FrancophonIA/ELRC3.0 huggingface dataset:
English: The steady-state mean peak and trough plasma concentrations of glycopyrronium for a 44 micrograms once-daily dosing regimen were 166 picograms/ml and 8 picograms/ml, respectively.
Slovenian: Pri shemi odmerjanja 44 mikrogramov enkrat na dan sta bili povprečni vrednosti najvišje in najnižje koncentracije glikopironija v stanju dinamičnega ravnovesja 166 pikogramov/ml oziroma 8 pikogramov/ml.
English: - When you start a new pack, use the new Tovanor Breezhaler inhaler that is supplied in the pack.
Slovenian: - Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Tovanor Breezhaler,
English: No studies have been conducted in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter niso izvedli nobenih študij.
English: Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms glycopyrronium).
Slovenian: Ena kapsula vsebuje 63 mikrogramov glikopironijevega bromida (kar ustreza 50 mikrogramom glikopironija).
English: At 12 weeks (primary endpoint), Tovanor Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001).
Slovenian: Po 12 tednih (primarni cilj opazovanja) je zdravilo Tovanor Breezhaler izboljšalo FEV1, izmerjen 24 ur po odmerjanju, za 108 ml v 6-mesečni študiji in za 97 ml v 12-mesečni študiji v primerjavi s placebom (p<0,001 za obe razliki).
English: Some side effects are common (may affect up to 1 in 10 people)
Slovenian: Nekateri neželeni učinki so pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov)
English: Some side effects are uncommon (may affect up to 1 in 100 people)
Slovenian: Nekateri neželeni učinki so občasni (lahko se pojavijo pri največ 1 od 100 bolnikov)
English: There was no attenuation of the bronchodilator effect over time in the 6and 12-month studies.
Slovenian: Tako v 6-mesečni kot v 12-mesečni študiji se bronhodilatatoren učinek s časom ni zmanjševal.
English: Cardiac disorders Atrial fibrillation
Slovenian: Srčne bolezni atrijska fibrilacija občasni palpitacije občasni
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišičnoskeletne bolečine pogosti bolečine v okončinah občasni mišičnoskeletna bolečina v prsnem košu občasni
English: The pooled analysis also showed fewer patients treated with Tovanor Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Slovenian: Rezultati analize združenih podatkov poleg tega kažejo, da je bil delež bolnikov, pri katerih je prišlo do akutnega poslabšanja, zaradi katerega je bila potrebna hospitalizacija, manjši med bolniki, ki so prejemali zdravilo Tovanor Breezhaler, v primerjavi s tovrstnim deležem pri tistih, ki so prejemali placebo (1,7 % v primerjavi s 4,2 %, p=0,003).
English: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Tovanor Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije manj kot 30 ml/min/1,73 m2), med katere sodijo tudi tisti s končno ledvično odpovedjo, ki potrebujejo dializno zdravljenje, je mogoče zdravilo Tovanor Breezhaler uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavje 5.2).
English: Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above and the company logo ( ) printed in black below a black bar.
Slovenian: prašek za inhaliranje, trda kapsula (prašek za inhaliranje) Prozorne oranžne kapsule, ki vsebujejo bel prašek in imajo natisnjeno črno oznako zdravila "GPL50" nad črno črto in črn zaščitni znak družbe ( ) pod črno črto.
English: - Do not push the capsule through the foil.
Slovenian: - Kapsul ne potiskajte skozi folijo.
English: • Weakness
Slovenian: • šibkost
English: Talk to your doctor before using Tovanor Breezhaler, if any of the following applies to you: - you have kidney problems.
Slovenian: Pred začetkom uporabe zdravila Tovanor Breezhaler se posvetujte z zdravnikom, če kaj od navedenega velja za vas: - če imate težave z ledvicami, - če imate očesno bolezen, ki se imenuje glavkom zaprtega zakotja, - če imate težave pri uriniranju.
English: No specific side effects have been reported when Tovanor Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Slovenian: Pri uporabi zdravila Tovanor Breezhaler skupaj z drugimi zdravili, ki se uporabljajo pri zdravljenju KOPB, kot so inhalacijski olajševalci (npr. salbutamol), metilksantini (npr. teofilin) in/ali peroralni ali inhalacijski kortikosteroidi (npr. prednizolon), niso poročali o posebnih neželenih učinkih.
English: The capsules must only be removed from the blister immediately before use.
Slovenian: Kapsule je treba vzeti iz pretisnega omota šele tik pred uporabo.
English: They have the product code “GPL50” printed in black above and a company logo ( ) printed in black below a black bar.
Slovenian: Na kapsulah je nad črno črto s črno natisnjena oznaka zdravila "GLP50", pod črno črto pa je s črno natisnjen zaščitni znak družbe ( ).
English: • Diarrhoea or stomach ache
Slovenian: • driska ali bolečine v trebuhu
English: 2) Reports have been received from post-approval marketing experience in association with the use of Tovanor Breezhaler.
Slovenian: 2) Poročila izhajajo iz izkušenj z uporabo zdravila Tovanor Breezhaler po njegovem prihodu na trg.
English: Immediate hypersensitivity reactions have been reported after administration of Tovanor Breezhaler.
Slovenian: Poročali so o primerih takojšnje preobčutljivostne reakcije po odmerjanju zdravila Tovanor Breezhaler.
English: In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Tovanor Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
Slovenian: Pri bolnikih s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije <30 ml/min/1,73 m2), vključno s tistimi s končno ledvično odpovedjo, ki potrebujejo dializo, je zdravilo Tovanor Breezhaler mogoče uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavje 4.4).
English: During treatment with Tovanor Breezhaler, stop taking this medicine and tell your doctor immediately: - if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Tovanor Breezhaler (signs of bronchospasm).
Slovenian: Med zdravljenjem z zdravilom Tovanor Breezhaler, takoj prenehajte uporabljati to zdravilo in obvestite zdravnika: - če vas začne takoj po uporabi zdravila Tovanor Breezhaler stiskati v prsih, če začnete kašljati, če vam v pljučih piska ali vam zmanjkuje sape (to so znaki bronhospazma), - če težko dihate ali požirate, če vam otekajo jezik, ustnice ali obraz, če se pojavi izpuščaj, srbenje in koprivnica (to so znaki alergijske reakcije), - če vas začne boleti ali ščemeti v očeh, če se vam začasno zamegli vid, če opažate svetlobne ali živobarvne kolobarje okrog luči, pri tem pa so vaše oči pordele.
English: • Runny or stuffy nose, sneezing, sore throat
Slovenian: • izcedek iz nosu ali zamašen nos, kihanje, vneto grlo oziroma žrelo
English: Tovanor Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Slovenian: Poleg tega je zdravilo Tovanor Breezhaler zmanjšalo dispnejo v mirovanju po oceni z indeksom spreminjanja dispneje v času (angl. Transitional Dyspnoea Index).
English: Tovanor Breezhaler contains lactose
Slovenian: Zdravilo Tovanor Breezhaler vsebuje laktozo
English: No change in mean heart rate or QTc interval was observed with Tovanor Breezhaler in doses up to 176 micrograms in COPD patients.
Slovenian: Pri odmerjanju zdravila Tovanor Breezhaler v odmerkih do 176 mikrogramov bolnikom s KOPB niso opažali nobenih sprememb srčne frekvence ali trajanja intervala QTc.
English: The effect on heart rate and QTc interval of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) administered intravenously was investigated in young healthy subjects.
Slovenian: Pri zdravih mladih prostovoljcih so proučevali učinek intravenskega odmerjanja 150 mikrogramov glikopironijevega bromida (kar ustreza 120 mikrogramom glikopironija) na srčno frekvenco in trajanje intervala QTc.
English: Tovanor Breezhaler was found to decrease dyspnoea and leg discomfort when exercising as measured using Borg scales.
Slovenian: Ugotovili so, da zdravilo Tovanor Breezhaler zmanjša dispnejo in bolečine v nogah pri naporu po Borgovi lestvici zaznavanja napora.
English: • Difficulty and pain when passing urine
Slovenian: • ovirano in boleče uriniranje
English: General disorders and administration site conditions Fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost občasni astenija občasni
English: Show the pack of Tovanor Breezhaler.
Slovenian: Tam pokažite škatlo z zdravilom Tovanor Breezhaler.
English: Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
Slovenian: En odmerek glikopironijevega bromida, ki pride skozi ustnik inhalatorja, vsebuje 55 mikrogramov glikopironijevega bromida, kar ustreza 44 mikrogramom glikopironija.
English: Metabolism and nutrition disorders Hyperglycaemia
Slovenian: Presnovne in prehranske motnje hiperglikemija občasni
English: Each inhaler should be disposed of after all capsules have been used.
Slovenian: Vsak inhalator je treba zavreči, ko porabite vse kapsule.
English: Breezhaler inhaler).
Slovenian: Tovanor Breezhaler).
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Slovenian: Po rezultatih analize združenih podatkov iz ključnih študij (6-mesečne in 12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje ocene SGRQ za 4 točke ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Tovanor Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (57,8 % v primerjavi s 47,6 %, p<0,001).
English: Tovanor Breezhaler 44 mcg inhalation powder glycopyrronium
Slovenian: Tovanor Breezhaler 44 μg prašek za inhaliranje glikopironij
English: Inhalation use only
Slovenian: samo za inhalacijo
English: Multipack comprising 3 packs (30 capsules + 1 inhaler)
Slovenian: Skupno pakiranje obsega 3 pakiranja (30 kapsul + 1 inhalator)
English: Psychiatric disorders Insomnia
Slovenian: Psihiatrične motnje nespečnost pogosti
English: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Slovenian: Po rezultatih analize združenih podatkov iz ključnih študij (6-mesečne in 12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje skupne ocene indeksa TDI za 1 točko ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Tovanor Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (58,4 % v primerjavi s 46,4 %, p<0,001).
English: Multipack: 90 (3 packs of 30 x 1) capsules + 3 inhalers.
Slovenian: Skupno pakiranje: 90 kapsul (3 pakiranja po 30 x 1) in 3 inhalatorji.
English: • Rash
Slovenian: • srbež
English: However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening.
Slovenian: Paradoksni bronhospazem je lahko življenjsko nevaren.
English: • One or more blister cards, each containing either 6 or 10 Seebri Breezhaler capsules to be used in the inhaler
Slovenian: • en ali več pretisnih omotov, vsak vsebuje 6 ali
English: Immune system disorders Hypersensitivity
Slovenian: Bolezni imunskega sistema preobčutljivost občasni angioedem občasni
English: • Numbness
Slovenian: • navzea
English: Do not remove from the blister until immediately before use.
Slovenian: Iz pretisnega omota jih vzemite šele tik pred uporabo.
English: How to use Tovanor Breezhaler
Slovenian: Kako uporabljati zdravilo Tovanor Breezhaler
English: Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhalers.
Slovenian: Skupno pakiranje vsebuje 90 trdih kapsul (3 pakiranja po 30x1) in 3 inhalatorje.
English: The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Slovenian: Uporabno do Inhalator vsakega pakiranja je treba zavreči, ko porabite vse kapsule tega pakiranja.
English: 24 x 1 capsules + 1 inhaler.
Slovenian: 24 x 1 kapsula + 1 inhalator.
English: Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena kapsula vsebuje 63 mikrogramov glikopironijevega bromida, kar ustreza 50 mikrogramom glikopironija.
English: 30 x 1 capsules + 1 inhaler.
Slovenian: 30 x 1 kapsula + 1 inhalator.
English: Skin and subcutaneous tissue disorders Rash
Slovenian: Bolezni kože in podkožja izpuščaj občasni pruritus občasni
English: • Cough with sputum
Slovenian: • kašelj z izmečkom
English: PA/Alu/PVC - Alu perforated unit-dose blister Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Slovenian: Pakiranja vsebujejo 6x1, 10x1, 12x1 ali 30x1 trdo kapsulo in en inhalator.
English: Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Tovanor Breezhaler and were well tolerated.
Slovenian: Zdravi prostovoljci so dobro prenašali najvišjo koncentracijo učinkovine v plazmi in celotno sistemsko izpostavljenost po intravenski aplikaciji 150 mikrogramov glikopironijevega bromida (kar ustreza 120 mikrogramom glikopironija).
English: Tovanor Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Slovenian: Bolniki z blago do zmerno okvaro ledvic lahko uporabljajo zdravilo Tovanor Breezhaler v priporočenem odmerku.
English: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Tovanor Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Tovanor Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Slovenian: (razmerje ogroženosti: 0,69, p=0,023), medtem ko je bil v 12-mesečni študiji odstotek takih bolnikov pri uporabi zdravila Tovanor Breezhaler 32,8 %, pri uporabi placeba pa
English: What Tovanor Breezhaler is
Slovenian: Kaj je zdravilo Tovanor Breezhaler
English: Other medicines and Tovanor Breezhaler
Slovenian: Shranjevanje zdravila Tovanor Breezhaler
English: Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol pogosti hipestezija občasni
English: Gastrointestinal disorders Dry mouth
Slovenian: Bolezni prebavil suha usta pogosti gastroenteritis pogosti navzea2)
English: Inhale deeply Check capsule is empty
Slovenian: vstavite predrite in izpustite globoko vdihnite preverite preverite, da je kapsula prazna
English: Your Seebri Breezhaler Inhaler pack contains: • One Seebri Breezhaler inhaler
Slovenian: Vaše pakiranje zdravila Tovanor Breezhaler vsebuje:
English: This will be done within the context of the 7th Framework Programme.
Slovenian: To se bo dogajalo v okviru 7. okvirnega programa.
English: NATIONAL COMPETENT AUTHORITIES 4,000 EUROPEAN EXPERTS
Slovenian: NACIONALNI PRISTOJNI ORGANI 4000 EVROPSKIH STROKOVNJAKOV
English: Contribute to the creation of an environment that stimulates innovation
Slovenian: Prispevati k nastanku okolja, ki spodbuja inovacije
English: The Agency's website will be at the forefront of this initiative.
Slovenian: Spletna stran Agencije bo v ospredju te pobude.
English: Participate in international standardisation activities.
Slovenian: Sodelovati pri mednarodnih standardizacijskih dejavnostih.
English: The SME Office has been set up within the Agency to address the particular needs of smaller companies.
Slovenian: Urad za mala in srednje velika podjetja je bil ustanovljen znotraj Agencije, da bi obravnaval posebne potrebe manjših družb.
English: Further interaction will develop in the areas specified by the European Commission.
Slovenian: Nadaljnji stiki bodo razviti na področjih, ki jih opredeljuje Evropska komisija.
English: The provision of understandable and clear information about medicines is an important goal for the Agency.
Slovenian: Zagotavljanje razumljivih in jasnih informacij o zdravilih je pomemben cilj Agencije.
English: 1.6. International cooperation
Slovenian: 1.6 Mednarodno sodelovanje
English: The documents will be improved in the light of stakeholders' expectations.
Slovenian: Te dokumente bo izboljšala glede na pričakovanja svojih zainteresiranih strani.
English: This document is a summary of the Agency's work programme for 2008.
Slovenian: Ta dokument je povzetek delovnega programa Agencije za leto 2008.
English: This trend is mirrored by the increased number of delegates from Member States attending meetings at the Agency.
Slovenian: Ta trend se odraža v povečanem številu delegatov iz držav članic, ki se udeležujejo srečanj na Agenciji.
English: Head: David Mackay
Slovenian: Vodja: David Mackay
English: Collaboration with patients will continue, building on the success achieved in previous years.
Slovenian: Sodelovanje z bolniki se bo nadaljevalo in gradilo na uspehih iz prejšnjih let.
English: Necessary changes in the assessment process have been made over the last year to meet this goal.
Slovenian: Za dosego tega cilja so bile lani izvedene potrebne spremembe procesa ocenjevanja.
English: Please note that figures for 2008 are estimates only.
Slovenian: Opozarjamo, da so številke za leto 2008 le ocene.
English: The Agency also plans to finalise the remaining work arising from the 2004 legislative review.
Slovenian: Hkrati namerava Agencija dokončati preostalo delo, ki izvira iz zakonodajnega pregleda iz leta 2004.
English: The constantly evolving environment in which the Agency operates will shape its priorities and work in 2008.
Slovenian: Stalno razvijajoče se okolje, v katerem deluje Agencija, bo narekovalo njene prednostne naloge in delo v letu 2008.
English: This will be done in collaboration with the national competent authorities.
Slovenian: To dejavnost bo izvajala v sodelovanju s pristojnimi nacionalnimi organi
English: Steps will be taken to prepare for its implementation.
Slovenian: Potekale bodo pripravo na njeno izvajanje.
English: The number of variations is growing every year.
Slovenian: Število sprememb se iz leta v leto povečuje.
English: Staff 11 Staff in active employment 13 Mission expenses 14 Socio-medical infrastructure 15 Exchange of civil servants and experts 16 Social welfare 17 Entertainment and representation expenses 18 Staff insurances Total Title 1 Building/equipment 20 Investment in immovable property, renting of building and associated costs 21 Expenditure on data processing 22 Movable property and associated costs 23 Other administrative expenditure 24 Postage and communications 25 Expenditure on formal and other meetings Total Title 2 Operational expenditure 300 Meetings 301 Evaluations 302 Translation 303 Studies and consultants 304 Publications 305 Community programmes Total Title 3
Slovenian: Osebje 11 Aktivno zaposleno osebje 13 Stroški službenih potovanj 14 Socialno-zdravstvena infrastruktura 15 Izmenjava javnih uslužbencev in strokovnjakov 16 Socialno varstvo 17 Stroški dodatkov za razvedrilo in reprezentanco 18 Zavarovanje osebja Naslov 1 skupaj Objekti/oprema 20 Naložbe v nepremičnine, najemi objektov in s tem povezani stroški 21 Odhodki za obdelavo podatkov 22 Premično premoženje in s tem povezani stroški 23 Drugi upravni odhodki 24 Poštnine in obveščanje 25 Izdatki za uradna in druga srečanja Naslov 2 skupaj Odhodki za poslovanje 300 Sestanki 301 Ocenjevanje 302 Prevajanje 303 Študije in svetovalci 304 Objavljanje 305 Programi Skupnosti Naslov 3 skupaj
English: Preparations for future enlargement
Slovenian: 1.5 Priprave na prihodnjo širitev
English: Regulatory affairs and organisational support
Slovenian: Regulativne zadeve in organizacijska podpora
English: This would help to further promote exchange of information within the European medicines network.
Slovenian: To bi prispevalo k nadaljnjemu spodbujanju izmenjave informacij znotraj Evropske mreže zdravil.
English: The Agency is responsible for operational aspects of mutual-recognition agreements (MRA) between the European Community and partner (third) countries.
Slovenian: Agencija je odgovorna za operativne vidike sporazumov o vzajemnem priznavanju med Evropsko skupnostjo in partnerskimi (tretjimi) državami.
English: The number of applications for initial marketing authorisation has doubled over the last four years.
Slovenian: Število vlog za začetno dovoljenje za promet z zdravilom se je v zadnjih štirih letih podvojilo.
English: These agreements are in operation with Australia, New Zealand, Switzerland, Canada and Japan, and allow the conclusions of inspections of manufacturers carried out by respective inspection services to be mutually recognised.
Slovenian: Dogovori veljajo z Avstralijo, Novo Zelandijo, Švico, Kanado in Japonsko ter omogočajo vzajemno priznavanje sklepov inšpekcijskih pregledov proizvajalcev, ki jih opravijo posamezne inšpekcijske službe.
English: Annex 3 Revenue and expenditure overview 2006-2008
Slovenian: Priloga 3 Pregled prihodkov in odhodkov za obdobje 2006-2008
English: The Agency's integrated quality policy has been in operation for ten years, and its robust, integrated quality-management system is subject to continuous improvement.
Slovenian: Politika Agencije o integrirani kakovosti se odvija že 10 let in njen trden sistem integriranega upravljanja kakovosti neprestano izboljšujejo.
English: The legislation on access to documents has put significant pressure on the Agency's resources.
Slovenian: Zakonodaja o dostopu do dokumentov je močno obremenila sredstva Agencije.
English: Meanwhile, requests for other types of information are forecast to increase by a further 29%, to some 4,500 requests.
Slovenian: Zahtevki za druge vrste informacij pa bodo verjetno narasli za nadaljnjih 29 %, na okoli 4.500 zahtevkov.
English: The EMEA receives, creates and manages a large amount of documents.
Slovenian: EMEA prejme, proizvede ter upravlja z velikim številom dokumentov.
English: Parallel distribution
Slovenian: Vzporedna distribucija
English: The Agency's role in the international arena has grown substantially in recent years.
Slovenian: Vloga Agencije v mednarodnem prostoru se je v zadnjih letih močno povečala.
English: The European Commission published in 2007 a report on the status of the implementation of the legislation on traditional herbal medicinal products.
Slovenian: Evropska komisija je leta 2007 objavila poročilo o statusu izvajanja zakonodaje o tradicionalnih zdravilih rastlinskega izvora.
English: Increase the Agency's contribution to international regulatory activities
Slovenian: Povečati doprinos Agencije k mednarodnim regulativnim dejavnostim
English: The new legislation on advanced-therapy medicinal products will enter into force by the end of 2008.
Slovenian: Nova zakonodaja o zdravilih za napredne terapije bo začela veljati proti koncu leta 2008.
English: The HMPC plans to establish 20 monographs and 10 list entries this year.
Slovenian: Letos namerava HMPC pripraviti 20 monografij in dodati 10 vnosov na seznam.