trg)="s14.5"> Abilify kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt .
(src)="s14.6"> Abilify should not be used in people who may be hypersensitive ( allergic ) to aripiprazole or any of the other ingredients .
(trg)="s14.6"> Abilifyt ei tohi kasutada patsiendid , kes võivad olla aripiprasooli või ravimi mis tahes muu koostisaine suhtes ülitundlikud ( allergilised ) .
(src)="s15.1"> Why has Abilify been approved ?
(trg)="s15.1"> Miks Abilify heaks kiideti ?
(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)="s15.2"> Inimravimite komitee jõudis otsusele , et Abilify kasulikkus on suurem kui sellega kaasnevad riskid skisofreenia ja mõõdukate või raskete maaniaepisoodide ja I tüüpi bipolaarse meeleoluhäire ravis ning uute maaniaepisoodide ennetamisel patsientidel , kellel esinevad valdavalt aripiprasooliga ravile alluvad maaniaepisoodid .
(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)="s15.3"> Komitee otsustas samuti , et süstelahuse kasulikkus on suurem kui sellega kaasnevad riskid selle kasutamisel rahutuse ja käitumishäirete kiireks leevendamiseks skisofreeniaga või I tüüpi bipolaarse meeleoluhäire maaniliste episoodidega patsientidel , kui suukaudset ravi ei saa kasutada .
(src)="s15.4"> The Committee recommended that Abilify be given marketing authorisation .
(trg)="s15.4"> Komitee soovitas anda Abilifyle müügiloa .
(src)="s16.1"> Other information about 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)="s16.1"> Muu teave Abilify kohta Euroopa Komisjon andis Abilify müügiloa , mis kehtib kogu Euroopa Liidu territooriumil , ettevõttele Otsuka Pharmaceutical Europe Ltd .
(trg)="s16.2"> 4 . juunil 2004 .
(src)="s17.1"> The full EPAR for Abilify can be found here .
(trg)="s17.1"> Euroopa avaliku hindamisaruande täisteksti Abilify kohta leiate siit .
(src)="s18.1"> This summary was last updated in 07-2008 .
(trg)="s18.1"> Kokkuvõtte viimane uuendus :
(trg)="s18.2"> 07- 2008 .
(src)="s19.1"> 3/ 3
(trg)="s19.1"> 3/ 3
# en/humandocs/PDFs/EPAR/abilify/089304en2.xml.gz
# et/humandocs/PDFs/EPAR/abilify/089304et2.xml.gz
(src)="s1.1"> EU Number
(trg)="s1.1"> Müügiloa nr Euroopa Nimi Liidus
(src)="s2.1"> Invented name
(trg)="s2.1"> Tugevus
(src)="s3.1"> Strength
(trg)="s3.1"> Ravimvorm
(src)="s4.1"> Pharmaceutical Form
(trg)="s4.1"> Manustamistee
(src)="s5.1"> Route of Administration
(trg)="s5.1"> Pakendi iseloomustus
(src)="s6.1"> Packaging
(trg)="s6.1"> Pakendi sisu
(src)="s8.1"> Package size
(trg)="s7.1"> Pakendi suurus
(src)="s9.1"> EU/ 1/ 04/ 276/ 001
(trg)="s8.1"> EU/ 1/ 04/ 276/ 001 Abilify
(src)="s11.1"> 5 mg
(trg)="s9.1"> 5 mg
(src)="s12.1"> Tablet
(trg)="s10.1"> Tablett
(src)="s13.1"> Oral use
(trg)="s11.1"> Peroraalne
(src)="s14.1"> unit dose perforated blister ( alu/ alu )
(trg)="s12.1"> Üheannuseline perforeeritav blister ( Alu/ Alu )
(src)="s15.1"> 14 x 1
(trg)="s13.1"> 14 x 1
(src)="s16.1"> EU/ 1/ 04/ 276/ 002
(trg)="s14.1"> EU/ 1/ 04/ 276/ 002 Abilify
(src)="s18.1"> 5 mg
(trg)="s15.1"> 5 mg
(src)="s19.1"> Tablet
(trg)="s16.1"> Tablett
(src)="s20.1"> Oral use
(trg)="s17.1"> Peroraalne
(src)="s21.1"> unit dose perforated blister ( alu/ alu )
(trg)="s18.1"> Üheannuseline perforeeritav blister ( Alu/ Alu )