FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in the rat have shown that miglustat adversely affects spermatogenesis and sperm parameters and reduces fertility (see sections 4.6 and 5.3).
Slovenian: Študije na podganah so pokazale, da miglustat neželeno vpliva na spermatogenezo in parametre spermijev ter zmanjšuje plodnost (glejte poglavji 4.6 in 5.3).
English: The usual dose of miglustat in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Slovenian: Običajni odmerek zdravila miglustat pri odraslih bolnikih je bil 200 mg trikrat dnevno, ustrezno prilagojen na površino telesa pri pediatričnih bolnikih.
English: Studies in the rat have shown that miglustat adversely affects sperm parameters (motility and morphology) thereby reducing fertility (see sections 4.4 and 5.3).
Slovenian: Študije na podganah so pokazale, da miglustat negativno vpliva na parametre spermijev (gibljivost in obliko), s čimer zmanjša plodnost (glejte poglavji 4.4 in 5.3).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products.
Slovenian: Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove.
English: Miglustat Dipharma contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Slovenian: Zdravilo Miglustat Dipharma vsebuje učinkovino miglustat, ki spada v skupino zdravil, ki vplivajo na presnovo.
English: • monitoring of blood platelet counts
Slovenian: • nadziranje števila trombocitov v krvi.
English: The benefit of treatment with miglustat for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with miglustat (see section 4.4).
Slovenian: Koristi zdravljenja z zdravilom miglustat pri nevroloških manifestacijah pri bolnikih z NiemannPickovo boleznijo tipa C je treba redno preverjati, npr. vsakih 6 mesecev; za nadaljevanje terapije se je treba ponovno odločiti po vsaj 1-letnem zdravljenju z zdravilom miglustat (glejte poglavje 4.4).
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma (see sections 4.4 and 5.3).
Slovenian: Moški morajo ves čas uporabe zdravila Miglustat Dipharma uporabljati zanesljiv način kontracepcije (glejte poglavji 4.4 in 5.3).
English: 100 mg once a day
Slovenian: je 200 mg trikrat dnevno.
English: Twenty-eight patients with mild to moderate type 1 Gaucher disease were enrolled in this 12-month non-comparative study, and 22 patients completed the study.
Slovenian: V 12-mesečno neprimerjalno študijo so vključili 28 bolnikov z blago do zmerno obliko Gaucherjeve bolezni tipa 1, študijo je zaključilo 22 bolnikov.
English: In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Slovenian: Poleg tega je bilo eksperimentalno in vitro dokazano zaviralno delovanje na ne-lizosomalno glikozilceramidazo.
English: Adverse events observed included granulocytopenia, dizziness and paraesthesia.
Slovenian: Opažani neželeni dogodki so bili granulocitopenija, omotičnost in parestezije.
English: Due to limited experience, miglustat should be used with caution in patients with renal or hepatic impairment.
Slovenian: Posebne populacije Zaradi malo izkušenj moramo zdravilo miglustat pri bolnikih z okvarjenim delovanjem ledvic ali jeter uporabljati previdno.
English: The recommended dose for the treatment of adult patients with Niemann-Pick type C disease is 200 mg three times a day.
Slovenian: Priporočeni odmerek za zdravljenje odraslih in bolnikov z Niemann-Pickovo boleznijo tipa C je 200 mg trikrat dnevno.
English: How to take Miglustat Dipharma 4.
Slovenian: Kako jemati zdravilo Miglustat Dipharma 4.
English: Other medicines and Miglustat Dipharma
Slovenian: Druga zdravila in zdravilo Miglustat Dipharma
English: Most serious side effects
Slovenian: Najresnejši neželeni učinki:
English: Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and reduced libido.
Slovenian: Drugi možni neželeni učinki so mišični krči ali slabost, utrujenost, mrzlice in splošno slabo počutje,
English: Sometimes your doctor will need to reduce the dose or stop Miglustat Dipharma treatment to stop the tremor.
Slovenian: Lahko se zgodi, da bo moral vaš zdravnik, da bi odpravil tremor, znižati vaš odmerek zdravila Miglustat Dipharma ali prekiniti zdravljenje z njim.
English: Until further information is available, it is advised that before seeking to conceive, male patients should cease Miglustat Dipharma and maintain reliable contraceptive methods for 3 months thereafter.
Slovenian: Dokler ne bo na voljo več informacij, je treba moškim svetovati, da pred poskusi zaploditve prenehajo uporabljati zdravilo Miglustat Dipharma in še 3 mesece potem uporabljajo zanesljivo metodo kontracepcije.
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia headache, dizziness
Slovenian: Pogosto periferna nevropatija, ataksija, amnezija, parestezije, hipoestezija,
English: If you stop taking Miglustat Dipharma
Slovenian: Če ste prenehali jemati zdravilo Miglustat Dipharma
English: There was a mean increase of 22.2 × 109/l in platelet count, and a mean increase of 0.95 g/dl in haemoglobin concentration.
Slovenian: Povprečno povečanje koncentracije trombocitov je bilo 22.2 x 109/l, povprečno povišanje koncentracije hemoglobina pa 0,95 g/dl.
English: • Miglustat Dipharma is used to treat mild to moderate type 1 Gaucher disease in adults.
Slovenian: • Zdravilo Miglustat Dipharma se uporablja za zdravljenje blage do zmerne Gaucherjeve bolezni tipa 1 pri odraslih.
English: There are no pharmacokinetic data available in patients with liver impairment or in the elderly (> 70 years).
Slovenian: Na voljo ni nobenih farmakokinetičnih podatkov za bolnike z okvarjenim delovanjem jeter, otroke ali mladostnike z Gaucherjevo boleznijo tipa 1 ali starostnike (> 70 let).
English: Dosage in type 1 Gaucher disease
Slovenian: Odmerjanje pri Gaucherjevi bolezni tipa 1
English: Pack size of 84x1 capsules in perforated unit dose blisters.
Slovenian: Velikost pakiranja po 84 x 1 kapsula v perforiranih deljivih pretisnih omotih s posameznimi odmerki.
English: Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Slovenian: Zdravilo Miglustat Dipharma je indicirano za peroralno zdravljenje odraslih bolnikov z blago do zmerno obliko Gaucherjeve bolezni tipa 1.
English: Elderly There is no experience with the use of miglustat in patients over the age of 70.
Slovenian: Ni izkušenj z zdravljenjem bolnikov, starih več kot 70 let, z zdravilom miglustat.
English: - The other ingredients are magnesium stearate, gelatine, titanium dioxide (E171), printing ink (consisting of black iron oxide (E172), propylene glycol (E1520) potassium hydroxide, shellac).
Slovenian: - Pomožne snovi so magnezijev stearat, želatina, titanov dioksid (E171), tiskarska črnilo
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Dipharma.
Slovenian: Učinek na spermatogenezo Bolniki moškega spola naj v času jemanja zdravila Miglustat Dipharma uporabljajo zanesljive kontracepcijske metode.
English: Miglustat Dipharma may make you feel dizzy.
Slovenian: Zaradi zdravila Miglustat Dipharma ste lahko omotični.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili vzeti zdravilo Miglustat Dipharma Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: An open-label, non-comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
Slovenian: ki so vsaj 3 leta prejemali ERT in so vsaj 2 leti izpolnjevali merila stabilne bolezni.
English: Cases of peripheral neuropathy have been reported in patients treated with miglustat with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Slovenian: Pri bolnikih, zdravljenih z miglustatom, s sočasnim stanjem, kot sta pomanjkanje vitamina B12 in monoklonska gamopatija ali brez teh stanj, so opazili primere periferne nevropatije.
English: Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical trials in patients treated with miglustat 100 mg t.i.d.
Slovenian: Manifestacije Gaucherjeve bolezni tipa 1 na kosteh so bile ocenjene v 3 odprtih kliničnih preskušanjih pri bolnikih, zdravljenih z miglustatom 100 mg trikrat dnevno do 2 leti (n = 72).
English: There is limited experience with the use of miglustat in Niemann-Pick type C disease patients under the age of 4 years.
Slovenian: Izkušenj z zdravljenjem z zdravilom miglustat a pri bolnikih z Niemann-Pickovo boleznijo tipa C, starih pod 4 leta, je malo.
English: Miglustat Dipharma 100 mg hard capsules
Slovenian: Miglustat Dipharma 100 mg trde kapsule
English: See section 4.
Slovenian: Odmerjanje 200
English: The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration).
Slovenian: Glavni učinki, skupni vsem vrstam, so bili izguba telesne mase in diareja ter, pri višjih odmerkih,
English: Leukopenia and neutropenia have also been observed in a similar group of patients receiving 800 mg/day or higher dose.
Slovenian: Pri podobni skupini bolnikov, ki so jemali 800 mg/dan ali več, so opazili levkopenijo in nevtropenijo.
English: Black iron oxide (E172) Potassium Hydroxide Shellac
Slovenian: Tiskarsko črnilo črn železov oksid (E172) kalijev hidroksid šelak propilenglikol (E1520)
English: Miglustat Dipharma 100 mg hard capsules miglustat
Slovenian: Miglustat Dipharma 100 mg trde kapsule miglustat
English: How to store Miglustat Dipharma 6.
Slovenian: Shranjevanje zdravila Miglustat Dipharma 6.
English: Check with your doctor or pharmacist if you are not sure.For typer 1 Gaucher disease: For adults the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
Slovenian: • Za 1 Gaucherjevo bolezen tipa 1: Za odrasle je običajni odmerek ena kapsula (100 mg) trikrat dnevno (zjutraj, popoldne, zvečer).
English: Male patients should use reliable birth control methods during their treatment with Miglustat Dipharma and for 3 months after finishing treatment.
Slovenian: Moški bolniki morajo med jemanjem zdravila Miglustat Dipharma in 3 mesece po končanju zdravljenja uporabljati zanesljivo obliko kontracepcije.
English: Twenty-one patients completed 24 months of miglustat treatment.
Slovenian: Enaindvajset bolnikov je zaključilo 24
English: Hepatic impairment Miglustat has not been evaluated in patients with hepatic impairment.
Slovenian: Okvarjeno delovanje jeter Zdravila Miglustat Dipharma pri bolnikih z okvarjenim delovanjem jeter niso ovrednotili.
English: Miglustat Dipharma is a white opaque 100 mg capsule with “DPH02” printed in black on the top and “100” printed in black on the body.
Slovenian: Miglustat Dipharma je bela neprozorna kapsula, ki ima v črni barvi na pokrovčku natisnjeno
English: Administration of miglustat to male and female CD1 mice by oral gavage at dose levels of 210, 420 and 840/500 mg/kg/day (dose reduction after half a year) for 2 years resulted in an increased incidence of inflammatory and hyperplastic lesions in the large intestine in both sexes.
Slovenian: 840/500 mg/kg/dan (zmanjšanje odmerka na pol leta) je povzročilo povišano incidenco vnetnih in hiperplastičnih lezij v debelem črevesu pri obeh spolih.
English: Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of miglustat having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
Slovenian: Enzyme Replacement Therapy) pri bolnikih z Gaucherjevo boleznijo tipa 1, ki predhodno niso bili zdravljeni, niso bile opravljene, ni dokazov, da bi bil miglustat učinkovitejši ali varnejši kot ERT. ERT
English: Each capsule contains 100 mg miglustat
Slovenian: Ena kapsula vsebuje 100 mg miglustata
English: The patients were switched to monotherapy with miglustat 100 mg t.i.d.
Slovenian: Bolniki so prešli na monoterapijo z miglustatom 100 mg trikrat dnevno.
English: Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with miglustat.
Slovenian: Pri nekaterih bolnikih z Niemann-Pickovo boleznijo tipa C, zdravljenih z zdravilom miglustat, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
English: Very common side effects - may affect more than 1 in 10 people The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Slovenian: Najbolj pogosti neželeni učinki so driska, flatulenca (vetrovi), bolečine v trebuhu, izguba telesne mase in zmanjšanje apetita.
English: How to take Miglustat Dipharma
Slovenian: Kako jemati zdravilo Miglustat Dipharma
English: adjusted for body surface area resulted in Cmax and AUCτ values which were approximately two fold those attained after 100 mg t.i.d.
Slovenian: mg trikrat dnevno pri otrocih, prilagojeno na površino telesa, je povzročilo vrednosti Cmax in AUCτ, ki so bile približno dvakratne od tistih, pridobljenih po odmerku 100 mg trikrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1, kar je skladno z farmakokinetiko miglustata, linearno z odmerkom.
English: Common side effects - may affect up to 1 in 10 people Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).
Slovenian: Pogosti neželeni učinki vključujejo glavobol, omotičnost, parestezije (mravljinčenje ali omrtvičenost), nenormalno koordinacijo, hipoestezijo (zmanjšana zmožnost čutenja na dotik), dispepsijo (zgago),
English: Limited data suggest that co-administration of miglustat and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Slovenian: Malo podatkov kaže, da lahko sočasna uporaba miglustata in encimskega nadomestnega zdravljenja z imiglucerazo pri bolnikih z Gaucherjevo boleznijo tipa 1 povzroči znižanje izpostavljenosti miglustatu
English: You must use effective birth control while taking Miglustat Dipharma.
Slovenian: V času jemanja zdravila Miglustat Dipharma morate uporabljati učinkovite metode preprečitve zanositve.
English: Do not breast-feed while you are taking Miglustat Dipharma.
Slovenian: V času jemanja zdravila Miglustat Dipharma ne smete dojiti.
English: Talk to your doctor or pharmacist before taking Miglustat Dipharma
Slovenian: Pred začetkom jemanja zdravila Miglustat Dipharma se posvetujte z zdravnikom ali farmacevtom
English: • Always take this medicine exactly as your doctor has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
English: Miglustat has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
Slovenian: V kliničnih preizkušanjih so miglustat jemali v odmerkih, ki so bili 10-krat višji kot priporočen odmerek.
English: Weight loss, decreased appetite
Slovenian: Presnovne in prehranske motnje Zelo pogosto izguba telesne mase, zmanjšan apetit
English: He or she may reduce the dose of Miglustat Dipharma or recommend other medicines to help control side effects.
Slovenian: Kadar neželeni učinki povzročajo skrbi ali neprijetnosti, se posvetujte s svojim zdravnikom, ki vam bo morda znižal odmerek zdravila Miglustat Dipharma ali, za nadzor nad neželenimi učinki, priporočil druga zdravila.
English: Mild reductions in platelet counts without association with bleeding were observed in patients with type 1 Gaucher disease who were switched from ERT to miglustat.
Slovenian: Gaucherjevo boleznijo tipa 1, ki so prešli z zdravljenja z ERT na miglustat, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
English: Package leaflet: Information for the user Miglustat Dipharma 100 mg hard capsules miglustat
Slovenian: Navodilo za uporabo Miglustat Dipharma 100 mg trde kapsule miglustat
English: How to store Miglustat Dipharma
Slovenian: Shranjevanje zdravila Miglustat Dipharma
English: Use in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s prilagojenim očistkom kreatinina 50-70 ml/min/1.73 m2
English: Fatigue, asthenia, chills and malaise
Slovenian: glavobol, omotičnost
English: The recommended dose for the treatment of adolescent patients (12 years of age and above) with Niemann-Pick type C disease is 200 mg three times a day.
Slovenian: Pediatrična populacija Priporočeni odmerek za zdravljenje mladostnikov (starih 12 let in več) z Niemann-Pickovo boleznijo tipa C
English: You should not take Miglustat Dipharma if you are pregnant or thinking of becoming pregnant.
Slovenian: Če ste noseči ali nameravate zanositi, zdravila Miglustat Dipharma ne smete jemati.
English: Description of selected adverse reactions
Slovenian: Seznam neželenih učinkov v obliki preglednice
English: No.
Slovenian: Ne.
English: Why not?
Slovenian: Zakaj ne?
English: What should I do?
Slovenian: Kaj naj storim?
English: The medicine you are looking for may be:
Slovenian: Zdravilo, ki ga iščete, je morda:
English: The Agency will reply in the same language.
Slovenian: Agencija bo nanje odgovorila v istem jeziku.
English: Fees are adjusted each year for inflation.
Slovenian: Pristojbine se vsako leto prilagodijo inflaciji.
English: 13 February 2017
Slovenian: 13. februar 2017
English: • still in development and not yet authorised;
Slovenian: • še vedno v razvoju in še ni odobreno;
English: These frequently asked questions are also available in all EU languages.
Slovenian: Ta pogosto zastavljena vprašanja so prav tako na voljo v vseh jezikih EU.
English: The European Medicines Agency does not control:
Slovenian: Evropska agencija za zdravila ne nadzoruje:
English: These are not always on the same days as the national holidays in the United Kingdom or other Member States.
Slovenian: Prazniki niso vedno na isti dan kot državni prazniki v Združenem kraljestvu ali drugih državah članicah.
English: Frequently asked questions EMA/527628/2011
Slovenian: Pogosta vprašanja EMA/527628/2011
English: • authorised through national procedures and not centrally through EMA.
Slovenian: • bilo odobreno z nacionalnim postopkom in ne centralno prek agencije EMA.
English: The Agency's normal business hours are 9.00am to 5.30pm, Monday to Friday.
Slovenian: Običajni delovni čas agencije je od ponedeljka do petka od 9:00 do 17:30.
English: Citizens can submit questions to the Agency in any official EU language.
Slovenian: Državljani lahko vprašanja agenciji pošljejo v katerem koli uradnem jeziku EU.
English: Each member and expert make an annual declaration of their financial interests.
Slovenian: Vsak član in strokovnjak predloži letno izjavo o finančnih interesih.
English: No, EMA does not directly fund research.
Slovenian: Ne, agencija EMA ne financira raziskav neposredno.
English: Sales are dealt with at a national level.
Slovenian: Prodaja se ureja na nacionalni ravni.
English: The Agency is closed for holidays on various days throughout the year.
Slovenian: Agencija je zaprta ob praznikih na različne dneve v letu.
English: Questions about pricing, sales and patents
Slovenian: Vprašanja o cenah, prodaji in patentih
English: These are publicly available.
Slovenian: Izjave so javno dostopne.
English: Frequently asked questions
Slovenian: Pogosta vprašanja
English: How is the financial transparency of patient and consumer organisations evaluated?
Slovenian: Kako se vrednoti finančna preglednost organizacij bolnikov in potrošnikov?
English: • searching by keyword;
Slovenian: • iskanjem po ključni besedi (keyword);
English: • not classified as a medicine but as a medical device or a nutritional supplement, both of which are authorised at national level.
Slovenian: • ni razvrščeno kot zdravilo, ampak kot medicinski pripomoček ali prehransko dopolnilo, ki se odobri na nacionalni ravni.
English: The Agency's Management Board is also made up of representatives of Member States and members nominated by the European Commission.
Slovenian: Upravni odbor agencije prav tako sestavljajo predstavniki držav članic in člani, ki jih imenuje Evropska komisija.
English: There are also two routes to allow companies to gain authorisation in more than one country: the mutual-recognition procedure and the decentralised procedure.
Slovenian: Obstajata tudi dva načina za pridobitev dovoljenja za promet z zdravilom v več kot eni državi: postopek z medsebojnim priznavanjem in decentralizirani postopek.
English: Each organisation is re-evaluated every two years.
Slovenian: Organizacije so ovrednotene na vsaki dve leti.
English: The Agency's old acronym of 'EMEA' should not be used any longer.
Slovenian: Stara okrajšava za agencijo „EMEA“ se ne uporablja več.
English: Can the Agency fund my work?
Slovenian: Ali lahko agencija financira moje delo?
English: Most of the members of the Agency's six scientific committees are nominated by the Member States or the European Commission.
Slovenian: Večino članov v šestih znanstvenih odborih agencije imenujejo države članice ali Evropska komisija.
English: How can I get hold of a medicine that is not yet authorised?
Slovenian: Kako lahko dobim zdravila, ki še niso odobrena?
English: This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question is not here, please use our online form: Send a question to EMA.
Slovenian: V tem dokumentu so odgovori na pogosta vprašanja, naslovljena na Evropsko agencijo za zdravila (EMA).Če ne najdete odgovora na svoje vprašanje, uporabite naš spletni obrazec: Pošljite vprašanje agenciji EMA.
English: The Agency is not responsible for patents on medicines: issues regarding patent law are not within the Agency's remit.
Slovenian: Ne. Agencija ni odgovorna za patente za zdravila: vprašanja glede patentne zakonodaje ne spadajo med njene pristojnosti.
English: Are all medicines approved via the Agency?
Slovenian: So vsa zdravila odobrena prek agencije?
English: Please give as much background information as possible to help us answer your query effectively.
Slovenian: Prosimo, navedite čim več podatkov, saj vam bomo tako lažje odgovorili na vprašanje.
English: These documents can be found on the webpages of the respective committees.
Slovenian: Ti dokumenti so na voljo na spletnih straneh zadevnih odborov.
English: Decisions on pricing and reimbursement are made at a national level following negotiations between governments and marketing authorisation holders.
Slovenian: Odločitve o ceni in povračilih se sprejemajo na nacionalni ravni po pogajanjih med vladami in imetniki dovoljenj za promet z zdravili.
English: Is the Agency's website available in languages other than English?
Slovenian: Ali je spletna stran agencije na voljo tudi v drugih jezikih poleg angleščine?
English: This is a set of documents that explains the scientific conclusion reached by the Agency's Committees at the end of the evaluation process.
Slovenian: To je vrsta dokumentov, v katerih so predstavljeni znanstveni zaključki, do katerih pridejo odbori agencije ob koncu postopka vrednotenja.