natgillin/translations-raw huggingface dataset:
Andriol Testocaps, 40 mg capsules capsule, soft oral use 
Andriol Testocaps, 40 mg capsules kapsula, mehka peroralna uporaba
30 mg/patch patch 
30 mg/patch obliž
Sweden Laboratoires Besins International 
Madžarska Laboratoires Besins International
Germany Laboratoires Besins international 
Romunija LABORATOIRES BESINS INTERNATIONAL
15 mg/patch patch 
15 mg/patch obliž
2,5 mg/25 mg/ ml suspension for injection 
2,5 mg/25 mg/ ml suspenzija za injiciranje
25 mg/ml 2,5 mg/ml suspension for injection 
25 mg/ml 2,5 mg/ml suspenzija za injiciranje
The Netherlands testosterone undecanoate Andriol capsule, soft oral use 
The Netherlands testosterone undecanoate Andriol kapsula, mehka peroralna uporaba
Lithuania Bayer Pharma AG Mullerstrasse 178 
Madžarska Bayer Pharma AG Müllerstrasse 178
The Netherlands testosterone undecanoate Testocaps capsule, soft oral use 
The Netherlands testosterone undecanoate Testocaps kapsula, mehka peroralna uporaba
Testogel cutaneous transdermal use 
Testogel dermalna transdermalna uporaba
Axxeron transdermal spray, solution 
Axxeron transdermalno pršilo, raztopina
1000 mg/dose solution for injection 
1000 mg/dose raztopina za injiciranje
Testim cutaneous and transdermal preparations 
Testim dermalna in transdermalna uporaba
Lithuania N.V. ORGANON P.O. 
Romunija N.V.
5340 BH Oss The Netherlands testosterone undecanoate Andriol Testocaps 40 mg lágy kapszula capsule, soft oral use 
The Netherlands testosterone undecanoate Andriol Testocaps 40 mg lágy kapszula kapsula, mehka peroralna uporaba
Ireland testosterone undecanoate Nebido 1000 mg/4ml, solution for injection intramuscular 
Ireland testosterone undecanoate Nebido 1000 mg/4ml, solution for injection intramuskularna
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Andriol capsule, soft oral use 
Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Andriol kapsula, mehka peroralna uporaba
2,4mg/24h, transdermales Pflaster transdermal patch 
2,4mg/24h, transdermales Pflaster transdermalni obliž
Axxeron cutaneous solution 
Axxeron dermalna raztopina
N.V. Organon 6 Kloosterstraat 5340 BH Oss The Netherlands testosterone undecanoate Undestor capsule, soft oral use 
Organon 6 Kloosterstraat 5340 BH Oss The Netherlands testosterone undecanoate Undestor kapsula, mehka peroralna uporaba
Testim cutaneous transdermal use 
Testim dermalna transdermalna uporaba
1,8mg/24h, transdermales Pflaster transdermal patch 
1,8mg/24h, transdermales Pflaster transdermalni obliž
Testogel gel in sachet cutaneous and transdermal preparations 
Testogel gel v vrečici dermalna in transdermalna uporaba
Germany testosterone undecanoate Andriol Testocaps capsule oral use 
85540 Haar Germany testosterone undecanoate Andriol Testocaps kapsula peroralna uporaba
1,2mg/24h, transdermales Pflaster transdermal patch 
1,2mg/24h, transdermales Pflaster transdermalni obliž
Denmark Bayer Pharma AG Müllerstrasse 170-178 
Norveška Bayer Pharma AG, Müllerstrasse 178
Tostrex cutaneous and transdermal preparations 
Tostrex dermalna in transdermalna uporaba
ProStrakan Limited Galabank Business Park Galashiels, TD1 1QH United Kingdom 
Madžarska ProStrakan Limited Galabank Business Park Galashiels, TD1 1QH United Kingdom
Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosterone undecanoate Nebido solution for injection intramuscular 
Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosterone undecanoate Nebido raztopina za intramuskularno injiciranje
N.V. ORGANON Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg capsule oral use 
ORGANON Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg kapsula peroralna uporaba
Besins International, S.A. 5, Rue du Bourg l'Abbé F-75003 Paris France 
Portugalska Besins International, S.A. 5, Rue du Bourg l'Abbé F-75003 Paris
2.4 mg/24 h transdermal patch 
2.4 mg/24 h transdermalni obliž
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Restandol Testocaps 40 mg capsules, soft oral use 
Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Restandol Testocaps 40 mg kapsula, mehka peroralna uporaba
50 mg/dose gel in sachetdose 
50 mg/dose gel v odmerni vrečici
1.2 mg/24 h transdermal patch 
1.2 mg/24 h transdermalni obliž
1.8 mg/24 h transdermal patch 
1.8 mg/24 h transdermalni obliž
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg capsule, soft oral use 
Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg kapsula, mehka peroralna uporaba
1.8 mg/24h transdermal patch 
1.8 mg/24h transdermalni obliž
Androgel 50 mg gel in sachet gel in sachet 
Androgel 50 mg gel in sachet gel v vrečici
1.2 mg/24h transdermal patch 
1.2 mg/24h transdermalni obliž
25 mg/dose gel in sachetdose 
25 mg/dose gel v odmerni vrečici
Germany ProStrakan Limited Galabank Business Park TD1 QH Galashiels United Kingdom 
Portugalska ProStrakan Limited Galabank Business Park TD1 1QH Galashiels United Kingdom
Androgel 25 mg gel in sachet gel in sachet 
Androgel 25 mg gel in sachet gel v vrečici
2.4 mg/24h transdermal patch 
2.4 mg/24h transdermalni obliž
Androtop 50 mg gel v blazinici gel in sachet 
Androtop 50 mg gel v blazinici gel v vrečici
Androtop 25 mg gel v blazinici gel in sachet 
Androtop 25 mg gel v blazinici gel v vrečici
Axiron cutaneous solution cutaneous and transdermal preparations 
Axiron dermalna raztopina dermalna in transdermalna uporaba
Fostering transparency, communication and the provision of information 
Spodbujanje preglednosti, obveščanja in zagotavljanja informacij
By the end of the year, 29.4 million people in Europe had been vaccinated with one of these products. 
Do konca leta se je s temi cepivi cepilo 29,4 milijona ljudi v Evropi.
Consolidating the Agency's international strategy in the light of global challenges 
Krepitev mednarodne strategije agencije v luči svetovnih izzivov
Improving the effectiveness and efficiency of the Agency's core activities 
Izboljšanje uspešnosti in učinkovitosti glavnih dejavnosti agencije
The CAT is a multidisciplinary committee made up of some of the best experts in the field. 
CAT je večdisciplinaren odbor, ki ga sestavljajo nekateri najboljši strokovnjaki na svojem področju.
Thirtytwo competent authorities are now registered, with a total of 150 different users. 
Zdaj je registriranih dvaintrideset pristojnih organov s skupno 150 posameznimi uporabniki.
Existing regulatory guidance documents were also updated, to take account of the new rules. 
Posodobljene so bile tudi obstoječe regulativne smernice, ki tako odražajo nova pravila.
There are also 111 organisations registered (marketing-authorisation holders and third parties), with a total of 176 different users. 
Registriranih je tudi 111 organizacij (imetnikov dovoljenj za promet z zdravilom in tretjih strani) s skupno 176 posameznimi uporabniki.
Implementing and operating the Advanced Therapies Regulation and other new legislation 
Izvajanje in delovanje uredbe o naprednem zdravljenju in druge nove zakonodaje
Strengthening the European medicines network 
Krepitev Evropske mreže zdravil
By the end of the year, the international strategy was included as an important part of the Agency's 'Road map to 2015', adopted by the Agency's Management Board for public consultation. 
Konec leta je bila mednarodna strategija vključena kot pomemben del „časovnega načrta agencije do leta 2015“, ki ga je upravni odbor agencije sprejel za javno posvetovanje.
In 2009, the European Medicines Agency delivered very good results across the range of its activities. 
V letu 2009 je Evropska agencija za zdravila dosegla zelo dobre rezultate na več področjih svojega delovanja.
All major companies are now registered and operating electronic reporting via EVVet. 
Zdaj so registrirane vse poglavitne družbe, ki prek sistema EVVet izvajajo elektronsko poročanje.
Thus, the CHMP was able to give positive recommendations for two pandemic-influenza vaccines (Focetria and Pandemrix) by late September, and for a third one (Celvapan) in early October. 
Zato je CHMP lahko dal pozitivno priporočilo dvema cepivoma proti pandemski gripi (Focetria in Pandemrix) konec septembra, v začetku oktobra pa še tretjemu cepivu (Celvapan).
In many areas, the Agency was able to make a significant further contribution to public and animal health in the European Union (EU). 
Na več področjih je agencija bistveno prispevala k javnemu zdravju in zdravju živali v Evropski uniji (EU).
The development of the Agency's international strategy started with the appointment of an International Liaison Officer in the beginning of 2009. 
Razvoj mednarodne strategije agencije se je začel z imenovanjem mednarodnega uradnika za zvezo na začetku leta 2009.
The Agency also cooperated closely with the European Commission on fostering innovation in the context of the Innovative Medicines Initiative (IMI), the 7th Framework Programme and the European Technology Platform for Global Animal Health. 
Agencija je tesno sodelovala tudi z Evropsko komisijo pri spodbujanju inovacij v okviru pobude za inovativna zdravila (IMI), 7. okvirnega programa in evropske tehnološke platforme za globalno zdravstveno varstvo živali.
The European Pharmacovigilance Issues Tracking Tool (EPITT) is now routinely used to support the signal-management process. 
Orodje European Pharmacovigilance Issues Tracking Tool (EPITT) se sedaj redno uporablja za podporo postopku obvladovanja signalov.
Highlights from the Agency's annual report 2009 
Poudarki letnega poročila za leto 2009
PROTECT is a collaborative European project bringing together 29 public and private partners, which aims to develop innovative methods in pharmacoepidemiology and pharmacovigilance. 
PROTECT je evropski projekt, v katerem sodeluje 29 javnih in zasebnih partnerjev, katerih skupni cilj je razviti inovativne metode v farmakoepidemiologiji in farmakovigilanci.
This plan is designed to improve the handling and coordination of any potential crisis involving a medicine in the European medicines system. 
Ta načrt je bil zasnovan za izboljšanje obvladovanja in usklajevanja morebitne krize, ki bi zajemala zdravilo v evropskem sistemu zdravil.
The Agency delivered good results on a number of processes and procedures that contribute to the innovation and availability of medicines for human and animal use. 
Agencija je dosegla dobre rezultate pri številnih procesih in postopkih, ki prispevajo k inovacijam in razpoložljivosti zdravil za uporabo v humani in veterinarski medicini.
Although the Agency devoted significant time and resources in 2009 to its involvement in managing the unanticipated influenza pandemic, it was still able to achieve very good results in delivering on its ambitious work programme for the year. 
Čeprav je agencija v letu 2009 velik del časa in virov namenila sodelovanju pri obvladovanju nepričakovane pandemije gripe, je vseeno dosegla zelo dobre rezultate pri izvedbi ambicioznega delovnega programa za to leto.
The EudraVigilance Support Programme was initiated at the end of January 2009 to assist Member States with their signal-detection and evaluation activities. 
Konec januarja 2009 se je začel podporni program EudraVigilance, katerega namen je bil državam članicam olajšati zaznavanje signalov in ocenjevalne aktivnosti.
In early May, the Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that the shelf-life of one of these medicines (Tamiflu) be extended, so that stocks of the medicine that would otherwise need to have been disposed of could continue to be used in the event of a pandemic being declared. 
V začetku maja je Odbor za zdravila za uporabo v humani medicini (CHMP) priporočil podaljšanje roka uporabnosti enega od teh zdravil (Tamiflu), da bi bilo zaloge zdravila, ki bi jih bilo sicer treba zavreči, mogoče uporabiti v primeru razglasitve pandemije.
The need for continuous reflection on the Agency's activities in the area of transparency was underlined by the continuing increase in the number of requests received for access to documents and information. 
Potrebo pa stalnem odzivanju na dejavnosti agencije na področju preglednosti poudarja stalno povečevanje prejetih zahtevkov za dostop do dokumentov in informacij.
Preparing for the implementation of the Variations Regulation, the Agency provided to the European Commission, at the end of February 2009, draft guidelines on the detailed classification of variations and on the procedure for handling of variations in accordance with the new legislation. 
V okviru priprav za izvajanje uredbe o spremembah je agencija konec februarja 2009 Evropski komisiji predložila osnutek smernic o podrobni razvrstitvi sprememb in o postopku za obravnavo sprememb v skladu z novo zakonodajo.
A number of pilot projects fostering international collaboration in the area of inspections were also launched during the year. 
Med letom so se začeli številni pilotni projekti, ki pospešujejo mednarodno sodelovanje na področju inšpekcijskih pregledov.
That the EU medicines system was able to deliver an appropriate response to this public-health crisis was further evidence of its robustness and good functioning. 
Sistem zdravil v EU se je torej ustrezno odzval na javnozdravstveno krizo, kar je bil še dodaten dokaz njegove trdnosti in dobrega delovanja.
During the year, the Agency continuously monitored the safety data for influenza vaccines and antivirals, to establish and revise, where necessary, their benefit-risk profile. 
Med letom je agencija nenehno spremljala varnostne podatke za cepiva proti gripi in protivirusna zdravila, da bi ugotovili in po potrebi popravili profil koristi in tveganj.
In addition, the Agency published, in June 2009, a report on patients', consumers' and healthcare professionals' expectations with regard to information on the benefit-risk evaluation of medicines. 
Poleg tega je agencija junija 2009 objavila poročilo o pričakovanjih bolnikov, potrošnikov in zdravstvenega osebja glede informacij o ocenah koristi in tveganj zdravil.
The Agency's sixth scientific committee, the Committee for Advanced Therapies (CAT), was inaugurated in January 2009, in accordance with provisions contained in the new legislation on advanced therapy medicinal products (ATMPs). 
Šesti znanstveni odbor pri agenciji, Odbor za napredno zdravljenje (CAT), je bil slovesno ustanovljen januarja leta 2009 v skladu z določbami nove zakonodaje o zdravilih za napredno zdravljenje (ATMP).
When the first reported cases of infection emerged from Mexico, in April, the Agency reacted quickly, working closely with its European and international partners to monitor the situation and develop appropriate measures to deal with the emerging crisis, including meeting with vaccine manufacturers and influenza experts from across the EU to prepare for the development and authorisation of vaccines that could be used to protect people and minimise the spread of the virus. 
Ko so aprila poročali o prvih primerih okužbe v Mehiki, se je agencija odzvala hitro ter pričela tesno sodelovati s svojimi evropskimi in mednarodnimi partnerji, da bi spremljali razmere in sprejeli ustrezne ukrepe za obvladovanje porajajoče se krize, vključno s sestanki z izdelovalci cepiv in strokovnjaki za gripo iz celotne EU, ter se pripravili na razvoj in odobritev cepiv, s katerimi bi zaščitili ljudi ter v čim bolj zmanjšali širjenje virusa.
A pilot phase of the EU regulatory system incident-management plan for medicines for human use was launched on 1 June 2009. 
Pilotna faza načrta za obvladovanje dogodkov v regulativnem sistemu EU za zdravila za uporabo v humani medicini se je začela 1. junija 2009.
A particular highlight was the introduction, in September 2009, of a range of measures to promote the authorisation of products for minor uses, minor species and limited markets. 
Zlasti je izstopala uvedba številnih ukrepov za pospeševanje odobritve zdravil za manjšo uporabo, redkejše živalske vrste in omejene trge septembra leta 2009.
Improving the safety-monitoring of medicines 
Izboljšanje spremljanja varnosti zdravil
On the basis of these scientific recommendations, the European Commission granted EU-wide marketing authorisations for all three vaccines, making them available for use by health authorities in the EU Member States as part of their national vaccination programmes. 
Na podlagi teh znanstvenih priporočil je Evropska komisija izdala dovoljenja za promet z vsemi tremi cepivi za celotno EU, kar je zdravstvenim organom v državah članicah EU omogočilo njihovo uporabo v okviru svojih nacionalnih cepilnih programov.
However, due to the strength of the network, the Agency was not only able to contribute to the EU-wide response to the pandemic by providing its scientific opinion on H1N1 vaccines and antiviral medicines, it was also able to deliver good results across the range of its activities. 
Vendar je lahko zaradi čvrstosti mreže agencija ne le prispevala k odzivu na pandemijo v celotni EU z zagotavljanjem strokovnih mnenj o cepivih ter zdravilih proti virusu H1N1, pač pa dobre rezultate dosegla tudi na vseh svojih področjih.
The public-health issue to which the Agency devoted most attention in 2009 was the outbreak and rapid global spread of the H1N1 influenza ('swine flu') virus. 
Javnozdravstvena težava, ki ji je agencija namenila največ pozornosti v letu 2009, je bil izbruh in hitro širjenje virusa gripe H1N1 („prašičje gripe“) po svetu.
The fast-track review of pandemic vaccines - and the close monitoring of these vaccines once they were being used to vaccinate millions of European citizens - demonstrated to Europe and to the world that the European medicines network can deliver high-quality scientific assessments even under enormous pressure. 
S hitrim pregledovanjem pandemskih cepiv ter skrbnim spremljanjem teh cepiv med cepljenjem milijonov Evropejcev smo Evropi in svetu dokazali, da lahko Evropska mreža zdravil zagotovi kakovostno znanstveno presojo tudi pod velikanskim pritiskom.
Contributing to improved availability of medicines 
Prispevki k boljši dostopnosti zdravil
The outbreak of the 2009 H1N1 influenza pandemic put significant pressure on the European Medicines Agency and the European medicines network. 
Izbruh pandemske gripe H1N1 v letu 2009 je povzročil velik pritisk na Evropsko agencijo za zdravila in Evropsko mrežo zdravil.
The European Medicines Agency appointed a staff member as a liaison officer to the FDA in July 2009. 
Evropska agencija za zdravila je svojega člana osebja kot uradnika za zvezo pri FDA imenovala julija leta 2009.
A reflection paper on the concept of risk-management plans for veterinary medicines was published for consultation. 
Za posvetovanje je bil objavljen razpravni dokument o konceptu načrtov za obvladovanje tveganja zdravil za uporabo v veterinarski medicini.
An action plan on paediatric pharmacovigilance, based on EudraVigilance data, was adopted in May 2009 to further strengthen the intensive monitoring of paediatric use of medicines. 
Maja leta 2009 je bil sprejet akcijski načrt za pediatrično farmakovigilanco, ki je temelji na podatkih EudraVigilance, da bi se dodatno okrepilo intenzivno spremljanje pediatrične rabe zdravil.
The influenza pandemic was by definition a global challenge, so much credit for the achievements in Europe is also owed to the international partners with which the EU enjoys a mutually beneficial working relationship, notably the World Health Organization and the medicines authorities of the United States, Japan, Canada and Australia, among others. 
Pandemija gripe je bila že po definiciji svetovni izziv, zato so za dosežke v Evropi predvsem zaslužni tudi mednarodni partnerji, s katerimi ima EU medsebojno koristne delovne povezave, zlasti Svetovna zdravstvena organizacija in organi, pristojni za zdravila v Združenih državah Amerike, na Japonskem, v Kanadi in Avstraliji ter drugje.
While many resources were devoted to dealing with the influenza pandemic, the European medicines network also made progress on a number of other initiatives during the year: work on the European Risk Management Strategy (ERMS) continued in accordance with the rolling two-year work programme; the Agency worked jointly with the Heads of Medicines Agencies (HMA) on developing a training strategy for the regulatory network; further progress was made on simplifying the contractual arrangements with the Member States for services provided to the Agency through the development of a Cooperation Agreement. 
Čeprav je bilo veliko virov usmerjenih v obvladovanje pandemije gripe, je Evropska mreža zdravil med letom napredovala tudi na številnih drugih področjih: delo v zvezi z evropsko strategijo za obvladovanje tveganja (ERMS) se je nadaljevalo v skladu s tekočim dveletnim delovnim programom; agencija se je skupaj z vodjami agencij za zdravila (HMA) ukvarjala z razvojem strategije usposabljanja za regulativno mrežo; razvoj pogodbe o sodelovanju pa je pomenil napredek tudi glede poenostavitve pogodb z državami članicami za storitve, ki jih zagotavljajo agenciji.
The network demonstrated its strength during the 2009 H1N1 influenza pandemic. 
Mreža je svojo čvrstost dokazala med pandemijo gripe H1N1 v letu 2009.
While awaiting the availability of vaccines, the Agency worked to facilitate the use of existing antiviral medicines that had shown effectiveness in treating people infected with the virus. 
Agencija je v obdobju čakanja na razpoložljivost cepiv poskušala olajšati uporabo obstoječih protivirusnih zdravil, ki so pokazali učinkovitost pri zdravljenju ljudi, okuženih z virusom.
The Committee deals with ATMPs for human use that are based on gene therapy, somatic cell therapy or tissue engineering. 
Odbor obravnava zdravila za napredno zdravljenje za uporabo v humani medicini, ki temeljijo na genski terapiji, terapiji s somatskimi celicami ali tkivnem inženirstvu.
Once a pandemic had been officially declared by the World Health Organization and the strain of the virus had been identified, in June, pharmaceutical companies were in a position to begin submitting data on H1N1 vaccines to the Agency. 
Ko je junija Svetovna zdravstvena organizacija uradno razglasila pandemijo in je bil identificiran sev virusa, so lahko farmacevtske družbe agenciji začele pošiljati podatke o cepivih proti virusu H1N1.
While the rate of submission of applications for veterinary medicines was reasonably steady, there was a considerable increase in the number of requests relating to veterinary scientific advice and pharmacovigilance activities. 
Čeprav je bila pogostost predložitev vlog za zdravila za uporabo v veterinarski medicini precej enakomerna, je bilo bistveno več zahtevkov v zvezi z veterinarskim znanstvenim svetovanjem in farmakovigilančnimi dejavnostmi.
This was done to fast-track the assessment process so that the urgent publichealth need for vaccines could be met before the autumn, when an intensification of the spread of the virus was expected in Europe. 
Namen tega postopka je bil pospešiti postopek ocene, da bi lahko odgovorili na nujno javnozdravstveno potrebo po cepivih pred jesenjo, ko se je pričakovalo pospešeno širjenje virusa v Evropi.
Public consultation on draft EudraVigilance access policies in relation to human and veterinary medicines was completed in the spring of 2009, and work on revising the draft policies began. 
Javna razprava o osnutku politike dostopa do zbirke EudraVigilance za zdravila za uporabo v humani in veterinarski medicini je bila končana spomladi leta 2009, začelo pa se je tudi popravljanje osnutka politike.
Initiatives were taken to facilitate the monitoring of adverse drug reactions in children using centrally authorised medicines. 
Sprejeli smo pobude, s katerimi smo želeli olajšati spremljanje neželenih učinkov zdravil pri otrocih s pomočjo centralno odobrenih zdravil.
In June 2009, an FDA official took up a posting at the Agency, followed by an official from the Japanese authorities in November 2009. 
Uradnik FDA je nastopil položaj v agenciji junija leta 2009, novembra 2009 pa mu je sledil uradnik iz japonskega pristojnega organa.