natgillin/translations-raw huggingface dataset:
months *from Tysabri Physician Information and Management Guidelines
72 mesecev *iz Informacij za zdravnike in smernic za ravnanje z zdravilom Tysabri
All patients taking Tysabri should undergo full MRI scans at least once a year, but on the basis of the new data EMA recommended that for patients at higher risk of PML more frequent MRI scans (e.g. every 3 to 6 months) performed using simplified protocols should be considered.
Pri vseh bolnikih, ki jemljejo zdravilo Tysabri, je treba vsaj enkrat letno opraviti MRS celotnih možganov, na osnovi novih podatkov pa je agencija EMA priporočila, da se pri bolnikih z večjim tveganjem MRS izvaja pogosteje (tj. vsakih 3 do 6 mesecev) s skrajšanimi protokoli.
Recent studies suggest that early detection and treatment of PML when the disease is asymptomatic (is still in the initial stages and shows no symptoms) may improve patients' outcomes.
Nedavne raziskave so pokazale, da lahko zgodnje odkritje in zdravljenje PML pri asimptomatski bolezni (tj. v začetnih stadijih, ko še ni simptomov) izboljšata bolnikovo prognozo.
Further stratification of PML risk by anti-JC virus antibody index interval for patients with no prior use of immunosuppressants were derived from combining the overall yearly risk with the antibody index distribution.
Nadaljnja stratifikacija tveganja za PML z intervalom indeksa protiteles proti virusu JC za bolnike brez predhodne uporabe imunosupresivov je bila izvedena z združitvijo celotnega letnega tveganja in razporeditve indeksa protiteles.
• After 2 years of treatment, patients should be informed again about the risk of PML with Tysabri.
• Po dveh letih zdravljenja je treba bolnike ponovno poučiti o tveganju za razvoj PML pri zdravljenju z zdravilom Tysabri.
Based on these data, updated risk estimates for PML2 in JC virus antibody-positive patients treated with Tysabri are available, as shown in Table 1 below:
Na osnovi teh podatkov so na voljo posodobljene ocene tveganja za PML2 pri bolnikih, ki so pozitivni na protitelesa proti virusu JC , zdravljenih z zdravilom Tysabri, kot je prikazano v preglednici 1 spodaj:
• Before starting treatment with Tysabri, and then regularly during treatment, your doctor will do blood tests to measure the level of antibodies for JC virus and MRI scans to monitor your condition.
• Pred začetkom zdravljenja z zdravilom Tysabri in med njim bo vaš zdravnik opravil krvne teste za merjenje ravni protiteles za virus JC in MR slikanje za spremljanje vašega stanja.
Known risk factors for the development of PML in patients treated with Tysabri are the presence of antibodies against JC virus, treatment with Tysabri for more than two years, and previous use of immunosuppressants.
Znani dejavniki tveganja za razvoj PML pri bolnikih, zdravljenih z zdravilom Tysabri, so prisotnost protiteles proti virusu JC, več kot dve leti trajajoče zdravljenje z zdravilom Tysabri in predhodna uporaba imunosupresivov.
New data from large clinical studies also suggest that, in patients who have not been treated with immunosuppressants (medicines that reduce the activity of the immune system) before starting Tysabri, the blood level of antibodies against JC virus (‘antibody index') relates to the level of risk for PML.
Novi podatki iz velikih kliničnih raziskav kažejo tudi, da je pri bolnikih, ki pred začetkom zdravljenja z zdravilom Tysabri niso bili zdravljeni z imunosupresivi (zdravili, ki zmanjšujejo dejavnost imunskega sistema), raven protiteles proti virusu JC v krvi („protitelesni indeks“) povezana s stopnjo tveganja za PML.
Index more than 1.5
Indeks več kot
• Before starting treatment, a baseline MRI should be available (usually within 3 months) as a reference, and a baseline anti-JCV antibody test should be performed to support PML risk stratification.
• Pred začetkom zdravljenja mora biti kot referenca na voljo izhodiščno MRS (običajno ne starejše od 3 mesecev), izvesti pa je treba tudi izhodiščni test protiteles proti virusu JC za podporo stratifikacije tveganja za PML.
• Patients and carers should be advised to continue to be vigilant about the risk of PML for up to 6 months following discontinuation of Tysabri.
• Bolnikom in negovalcem je treba svetovati, da so na pojav znakov in simptomov PML pozorni še do 6 mesecev po prenehanju zdravljenja z zdravilom Tysabri.
Asymptomatic cases of PML can be detected on MRI scans, and experts in the field of MRI and multiple sclerosis agree that simplified MRI protocols (which allow for shorter procedures, and also limit the burden for patients undergoing the scans) permit the identification of PML lesions.
Strokovnjaki za MRS in multiplo sklerozo se strinjajo, da lahko skrajšani protokoli MRS (ki omogočajo krajše postopke in tudi zmanjšujejo obremenitev slikanih bolnikov) omogočajo odkrivanje lezij PML.
Cases of asymptomatic PML based on MRI and positive JC virus DNA in the CSF have been reported.
Poročali so o primerih asimptomatske PML, ugotovljene po MR-posnetkih in pozitivni DNK virusa JC v cerebrospinalni tekočini (CSF).
• If PML is suspected, the MRI protocol should be extended to include contrast-enhanced T1weighted imaging and testing of CSF for the presence of JC virus DNA using ultrasensitive PCR should be considered.
• Ob sumu na PML je treba protokol MRS razširiti, tako da vključuje s kontrastom izboljšano T1-obteženo slikanje in test CSF na prisotnost DNA virusa JC z uporabo visoko občutljive PCR.
If lesions suggestive of PML are discovered, the MRI protocol should be extended to include ‘contrast-enhanced T1-weighted MRI', and testing the spinal fluid for the presence of JC virus should be considered.
Če se ugotovijo lezije, ki kažejo na PML, je treba protokol MRS razširiti, tako da vključuje „T1-obteženo MRS z izboljšanim kontrastom“, in premisliti o ugotavljanju prisotnosti virusa JC v spinalni tekočini.
Table 1: PML risk estimates per 1,000 patients in anti-JC virus antibody positive patients* Duration of Tysabri use
Preglednica 1: Ocena tveganja za PML na 1 000 bolnikov, pri bolnikih, pozitivnih na protitelesa proti virusu JC*
Pooled data from large clinical studies suggest that, in patients with no prior immunosuppressant use, the level of anti-JC virus antibody response (index) relates to the level of risk for PML.
Zbrani podatki iz velikih kliničnih raziskav kažejo, da se pri bolnikih brez predhodne uporabe imunosupresivov raven odziva protiteles virusa JC (indeks) povezuje s tveganjem za PML.
This virus is very common in the general population and is normally harmless; however, it can lead to PML in persons whose immune system is weakened.
Ta virus je med prebivalstvom zelo pogost in običajno neškodljiv.
These tests may be done more often if you are considered at higher risk for PML.
Če obstaja večje tveganje za PML, se lahko ti testi izvedejo pogosteje.
Patients who have low index values and no history of prior immunosuppressant use should also be retested every 6 months once they reach the 2-year treatment point.
Potem, ko dosežejo dveletno točko zdravljenja, je treba vsakih 6 mesecev testirati tudi bolnike, pri katerih so indeksne vrednosti nizke in ki imunosupresivov doslej niso uporabljali.
If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Če sum na PML obstaja v katerem koli trenutku, je treba zdravljenje z zdravilom Tysabri do izključitve PML prekiniti.
• If PML is suspected, your doctor will stop treatment with Tysabri until PML can be ruled out.
• Če bo zdravnik posumil na PML, vas bo prenehal zdraviti z zdravilom Tysabri, dokler ne bo PML izključen.
• If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
• Če sum na PML obstaja v katerem koli trenutku, je treba zdravljenje z zdravilom Tysabri do izključitve PML prekiniti.
More frequent MRI scans should be considered for patients at higher risk
Pri bolnikih s povečanim tveganjem je treba razmisliti o pogostejšem magnetnoresonačnem slikanju.
• For patients at higher risk of PML, more frequent MRIs (e.g. every 3-6 months) using an abbreviated protocol (e.g.
• Pri bolnikih s povečanim tveganjem za PML je treba premisliti o pogostejšem MRS (npr. na 3 do 6 mesecev) z uporabo skrajšanega protokola (npr. FLAIR, T2-obteženo in DW-slikanje), saj je pri zgodnejšem odkritju PML pri asimptomatskih bolnikih prognoza PML boljša.
This is expected to help to prevent organ damage.
To naj bi pomagalo preprečevati poškodbe organov.
London, 19 March 2008 Doc.
London, 19.03.2008 Sklic dok.
Ref. EMEA/136938/2008
EMEA/180150/2008
International non-proprietary name (INN): eprodisate sodium
Mednarodno nelastniško ime (INN): natrijev eprodizat
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preskušanje in potrebujete več podatkov o svojem zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Družba je zahtevala ponovno preučitev negativnega mnenja, ki pa še ni bila zaključena, ko se je odločila za umik svoje vloge.
The main measure of effectiveness was the number of patients whose kidney function got significantly worse or who died over two years of treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je ledvična funkcija po dveh letih zdravljenja močno poslabšala ali pa so umrli.
What are the consequences of the withdrawal for patients in clinical trials with Kiacta?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Kiacta?
The effects of Kiacta were first tested in experimental models before being studied in humans.
Učinki zdravila Kiacta so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Although there was a suggestion that Kiacta may be active, the Committee concluded that another study would be needed to demonstrate the medicine's effectiveness.
Čeprav je bilo videti, da bi zdravilo Kiacta lahko učinkovalo, pa je Odbor menil, da bi bila za dokaz učinkovitosti zdravila potrebna še druga študija.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for KIACTA
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom KIACTA
Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Kiacta for the treatment of AA amyloidosis.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet z zdravilom Kiacta, namenjenim zdravljenju amiloidoze AA.
In addition, following an inspection of the site where the data from the study were analysed, the CHMP had concerns over the reliability of the study's findings because of the way the analysis was carried out.
Poleg tega je imel CHMP pomisleke gledę zanesljivosti rezultatov študije tudi potem, ko je pregledal mesto, kjer so bili podatki iz študije analizirani, in sicer zaradi načina izvedbe analize.
The effectiveness of Kiacta was studied in one main study involving 183 patients with AA amyloidosis, in which Kiacta was compared with placebo (a dummy treatment).
Učinkovitost zdravila Kiacta je bila preučena v eni glavni študiji, v katero je bilo vključenih 183 bolnikov z amiloidozo AA in v kateri so zdravilo Kiacta primerjali s placebom (zdravilom brez zdravilne učinkovine).
The most serious symptoms of the disease are caused by AA deposits building up in the kidneys and damaging them.
Najresnejše simptome bolezni povzročajo odlagi AA, ki se kopičijo v ledvicah in jih tako poškodujejo.
What is Kiacta?
Kaj je zdravilo Kiacta?
The CHMP was concerned that the effectiveness of Kiacta in treating AA amyloidosis had not been demonstrated sufficiently in the single main study.
CHMP je menil, da učinkovitost zdravila Kiacta pri zdravljenju amiloidoze AA z eno samo glavno študijo ni bila zadostno dokazana.
On 13 March 2008, Neurochem Luxco II SARL officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kiacta for the treatment of amyloid A amyloidosis.
Družba Neurochem Luxco II SARL je dne 13. marca 2007 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Kiacta, namenjenim zdravljenju amiloidoze amiloida A. Zdravilo Kiacta je bilo kot zdravilo sirota določeno dne 31. julija 2001.
Kiacta is a medicine containing the active substance eprodisate disodium.
Kiacta je zdravilo, ki vsebuje zdravilno učinkovino dinatrijev eprodizat.
The company informed the CHMP that the ongoing clinical trial with Kiacta is being stopped, so that it can carry out a second study to compare Kiacta with placebo.
Družba je agencijo EMEA obvestila, da je prekinila klinično preskušanje, ki je potekalo z zdravilom Kiacta, da bo lahko izvedla drugo študijo, v kateri bo primerjala zdravilo Kiacta s placebom.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Kiacta had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Zato je CHMP v času umika menil, da koristi zdravila Kiacta niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
Amyloid A amyloidosis is caused by the build-up of insoluble ‘fibrils' (fine threads) of a protein called ‘amyloid A' (AA) in the organs of the body.
Amiloidozo amiloida A povzroča kopičenje netopnih „fibril“ (finih vlaken) beljakovine imenovane „amiloid A“ (AA) v organih v telesu.
AA is produced in the body from a protein called ‘serum amyloid A', which is released by liver cells in response to inflammation.
AA v telesu nastaja iz beljakovine, imenovane „serumski amiloid A“, ki se pri vnetjih sprošča iz jetrnih celic.
The active substance in Kiacta, eprodisate disodium, is expected to work by interfering with the formation of fibrils of AA, preventing the deposits from building up in the organs.
Zdravilna učinkovina v zdravilu Kiacta, dinatrijev eprodizat, naj bi delovala tako, da bi vplivala na tvorjenje fibrilov AA in tako preprečevala, da se odlagi kopičijo v organih.
What was Kiacta expected to be used for?
Za kaj naj bi se zdravilo Kiacta uporabljalo?
How is Kiacta expected to work?
Kako naj bi zdravilo Kiacta delovalo?
This is a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
Zdravilo Kiacta naj bi se uporabljalo za zdravljenje amiloidoze amiloida A. To je redka, življenjsko nevarna bolezen, ki se pojavi pri bolnikih z dolgotrajnimi vnetji, največkrat kot posledica revmatoidnega artritisa.
Pilisborosjenő 2097 Hungary
Pilisborosjenő 2097 Madžarska
(Invented) Name
(Izmišljeno ime) Ime
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
They may also have episodes of depression.
Ima pa lahko tudi epizode depresije.
The full EPAR and risk management plan summary for Aripiprazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Aripiprazol Accord sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• 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 (false beliefs).
• shizofrenijo, tj. duševno boleznijo s številnimi simptomi, ki vključujejo neorganizirano mišljenje in govor, halucinacije (bolnik vidi ali sliši stvari, ki jih ni), sumničavost ter blodnje (zmotna prepričanja).
To prevent manic episodes in adults, the same dose should be continued.
Za preprečevanje maničnih epizod pri odraslih je treba nadaljevati jemanje enakega odmerka.
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.
Ker dopamin in 5-hidroksitriptamin sodelujeta pri shizofreniji in bipolarni motnji, aripiprazol pomaga normalizirati delovanje možganov, zmanjšati psihotične ali manične simptome in preprečiti njihov ponoven pojav.
Aripiprazole Accord is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Zdravilo Aripiprazol Accord je na voljo v obliki tablet (5, 10, 15 in 30 mg) in se izdaja le na recept.
For further information, see the Summary of Product Characteristics (also part of the EPAR).
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
The Committee recommended that Aripiprazole Accord be approved for use in the EU.
Priporočil je, da se zdravilo Aripiprazol Accord odobri za uporabo v EU.
In addition, the company that markets Aripiprazole Accord will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Poleg tega bo družba, ki trži zdravilo Aripiprazol Accord, priskrbela izobraževalno gradivo, ki ga bodo prejeli bolniki ali njihovi negovalci ter zdravniki, v katerem bo pojasnjena varna uporaba zdravila pri bolnikih, starih od 13 do 17 let.
This is a summary of the European public assessment report (EPAR) for Aripiprazole Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aripiprazol Accord.
• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
• bipolarno motnjo I, tj. duševno boleznijo, pri kateri ima bolnik manične epizode (obdobja nenormalno privzdignjenega razpoloženja), ki se izmenjujejo z obdobji normalnega razpoloženja.
What measures are being taken to ensure the safe and effective use of Aripiprazole Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aripiprazol Accord?
A risk management plan has been developed to ensure that Aripiprazole Accord is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Aripiprazol Accord je bil pripravljen načrt obvladovanja tveganj.
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Accord is broken down in the body.
Odmerek je treba prilagoditi pri bolnikih, ki jemljejo druga zdravila, ki vplivajo na presnovo zdravila Aripiprazol Accord v telesu.
Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Aripiprazol domnevno deluje predvsem kot „delni agonist“ receptorjev za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovan tudi serotonin).
This means that Aripiprazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Abilify.
What are the benefits and risks of Aripiprazole Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Aripiprazol Accord?
Aripiprazole Accord is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Zdravilo Aripiprazol Accord se uporablja pri odraslih za zdravljenje zmernih in hudih maničnih epizod ter za preprečevanje pojava novih maničnih epizod pri odraslih, ki so se v preteklosti že odzvali na zdravilo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Aripiprazol Accord primerljivo raven kakovosti kot zdravilo Abilify ter da mu je biološko enakovredno.
Because Aripiprazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Aripiprazol Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Aripiprazole Accord is used in patients aged 15 years or over;
Zdravilo Aripiprazol Accord se uporablja pri bolnikih, starejših od 15 let;
What is Aripiprazole Accord and what is it used for?
Kaj je zdravilo Aripiprazol Accord in za kaj se uporablja?
This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
To pomeni, da aripiprazol z aktiviranjem teh receptorjev deluje kot dopamin in 5-hidroksitriptamin, vendar šibkeje kot živčni prenašalci.
Aripiprazole Accord is a medicine used in patients with the following mental illnesses:
Zdravilo Aripiprazol Accord se uporablja pri bolnikih z naslednjimi duševnimi boleznimi:
For more information about treatment with Aripiprazole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Aripiprazol Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Because Aripiprazole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Ker je zdravilo Aripiprazol Accord generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Abilify.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Aripiprazole Accord aripiprazole
Aripiprazol Accord aripiprazol
Aripiprazole Accord contains the active substance aripiprazole and is a ‘generic medicine'.
Zdravilo Aripiprazol Accord vsebuje zdravilno učinkovino aripiprazol in je „generično zdravilo“.
It is not intended to provide practical advice on how to use Aripiprazole Accord.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Other information about Aripiprazole Accord
Druge informacije o zdravilu Aripiprazol Accord
For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg once a day, either on its own or in combination with other medicines.
Za zdravljenje maničnih epizod pri bipolarni motnji pri odraslih je priporočeni začetni odmerek 15 mg enkrat na dan, ki se jemlje samostojno ali v kombinaciji z drugimi zdravili.
For practical information about using Aripiprazole Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Aripiprazol Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The active substance in Aripiprazole Accord, aripiprazole, is an antipsychotic medicine.
Zdravilna učinkovina v zdravilu Aripiprazol Accord, aripiprazol, je antipsihotično zdravilo.
Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Abilify odtehtajo znana tveganja.