natgillin/translations-raw huggingface dataset:
The adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (very common  1/10; common: 1/100 to < 1/10; uncommon:  1/1,000 to ≤ 1/100; rare:  1/10,000 to ≤1/1,000; very rare ≤1/10,000) and system organ class by decreasing order of seriousness; these adverse reactions should be interpreted within the surgical and medical context.
Neželeni učinki, o katerih so poročali raziskovalci in za katere je možna vsaj majhna povezava s fondaparinuksom, so navedeni v skupinah glede na pogostnost (zelo pogosti  1/10; pogosti  1/100 do < 1/10; občasni  1/1.000 do < 1/100; redki  1/10.000 do < 1/1.000; zelo redki ≤ 1/10.000) in organski sistem v padajočem vrstnem redu po resnosti; te neželene učinke moramo interpretirati v povezavi s kirurškim in internističnim posegom.
The adverse reactions reported during clinical trials conducted with SCENESSE are listed in the table below by MedDRA system organ class and frequency convention.
Neželeni učinki, o katerih so poročali v kliničnih preskušanjih z zdravilom SCENESSE, so navedeni v spodnji preglednici glede na organske sisteme po MedDRA in naslednjo pogostnost.
The adverse reactions reported in the clinical trial of predominantly paediatric patients with nmDMD treated at the recommended dose of 10-, 10-, 20 mg/kg are classified according to the System Organ Class of MeDRA and frequency.
Neželeni učinki, o katerih so poročali v kliničnem preskušanju, v katerem so sodelovali predvsem pediatrični bolniki z DMD zaradi nesmiselne mutacije, ki so jih zdravili s priporočenimi odmerki 10, 10 in 20 mg/kg, so razvrščeni po organskih sistemih po MedDRA in pogostnosti.
The adverse reactions reported in these tables are those events that occurred in 0,1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Navedeni so neželeni učinki, ki so se pojavili pri 0,1 % ali več bolnikov, zdravljenih s pramipeksolom, in o katerih so poročali pomembno pogosteje pri bolnikih, ki so jemali pramipeksolom, kot pri bolnikih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
The adverse reactions reported with abacavir, lamivudine and zidovudine are presented in Table 2.
Neželeni učinki, o katerih so poročali po uporabi abakavirja, lamivudina in zidovudina so predstavljene v tabeli 1.
The adverse reactions reported with Vivanza film-coated tablets or 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature.
Neželeni učinki o katerih so poročali v kliničnih preskušanjih pri uporabi zdravila Vivanza filmsko obložene tablete in orodisperzibilnih tablet po 10 mg vardenafila, so bili v glavnem prehodni in blagi do zmerni.
The adverse reactions reported with Vivanza film-coated tablets or vardenafil 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature.
Neželeni učinki, o katerih so poročali v kliničnih preskušanjih pri uporabi zdravila Vivanza filmsko obložene tablete in orodisperzibilnih tablet po 10 mg vardenafila, so bili v glavnem prehodni in blagi do zmerni.
The adverse reactions table below therefore applies to Kineret treatment both in RA and CAPS patients.
Preglednica neželenih učinkov spodaj se torej nanaša na zdravljenje bolnikov z RA in s CAPS.
The adverse reactions that may occur during treatment with ONIVYDE are summarised below and are presented by system organ class and frequency category (Table 3).
Neželeni učinki, ki se lahko pojavijo med zdravljenjem z zdravilom ONIVYDE, so povzeti spodaj in so navedeni po organskem sistemu in pogostnosti (preglednica 3).
The adverse reactions were generally mild or moderate in severity.
Neželeni učinki so bili običajno blagi do zmerni.
The adverse reactions were obtained from clinical studies and post- marketing data with TRAVATAN.
Neželeni učinki so bili ugotovljeni v kliničnih študijah in iz podatkov v obdobju trženja zdravila TRAVATAN.
The adverse reactions were those typically seen with standard chemotherapy and also with dexrazoxane: Nausea/vomiting in about one third of the patients, neutropenia and thrombocytopenia in about half of the patients, more rarely increased concentration of liver enzymes (ALT/AST).
Opazili so neželene učinke, značilne za standardno kemoterapijo in deksrazoksan: slabost/bruhanje so opazili pri približno tretjini bolnikov, nevtropenijo in trombocitopenijo pri približno polovici bolnikov, redkeje pa zvišane ravni jetrnih encimov (ALT/AST).
The adverse reactions which most often led to permanent discontinuation of CRESEMBA treatment were confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnoea (0.5%), epilepsy (0.5%), respiratory failure (0.5%) and vomiting (0.5%).
Neţeleni učinki, ki so najpogosteje privedli do trajne prekinitve zdravljenja z zdravilom CRESEMBA, so bili stanje zmedenosti (0,7 %), akutna odpoved ledvic (0,7 %), zvišan bilirubin v krvi (0,5 %), konvulzije (0,5 %), dispneja (0,5 %), epilepsija (0,5 %), respiratorna odpoved (0,5 %) in bruhanje (0,5 %).
The adverse reactions with a reasonable possibility of causal relationship to the injection procedure or JETREA are listed by MedDRA system organ class and frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Neželeni učinki, za katere je vzročna povezava s postopkom injiciranja ali z zdravilom JETREA razumno mogoča, so navedeni po organskih sistemih MedDRA in pogostnosti po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The adverse reactions with at least a reasonable possibility of a causal relationship with levofloxacin are presented according to the MedDRA System Organ Classification.
Neželeni učinki z vsaj razumno možnostjo vzročne zveze z levofloksacinom so predstavljeni po razvrstitvi na organske sisteme v skladu z MedDRA.
The adverse reactions with at least a reasonable possibility of a causal relationship with Quinsair are presented according to the MedDRA System Organ Classification.
Neželeni učinki z vsaj razumno možnostjo vzročne zveze z zdravilom Quinsair so predstavljeni po razvrstitvi na organske sisteme v skladu z MedDRA.
The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body syste organ class and frequency.
Spodaj so navedeni neželeni učinki, domnevno (vsaj možno) povezani z zdravljenjem, po organskih sistemih in pogostosti.
The advisability of driving should be considered in these circumstances.
V takšnih okolišcinah je treba pretehtati, ali je priporocljivo, da bolnik vozi.
The AE profile for healthy subjects was similar to the AE profile in patients relative to GI disorders (diarrhoea and abdominal pain).
Profil neželenih učinkov, povezanih z boleznimi prebavil (driska in bolečine v trebuhu), pri zdravih posameznikih je bil podoben kot pri bolnikih.
The aetiology of PAH, according to Dana Point classification, included idiopathic PAH (46%), heritable PAH (3%), associated PAH after corrective cardiac surgery (38%), and PAH-CHD associated with systemic-to-pulmonary shunts, including Eisenmenger syndrome (13%).
Etiologija PAH po klasifikaciji Dana Point je vključevala idiopatsko PAH (46 %), dedno PAH (3 %), PAH po korektivni srčni operaciji (38 %) in PAH-CHD, povezano s sistemsko pljučnim šantom, vključno z Eisenmengerjevim sindromom (13 %).
The affected “B-lymphocytes” multiply too quickly and live too long.Gazyvaro binds to targets on the surface of the affected “B lymphocyte” cells and causes them to die.
Zdravilo Gazyvaro se veže na tarče na površini prizadetih limfocitov B in povzroči, da te celice odmrejo.
The affinity of antibodies against the HA1 domain of the H5 HA in the H5N1 P/LAIV-primed groups was significantly higher than the 2- dose inactivated vaccine group, which correlated with cross-clade H5N1 neutralization.
Afiniteta protiteles proti domeni HA1 H5 HA v skupini, ki je primarno prejela P/LAIV H5N1, je bila značilno večja kot v skupini z 2 odmerkoma inaktiviranega cepiva, kar je koreliralo z navzkrižno nevtralizacijo med kladi H5N1.
The affinity of brinzolamide and metabolite to RBC and tissue CA results in low plasma concentrations.
Zaradi afinitete brinzolamida in njegovega presnovka za eritrocitni in tkivni CA so njegove plazemske koncentracije nizke.
The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma.
Afiniteta insulina degludek za serumski albumin ustreza > 99 % vezavi na plazemske beljakovine v človeški plazmi.
The age of the DFSP patients ranged from 23 to
Starost bolnikov z DFSP se je gibala med 23 in 75 leti.
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m² daily or doses ranging from 200 to 400 mg daily.
Ti bolniki so bili stari od 2 do 16 let, imatinib pa so prejemali v odmerku 300 mg/m2 na dan oziroma v odmerkih od 200 do 400 mg na dan.
The age of these patients ranged from 2 to 16years and imatinib was given at dose 300mg/m2 daily or doses ranging from 200 to 400mg daily.
Ti bolniki so bili stari od 2 do 16 let, imatinib pa so prejemali v odmerku 300 mg/m2 na dan oziroma v odmerkih od 200 do 400 mg na dan.
The age of these patients ranged from 25 to 72years.
Ti bolniki so bili stari od 25 do 72 let.
The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m² daily.
Ti bolniki so bili stari od 3 mesece do 4 leta, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 92,5 do 340 mg/m2 na dan.
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m² daily.
Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 400 do 520 mg/m2 na dan.
The age of these patients ranged from newborn to 14years and imatinib was given at dose 50mg daily or doses ranging from 400 to 520mg/m2 daily.
Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 400 do 520 mg/m2 na dan.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Aerivio Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Aerivio Spiromax primerljivo raven kakovosti kot zdravilo Seretide Diskus ter da mu je biološko enakovredno.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Airexar Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Airexar Spiromax primerljivo raven kakovosti kot zdravilo Seretide Diskus ter da mu je biološko enakovredno.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo BiResp Spiromax v jakostih 160/4,5 mikrogramov in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je biološko enakovredno pri ustrezajočih jakostih.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Budesonide/Formoterol Teva v jakostih 160/4,5 mikrograma in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je pri ustrezajočih jakostih biološko enakovredno.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva Pharma B.V. 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Budesonide/Formoterol Teva Pharma B.V. v jakostih 160/4,5 mikrograma in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je pri ustrezajočih jakostih biološko enakovredno.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Cresemba’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Cresemba večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Defitelio’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Defitelio večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that DuoResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo DuoResp Spiromax v jakostih 160/4,5 mikrogramov in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je biološko enakovredno pri ustrezajočih jakostih.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Eperzan’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Eperzan večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Holoclar treatment was effective in restoring healthy corneal surfaces in patients with moderate or severe limbal stem-cell deficiency caused by burns as well as in improving their symptoms and vision.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo zdravilo Holoclar učinkovito pri ponovni vzpostavitvi zdrave površine roženice pri bolnikih z zmernim ali hudim pomanjkanjem limbusnih matičnih celic zaradi opekline ter pri izboljšanju njihovih simptomov in vida.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Incresync’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Incresync večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Ivabradine Anpharm was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta‑blockers or whose disease is not controlled with them.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so dokazali, da je zdravilo Ivabradine Anpharm učinkovito pri zdravljenju dolgotrajne angine pektoris in ima sprejemljiv varnostni profil za alternativno zdravljenje bolnikov, ki ne morejo jemati antagonistov adrenergičnih receptorjev beta oziroma pri katerih bolezen z njimi ni urejena.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and the use of high-dose dexamethasone in multiple meyloma is well established.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo dokazano, da je zdravilo Neofordex po kakovosti primerljivo zdravilu Dectancyl in da je uporaba deksametazona v velikem odmerku pri multiplem mielomu dobro uveljavljena.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Nordimet has been shown to be comparable to reference medicine.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil,da je bilo dokazano, da je zdravilo Nordimet primerljivo z referenčnim zdravilom.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Numient’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Numient večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Opsumit’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Opsumit večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Ovaleap has been shown to have a comparable quality, safety and efficacy profile to GONAL-f.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo dokazano, da so kakovost, varnost in učinkovitost zdravila Ovaleap in zdravila GONAL-f primerljive.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Pheburane has been shown to have comparable quality and to be bioequivalent to Ammonaps.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da ima zdravilo Pheburane primerljivo raven kakovosti kot zdravilo Ammonaps ter da mu je biološko enakovredno.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Plegridy’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Plegridy večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Simbrinza was shown to be more effective than either active substance used alone and at least as effective as the combination of the active substances given as separate eye drops.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo dokazano, da je zdravilo Simbrinza učinkovitejše od katere koli od obeh zdravilnih učinkovin, uporabljenih posamično, in vsaj tako učinkovito kot kombinacija obeh zdravilnih učinkovin, danih z ločenimi kapljicami za oko.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Jetrea outweigh its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Jetrea večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative.
Odbor CHMP je zaključil, da so koristi zdravljenja z zdravilom Ameluz večje od večinoma blagih neželenih učinkov ter da je bilo učinkovitejše in nekoliko varnejše kot standardno zdravljenje.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Vantobra’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Vantobra večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Vipidia’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vipidia večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Vylaer Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Vylaer Spiromax v jakostih 160/4,5 mikrograma in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je pri ustrezajočih jakostih enakovredno.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Actelsar HCT primerljivo raven kakovosti kot zdravilo MicardisPlus ter da mu je biološko enakovredno.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Amlodipine/Valsartan Mylan has been shown to have comparable quality and to be bioequivalent/be comparable to Exforge.
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 Amlodipin/Valsartan Mylan primerljivo raven kakovosti kot zdravilo Exforge ter da mu je biološko enakovredno/je z njim primerljivo.
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.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Mylan Pharma 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 Mylan Pharma primerljivo raven kakovosti kot zdravilo Abilify ter da mu je biološko enakovredno.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Sandoz 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 Aripiprazole Sandoz primerljivo raven kakovosti kot zdravilo Abilify ter da mu je biološko enakovredno.