FrancophonIA/ELRC3.0 huggingface dataset:
English: TOVIAZ (listed in section 6) (see section 2, “TOVIAZ contains lactose and soya oil”) - if you are not able to completely empty your bladder (urinary retention) - if your stomach empties slowly (gastric retention) - if you have an eye disease called narrow angle glaucoma (high pressure in the eye), which is not under control - if you have excessive weakness of the muscles (myasthenia gravis) - if you have ulceration and inflammation of the colon (severe ulcerative colitis) - if you have an abnormally large or distended colon (toxic megacolon) - if you have severe liver problems.
Slovenian: Ne jemljite zdravila TOVIAZ: - če ste alergični na fesoterodin ali arašide ali sojo ali katerokoli sestavino tega zdravila (navedeno v poglavju 6) (glejte poglavje 2, “Zdravilo TOVIAZ vsebuje laktozo in sojino olje”); - če ne morete popolnoma izprazniti sečnega mehurja (retencija urina); - če se vaš želodec prazni počasi (želodčna retencija); - če imate očesno bolezen, imenovano glavkom z zaprtim zakotjem (visok tlak v očesu), ki ni pod nadzorom; - če imate pretirano šibke mišice (miastenija gravis); - če imate razjede v debelem črevesu in vnetje debelega črevesa (hud ulcerozni kolitis); - če imate nenormalno povečano ali razširjeno debelo črevo (toksični megakolon); - če imate hude težave z jetri; - če imate težave z ledvicami ali zmerne do hude težave z jetri in jemljete zdravila, ki vsebujejo katero od naslednjih učinkovin: itrakonazol ali ketokonazol (uporabljata se za zdravljenje glivičnih okužb), ritonavir, atazanavir, indinavir, sakvinavir ali nelfinavir (protivirusna zdravila za zdravljenje HIV), klaritromicin ali telitromicin (uporabljata se za zdravljenje bakterijskih okužb) in nefazodon (uporablja se za zdravljenje depresije).
English: • difficulty tasting (dysgeusia)
Slovenian: • težave pri okušanju (disgevzija)
English: Following inhibition of CYP3A4 by co-administration of ketoconazole 200 mg twice daily, Cmax and AUC of the active metabolite of fesoterodine increased 2.0 and 2.3-fold in CYP2D6 extensive metabolisers and 2.1 and 2.5-fold in CYP2D6 poor metabolisers, respectively.
Slovenian: Po zaviranju encima CYP3A4 s sočasnim jemanjem ketokonazola 200 mg dvakrat na dan se je pri dobrih presnavljalcih CYP2D6 vrednost Cmax aktivnega presnovka fesoterodina povečala za 2,0-krat, vrednost AUC pa za 2,3-krat.
English: - certain medicines used to enhance gastrointestinal motility or to relieve stomach cramps or spasm and to prevent travel sickness like medicines containing metoclopramide.
Slovenian: - zdravila, ki vsebujejo učinkovino amantadin (uporablja se za zdravljenje parkinsonove bolezni) - določena zdravila, ki povečujejo gibljivost prebavil, lajšajo želodčne krče ali preprečujejo slabost med potovanji, kot so zdravila, ki vsebujejo metoklopramid - določena zdravila za zdravljenje psihiatričnih bolezni, kot so antidepresivi in nevroleptiki
English: How to store TOVIAZ
Slovenian: Shranjevanje zdravila TOVIAZ
English: System organ class Very common Common Uncommon
Slovenian: Organski sistem Zelo pogosti
English: Dysgeusia; Somnolence
Slovenian: Bolezni živčevja omotica; glavobol disgevzija; zaspanost
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 oseb):
English: Each tablet contains 4 mg fesoterodine fumarate
Slovenian: Ena tableta vsebuje 4 mg fesoterodinijevega fumarata.
English: TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Slovenian: TOVIAZ 8 mg tablete s podaljšanim sproščanjem fesoterodinijev fumarat
English: Each tablet contains 8 mg fesoterodine fumarate
Slovenian: Ena tableta vsebuje 8 mg fesoterodinijevega fumarata.
English: • urticaria
Slovenian: • vrtoglavica
English: Infections and infestations
Slovenian: Infekcijske in parazitske bolezni okužba sečil
English: TOVIAZ 4 mg prolonged-release tablets fesoterodine fumarate
Slovenian: TOVIAZ 4 mg tablete s podaljšanim sproščanjem fesoterodinijev fumarat
English: TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets
Slovenian: TOVIAZ 4 mg tablete s podaljšanim sproščanjem TOVIAZ 8 mg tablete s podaljšanim sproščanjem
English: Blister label 4 mg
Slovenian: Oznaka na pretisnem omotu 4 mg
English: The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FT'.
Slovenian: 8 mg tablete so modre, ovalne, bikonveksne, filmsko obložene in imajo na eni strani vtisnjeno oznako “FT”.
English: Mean Cmax and AUC of the active metabolite are 1.7 and 2-fold higher, respectively, in CYP2D6 poor metabolisers as compared to extensive metabolisers.
Slovenian: Povprečna vrednost Cmax aktivnega presnovka se je pri slabih presnavljalcih CYP2D6 v primerjavi z dobrimi presnavljalci povečala za 1,7-krat, vrednost AUC pa za 2-krat.
English: Hepatic impairment
Slovenian: Psihiatrične motnje nespečnost zmedenost
English: TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved outwards on both sides, filmcoated tablets, and engraved on one side with the letters ‘FS'.
Slovenian: Tablete s podaljšanim sproščanjem TOVIAZ 4 mg so svetlo modre, ovalne, na obeh straneh izbočene, filmsko obložene in imajo na eni strani vtisnjeno oznako “FS”.
English: # primary end points
Slovenian: Vrednost p # primarni opazovani dogodki
English: TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved outwards on both sides, film-coated tablets, and engraved on one side with the letters ‘FT'.
Slovenian: Tablete s podaljšanim sproščanjem TOVIAZ 8 mg so modre, ovalne, na obeh straneh izbočene, filmsko obložene in imajo na eni strani vtisnjeno oznako “FT”.
English: TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Slovenian: TOVIAZ 4 mg tablete s podaljšanim sproščanjem TOVIAZ 8 mg tablete s podaljšanim sproščanjem fesoterodinijev fumarat
English: The active metabolite is further metabolised in the liver to its carboxy, carboxy-N-desisopropyl, and N-desisopropyl metabolite with involvement of CYP2D6 and CYP3A4.
Slovenian: Aktivni presnovek se nato z encimi CYP2D6 in CYP3A4 presnavlja v jetrih v karboksilni, karboksi-N-desizopropilni in N-desizopropilni presnovek.
English: The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FS'.
Slovenian: 4 mg tablete so svetlo modre, ovalne, bikonveksne, filmsko obložene in imajo na eni strani vtisnjeno oznako “FS”.
English: - Clinically significant bladder outflow obstruction at risk of urinary retention (e.g. clinically significant prostate enlargement due to benign prostatic hyperplasia, see section 4.3) - Gastrointestinal obstructive disorders (e.g. pyloric stenosis) - Gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis - Decreased gastrointestinal motility - Autonomic neuropathy - Controlled narrow-angle glaucoma
Slovenian: - z gastroezofagealnim refluksom in/ali bolnikih, ki sočasno jemljejo zdravila (npr. peroralne bifosfonate), ki lahko povzročijo ali poslabšajo ezofagitis; - z zmanjšano gibljivostjo gastrointestinalnega trakta; - z avtonomno nevropatijo; - z nadzorovanim glavkomom z zaprtim zakotjem.
English: Blister label 8 mg
Slovenian: Oznaka na pretisnem omotu 8 mg
English: Weak CYP3A4 inhibitors
Slovenian: Šibki zaviralci CYP3A4
English: • vertigo
Slovenian: • driska
English: Dyspepsia;
Slovenian: Zalepljeno.
English: Moderate(3) or potent(4) CYP3A4 inhibitors None
Slovenian: Zmerni ali močni zaviralci CYP3A4
English: • feeling sick (nausea)
Slovenian: • slabost s siljenjem na bruhanje (navzea)
English: See section 4.5 (4) Potent CYP3A4 inhibitors.
Slovenian: (4) Močni zaviralci CYP3A4.
English: OTHER
Slovenian: Brez
English: • nasal dryness
Slovenian: • suha nosna sluznica
English: Dysuria
Slovenian: Huda
English: Angioedema; Urticaria
Slovenian: Okvara ledvic in jeter
English: Potent CYP3A4 inhibitors
Slovenian: Močni zaviralci CYP3A4
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Shranjevanje zdravila TOVIAZ Vsebina pakiranja in dodatne informacije
English: EUR thousand
Slovenian: v tisoč EUR
English: Eight requests were for minor use/minor species (MUMS)/limited markets.
Slovenian: Osem zahtev je bilo za uporabo v manjši meri in manj pomembne vrste (MUMS)/omejene trge.
English: I am pleased to report that the Agency has now addressed all of the errors, and we expect a successful discharge of the budget in the near future.
Slovenian: Z veseljem sporočam, da je agencija odpravila vse napake in da v bližnji prihodnosti pričakujemo uspešno razrešnico za proračun.
English: These types of treatment remain a priority area for the companion-animal health sector.
Slovenian: Te vrste zdravljenja so še naprej prednostno področje za področje zdravja hišnih živali.
English: Fees and other income
Slovenian: Pristojbine in drugi prihodki
English: These errors, which occurred primarily due to the rapid diversification of the Agency's activities, contributed to the European Parliament's vote to postpone the discharge for the 2009 budget - the first time this has happened since the Agency was established, in 1995.
Slovenian: Te napake, ki so se v glavnem zgodile zaradi hitre diverzifikacije dejavnosti , so prispevale k temu, da je Evropski parlament odložil glasovanje o razrešnici za proračun za leto 2009, kar se ni zgodilo od ustanovitve agencije leta 1995.
English: EMA budget evolution
Slovenian: Razvoj proračuna agencije EMA
English: General EU contribution
Slovenian: Splošni prispevek EU
English: It is extracted from the milk of rabbits that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Slovenian: Pridobiva se iz mleka zajcev, ki so jim vstavili gen (DNK), zaradi česar lahko v svojem mleku proizvajajo človeško beljakovino;
English: Throughout the year, we worked to develop a new five-year strategy for the Agency - the 'Road map to 2015', adopted by the Management Board and published in December - which should help to ensure the Agency is fit to tackle the challenges ahead.
Slovenian: Čez vse leto smo se ukvarjali z oblikovanjem nove petletne strategije pod nazivom „Časovni načrt (Road Map) do leta 2015“, ki jo je sprejel upravni odbor in je bila objavljena decembra in bo pomagala zagotoviti, da je agencija pripravljena na obvladovanje prihodnjih izzivov.
English: Office of the Executive Director
Slovenian: Urad izvršnega direktorja
English: The year 2010 saw many changes at the European Medicines Agency, the most poignant of which was the departure of the Agency's Executive Director, Thomas Lönngren.
Slovenian: V letu 2010 so se v Evropski agenciji za zdravila zgodile številne spremembe, najbolj odmevajoča pa je bila odhod izvršnega direktorja Thomasa Lönngrena.
English: Thomas left the Agency in December after ten successful years at its helm, overseeing the phenomenal growth of the Agency, not only in terms of sheer size, but also in the range of its activities.
Slovenian: Thomas je agencijo zapustil decembra po tem, ko jo je deset let uspešno vodil in nadzoroval njeno izjemno rast, ne le v smislu velikosti, temveč tudi nabora njenih dejavnosti.
English: The distribution of types of variations changed significantly throughout the year as a consequence of the new legislation on variations.
Slovenian: Porazdelitev tipov sprememb se je čez vse leto precej spreminjala zaradi nove zakonodaje o spremembah.
English: I am grateful for the hard work, dedication and support of all of the Agency's staff, the members of its committees, working parties and working groups, and the Management Board, who enabled the Agency to meet its commitments successfully, despite increases in workload throughout the year.
Slovenian: Za trdo delo, predanost in podporo sem hvaležen vsem članom osebja , članom njenih odborov, delovnih skupin in timov ter upravnega odbora, ki so omogočili, da je agencija kljub povečani delovni obremenitvi lani uspešno izpolnjevala svoje obveznosti.
English: Of the applications received, 46 related to new medicines, 12 of which were designated orphan medicines.
Slovenian: Od prejetih vlog se jih je 46 nanašalo na nova zdravila, od tega jih je 12 imelo status zdravila sirote.
English: In the lead-up to his departure, much effort was put into evaluating where the Agency currently stands and making preparations for the future.
Slovenian: V obdobju pred njegovim odhodom se je agencija precej trudila oceniti na kateri točki se nahaja in se pripraviti na prihodnost.
English: These vaccines were authorised under exceptional circumstances to protect cattle and sheep against clinical signs, and to reduce or prevent transmission of serotypes 1, 2, 4 and 8 of the highly variable bluetongue virus.
Slovenian: Ta cepiva so bila odobrena v izjemnih okoliščinah za zaščito goveda in ovac pred kliničnimi znaki ter za omejitev ali preprečevanje prenosa serotipov 1, 2, 4 in 8 zelo raznovrstnega virusa bolezni modrikastega jezika.
English: Pharmacovigilance and maintenance activities
Slovenian: Farmakovigilanca in vzdrževalne dejavnosti
English: In October, we published new rules on conflicts of interests, addressing our need to access Europe's best scientific experts while ensuring they have no financial or other interests that could affect their impartiality.
Slovenian: Oktobra smo objavili nova pravila o navzkrižjih interesov, v katerih je obravnavana potreba agencije, da ima dostop do najboljših evropskih znanstvenih strokovnjakov, obenem pa zagotavlja, da ti nimajo finančnih ali drugih interesov, ki bi lahko vplivali na njihovo nepristranskost.
English: Key figures in 2010
Slovenian: Ključne številke v letu 2010
English: Authorisation at EU level makes vaccines immediately available for use as part of national and transnational diseasecontrol campaigns against this highly virulent and contagious disease of domestic livestock.
Slovenian: Z odobritvijo na ravni EU postanejo cepiva takoj na voljo za uporabo kot del nacionalnih in nadnacionalnih kampanj za nadzor bolezni v boju proti tej zelo virulentni in nalezljivi bolezni živine;
English: • European Commission starts recruitment procedure for the EMA's new Executive Director.
Slovenian: • Evropska komisija začne postopek zaposlitve novega izvršnega direktorja agencije EMA.
English: These relate to 73 applications by active substance, representing an increase of 16% compared to 2009.
Slovenian: Te se nanašajo na 73 vlog za zdravilno učinkovino, kar pomeni 16-odstotno povečanje v primerjavi s prejšnjim letom.
English: Orphan medicines are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Union, or where for economic reasons such medicines would not be developed without incentives.
Slovenian: Zdravila sirote so namenjena diagnosticiranju, preprečevanju ali zdravljenju smrtno nevarnih ali kronično izčrpavajočih bolezni, ki prizadenejo največ pet od deset tisoč oseb v Evropski uniji oziroma tam, kjer taka zdravila zaradi ekonomskih razlogov ne bi bila razvita brez spodbud.
English: • Four vaccines against bluetongue disease.
Slovenian: • štiri cepiva proti bolezni modrikastega jezika.
English: Submitted Positive opinions Negative opinions Withdrawals Commission decisions
Slovenian: Vloge Pozitivna mnenja Negativna mnenja Umiki
English: The total number of inspections was 20% above the forecast, mainly due to an unexpected increase in the number of good-clinical-practice (GCP) inspections requested.
Slovenian: Inšpekcijskih pregledov je bilo skupaj za 20 % več od napovedi, predvsem zaradi nepričakovanega povečanja števila zahtevanih inšpekcijskih pregledov dobre klinične prakse.
English: 21 October 2011
Slovenian: 28 november 2011
English: And in November, we took a major step forward in transparency, publishing a policy on access to documents that gives wider public access than ever before to the documents we hold concerning both human and veterinary medicines.
Slovenian: Novembra pa smo naredili pomemben korak naprej na področju preglednosti z objavo politike o dostopu do dokumentov, ki zagotavlja širši javni dostop kot kdaj koli prej do dokumentov, ki jih hranimo in so povezani z zdravili za uporabo v humani in veterinarski medicini.
English: Number of inspections
Slovenian: Število inšpekcijskih pregledov
English: The CVMP therefore considered it appropriate to recommend that the product be authorised under exceptional circumstances on the basis of a positive benefit-risk balance while further studies are carried out to determine more precisely the efficacy in goats.
Slovenian: Odbor CVMP je zato menil, da je primerno, da se ta izdelek priporoči za odobritev v izjemnih okoliščinah na podlagi pozitivnega razmerja med koristmi in tveganji, pri čemer se izvajajo nadaljnje študije za natančnejšo opredelitev učinkovitosti pri kozah;
English: Uptake of scientific advice by companies developing medicines for veterinary use was strong in 2010, especially among small and medium-sized enterprises.
Slovenian: Upoštevanje znanstvenih nasvetov med podjetji, ki razvijajo zdravila za uporabo v veterinarski medicini, je bilo v letu 2010 zelo visoko, zlasti med malimi in srednjimi podjetji.
English: The Agency provides scientific advice and protocol assistance to sponsors during the phase of research and development of medicinal products.
Slovenian: Agencija zagotavlja znanstveno svetovanje in pomoč pri pripravi protokola sponzorjem v fazi raziskave in razvoja zdravil.
English: • New pharmacovigilance legislation is adopted by European Parliament.
Slovenian: • Evropski parlament sprejme novo zakonodajo o farmakovigilanci.
English: General EU contribution (excl. funds for orphan medicines) as proportion of total budget
Slovenian: Splošni prispevek EU (brez sredstev za zdravila sirote) kot del skupnega proračuna
English: The use of veterinary medicines in food-producing animals may result in the presence of residues in foodstuffs obtained from treated animals.
Slovenian: Posledica uporabe zdravil za uporabo v veterinarski medicini pri živalih za proizvodnjo živil ima so lahko ostanki v živilih, ki se pridobivajo iz zdravljenih živali.
English: The product is of major public-health interest in light of the shortage of the authorised medicine for the treatment of this disease.
Slovenian: Ta izdelek je zelo pomemben za javno zdravje zaradi pomanjkanja odobrenega zdravila za zdravljenje te bolezni;
English: Annual report highlights
Slovenian: Poudarki letnega poročila
English: In addition to the progress made in many priority areas, 2010 saw an increase in almost all areas of activity of the Agency's core business.
Slovenian: Poleg napredka, doseženega na številnih prednostnih področjih, so se v letu 2010 povečale dejavnosti na skoraj vseh glavnih področjih dejavnosti agencije.
English: The Agency establishes maximum residue limits (MRLs) for pharmacologically active substances used to treat animals, to provide for the safe use of foodstuffs of animal origin, including meat, fish, milk, eggs and honey.
Slovenian: Agencija določa mejne vrednosti ostankov farmakološko aktivnih snovi, ki se uporabljajo za zdravljenje živali, da zagotavlja varno uporabo živil živalskega izvora, vključno z mesom, ribami, mlekom, jajci in medom.
English: • EMA strengthens rules on conflicts of interests for its scientific experts.
Slovenian: • Agencija EMA poostri pravila o navzkrižjih interesov svojih znanstvenih strokovnjakov.
English: As we look forward to 2011, I am sure that the Agency will take new challenges in its stride, including the appointment of a new Executive Director and the implementation of new legislative requirements, while continuing to fulfil its core business of protecting public and animal health in the European Union.
Slovenian: Prepričan sem, da bo tudi v letu 2011 uspešno obvladovala nove izzive, vključno z imenovanjem novega izvršnega direktorja in izvajanjem novih zakonodajnih zahtev, hkrati pa še naprej izpolnjevala svojo glavno nalogo - varovanje zdravja ljudi in živali v Evropski uniji.
English: Number of quality defects reported
Slovenian: Število sporočenih napak v kakovosti
English: In July, we launched a new website for the Agency, giving our online audiences easier access to information on medicines, to guidelines, to regulatory and scientific advice, and to information on other Agency activities.
Slovenian: Julija smo uvedli novo spletišče, ki našemu spletnemu občinstvu zagotavlja lažji dostop do informacij o zdravilih, smernic, regulativnih in znanstvenih nasvetov ter informacij o naših drugih dejavnostih.
English: • EMA and US FDA extend their confidentiality arrangement indefinitely.
Slovenian: • Agencija EMA in ameriški urad FDA za nedoločen čas podaljšata svoj dogovor glede zaupnosti.
English: The Agency coordinates the verification of compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), and with pharmacovigilance obligations and certain aspects of the supervision of authorised medicinal products in use in the European Union.
Slovenian: Agencija usklajuje preverjanje skladnosti z načeli dobre proizvodne prakse (DPP), dobre klinične prakse (DKP), dobre laboratorijske prakse (DLP), obveznostmi farmakovigilance in nekaterimi vidiki nadzora odobrenih zdravil, ki se uporabljajo v Evropski uniji.
English: ADR = adverse drug reaction.
Slovenian: ADR = neželeni učinek zdravil.
English: Type-I variations Type-II variations Extensions
Slovenian: Spremembe tipa IA Spremembe tipa IB Spremembe tipa II Razširitev indikacij
English: • EMA holds workshop to review success of ten years of orphan-medicines legislation in Europe.
Slovenian: • Agencija EMA organizira delavnico za pregled uspešnosti desetletnega izvajanja zakonodaje o zdravilih sirotah v Evropi.
English: It does this through inspections requested by the CHMP or CVMP in connection with the assessment of marketing-authorisation applications and/or the assessment of matters referred to these committees in accordance with EU legislation.
Slovenian: To počne z inšpekcijskimi pregledi, ki jih zahtevata odbora CHMP ali CVMP v zvezi z oceno vlog za izdajo dovoljenja za promet z zdravilom in/ali presojo zadev, posredovanih tema odboroma v skladu z zakonodajo EU.
English: • Committee for Advanced Therapies gives first certification opinion for an advanced therapy medicinal product.
Slovenian: • Odbor za napredno zdravljenje izda prvo mnenje o certifikaciji za zdravilo za napredno zdravljenje.
English: Reports on serious suspected adverse drug reactions (ADRs) in animals and humans
Slovenian: Poročila o sumih resnih neželenih učinkov pri živalih in ljudeh
English: • European Medicines Agency (EMA) launches consultation on its 'Road map to 2015'.
Slovenian: • Evropska agencija za zdravila (EMA) začne posvetovanje o „časovnem načrtu do leta 2015“.
English: Scientific advice is provided on any aspect of research and development relating to quality, safety or efficacy of medicines for veterinary use, and to the establishment of maximum residue limits.
Slovenian: Znanstveno svetovanje se zagotavlja o vseh vidikih raziskav in razvoja v zvezi s kakovostjo, varnostjo ali učinkovitostjo zdravil za uporabo v veterinarski medicini ter določitvijo mejnih vrednosti ostankov.
English: In a referral, the European Medicines Agency is requested to conduct, on behalf of the European Community, a scientific assessment of a particular medicine or class of medicines to agree on a recommendation for a harmonised position across the European Union.
Slovenian: Pri napotitvah se od Evropske agencije za zdravila zahteva, naj v imenu Evropske skupnosti opravi znanstveno oceno posebnega zdravila ali razreda zdravil, da se sprejme dogovor o priporočilu za usklajeno mnenje v vsej Evropski uniji.
English: Referral procedures are used to resolve disagreements and address concerns among EU Member States.
Slovenian: Postopki napotitve se uporabljajo za reševanje sporov in obravnavo zaskrbljenosti med državami članicami EU.
English: • EMA's SME Office wins award for 'Most significant contribution to mediscience sector'.
Slovenian: • Urad agencije EMA za mala in srednja podjetja prejme nagrado za „najpomembnejši prispevek k medicini“.