FrancophonIA/ELRC3.0 huggingface dataset:
English: Following administration of a single 500 mg dose of telotristat ethyl (twice the recommended dosage) under fasted conditions in healthy subjects, the mean Cmax and AUC0-inf were 4.4 ng/mL and 6.23 ng•hr/mL, respectively for telotristat ethyl.
Slovenian: Pri zdravih osebah je po uporabi enkratnega 500-mg odmerka etiltelotristata (dvakratni priporočeni odmerek) na tešče povprečna vrednost Cmax za etiltelotristat znašala 4,4 ng/ml, vrednost AUC0-inf pa 6,23 ng•hr/ml.
English: Pharmacokinetic/pharmacodynamic relationship(s)
Slovenian: Farmakokinetično/farmakodinamično razmerje Zdravila za zmanjševanje kislosti želodčnega soka
English: You should keep having injections of these other medicines when taking Xermelo.
Slovenian: Med jemanjem zdravila Xermelo morate še naprej prejemati injekcije teh zdravil.
English: • Your doctor may carry out blood tests before you start taking this medicine and while you are taking it.
Slovenian: • Zdravnik lahko pred začetkom jemanja in med jemanjem tega zdravila s krvnimi preiskavami preverja, če vaša jetra delujejo normalno.
English: Telotristat reduces bowel movement (BM) frequency.
Slovenian: Telotristat zmanjšuje pogostnost odvajanja blata.
English: Telotristat had no effect on fertility in animal studies (see section 5.3).
Slovenian: Pri študijah na živalih vpliva telotristata na plodnost niso ugotovili (glejte poglavje 5.3).
English: Other CYPs Based on in vitro findings, no clinically-relevant interaction is expected with other cytochromes P450.
Slovenian: Na osnovi in vitro izsledkov pri drugih encimih citokroma P450 klinično pomembnih interakcij ne pričakujemo.
English: Primary endpoint: change from baseline in BMs/day averaged over 12 weeks
Slovenian: Primarni cilj študije: povprečna sprememba odvajanja blata/dan od izhodišča v 12 tednih
English: CL=confidence limit; tid=three times daily; SD=standard deviation; u5-HIAA = urinary 5--hydroxyindoleacetic acid.
Slovenian: IZ=interval zaupanja; SD=standardni odklon (deviacija); u5-HIAA = 5-hidroksiindolocetna kislina v urinu a. Izhodiščni podatki na osnovi vseh bolnikov s podatki v izhodišču.
English: CYP3A4 substrates
Slovenian: Substrati za CYP3A4
English: In rats decrease in brain serotonin (5-HT) was observed at doses≥1,000 mg/kg/day of telotristat etiprate per os.
Slovenian: Pri podganah so pri peroralni uporabi telotristatijevega etiprata v odmerkih ≥ 1.000 mg/kg/dan opazili zmanjšanje vrednosti serotonina (5-HT) v možganih.
English: What Xermelo is and what it is used for 2.
Slovenian: Kaj je zdravilo Xermelo in za kaj ga uporabljamo
English: How to take Xermelo
Slovenian: Kako jemati zdravilo Xermelo
English: In rabbits the NOAEL for maternal and prenatal toxicity is 125 mg/kg/d corresponding to 1.5 to 4 times the estimated human exposure (AUC0-24) of the active metabolite LP-778902 at the MRHD.
Slovenian: Pri kuncih NOAEL za maternalno in prenatalno toksičnost znaša 125 mg/kg/dan, kar ustreza 1,5- do 4-kratni ocenjeni izpostavljenosti aktivnemu presnovku LP-778902 pri človeku (AUC0-24), pri največjem priporočenem odmerku za človeka.
English: a. Analysis of covariance including treatment group and urinary 5-HIAA stratification at randomisation as fixed effects, and the baseline number of BM as a fixed covariate.
Slovenian: OB = odvajanje blata; IZ=interval zaupanja; SD=standardni odklon (deviacija) a. Analiza kovariance vključuje skupino zdravljenja in stratifikacijo glede na vrednost 5-HIAA v urinu v času randomizacije kot fiksna učinka in število odvajanj blata v izhodišču kot fiksno kovariato.
English: How Xermelo works
Slovenian: Kako deluje zdravilo Xermelo
English: Talk to your doctor or pharmacist before taking Xermelo:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Xermelo se posvetujte z zdravnikom ali farmacevtom:
English: Carboxylesterase (CES) inhibitors
Slovenian: Zaviralci karboksilesteraze
English: The NOAEL for parental / maternal / prenatal and postnatal toxicity is 500 mg/kg/day in rats corresponding to 3 to 4 times the estimated human exposure (AUC0-24) of the active metabolite LP-778902 at the MRHD.
Slovenian: Pri podganah NOAEL za parentalno/maternalno/prenatalno in postnatalno toksičnost znaša 500 mg/kg/dan, kar ustreza 3- do 4-kratni ocenjeni izpostavljenosti aktivnemu presnovku LP-778902 pri človeku (AUC0-24), pri največjem priporočenem odmerku za človeka.
English: In the subjects with severe to moderate renal impairment, an increase (1.3- fold) in peak exposure Cmax of telotristat ethyl and an increase (<1.52- fold) in plasma exposure (AUC) and Cmax of its active metabolite telotristat was observed compared to healthy to mildly impaired subjects.
Slovenian: V primerjavi z osebami z normalnim delovanjem ledvic oziroma največ blago okvaro ledvic so pri osebah s hudo do zmerno okvaro ledvic opazili povečanje (1,3-krat) vrednosti največje izpostavljenosti (Cmax) etiltelotristatu in povečanje (< 1,52-krat) vrednosti plazemske izpostavljenosti (AUC) in vrednosti Cmax njegovega aktivnega presnovka telotristata.
English: Finally, it is recommended to add depression and depressed mood to section 4.8 of the SmPC and section 4 of PL under Psychiatric disorders with frequency “common”.
Slovenian: Nazadnje je v poglavje 4.8 povzetka glavnih značilnosti zdravila in poglavje 4 navodila za uporabo priporočljivo pod Psihiatrične motnje dodati depresijo in depresivno razpoloženje z navedbo pogostnosti “pogosti”.
English: Constipation was reported in 5.7% of patients (4/70) in the telotristat ethyl 250 mg group and in 4.2% of patients (3/71) in the placebo group.
Slovenian: O zaprtju so poročali pri 5,7 % bolnikov (4/70) v skupini, ki je prejemala etiltelotristat v odmerku 250 mg, in pri 4,2 % bolnikov (3/71) v skupini, ki je prejemala placebo.
English: No decrease in brain 5-HT and 5-HIAA levels were observed after intravenous application of active metabolite.
Slovenian: Po intravenski aplikaciji aktivnega presnovka zmanjšanja vrednosti 5-HT in 5-HIAA v možganih niso opazili.
English: Xermelo 250 mg film-coated tablets telotristat ethyl
Slovenian: IME ZDRAVILA Xermelo 250 mg filmsko obložene tablete etiltelotristat
English: Each film-coated tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl.
Slovenian: Ena filmsko obložena tableta vsebuje 250 mg etiltelotristata v obliki telotristatijevega etiprata.
English: Your doctor will prescribe this medicine if your diarrhoea is not well controlled with injections of other medicines called ‘somatostatin analogues' (lanreotide or octreotide).
Slovenian: Zdravnik bo predpisal to zdravilo, če driska ni dobro obvladana z injekcijami drugih zdravil,
English: The mean u5-HIAA excretion at baseline was 69.1 mg/24hours in the 250 mg group (n=17) and
Slovenian: Povprečna vrednost izločanja u5-HIAA v izhodišču je v skupini z odmerkom 250 mg (n=17) znašala 69,1 mg/24 ur, v skupini s placebom (n=22) pa 84,8 mg/24 ur.
English: CYP2B6 substrates
Slovenian: Substrati za CYP2B6
English: Alanine aminotransferase increased (ALT), Aspartate aminotransferase increased (AST),
Slovenian: žolčnika in žolčevodov zvišane vrednosti gama glutamiltransferazeb zvišane vrednosti alaninaminotransferaze (ALT), zvišane vrednosti aspartataminotransferaze (AST), zvišane vrednosti alkalne fosfataze v krvi
English: • The active substance is telotristat ethyl.
Slovenian: • Učinkovina je etiltelotristat.
English: In a specific clinical DDI study, the Cmax and AUC of fexofenadine (a P-gp and MRP-2 substrate) increased by 16% when a single 180 mg dose of fexofenadine was co-administered orally with a dose of telotristat ethyl 500 mg administered tid (twice the recommended dose) for 5 days.
Slovenian: feksofenadina (substrata za P-gp in MRP-2), pri uporabi enkratnega 180-mg odmerka feksofenadina peroralno skupaj z etiltelotristatom v odmerku 500 mg trikrat na dan (dvakratni priporočeni odmerek), v trajanju 5 dni, povečali za 16 %.
English: Variability of the main plasma telotristat PK parameters was higher in subjects with severe to moderate renal impairment, with CV% ranging from 53.3% for Cmax to 77.3% for AUC as compared to 45.4% for Cmax and 39.7% for AUC in healthy to mildly impaired subjects, respectively.
Slovenian: 77,3 % za vrednost AUC v primerjavi s 45,4 % za vrednost Cmax in 39,7 % za vrednost AUC pri osebah z normalnim delovanjem ledvic oziroma največ blago okvaro ledvic.
English: • Feeling sick (nausea)
Slovenian: • siljenje na bruhanje (navzea)
English: In patients treated at 500 mg tid (twice the recommended dose), a median accumulation ratio based on AUC0-4h of 1.095 (minimum, 0.274; maximum, 11.46; n=16; week 24) was observed, with a high inter-subject variability (%CV = 141.8%).
Slovenian: Pri bolnikih, ki so se zdravili z odmerkom 500 mg trikrat na dan (dvakratni priporočeni odmerek), so opazili mediano razmerje kopičenja na osnovi vrednosti AUC0-4ure 1,095 (najmanj 0,274; največ 11,46;
English: BEAUFOUR IPSEN INDUSTRIE RUE ETHE VIRTON DREUX
Slovenian: RUE ETHE VIRTON
English: It is also recommended that the MAH should add the ADR “intestinal obstruction” to the section 4.8 of the SmPC and section 4 of PL with the frequency “uncommon”.
Slovenian: Prav tako je priporočljivo, da imetnik dovoljenja za promet z zdravilom v poglavje 4.8 povzetka glavnih značilnosti zdravila (SmPC) in poglavje 4 navodila za uporabo (PIL) doda neželeni učinek “intestinalna obstrukcija” z navedbo pogostnosti “občasni”.
English: Posology The recommended dose is 250 mg three times daily (tid).
Slovenian: Priporočeni odmerek je 250 mg trikrat na dan.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Povprečna vrednost v izhodišču (SD)
English: This is because this medicine has not been tested in patients with severe liver problems.
Slovenian: Pri bolnikih, ki imajo hude težave z jetri, uporaba tega zdravila namreč ni bila raziskana.
English: Abdominal distension was reported in 7.1% of patients (5/70) receiving telotristat ethyl 250 mg tid, versus 4.2% in the placebo group (3/71).
Slovenian: O napihnjenosti trebuha so poročali pri 7,1 % bolnikov (5/70), ki so prejemali etiltelotristat v odmerku 250 mg trikrat na dan, v primerjavi s 4,2 % bolnikov v skupini s placebom (3/71).
English: There was no significant difference between treatment groups for the endpoints of flushing and abdominal pain.
Slovenian: c. p<0,001 Pri opazovanih dogodkih vročinski oblivi in bolečina v trebuhu med skupinama zdravljenja ni bilo pomembne razlike.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij BEAUFOUR IPSEN INDUSTRIE
English: P-glycoprotein (P-gp) and Multi-drug Resistance associated Protein 2 (MRP-2) In vitro telotristat ethyl inhibited P-gp, but its active metabolite did not at the clinically relevant concentrations.
Slovenian: P-glikoprotein (P-gp) in protein, povezan z rezistenco na več učinkovin 2 (MRP-2; “Multi-drug Resistance associated Protein 2”)
English: This medicine contains the active substance telotristat ethyl.
Slovenian: Kaj je zdravilo Xermelo To zdravilo vsebuje učinkovino etiltelotristat.
English: Therefore, dose adjustment does not appear necessary in patients with mild, moderate or severe renal impairment; who are not requiring dialysis.
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro ledvic, ki ne potrebujejo zdravljenja z dializo, odmerka tako ni treba prilagajati.
English: Telotristat ethyl 250 mg showed that stool consistency, as measured by Bristol Stool Form Scale, was improved compared with placebo.
Slovenian: Bristol Stool Form, izboljšala v primerjavi s placebom.
English: Xermelo contains anhydrous lactose as an excipient.
Slovenian: Laktozna intoleranca Zdravilo Xermelo vsebuje brezvodno laktozo kot pomožno snov.
English: Each tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl.
Slovenian: Ena tableta vsebuje 250 mg etiltelotristata v obliki telotristatijevega etiprata.
English: Patients with a mean reduction of at least 1.5 BM per day: 46.7% (telotristat ethyl 250 mg) and 20.0% (placebo);
Slovenian: - bolniki s povprečnim zmanjšanjem za vsaj 1 odvajanje blata na dan: 66,7 % (etiltelotristat v odmerku 250 mg) in 31,1 % (placebo); - bolniki s povprečnim zmanjšanjem za vsaj 1,5 odvajanj blata na dan: 46,7 % (etiltelotristat v odmerku 250 mg) in 20,0 % (placebo); - bolniki s povprečnim zmanjšanjem za vsaj 2 odvajanji blata na dan: 33,3 % (etiltelotristat v odmerku 250 mg) in 4,4 % (placebo).
English: Uncommon side effects:
Slovenian: Pogosti neželeni učinki:
English: Peak plasma levels of telotristat ethyl were achieved in 0.53 to 2.00 hours and those of the active metabolite in 1.50 to 3.00 hours after oral administration.
Slovenian: do 2,00 urah, aktivnega presnovka pa v 1,50 do 3,00 urah po peroralni uporabi.
English: Fertility
Slovenian: Etiltelotristat
English: Telotristat ethyl 250 mg tid u5-HIAA excretion (mg/24 hours) at baseline
Slovenian: Izločanje u5-HIAA (mg/24 ur) v izhodišču
English: Bucureşti, 010623
Slovenian: Bucureşti, 010623 Tel: + 40 21 231 27 20
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Xermelo Vsebina pakiranja in dodatne informacije
English: In patients treated at 250 mg tid, a slight accumulation of telotristat levels was observed with a median accumulation ratio based on AUC0-4h of 1.55 [minimum, 0.25; maximum, 5.00; n=11; week 12], with a high inter-subject variability (%CV = 72%).
Slovenian: Linearnost/nelinearnost Pri bolnikih, ki so se zdravili z odmerkom 250 mg trikrat na dan, so opazili rahlo kopičenje vrednosti telotristata z medianim razmerjem kopičenja na osnovi vrednosti AUC0-4ure 1,55 [najmanj 0,25; največ
English: What Xermelo is and what it is used for What Xermelo is
Slovenian: Kaj vsebuje navodilo Kaj je zdravilo Xermelo in za kaj ga uporabljamo
English: Administration of a single dose of 250 mg was well tolerated in subjects with severe to moderate renal impairment.
Slovenian: Osebe s hudo do zmerno okvaro ledvic so enkratni 250-mg odmerek dobro prenašale.
English: How to store Xermelo
Slovenian: Shranjevanje zdravila Xermelo
English: Gastrointestinal disorders including nausea, diarrhoea, abdominal pain and vomiting have been reported in healthy subjects taking a single dose of 1,500 mg in a phase 1 study.
Slovenian: Pri zdravih osebah, ki so v študiji 1. faze prejele enkratni odmerek 1.500 mg, so poročali o boleznih prebavil, vključno z navzeo, drisko, bolečino v trebuhu in bruhanjem.
English: The apparent half-life of telotristat ethyl in normal healthy volunteers following a single 500 mg oral dose 14C-telotristat ethyl was approximately 0.6 hour and that of its active metabolite was 5 hours.
Slovenian: Navidezni razpolovni čas etiltelotristata je pri zdravih prostovoljcih po enkratnem 500-mg peroralnem odmerku
English: Flatulence was seen in 5.7% of patients (4/70) and 1.4% (1/71) in the telotristat ethyl 250 mg and placebo groups, respectively.
Slovenian: O flatulenci so poročali pri 5,7 % bolnikov (4/70), ki so prejemali etiltelotristat v odmerku 250 mg, in pri 1,4 % (1/71)
English: This is because this medicine has not been tested in patients with end-stage kidney disease, requiring dialysis.
Slovenian: Pri bolnikih s končno odpovedjo ledvic, ki se morajo zdraviti z dializo, uporaba tega zdravila namreč ni bila raziskana.
English: Abdominal distension, Constipation, Flatulence
Slovenian: Presnovne in prehranske motnje zmanjšanje apetita
English: A post-hoc analysis showed that the average number of daily short-acting SSA injections used for rescue therapy over the 12-week DBT period was 0.3 and 0.7 in the telotristat ethyl 250 mg and placebo groups, respectively.
Slovenian: Post-hoc analiza je pokazala, da je povprečno število dnevnih injekcij kratkodelujočega analoga somatostatina, uporabljenih kot rešilno zdravljenje v 12-tedenskem obdobju dvojno slepega
English: Elevations in ALT >3 × upper limit of normal (ULN) or ALP>2 ULN have been reported in patients receiving therapy with telotristat, most cases being reported at a higher dose (500 mg).
Slovenian: Pri bolnikih, ki so se zdravili s telotristatom, so poročali o zvišanju vrednosti ALT > 3 × zgornja meja normalne vrednosti (ZMN) ali vrednosti alkalne fosfataze > 2 ZMN.
English: You may feel sick or be sick, have diarrhoea or stomach ache.
Slovenian: Če ste vzeli večji odmerek zdravila Xermelo, kot bi smeli Lahko se pojavi občutek siljenja na bruhanje ali bruhanje, driska ali bolečina v trebuhu.
English: Tablet core
Slovenian: Drugi CYP
English: Acid Reducers
Slovenian: • zvišana telesna temperatura
English: pain in the upper right belly.
Slovenian: rumeno obarvanje kože ali očesnih beločnic, bolečina v zgornjem desnem predelu trebuha.
English: Number of patients Change averaged over 12 weeks: mean (SD)
Slovenian: Povprečna sprememba v 12 tednih:
English: A.
Slovenian: (SD)
English: This is approximately 14 times the human exposure (AUC total) at the maximum recommended human dose (MRHD) of 750 mg/day for the active metabolite LP-778902.
Slovenian: To je približno 14-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
English: This is approximately 0.4 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Slovenian: To je približno 0,4-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
English: This is approximately 21 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Slovenian: To je približno 21-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
English: This is approximately 20 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Slovenian: To je približno 20-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
English: However, 100% compliance has still not been achieved.
Slovenian: Kljub temu 100-odstotna skladnost še vedno ni bila dosežena.
English: London, 17 June 2008
Slovenian: London, 17. junija 2008
English: Early dialogue with sponsors
Slovenian: Zgodnji dialog s sponzorji
English: A decision was taken to extend the pilot phase into 2008.
Slovenian: Sprejeta je bila odločitev za podaljšanje pilotne faze v leto 2008.
English: I look forward to continued progress and success in 2008.
Slovenian: Že vnaprej se veselim nadaljnjega napredka in uspehov v letu 2008.
English: Bulgaria and Romania joined the EU on 1 January 2007.
Slovenian: Bolgarija in Romunija sta se pridružili EU 1. januarja 2007.
English: The levels of activity in these areas increased again in 2007 (see chapter 2).
Slovenian: Stopnja dejavnosti na teh področjih se je leta 2007 znova zvišala (glej poglavje 2).
English: Vaccination is seen as an important method of control.
Slovenian: Cepljenje se šteje za pomembno nadzorno metodo.
English: System or process (Status in 2006)
Slovenian: Sistem ali postopek (stanje v letu 2006)
English: Workshops, conferences, training
Slovenian: Delavnice, konference, usposabljanje
English: Following this meeting, it was concluded that joint meetings would be held at least once a year, and that representatives from each group would attend meetings of the other group.
Slovenian: Po tem sestanku je bila sprejeta odločitev, da bo skupni sestanek vsaj enkrat na leto in da se bodo predstavniki iz vsake skupine udeleževali sestankov druge skupine.
English: These systems are evolving in line with communicated requirements.
Slovenian: Ti sistemi se razvijajo v skladu s sporočenimi zahtevami.
English: 2.5 Parallel distribution
Slovenian: 2.5 Vzporedna distribucija
English: Communication on safety issues between all stakeholders is also considered a high priority.
Slovenian: Visoko prednost ima tudi obveščanje o varnostnih vprašanjih med vsemi zainteresiranimi stranmi.
English: In summary, 2007 was a very productive year with intense activity in many areas, as you will note when you read the detail of this annual report.
Slovenian: Če povzamemo, je bilo leto 2007 zelo plodno leto z intenzivnim delovanjem na številnih področjih, kar boste spoznali, ko boste podrobneje prebrali to letno poročilo.
English: • We assure continual improvement of our processes and procedures, in accordance with recognised quality standards.
Slovenian: • Zagotavljamo nenehne izboljšave naših procesov in postopkov v skladu s priznanimi standardi kakovosti.
English: Resource planning in the network
Slovenian: Načrtovanje sredstev v mreži
English: Information about medicines in all EU languages
Slovenian: Informacije o zdravilih v vseh jezikih EU
English: As in previous years, the Agency and the Scientific Advice Working Party (SAWP) once again shortened the average time required for the delivery of scientific advice.
Slovenian: Kot v preteklih letih sta Agencija in delovna skupina za znanstveno svetovanje (SAWP) znova skrajšali povprečen čas, ki je potreben za zagotovitev znanstvenega svetovanja.
English: A series of conclusions were reached that will assist decisionmakers in the relevant organisations.
Slovenian: Sprejetih je bilo vrsto sklepov, ki bodo pomagali nosilcem odločanja v ustreznih organizacijah.
English: I succeeded Professor Hannes Wahlroos, who had so successfully chaired the Management Board for the previous three years.
Slovenian: Nasledil sem profesorja Hannesa Wahlroosa, ki je zadnja tri leta tako uspešno predsedoval upravnemu odboru.
English: The majority of EU telematics systems were in use at the beginning of 2007.
Slovenian: Večina telematskih sistemov EU se je uporabljala na začetku leta 2007.
English: Safety of medicines included in 7th Framework Programme
Slovenian: Varnost zdravil, vključenih v 7. okvirni program
English: Thirty-six procedures were finalised.
Slovenian: Končanih je bilo 36 postopkov.
English: Efforts to provide product-related information in all EU languages continued throughout 2007.
Slovenian: Prizadevanja za zagotovitev informacij, povezanih z izdelki, v vseh jezikih EU so se nadaljevala skozi vse leto 2007.
English: Paediatric Committee fully operational
Slovenian: Odbor za pediatrijo v celoti deluje
English: This was the first medicine for which an accelerated-assessment procedure was concluded successfully.
Slovenian: To je bilo prvo zdravilo, za katero je bil uspešno dokončan postopek za pospešeno vrednotenje.
English: It was also the first medicine submitted by a company benefiting from incentives for SMEs.
Slovenian: To je bilo tudi prvo zdravilo, ki ga je predložilo podjetje, ki uporablja spodbude za MSP;
English: Action plan for European Surveillance Strategy
Slovenian: Akcijski načrt za evropsko strategijo nadzorovanja
English: CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports
Slovenian: CAP EEA reports CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports
English: The number of withdrawn applications - 19 - was the lowest in the past seven years.
Slovenian: Število umaknjenih vlog - 19 - je bilo najnižje v zadnjih sedmih letih.
English: These proposals require contributions from both the Agency and national competent authorities.
Slovenian: Ti predlogi zahtevajo prispevek Agencije in nacionalnih pristojnih organov.
English: • We are strongly committed to public and animal health.
Slovenian: • Močno smo zavezani zdravju ljudi in živali.
English: Good progress on implementing rules on access to documents
Slovenian: Dober napredek pri izvajanju pravil o dostopu do dokumentov
English: Work on this has barely started, as guidelines fundamental to the determination of the scope and functionality of the proposed system are not yet available in final form.
Slovenian: Delo pri tem sistemu se je komaj začelo, saj smernice, ki so temelj določanja obsega in funkcionalnosti predlaganega sistema, še niso na voljo v končni obliki.