FrancophonIA/ELRC3.0 huggingface dataset:
English: Previously treated patients - Retreatment of prior treatment failures (relapse and non-responder patients) with peginterferon alfa2b in combination with ribavirin:
Slovenian: Predhodno zdravljeni bolniki - Ponovno zdravljenje s peginterferonom alfa-2b v kombinaciji z ribavirinom v primeru neuspešnega prejšnjega zdravljenja (za bolnike s ponovitvijo bolezni in tiste, ki se niso odzvali na predhodno terapijo):
English: In combination with peginterferon alfa-2b
Slovenian: Ribavrin v kombinaciji s peginterferonom alfa-2b
English: How to store Ribavirin Mylan
Slovenian: Kako uporabaljati zdravilo Ribavirin Mylan
English: Ribavirin in combination with Direct Antiviral Agent (DAA):
Slovenian: Klinična učinkovitost in varnost Ribavirin v kombinaciji z učinkovinami z direktnim protivirusnim delovanjem (DAA):
English: The use of ribavirin in combination treatment with peginterferon alfa-2b or interferon alfa-2b was evaluated in a number of clinical trials.
Slovenian: Kombinirano zdravljenje z peginterferonom alfa-2b ali interferonom alfa-2b: Uporabo ribavirina v kombinirani terapiji s peginterferonom alfa-2b ali interferonom alfa-2b so ovrednotili v številnih kliničnih preskušanjih.
English: • Genotype 1: Treatment should be continued for another six month period (i.e., a total of one year) in patients who exhibit negative HCV-RNA after six months of treatment.
Slovenian: • Genotipi 1: Pri bolnikih, pri katerih je po šestih mesecih zdravljenja vrednost serumske RNAHCV še vedno negativna, je treba zdravljenje nadaljevati še vsaj 6 mesecev (t.j.
English: A decrease in haemoglobin levels to < 10 g/dl was observed in up to 14% of adult patients and 7% of children and adolescents treated with ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials.
Slovenian: V kliničnih preskušanjih so pri do 14 % odraslih bolnikov in 7 % otrok in mladostnikov, zdravljenih z ribavirinom v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b, opažali zmanjšanje vrednosti hemoglobina na < 10 g/dl.
English: Mylan AB Tel: +46 855 522 750
Slovenian: Tel: +46 855 522 750
English: Naïve patients
Slovenian: Odrasli bolniki
English: HCV/HIV co-infected patients
Slovenian: Bolniki, ki imajo sočasno okužbo s HCV/HIV
English: Adverse Reactions
Slovenian: Očesne spremembe
English: Posology and method of administration
Slovenian: NAČIN IN REŽIM IZDAJE ZDRAVILA
English: 4 capsules b Refer to adult dose recommendations a1 morning, 2 evening 2 morning, 2 evening
Slovenian: 1 zjutraj, 2 zvečer a 2 zjutraj, 2 zvečer
English: There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa.
Slovenian: Kombinirano zdravljenje z zdravilom Ribavirin Mylan in (peg)interferonom alfa je povezano z več resnimi neželenimi učinki.
English: Pack sizes of 84, 112, 140 and 168 capsules.
Slovenian: HDPE plastenko, zaprto z za otroke varno (CR) polipropilensko (PP) navojno zaporko s po 84, 112, 140 ali 168 kapsul.
English: Paediatric population (patients under the age of 18 years): Ribavirin Mylan may be used in combination with interferon alfa-2b in children (3 years of age and older) and adolescents.
Slovenian: Zdravilo Ribavirin Mylan se lahko uporablja v kombinaciji s peginterferonom alfa-2b pri otrocih (starih, 3 leta ali več) in mladostnikih.
English: Fatigue, rigors, pyrexia, influenza-like illness, asthenia, malaise, irritability
Slovenian: utrujenost, mrzlica, zvišana telesna temperatura, gripi podobna bolezen, astenija, bolehnost, razdražljivost
English: HCV-RNA negative or ≥ 1 log decrease in viral load
Slovenian: ali zmanjšanje virusnega bremena za ≥ 1 log
English: Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Slovenian: konjunktivitis, očesne bolečine, motnje vida, bolezni solzne žleze
English: Mylan is by an additional 200 mg/day.
Slovenian: Po potrebi se lahko zmanjša 2. odmerek zdravila Ribavirin Mylan za dodatnih 200 mg/dan.
English: Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and ribavirin when administered to paediatric patients with chronic hepatitis C Parameter
Slovenian: Preglednica 15 Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju interferona alfa-2b in ribavirina pri pediatričnih bolnikih s kroničnim hepatitisom C Parameter ribavirin 15 mg/kg na dan v obliki 2 deljenih odmerkov (n = 17)
English: Suicidal ideation, aggression, confusion, affect liability, behaviour disorder, agitation, somnambulism, anxiety, mood altered, restlessness, nervousness, sleep disorder, abnormal dreaming, apathy
Slovenian: somnambulizem, tesnoba, spreminjajoče razpoloženje, nemir, živčnost, motnje spanja, nenormalne sanje, apatičnost
English: Diarrhoea, vomiting, nausea, abdominal pain
Slovenian: driska, bruhanje, slabost, trebušne bolečine
English: Taking this medicine in combination with an alpha interferon and an anti-HIV medicine may increase the risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).
Slovenian: - zdravila proti virusu humane imunske pomanjkljivosti (HIV) - nukleozidni zaviralec reverzne transkriptaze (NRTI) in/ali kombinirano protiretrovirusno terapijo (cART): - jemanje tega zdravila v kombinaciji z interferonom alfa in zdravilom proti virusu HIV lahko poveča tveganje za pojav laktacidoze, jetrne odpovedi in krvnih bolezni (zmanjšanje števila rdečih krvnih celic, ki prenašajo kisik po telesu, določenih belih krvnih celic, ki služijo za boj proti okužbam, in celic za strjevanje krvi, ki jim pravimo trombociti).
English: Breast-feeding
Slovenian: Bilirubin-indiraktni
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b The safety of ribavirin is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied ribavirin capsules in combination with interferon alfa-2b, two trials studied ribavirin capsules in combination with peginterferon alfa-2b.
Slovenian: Kombinirano zdravljenje z peginterferonom alfa-2b ali interferonom alfa-2b Varnost uporabe ribavirina so ovrednotili na podlagi izsledkov štirih kliničnih preskušanj pri bolnikih, ki še niso bili izpostavljeni interferonu (predhodno nezdravljeni bolniki).
English: • Ribavirin (1,000/1,200 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) (n=514).
Slovenian: • ribavirin (1.000/1.200 mg/dan) + peginterferon alfa-2b (1,5 mikrogramov/kg na teden en mesec,
English: Commonly reported side effects (may affect up to 1 in 10 people): decrease in blood clotting cells called platelets (that may result in easy bruising and spontaneous bleeding), excess of triglycerides in the blood, excess of uric acid (as in gout) in the blood, increase in thyroid gland activity (which may cause nervousness, heat intolerance and excessive sweating, weight loss, palpitation, tremors), agitation, anger, aggressive behaviour, behaviour disorder, difficulty concentrating, emotional instability, fainting, feeling anxious or nervous, feeling cold, feeling confused, feeling of restlessness, feeling sleepy, lack of interest or attention, mood changes, pain, poor quality sleep, sleepwalking, suicide attempt, trouble sleeping, unusual dreams, wanting to harm yourself, bacterial infections, common cold, fungal infections, abnormal vision, dry or teary eyes, ear infection, eye irritation or pain or infection, change in taste, changes in your voice, cold sores,
Slovenian: Pogosto poročani neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): zmanjšanje števila krvnih celic, odgovornih za strjevanje krvi, ki jim pravimo trombociti (kar lahko vodi do nagnjenosti k nastanku podplutb in spontanih krvavitev), previsoka koncentracija trigliceridov v krvi, previsoka koncentracija sečne kisline v krvi (kot pri protinu), povečano delovanje žleze ščitnice (ki lahko povzroči živčnost, neprenašanje vročine in čezmerno potenje, hujšanje, razbijanje srca in tresenje), vznemirjenost, jeza, agresivno vedenje, vedenjske motnje, težave s koncentracijo, čustvena nestabilnost, omedlevica, občutek tesnobe ali živčnosti, občutek mrazenja, občutek zmedenosti, občutek nemira, občutek zaspanosti, pomanjkanje zanimanja za kar koli ali zmanjšana pozornost,
English: Chest discomfort, facial pain
Slovenian: meugodje v prsih, obrazna bolečina
English: Overall Responsea (n = 118) Genotype 1 (n = 92)
Slovenian: (n=118)
English: Interferon medicine that is used in combination with Ribavirin Mylan may cause unusual tiredness; if you are injecting this medicine yourself or giving it to a child, use it at bedtime.
Slovenian: Interferoni, ki se uporabljajo v kombinaciji z zdravilom Ribavirin Mylan lahko povzročijo neobičajno utrujenost.
English: For complete information be sure to read the “How to use” section of the Package Leaflet for interferon alfa-2b.
Slovenian: Opozorilo: Prosimo, preberite poglavje “Ne uporabljajte” v navodilih za uporabo za interferon alfa-2b,
English: *HCV-RNA PCR assay, with a lower limit of quantitation of 27 IU/ml
Slovenian: TVO pri bolnikih z nemerljivo koncentracijo HCVRNA v 12. tednu zdravljenja *PCR test za določitev HCV-RNA s spodnjo mejo kvantifikacije 27 i.e./ml
English: Retinopathy including retinal haemorrhages, retinal exudates, papilloedema, optic neuropathy and retinal artery or vein occlusion which may result in loss of vision have been reported in rare instances with combination therapy with alpha interferons.
Slovenian: V redkih primerih so pri takšni kombinirani terapiji z interferoni alfa poročali o retinopatiji, vključno z mrežničnimi krvavitvami, eksudati na mrežnici, edemom papile, nevropatijo vidnega živca in zamašitvijo mrežnične arterije ali vene, ki lahko povzroči izgubo vida.
English: - azathioprine is a medicine that suppresses your immune system, using this medicine in combination with ribavirin and pegylated alpha interferons and, therefore may increase your risk of developing severe blood disorders.
Slovenian: Obsvestite zdravnika ali farmacevta, če vi ali otrok za katerega skrbite jemljete, ste pred kratkim jemali ali pa boste mora zečeli jemati katero koli drugo zdravilo: - azatioprin je zdravilo, ki zavira delovanje vašega imunskega sistema; njegova uporaba v kombinaciji z ribavirinom in pegiliranim alfa interferonom lahko pri vas poveča tveganje za nastanek hudih krvnih bolezni.
English: Interferon alfa-2b 3 MIU/m2 3 times a week (n = 54)
Slovenian: interferon alfa-2b 3 mio i.e./m
English: Reminder: This medicine is used in combination with interferon alfa-2b for hepatitis C virus infection.
Slovenian: Opozorilo:To zdravilo se lahko uporablja samo v kombinaciji s interferonom alfa-2b za virusno okužbo s hepatitisom C. Za popolnejše informacije morate prebrati tudi poglavje “Kako uporabljati zdravilo” v navodilih za uporabo interferon alfa-2b.
English: *Genotype 1 receive 48 weeks treatment **Genotype 2, 3 receive 24 weeks treatment ***The presented results are from a single point of time.
Slovenian: *Genotip 1 naj prejme 48 tednov zdravljenja.
English: - are breast-feeding.
Slovenian: - Navodilo shranite.
English: At the end of 24 weeks post-treatment follow-up, mean decrease from baseline in weight and height percentiles were still 3 percentiles and 7 percentiles, respectively, and 20% of the children continued to have inhibited growth (growth velocity < 3
Slovenian: Po 24. tednih spremljanja bolnikov po zaključku zdravljenja, se je njihova telesna masa, glede na osnovne vrednosti, zmanjšala za 3 percentile, telesna višina pa za 7 percentilov.
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika Če ste negotovi se posvetujte z zdravnikom ali farmacevtom.
English: Uric acid may increase with Ribavirin Mylan due to haemolysis; therefore, the potential for development of gout must be carefully monitored in pre-disposed patients.
Slovenian: Koncentracija sečne kisline se lahko poveča pri zdravljenju z zdravilom Ribavirin Mylan zaradi hemolize.
English: Some data suggest that HIV/HCV co-infected patients receiving abacavir-containing ART may be at risk of a lower response rate to pegylated interferon/ribavirin therapy.
Slovenian: z abakavirjem, tveganje za manjšo stopnjo odziva na zdravljenje s pegiliranim interferonom in ribavirinom.
English: inflammation of pancreas, pain in bone, diabetes mellitus, muscle weakness.
Slovenian: boleče okončine, bolečine v križu, mišični krči
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Periodična posodobljena varnostna poročila (PSUR)
English: In HCV/HIV co-infected patients receiving cART, the following other side effects have occurred with the combination of ribavirin and peginterferon alfa-2b (not listed above in adults side effects): appetite decreased, back pain,
Slovenian: Pri bolnikih, ki so bili sočasno okuženi z virusoma HCV in HIV in so prejemali zdravljenje cART, so se med jemanjem kombinacije zdravila Rivastigmin Mylan trde kapsule in peginterferona alfa-2b pojavili naslednji drugi neželeni učinki (ki niso našteti zgoraj med neželenimi učinki pri odraslih): zmanjšan apetit, bolečine v hrbtu, zmanjšano število limfocitov CD4, motnje presnove maščob, hepatitis, bolečine v udih, kandidoza v ustih (sor), nenormalni izvidi različnih laboratorijskih krvnih preiskav.
English: Haemoglobin levels dropped below 10 g/dl in up to 14% of adult patients and 7% of children and adolescents treated with ribavirin in combination with either peginterferon alfa-2b or interferon alfa2b.
Slovenian: Pri do 14 % odraslih bolnikov in 7 % otrok in mladostnikov, zdravljenih z ribavirinom v kombinaciji bodisi s peginterferonom alfa-2b ali z interferonom alfa-2b, se je vrednost hemoglobina znižala pod 10 g/dl.
English: Ribavirin Mylan dose based on body weight when used in combination with interferon alfa-2b or peginterferon alfa-2b in children above 3 years of age and adolescents
Slovenian: Zdravilo Ribavirin Mylan trde kapsule se lahko uporabljata v kombinaciji z interferonom alfa-2b pri otrocih, starih 3 leta in več, in mladostnikih.
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Ribavirin and peginterferon alfa-2b or interferon alfa-2b.
Slovenian: Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravil ribavirina in peginterferona alfa-2b ali interferona alfa-2b imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
English: Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction), constant cough, eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots (white deposits on the retina), enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement,
Slovenian: bronhokonstrikcija in anafilaksija (huda alergijska reakcija po vsem telesu), neprekinjen kašelj, očesne težave, vključno z okvaro mrežnice, zamašitvijo mrežnične arterije, vnetjem očesnega živca, otekanjem očesa in belimi lisami na mrežnici (na mrežnici se pojavijo bele usedline), povečanje trebuha, zgaga, težave z odvajanjem blata ali boleče odvajanje blata, akutne preobčutljivostne reakcije, vključno z urtikarijo (koprivnico), podplutbami, močnimi bolečinami v udih, bolečinami v nogah ali stegnih, zmanjšanjem obsega gibov, okorelostjo, sarkoidozo (za to bolezen so značilni trdovratna zvišana telesna temperatura, hujšanje, sklepne bolečine in otekanje sklepov, kožne spremembe in otekle žleze).
English: Please refer to the corresponding SmPC of medicinal products used in combination with ribavirin for further dosage recommendations on co-administration.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z ribavirinom, za priporočila o prenehanju uporabe oziroma prilagoditvi odmerkov.
English: Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia Ear and labyrinth disorders
Slovenian: krvavitev veznice, očesni pruritus, keratitis, zamegljen vid, fotofobija Ušesne bolezni, vključno z motnjami labirinta Pogosti:
English: Weight decrease
Slovenian: Zmanjšajte odmerek zdravila
English: Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Mylan may be used in combination with peginterferon alfa-2b or interferon alfa-2b (see section 4.4).
Slovenian: Odmerek zdravila Ribavirin Mylan na podlagi telesne mase pri otrocih, starejših od 3 let, in mladostnikih, če je zdravilo uporabljeno v kombinaciji z interferonom alfa-2b ali peginterferonom alfa-2b
English: Each hard capsule contains 200 mg of ribavirin.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 200 mg ribavirina.
English: Table 4 provides guidelines for dose modification for patients with renal dysfunction.
Slovenian: Preglednica 4 Prilagoditev odmerka v primeru okvare ledvic pri odraslih bolnikih Očistek kreatinina
English: Annex Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Slovenian: Priloga Znanstveni zaključki in podlaga za zavrnitev, ki jih je predstavila Evropska agencija za zdravila
English: At individual level the variability between patients is evident and separation between groups is not so clear.
Slovenian: Variabilnost med bolniki je očitna na ravni posameznikov, ločitev med skupinami pa ni tako jasna.
English: Overall summary of the scientific evaluation of Exondys after re-examination
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Exondys po ponovnem pregledu
English: The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the efficacy and the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Slovenian: Odbor CHMP zato meni, da v skladu s členom 12 Uredbe (ES) št. 726/2004 učinkovitost in varnost zgoraj navedenega zdravila nista bili ustrezno ali zadovoljivo dokazani.
English: • Efficacy of eteplirsen remains not demonstrated.
Slovenian: • učinkovitost eteplirsena še vedno ni dokazana.
English: • Grounds for refusal
Slovenian: • Podlaga za zavrnitev
English: This is even more relevant when the external controls are retrospectively selected.
Slovenian: To je še pomembnejše pri retrospektivni izbiri zunanjih kontrolnih skupin.
English: The applicant requested a Conditional marketing authorisation based on their claim that their application fulfils all the requirements from in Regulation (EC) No 507/2006.
Slovenian: Predlagatelj je predložil vlogo za pridobitev pogojnega dovoljenja za promet z zdravilom in to utemeljil s trditvijo, da predložena vloga izpolnjuje vse zahteve iz Uredbe (ES) št. 507/2006.
English: The comparison with external control cohort from natural history databases presents with methodological deficiencies, and its results can only be considered as exploratory or supportive.
Slovenian: Primerjava z zunanjo kontrolno kohorto iz podatkovnih zbirk naravnega poteka ima metodološke pomanjkljivosti, njeni izidi pa se lahko štejejo samo kot raziskovalni ali podporni.
English: The additional data provided from the open-label phase, a 4-year period of treatment, do not allow to convincingly conclude on a relevant effect of eteplirsen in this population.
Slovenian: Dodatni podatki iz odprte faze, štiriletnega obdobja zdravljenja, ne omogočajo prepričljivega sklepa o zadevnem učinku eteplirsena pri tej populaciji.
English: Therefore, the CHMP has recommended the refusal of the granting of the conditional marketing authorisation for Exondys.
Slovenian: Odbor CHMP je zato priporočil zavrnitev vloge za pridobitev pogojnega dovoljenja za promet z zdravilom Exondys.
English: During the initial CHMP assessment, three additional clinical studies were being conducted, in order to provide additional data to support the application.
Slovenian: Med prvotnim ocenjevanjem odbora CHMP so potekale tri dodatne klinične študije, da bi vlogo podprli z dodatnimi podatki.
English: The Applicant has defined post-hoc several external controls that have been used for different comparisons.
Slovenian: Predlagatelj je naknadno opredelil več zunanjih kontrolnih skupin, ki jih je uporabil za različne primerjave.
English: The assessment of the safety profile of eteplirsen was hampered by the limitations of the safety database.
Slovenian: Oceno varnostnega profila eteplirsena so ovirale omejitve zbirke podatkov o varnosti.
English: The potential sources of bias, using this strategy, seriously affect the reliability of the subsets and comparisons, and the conclusions made thereof.
Slovenian: Možni viri pristranskosti pri tej strategiji resno vplivajo na zanesljivost podskupin in primerjav ter na oblikovane sklepe.
English: Separation between curves is apparent at Year 3 (Year 3 - 144 metres, p=0.0055; Year 4 - 161 metres, p=0.0007).
Slovenian: Ločitev krivulj je opazna pri tretjem letu (tretje leto - 144 metrov, p = 0,0055; četrto leto - 161 metrov, p = 0,0007).
English: Regarding the laboratory findings the main concern is proteinuria that has already been observed in nonclinical studies.
Slovenian: Kar zadeva laboratorijske izvide, vzbuja največjo zaskrbljenost proteinurija, ki je bila opažena že v predkliničnih študijah.
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Slovenian: Proučeni so bili fizikalno-kemični in biološki vidiki, pomembni za enotno klinično učinkovitost zdravila, ki so zadovoljivo nadzorovani.
English: Without an appropriate concurrent control it is not possible to conclude that the results are reflecting a true and clinically meaningful change (slowing the progression) in the course of the condition.
Slovenian: Brez ustrezne sočasne kontrole ni mogoče skleniti, da izidi izražajo pravo in klinično pomembno spremembo (upočasnitev napredovanja) med potekom bolezni.
English: • Due to the limited number of patients exposed to eteplirsen the safety profile remains not thoroughly characterised.
Slovenian: • zaradi omejenega števila eteplirsenu izpostavljenih bolnikov varnostni profil še vedno ni popolnoma določen.
English: This small and acquired in a non-comparative manner, dataset makes the assessment of the long-term safety impossible.
Slovenian: Ta manjši nabor podatkov, pridobljen na neprimerjalen način, onemogoča oceno dolgoročne varnosti.
English: In general, this strategy increases the uncertainty about the results rather than providing reassuring comparisons.
Slovenian: Ta strategija na splošno povečuje negotovost glede rezultatov in ne omogoča zanesljivih primerjav.
English: Therefore, safety data have to be interpreted with caution, precluding any firm conclusions on the safety profile of the product.
Slovenian: Podatke o varnosti je zato treba razlagati previdno in brez sprejemanja dokončnih sklepov o varnostnem profilu zdravila.
English: As the minimum amount of truncated dystrophin expression that is needed to achieve a clinically relevant benefit remains unknown, the value of these data is mainly to serve as supportive for the proposed mechanism of action of the product.
Slovenian: Ker najmanjša količina zaznanega izražanja skrajšanega distrofina, potrebnega za dosego klinično pomembne koristi, ostaja neznana, so ti podatki pomembni predvsem zato, ker podpirajo predlagani mehanizem delovanja zdravila.
English: However, the CHMP concluded that the medicinal product did not fulfil all of the criteria set out in Article 4(1) of the Regulation, such as, the current benefit-risk balance could not be considered positive based on the available, submitted data.
Slovenian: Odbor CHMP pa je sklenil, da zdravilo ne izpolnjuje vseh meril iz člena 4(1) navedene uredbe, kot na primer, da na podlagi razpoložljivih in predloženih podatkov trenutnega razmerja med tveganji in koristmi ni mogoče šteti za pozitivnega.