FrancophonIA/ELRC3.0 huggingface dataset:
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate
Slovenian: Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate
English: Sweden N.V. Organon Kloosterstraat 6
Slovenian: Organon Kloosterstraat 6
English: 25 mg/ml 2,5 mg/ml suspension for injection
Slovenian: 25 mg/ml 2,5 mg/ml suspenzija za injiciranje
English: The Netherlands testosterone undecanoate Andriol capsule, soft oral use
Slovenian: The Netherlands testosterone undecanoate Andriol kapsula, mehka peroralna uporaba
English: Lithuania Bayer Pharma AG Mullerstrasse 178
Slovenian: Madžarska Bayer Pharma AG Müllerstrasse 178
English: Ferring Lægemidler A/S (F) Kay Fiskers Plads 11.
Slovenian: Ferring Lægemidler A/S (F) Kay Fiskers Plads 11. 2300 Köbenhavn S Denmark testosteronum
English: The Netherlands testosterone undecanoate Testocaps capsule, soft oral use
Slovenian: The Netherlands testosterone undecanoate Testocaps kapsula, mehka peroralna uporaba
English: Testogel cutaneous transdermal use
Slovenian: Testogel dermalna transdermalna uporaba
English: Axxeron transdermal spray, solution
Slovenian: Axxeron transdermalno pršilo, raztopina
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoat
Slovenian: Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoat
English: Bayer Pharma AG Müllerstrasse 178 D-13342 Berlin Germany
Slovenian: Bayer Pharma AG Müllerstrasse 170-178 DE-13342 Berlin Germany
English: TESTIM 50 mg transdermalni gel transdermal gel
Slovenian: TESTIM 50 mg transdermalni gel transdermalni gel
English: Luxembourg Prostrakan Ltd Galabank Business Park Galashiels
Slovenian: Luksemburg Prostrakan Ltd Galabank Business Park Galashiels
English: 1000 mg/dose solution for injection
Slovenian: 1000 mg/dose raztopina za injiciranje
English: Testim cutaneous and transdermal preparations
Slovenian: Testim dermalna in transdermalna uporaba
English: Lithuania N.V. ORGANON P.O.
Slovenian: Romunija N.V.
English: 5340 BH Oss The Netherlands testosterone undecanoate Andriol Testocaps 40 mg lágy kapszula capsule, soft oral use
Slovenian: The Netherlands testosterone undecanoate Andriol Testocaps 40 mg lágy kapszula kapsula, mehka peroralna uporaba
English: Ireland testosterone undecanoate Nebido 1000 mg/4ml, solution for injection intramuscular
Slovenian: Ireland testosterone undecanoate Nebido 1000 mg/4ml, solution for injection intramuskularna
English: Bayer Pharma AG 13342 Berlin Germany
Slovenian: Bayer Pharma AG DE-13342 Berlin Germany
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Andriol capsule, soft oral use
Slovenian: Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Andriol kapsula, mehka peroralna uporaba
English: 2,4mg/24h, transdermales Pflaster transdermal patch
Slovenian: 2,4mg/24h, transdermales Pflaster transdermalni obliž
English: Axxeron cutaneous solution
Slovenian: Axxeron dermalna raztopina
English: N.V. Organon 6 Kloosterstraat 5340 BH Oss The Netherlands testosterone undecanoate Undestor capsule, soft oral use
Slovenian: Organon 6 Kloosterstraat 5340 BH Oss The Netherlands testosterone undecanoate Undestor kapsula, mehka peroralna uporaba
English: ProStrakan Ltd Galabank Business Park Galashiels, TD1 1PR United Kingdom
Slovenian: Norveška ProStrakan Ltd Galabank Business Park Galashiels, TD1 1PR United Kingdom
English: Luxembourg Besins International S.A. 3, rue du Bourg l'Abbe 75003 Paris
Slovenian: Luksemburg Besins International S.A. 3, rue du Bourg l'Abbe 75003 Paris
English: Testim cutaneous transdermal use
Slovenian: Testim dermalna transdermalna uporaba
English: 1,8mg/24h, transdermales Pflaster transdermal patch
Slovenian: 1,8mg/24h, transdermales Pflaster transdermalni obliž
English: Testogel gel in sachet cutaneous and transdermal preparations
Slovenian: Testogel gel v vrečici dermalna in transdermalna uporaba
English: Germany testosterone undecanoate Andriol Testocaps capsule oral use
Slovenian: 85540 Haar Germany testosterone undecanoate Andriol Testocaps kapsula peroralna uporaba
English: 1,2mg/24h, transdermales Pflaster transdermal patch
Slovenian: 1,2mg/24h, transdermales Pflaster transdermalni obliž
English: Denmark Bayer Pharma AG Müllerstrasse 170-178
Slovenian: Norveška Bayer Pharma AG, Müllerstrasse 178
English: Belgium Eli Lilly Benelux S.A.-N.V. Rue du Marquis 1
Slovenian: Eli Lilly Benelux S.A.-N.V.
English: Tostrex cutaneous and transdermal preparations
Slovenian: Tostrex dermalna in transdermalna uporaba
English: ProStrakan Limited Galabank Business Park Galashiels, TD1 1QH United Kingdom
Slovenian: Madžarska ProStrakan Limited Galabank Business Park Galashiels, TD1 1QH United Kingdom
English: Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosterone undecanoate Nebido solution for injection intramuscular
Slovenian: Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosterone undecanoate Nebido raztopina za intramuskularno injiciranje
English: N.V. ORGANON Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg capsule oral use
Slovenian: ORGANON Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg kapsula peroralna uporaba
English: Besins International, S.A. 5, Rue du Bourg l'Abbé F-75003 Paris France
Slovenian: Portugalska Besins International, S.A. 5, Rue du Bourg l'Abbé F-75003 Paris
English: Belgium ProStrakan Ltd. Galabank Business Park TD1 1QH Galashiels Selkirkshire
Slovenian: Galabank Business Park TD1 1QH Galashiels Selkirkshire
English: The Netherlands testosterone undecanoate Undestor® Testocaps®
Slovenian: The Netherlands testosteronundecanoaat
English: Sweden Bayer Pharma AG DE-13342 Berlin
Slovenian: Slovenija Bayer Pharma AG 13342 Berlin
English: Sweden Laboratoires Besins International, 3, rue du Bourg l´ Abbé FR-75003 Paris
Slovenian: Laboratoires Besins International, 3, rue du Bourg l´ Abbé FR-75003 Paris
English: 2.4 mg/24 h transdermal patch
Slovenian: 2.4 mg/24 h transdermalni obliž
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Restandol Testocaps 40 mg capsules, soft oral use
Slovenian: Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Restandol Testocaps 40 mg kapsula, mehka peroralna uporaba
English: 50 mg/dose gel in sachetdose
Slovenian: 50 mg/dose gel v odmerni vrečici
English: Denmark Laboratoires Besins Int., 3 rue du Bourg l'Abbé 75003 Paris
Slovenian: Laboratoires Besins Int., 3 rue du Bourg l'Abbé 75003 Paris
English: 1.2 mg/24 h transdermal patch
Slovenian: 1.2 mg/24 h transdermalni obliž
English: 3, rue du Bourg l´ Abbé FR-75003 Paris
Slovenian: 3, rue du Bourg l'Abbé 75003 Paris
English: 1.8 mg/24 h transdermal patch
Slovenian: 1.8 mg/24 h transdermalni obliž
English: 3 rue du Bourgl Abbe 75003 Paris testosteron
Slovenian: Laboratoires Besins international 3 rue du Bourgl Abbe 75003 Paris France testosteron
English: Denmark Laboratoires Besins Int. 3 rue du Bourg l'Abbé 75003 Paris
Slovenian: Laboratoires Besins Int. 3 rue du Bourg l'Abbé 75003 Paris
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg capsule, soft oral use
Slovenian: Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg kapsula, mehka peroralna uporaba
English: 1.8 mg/24h transdermal patch
Slovenian: 1.8 mg/24h transdermalni obliž
English: Androgel 50 mg gel in sachet gel in sachet
Slovenian: Androgel 50 mg gel in sachet gel v vrečici
English: 1.2 mg/24h transdermal patch
Slovenian: 1.2 mg/24h transdermalni obliž
English: 25 mg/dose gel in sachetdose
Slovenian: 25 mg/dose gel v odmerni vrečici
English: Germany ProStrakan Limited Galabank Business Park TD1 QH Galashiels United Kingdom
Slovenian: Portugalska ProStrakan Limited Galabank Business Park TD1 1QH Galashiels United Kingdom
English: Androgel 25 mg gel in sachet gel in sachet
Slovenian: Androgel 25 mg gel in sachet gel v vrečici
English: 2.4 mg/24h transdermal patch
Slovenian: 2.4 mg/24h transdermalni obliž
English: Androtop 50 mg gel v blazinici gel in sachet
Slovenian: Androtop 50 mg gel v blazinici gel v vrečici
English: Bayer Portugal, S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal testosterone enantate
Slovenian: 2794-003 Carnaxide Portugal testosterone enantate
English: Androtop 25 mg gel v blazinici gel in sachet
Slovenian: Androtop 25 mg gel v blazinici gel v vrečici
English: The Netherlands testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate
Slovenian: 5340 BH Oss The Netherlands testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate
English: Axiron cutaneous solution cutaneous and transdermal preparations
Slovenian: Axiron dermalna raztopina dermalna in transdermalna uporaba
English: Fostering transparency, communication and the provision of information
Slovenian: Spodbujanje preglednosti, obveščanja in zagotavljanja informacij
English: By the end of the year, 29.4 million people in Europe had been vaccinated with one of these products.
Slovenian: Do konca leta se je s temi cepivi cepilo 29,4 milijona ljudi v Evropi.
English: Consolidating the Agency's international strategy in the light of global challenges
Slovenian: Krepitev mednarodne strategije agencije v luči svetovnih izzivov
English: Improving the effectiveness and efficiency of the Agency's core activities
Slovenian: Izboljšanje uspešnosti in učinkovitosti glavnih dejavnosti agencije
English: The CAT is a multidisciplinary committee made up of some of the best experts in the field.
Slovenian: CAT je večdisciplinaren odbor, ki ga sestavljajo nekateri najboljši strokovnjaki na svojem področju.
English: Thirtytwo competent authorities are now registered, with a total of 150 different users.
Slovenian: Zdaj je registriranih dvaintrideset pristojnih organov s skupno 150 posameznimi uporabniki.
English: Existing regulatory guidance documents were also updated, to take account of the new rules.
Slovenian: Posodobljene so bile tudi obstoječe regulativne smernice, ki tako odražajo nova pravila.
English: There are also 111 organisations registered (marketing-authorisation holders and third parties), with a total of 176 different users.
Slovenian: Registriranih je tudi 111 organizacij (imetnikov dovoljenj za promet z zdravilom in tretjih strani) s skupno 176 posameznimi uporabniki.
English: Implementing and operating the Advanced Therapies Regulation and other new legislation
Slovenian: Izvajanje in delovanje uredbe o naprednem zdravljenju in druge nove zakonodaje
English: Strengthening the European medicines network
Slovenian: Krepitev Evropske mreže zdravil
English: 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.
Slovenian: 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.
English: In 2009, the European Medicines Agency delivered very good results across the range of its activities.
Slovenian: V letu 2009 je Evropska agencija za zdravila dosegla zelo dobre rezultate na več področjih svojega delovanja.
English: All major companies are now registered and operating electronic reporting via EVVet.
Slovenian: Zdaj so registrirane vse poglavitne družbe, ki prek sistema EVVet izvajajo elektronsko poročanje.
English: 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.
Slovenian: 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).
English: In many areas, the Agency was able to make a significant further contribution to public and animal health in the European Union (EU).
Slovenian: Na več področjih je agencija bistveno prispevala k javnemu zdravju in zdravju živali v Evropski uniji (EU).
English: The development of the Agency's international strategy started with the appointment of an International Liaison Officer in the beginning of 2009.
Slovenian: Razvoj mednarodne strategije agencije se je začel z imenovanjem mednarodnega uradnika za zvezo na začetku leta 2009.
English: 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.
Slovenian: 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.
English: The European Pharmacovigilance Issues Tracking Tool (EPITT) is now routinely used to support the signal-management process.
Slovenian: Orodje European Pharmacovigilance Issues Tracking Tool (EPITT) se sedaj redno uporablja za podporo postopku obvladovanja signalov.
English: Highlights from the Agency's annual report 2009
Slovenian: Poudarki letnega poročila za leto 2009
English: PROTECT is a collaborative European project bringing together 29 public and private partners, which aims to develop innovative methods in pharmacoepidemiology and pharmacovigilance.
Slovenian: PROTECT je evropski projekt, v katerem sodeluje 29 javnih in zasebnih partnerjev, katerih skupni cilj je razviti inovativne metode v farmakoepidemiologiji in farmakovigilanci.
English: This plan is designed to improve the handling and coordination of any potential crisis involving a medicine in the European medicines system.
Slovenian: Ta načrt je bil zasnovan za izboljšanje obvladovanja in usklajevanja morebitne krize, ki bi zajemala zdravilo v evropskem sistemu zdravil.
English: 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.
Slovenian: Agencija je dosegla dobre rezultate pri številnih procesih in postopkih, ki prispevajo k inovacijam in razpoložljivosti zdravil za uporabo v humani in veterinarski medicini.
English: 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.
Slovenian: 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.
English: The EudraVigilance Support Programme was initiated at the end of January 2009 to assist Member States with their signal-detection and evaluation activities.
Slovenian: Konec januarja 2009 se je začel podporni program EudraVigilance, katerega namen je bil državam članicam olajšati zaznavanje signalov in ocenjevalne aktivnosti.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Potrebo pa stalnem odzivanju na dejavnosti agencije na področju preglednosti poudarja stalno povečevanje prejetih zahtevkov za dostop do dokumentov in informacij.
English: 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.
Slovenian: 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.
English: A number of pilot projects fostering international collaboration in the area of inspections were also launched during the year.
Slovenian: Med letom so se začeli številni pilotni projekti, ki pospešujejo mednarodno sodelovanje na področju inšpekcijskih pregledov.
English: 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.
Slovenian: Sistem zdravil v EU se je torej ustrezno odzval na javnozdravstveno krizo, kar je bil še dodaten dokaz njegove trdnosti in dobrega delovanja.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Poleg tega je agencija junija 2009 objavila poročilo o pričakovanjih bolnikov, potrošnikov in zdravstvenega osebja glede informacij o ocenah koristi in tveganj zdravil.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: A pilot phase of the EU regulatory system incident-management plan for medicines for human use was launched on 1 June 2009.
Slovenian: Pilotna faza načrta za obvladovanje dogodkov v regulativnem sistemu EU za zdravila za uporabo v humani medicini se je začela 1. junija 2009.
English: 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.
Slovenian: Zlasti je izstopala uvedba številnih ukrepov za pospeševanje odobritve zdravil za manjšo uporabo, redkejše živalske vrste in omejene trge septembra leta 2009.
English: Improving the safety-monitoring of medicines
Slovenian: Izboljšanje spremljanja varnosti zdravil
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Contributing to improved availability of medicines
Slovenian: Prispevki k boljši dostopnosti zdravil
English: The outbreak of the 2009 H1N1 influenza pandemic put significant pressure on the European Medicines Agency and the European medicines network.
Slovenian: Izbruh pandemske gripe H1N1 v letu 2009 je povzročil velik pritisk na Evropsko agencijo za zdravila in Evropsko mrežo zdravil.
English: The European Medicines Agency appointed a staff member as a liaison officer to the FDA in July 2009.
Slovenian: Evropska agencija za zdravila je svojega člana osebja kot uradnika za zvezo pri FDA imenovala julija leta 2009.
English: A reflection paper on the concept of risk-management plans for veterinary medicines was published for consultation.
Slovenian: Za posvetovanje je bil objavljen razpravni dokument o konceptu načrtov za obvladovanje tveganja zdravil za uporabo v veterinarski medicini.
English: 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.
Slovenian: 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.