FrancophonIA/ELRC3.0 huggingface dataset:
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Zarzio Vsebina pakiranja in dodatne informacije
English: Zarzio works by encouraging the bone marrow to produce more white blood cells.
Slovenian: Zdravilo Zarzio deluje tako, da spodbuja kostni mozeg k proizvajanju več belih krvnih celic.
English: Your doctor will tell you how long you will need to take Zarzio.
Slovenian: Vaš zdravnik vam bo povedal, kako dolgo boste morali zdravilo Zarzio uporabljati.
English: In patients treated with myeloablative therapy followed by bone marrow transplantation
Slovenian: Pri bolnikih, zdravljenih z mieloablacijsko terapijo, ki ji sledi presaditev kostnega mozga Odmerjanje
English: Solution for injection or infusion in pre-filled syringe.
Slovenian: Raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi.
English: Zarzio may have a minor influence on your ability to drive and use machines.
Slovenian: Zdravilo Zarzio ima lahko blag vpliv na sposobnost upravljanja vozil in strojev.
English: Zarzio contains no preservative.
Slovenian: Zdravilo Zarzio ne vsebuje konzervansov.
English: Zarzio contains sorbitol (E420).
Slovenian: Zdravilo Zarzio vsebuje sorbitol (E420).
English: - have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
Slovenian: - se nenadoma pojavijo znaki alergije, kot so izpuščaj, srbenje ali koprivnica na koži, otekanje obraza, ustnic, jezika ali drugih delov telesa, zasoplost, piskanje v pljučih ali oteženo dihanje,
English: If required, Zarzio may be diluted in glucose 50 mg/ml (5%) solution.
Slovenian: Če je potrebno, se zdravilo Zarzio lahko razredči v 5 % (50 mg/ml) raztopini glukoze.
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive treatments.
Slovenian: Zdravljenje s filgrastimom samim ne prepreči trombocitopenije in anemije, povzročenih z mielosupresivnimi zdravili.
English: What Zarzio looks like and contents of the pack
Slovenian: Izgled zdravila Zarzio in vsebina pakiranja
English: Zarzio must not be diluted with sodium chloride solution.
Slovenian: Zdravila Zarzio se ne sme redčiti z raztopinami natrijevega klorida.
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe EU/1/08/495/001
Slovenian: Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi EU/1/08/495/001
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe EU/1/08/495/005
Slovenian: Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi EU/1/08/495/005
English: It is advisable to wait and see how you feel after taking Zarzio and before driving or operating machinery.
Slovenian: Pred vožnjo ali upravljanjem s stroji je priporočljivo počakati, da vidite, kako se po uporabi zdravila Zarzio počutite.
English: Zarzio is one of a group of products that stimulate the production of white blood cells.
Slovenian: Zdravilo Zarzio sodi v skupino zdravil, ki spodbujajo nastanek belih krvnih celic.
English: Special precautions in patients with HIV infection
Slovenian: Posebni previdnostni ukrepi pri bolnikih z okužbo s HIV Število krvnih celic
English: The recommended dose of filgrastim is 0.5 MU/kg/day (5 μg/kg/day).
Slovenian: Odmerjanje Priporočeni odmerek filgrastima je 0,5 M e./kg/dan (5 µg/kg/dan).
English: • unusual hair loss or thinning (alopecia)
Slovenian: • neobičajno izpadanje ali redčenje las (alopecija) • utrujenost (izčrpanost)
English: Using the pre-filled syringe with a needle safety guard The needle safety guard covers the needle after injection to prevent needle stick injury.
Slovenian: Varnostna zaščita za iglo po injiciranju iglo prekrije, da bi tako preprečila poškodbe zaradi vboda z iglo.
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) filgrastim*.
Slovenian: Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi En mililiter raztopine vsebuje 96 milijonov enot (M e.) (kar je enako 960 mikrogramom [µg]) filgrastima*.
English: Zarzio is not recommended during pregnancy.
Slovenian: Zdravila Zarzio ne uporabljajte pri nosečnicah.
English: Cutaneous vasculitisa Sweets syndrome (acute febrile neutrophilic dermatosis)
Slovenian: Bolezni kože in podkožja alopecijaa izpuščaja eritem makulopapularni izpuščaj kožni vaskulitisa Sweetov sindrom (akutna febrilna nevtrofilna dermatoza)
English: Neutropenia may be due to bone marrow-infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Slovenian: kompleksom Mycobacterium avium ali malignimi obolenji, npr. limfomi.
English: Unless your doctor directs you otherwise, you must stop breast feeding if you use Zarzio.
Slovenian: Če uporabljate zdravilo Zarzio, morate prenehati z dojenjem, razen če vam zdravnik svetuje drugače.
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 30 MU filgrastim in 0.5 ml, corresponding to 60 MU/ml.
Slovenian: Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi: Ena napolnjena injekcijska brizga vsebuje 30 milijonov enot filgrastima v 0,5 ml, kar ustreza 60 M e./ml.
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) filgrastim*.
Slovenian: Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi En mililiter raztopine vsebuje 60 milijonov enot (M e.) (kar je enako 600 mikrogramom [µg]) filgrastima*.
English: How to store Zarzio
Slovenian: Shranjevanje zdravila Zarzio
English: Zarzio is a biosimilar medicinal product.
Slovenian: Zdravilo Zarzio je podobno biološko zdravilo.
English: • if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Slovenian: oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje,
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Slovenian: Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Slovenian: Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Slovenian: Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
English: Pre-filled syringe without needle safety guard
Slovenian: Uporaba napolnjene injekcijske brizge brez varnostne zaščite za iglo
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 48 MU filgrastim in 0.5 ml, corresponding to 96 MU/ml - The other ingredients are glutamic acid, sorbitol (E420), polysorbate 80 and water for injections.
Slovenian: Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi: Ena napolnjena injekcijska brizga vsebuje 48 milijonov enot filgrastima v 0,5 ml, kar ustreza 96 M e./ml.
English: For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Slovenian: Za izplavljanje krvotvornih matičnih celic v periferno kri pri bolnikih, pri katerih se izvaja mielosupresivno ali mieloablacijsko zdravljenje, ki mu sledi avtologna presaditev matičnih celic izplavljenih v periferno kri Odmerjanje
English: Glutamic acid Sorbitol (E420) Polysorbate 80
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glutaminska kislina sorbitol (E420) polisorbat 80 voda za injekcije
English: Zarzio 48 MU/0.5 ml injection or infusion Filgrastim
Slovenian: Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje filgrastim s.c./i.v.
English: Talk to your doctor, pharmacist or nurse before using Zarzio.
Slovenian: Pred začetkom uporabe zdravila Zarzio se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Pre-filled syringe with needle safety guard
Slovenian: Uporaba napolnjene injekcijske brizge z varnostno zaščito za iglo
English: Immunogenicity
Slovenian: Trombocitopenija
English: Zarzio 30 MU/0.5 ml injection or infusion Filgrastim
Slovenian: Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje filgrastim s.c./i.v.
English: • tiredness (fatigue)
Slovenian: • slabost (navzea)
English: Permanently discontinue Zarzio in patients with clinically significant hypersensitivity.
Slovenian: Pri bolnikih s klinično pomembno preobčutljivostjo je treba z uporabo zdravila Zarzio trajno prenehati.
English: Muscle spasms Osteoporosis
Slovenian: - osteoporozo (bolezen kosti).
English: 84 x 1 capsules (unit dose)
Slovenian: 84x1 kapsul (enotni odmerek)
English: 84 capsules
Slovenian: 84 kapsul
English: EMA procedure number
Slovenian: Številka postopka EMA
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the trial.
Slovenian: Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: The methods for comparing results of the main studies with historical data were not satisfactory for showing that the medicine was effective.
Slovenian: Metode za primerjavo rezultatov glavne študije s preteklimi podatki niso bile zadovoljive za dokazovanje, da je bilo zdravilo učinkovito.
English: The company also compared the results of these studies with those from a variety of historical data.
Slovenian: Družba je rezultate teh študij primerjala tudi z rezultati iz izbora preteklih podatkov.
English: The company that applied for authorisation, AVI Biopharma International Ltd, requested a re-examination of the CHMP's opinion on 1 June 2018.
Slovenian: Družba, ki je vložila vlogo za pridobitev dovoljenja za promet z zdravilom, AVI Biopharma International Ltd, je 1. junija 2018 zahtevala ponoven pregled mnenja odbora CHMP.
English: Refusal of the marketing authorisation for Exondys (eteplirsen) EMA/621972/2018
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Exondys (eteplirsen) EMA/621972/2018
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 20 September 2018.
Slovenian: Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in 20. septembra 2018 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
English: Refusal of the marketing authorisation for Exondys (eteplirsen)
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Exondys (eteplirsen)
English: Patients with DMD do not produce a protein called dystrophin.
Slovenian: Bolniki z DMD ne proizvajajo beljakovine, imenovane distrofin.
English: The company presented the results of two main studies involving 12 boys aged 7 to 13 years with DMD who had a genetic mutation amenable to exon 51 skipping.
Slovenian: Družba je predložila rezultate dveh glavnih študij, v kateri je bilo vključenih 12 dečkov z DMD, ki so bili stari med 7 in 13 let in so imeli genetsko mutacijo, ki je omogočala preskakovanje eksona 51.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Exondys.
Slovenian: Družba je obvestila odbor CHMP, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Exondys.
English: This shortened protein is expected to act in a similar way to normal dystrophin, helping the body to make up for the lack of dystrophin, and so relieve the symptoms of DMD.
Slovenian: Ta krajša oblika beljakovine naj bi delovala podobno kot običajni distrofin, tako da telesu pomaga nadomestiti pomanjkanje distrofina, in s tem lajšala simptome DMD.
English: On 31 May 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Exondys, intended for the treatment of Duchenne muscular dystrophy.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 31. maja 2018 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Exondys, namenjenim zdravljenju Duchennove mišične distrofije.
English: Exondys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 December 2008 for the treatment of DMD.
Slovenian: Zdravilo Exondys je bilo 3. decembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje DMD.
English: Therefore, the CHMP was of the opinion that the balance of benefits and risks of Exondys in the treatment of DMD could not be established and recommended that the marketing authorisation be refused.
Slovenian: Zato je zaključil, da razmerja med koristmi in tveganji zdravila Exondys za zdravljenje DMD ni mogoče določiti, in priporočil zavrnitev vloge za izdajo dovoljenja za promet z zdravilom.
English: The medicine allows exon 51 to be skipped over and so promote the production of a shortened form of dystrophin.
Slovenian: Zdravilo omogoči preskok eksona 51 in tako spodbudi proizvodnjo krajše oblike distrofina.
English: The CHMP was concerned that the main study, which involved just 12 patients, did not compare Exondys with placebo beyond 24 weeks, during which there was no meaningful difference between Exondys and placebo in the 6-minute walking distance.
Slovenian: Odbor CHMP je izrazil zadržek, da v glavni študiji, v katero je bilo vključenih samo 12 bolnikov, zdravila Exondys niso primerjali s placebom dlje kot 24 tednov in da v njej niso opazili pomembne razlike glede prehojene razdalje v šestih minutah med bolniki, ki so prejemali zdravilo Exondys oziroma placebo.
English: The main measure of effectiveness was the change in the distance walked during a 6-minute walking test after 24 weeks.
Slovenian: Glavno merilo učinkovitosti je bila sprememba razdalje, ki jo je bolnik po 24 tednih zdravljenja lahko prehodil v šestih minutah.
English: It was to be available as a concentrate for solution for infusion (drip) into a vein.
Slovenian: Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: What was Exondys expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Exondys uporabljalo?
English: The Committee considered further data were needed to show that the very low amounts of shortened dystrophin produced as a result of Exondys treatment bring lasting benefits relevant to the patient.
Slovenian: Odbor je menil, da so potrebni nadaljnji podatki, ki bi pokazali, da bolniku trajne koristi prinesejo prav majhne količine krajše oblike distrofina, ki so proizvedene kot rezultat zdravljenja z zdravilom Exondys.
English: In the first study, Exondys was compared with placebo (a dummy treatment) for the first 24 weeks, after which all patients were treated with Exondys.
Slovenian: V prvi študiji so zdravilo Exondys primerjali s placebom (zdravilom brez učinkovine) prvih 24 tednov, nato pa so vse bolnike zdravili z zdravilom Exondys.
English: Exondys was expected to be used for treating Duchenne muscular dystrophy (DMD) in patients aged from 4 years with mutation (change) in the DMD gene that allows treatment involving ‘exon 51 skipping'.
Slovenian: Zdravilo Exondys naj bi se uporabljalo za zdravljenje Duchennove mišične distrofije (DMD) pri bolnikih, starejših od štirih let, z mutacijo (spremembo) v genu za DMD, ki omogoča zdravljenje s „tehnologijo preskakovanja eksona 51“.
English: Exondys is a medicine that contains the active substance eteplirsen.
Slovenian: Zdravilo Exondys vsebuje učinkovino eteplirsen.
English: The second study, an extension of the first one, involved the same patients who were all treated with Exondys for another 4 years.
Slovenian: Druga študija je bila podaljšek prve in je vključevala iste bolnike, ki so bili z zdravilom Exondys zdravljeni nadaljnja štiri leta.
English: This means that the patients' DMD gene can make a working form of the dystrophin protein when a part of the gene called exon 51 is not used.
Slovenian: To pomeni, da lahko bolnikov gen za DMD izdela delovno obliko beljakovine distrofin, ko del gena, imenovanega ekson 51, ni v rabi.
English: What is Exondys?
Slovenian: Kaj je zdravilo Exondys?
English: What were the CHMP's main concerns that led to the refusal?
Slovenian: Kateri so bili glavni zadržki, zaradi katerih je odbor CHMP predlagal zavrnitev vloge za pridobitev dovoljenja za promet?
English: How does Exondys work?
Slovenian: Kako zdravilo Exondys deluje?
English: The financial impact of the scheme was in excess of € 140,000.
Slovenian: Finančni učinek programa je presežen za 140 000 EUR.
English: The workshop was successful with 170 delegates from around 50 countries attending.
Slovenian: Delavnice je bila uspešna, udeležilo pa se je je 170 delegatov iz približno 50 držav.
English: The draft conclusions concern the issue of relative effectiveness.
Slovenian: Ta osnutek se nanaša na vprašanje relativne učinkovitosti.
English: The policy will be published in November 2010.
Slovenian: Politika bo objavljena novembra 2010.
English: The Agency's revenue and expenditure for 2010 are also on target.
Slovenian: Prihodki in odhodki agencije za leto 2010 so tudi v skladu s cilji.
English: All bodies which had a role in responding to the pandemic participated.
Slovenian: V njej so sodelovali vsi organi, ki so imeli vlogo pri odzivanju na pandemijo.
English: The European Commission already gave its agreement to the draft policy in accordance with Article 110 of the Staff Regulations.
Slovenian: Evropski komisar je že dal soglasje k osnutku politike v skladu s členom 110 kadrovskih predpisov.
English: The European Commission is seeking a solution for the support and coordination of the EU level tasks.
Slovenian: Evropska komisija si prizadeva najti rešitev za podporo in usklajevanje nalog na ravni EU.
English: This aim can be achieved in the context of the transparency policy and the implementation of the pharmacovigilance legislation.
Slovenian: Ta cilj je mogoče doseči v okviru politike preglednosti in izvajanja zakonodaje o farmakovigilanci.
English: • Wider application of teleconferencing tools involving larger number of participants.
Slovenian: • širšo uporabo telekonferenčnih orodij, ki bodo zajela več udeležencev;
English: The amendment takes into account the size of the Agency and specialisation of staff.
Slovenian: V spremembi sta upoštevani velikost agencije in specializacija osebja.
English: The policy will be implemented in the second quarter of 2011 once practical arrangements have been put in place.
Slovenian: Politika se bo začela uvajati v drugem četrtletju leta 2011, ko bo uvedena praktična ureditev.
English: The existing and new responsibilities, notably the new responsibilities in the field of pharmacovigilance, will increase pressure on financial resources.
Slovenian: Zaradi sedanjih in novih pristojnosti, zlasti novih pristojnosti na področju farmakovigilance, se bo povečal pritisk na finančna sredstva.
English: The traceability is a complex issue, particularly for medicinal products due to their wide distribution.
Slovenian: Sledljivost je zapleteno vprašanje, zlasti pri zdravilih, zaradi njihove razširjenosti.
English: The rules come into effect on 7 October 2010 and will be published on the Agency's website.
Slovenian: Pravila so začela veljati 7. oktobra 2010 in bodo objavljena na spletni strani agencije.
English: The European Parliament hearing on H1N1 pandemic
Slovenian: Razprava v Evropskem parlamentu o pandemični gripi H1N1
English: The European Commission anticipates that an extraordinary meeting can be convened for the last week of February 2011.
Slovenian: Evropska komisija pričakuje, da bi bilo mogoče izredno sejo sklicati v zadnjem tednu februarja 2011.
English: The Board will review an interim report on experience with the revised policy in 6 months time and a full report in 18-24 months time.
Slovenian: Odbor bo pregledal vmesno poročilo o izkušnjah z revidirano politiko v 6 mesecih in celotno poročilo za 18-24 mesecev.
English: The regulation replaces the version provisionally adopted by the Board on 11 December 2008.
Slovenian: Uredba nadomešča različico, ki jo je upravni odbor začasno sprejel 11. decembra 2008.
English: 4 October 2010.
Slovenian: 4. oktobra 2010.
English: Minor Use Minor Species policy: Annual report 2010
Slovenian: Politika manjše uporabe in manj pomembnih živalskih vrst: Letno poročilo za leto 2010
English: The fee system should be re-examined to assure appropriate financing of the Agency and the network.
Slovenian: Znova je treba proučiti sistem pristojbin, da se zagotovi ustrezno financiranje agencije in mreže.
English: The amendment concerns the replacement of mandatory mobility with ex-post controls and/or focused audits every two years for sensitive functions.
Slovenian: Sprememba se nanaša na nadomestitev obvezne mobilnosti z naknadnimi kontrolami in/ali osredotočenimi presojami vsaki dve leti za občutljive funkcije.
English: The latter outlines how principles set out in the policy will be interpreted.
Slovenian: V tem dokumentu je opisano, kako se bodo razlagala načela, določena v politiki.
English: • The adoption of the draft Strategy Paper II 2011-2015 for public consultation.
Slovenian: • sprejetjem osnutka strateškega dokumenta II 2011-2015 za javno posvetovanje;
English: Preparation for written procedure on adoption of the Agency's policy on protecting the dignity of the person and preventing any form of psychological or sexual harassment
Slovenian: Priprava pisnega postopka o sprejetju politike agencije o varstvu človekovega dostojanstva in preprečevanju vseh oblik psihološkega ali spolnega nadlegovanja
English: The new policy is built with three principles in mind: robustness, efficiency and transparency.
Slovenian: Ta nova politika je oblikovana na treh glavnih načelih, in sicer stabilnosti, učinkovitosti in preglednosti.
English: 9bis Transfer of appropriations in the budget 2010 in accordance with Article 23 (2) of the Financial Regulation
Slovenian: 9 a) Prerazporejanje proračunskih sredstev v proračunu za leto 2010 v skladu s členom 23(2) finančne uredbe
English: The political process to examine the fee system will be lengthy and therefore it is important to proceed as soon as possible and envisage interim solutions.
Slovenian: Politični proces proučitve sistema pristojbin bo dolgotrajen, zato je treba z delom čim prej nadaljevati in predvideti začasne rešitve.
English: The Agency anticipates that the EU contribution for the Agency will not increase and is likely to decrease as a proportion of the Agency's budget.
Slovenian: Agencija pričakuje, da se prispevek EU za agencijo ne bo povečal in da se bo kot delež v proračunu agencije verjetno zmanjšal.
English: The role of patients and consumers in the different scientific committees of the Agency will also be defined.
Slovenian: Opredeljena bo tudi vloga bolnikov in potrošnikov v različnih znanstvenih odborih agencije.
English: Draft agenda for 7 October 2010 meeting
Slovenian: Osnutek dnevnega reda za sejo dne 7. oktobra 2010