FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, although the PD study did not include a comparative arm, based on extensive results from published clinical studies and considering that the extended regimen in Seasonique is a minor modification from existing products, Seasonique is expected to have a greater control over ovulation compared to the existing LNG/EE combination products for which the efficacy is well documented.
Slovenian: Čeprav FD-študija ni vključila primerjalne skupine, je odbor menil, da je mogoče na podlagi obsežnih rezultatov iz objavljenih kliničnih študij in predpostavke, da je podaljšan režim pri zdravilu Seasonique majhna sprememba v primerjavi z obstoječimi zdravili, pričakovati, da bo imelo zdravilo Seasonique večji nadzor nad ovulacijo v primerjavi z obstoječimi kombiniranimi zdravili LNG/EE, pri katerih je učinkovitost dobro dokumentirana.
English: Therefore the CHMP considered the efficacy of Seasonique adequately demonstrated.
Slovenian: Odbor CHMP je zato menil, da je bila učinkovitost zdravila Seasonique zadostno dokazana.
English: The total number of days with bleeding/spotting within the planned study duration of 1 year was higher for the Seasonique group than for the comparator group (mean 61-62 vs. 55-56 depending on the extrapolation rule).
Slovenian: Skupno število dni krvavitve/krvavkastega izcedka med načrtovanim enoletnim trajanjem študije je bilo višje v skupini z zdravilom Seasonique kot v primerjalni skupini (povprečno 61-62 v primerjavi s 55-56, odvisno od pravila za ekstrapolacijo).
English: Seasonique is a 91-day extended regimen oral contraceptive consisting of a fixed dose combination of levonorgestrel 150 µg/ ethinylestradiol 30 µg for 84 days followed by ethinylestradiol 10 µg film-coated tablets for 7 days.
Slovenian: Seasonique je peroralni kontraceptiv z 91─dnevnim podaljšanim režimom, ki se začne s fiksno kombinacijo 150 µg levonorgestrela in 30 µg etinilestradiola v obdobju 84 dni ter nadaljuje z 10 µg filmsko obloženimi tabletami etinilestradiola v obdobju 7 dni.
English: Although, based on women who completed one year of treatment discontinuation due to bleeding/spotting adverse events was more frequent in the Seasonique group (7.4%) than the comparator group (1.1%), the mean total number of days of bleeding/spotting (including scheduled and unscheduled) per patient month was similar, i.e. 4.4 days for both Seasonique and the comparator.
Slovenian: Čeprav je bila glede na ženske, ki so končale enoletno zdravljenje, prekinitev zdravljenja zaradi neželenih dogodkovkrvavitev ali krvavkastega izcedka - pogostejša v skupini z zdravilom Seasonique (7,4 %) kot v primerjalni skupini (1,1 %), je bilo povprečno skupno število dni krvavitve/krvavkastega izcedka (vključno z rednimi in nepredvidenimi) na bolnico na leto 4,4 dneva tako pri zdravilu Seasonique kot pri primerjalnem zdravilu.
English: This was further supported by the absence of anaemia or clinically important changes in the laboratory results compared to the 21/7-day COC.
Slovenian: To je dodatno podprla odsotnost primerov anemije ali klinično pomembnih sprememb rezultatov laboratorijskih preiskav v primerjavi z 21/7─dnevnim kombiniranim peroralnim kontraceptivom.
English: • The Committee reviewed all the data submitted by the applicant in support of the efficacy of Seasonique and associated names in oral contraception as an extended regimen.
Slovenian: • odbor je pregledal vse podatke, ki jih je predlagatelj predložil v podporo učinkovitosti zdravila Seasonique in povezanih imen kot peroralnih kontraceptivov s podaljšanim režimom;
English: Thus the absence of HFI is not considered to decrease the contraceptive efficacy and the CHMP considered that the well- documented contraceptive efficacy with 28-day LGN 150 µg/ EE 30 µg combination can be extrapolated to the Seasonique regimen.
Slovenian: Odsotnost obdobja brez hormonov naj torej ne bi zmanjšala kontracepcijske učinkovitosti, poleg tega pa je odbor CHMP menil, da je dobro dokumentirano kontracepcijsko učinkovitost 28─dnevne kombinacije 150 µg LNG in 30 µg EE mogoče ekstrapolirati na režim zdravila Seasonique.
English: • The Committee is also of the opinion that the bleeding pattern associated with the use of Seasonique and associated names constitutes neither a safety issue nor impairs the contraceptive efficacy, and that adequate information is included in the proposed product information in this regard.
Slovenian: • odbor prav tako meni, da vzorec krvavitev, povezan z uporabo zdravila Seasonique in povezanih imen, ne predstavlja varnostnega tveganja niti ne zmanjšuje kontracepcijske učinkovitosti in da so v predlagane informacije o zdravilu že vključene ustrezne informacije v zvezi s tem;
English: The CHMP also considered that the bleeding pattern associated with the use of Seasonique neither constituted a safety issue, nor impaired efficacy.
Slovenian: Odbor CHMP je prav tako menil, da vzorec krvavitev, povezan z uporabo zdravila Seasonique, ne predstavlja varnostnega tveganja niti ne zmanjšuje učinkovitosti.
English: With this method, chosen post-hoc, adequate precision with regard to requirements for hormonal contraceptive methods in the CHMP Guideline on Clinical Investigation of steroid contraceptives in women (EMEA/CPMP/EWP/519/98 Rev. 1) would just be reached (depending on the specific bootstrap simulation) with a point estimate of 0.76 and a 95 % CI of (0.0 - 1.76).
Slovenian: S to metodo, izbrano post hoc, bi bila zadostna natančnost glede na zahteve za hormonske kontracepcijske metode v smernicah odbora CHMP za klinične raziskave steroidnih kontracepcijskih sredstev pri ženskah (EMEA/CPMP/EWP/519/98 Rev. 1) ravno še dosežena (odvisno od specifične simulacije z metodo zankanja) z ocenjeno vrednostjo 0,76 in 95─odstotnim IZ
English: Comparable withdrawal rates were observed in Study PSE-302 for the Seasonique group (51.6%) and for the comparator group (49.5%).
Slovenian: V študiji PSE─302 so opazili podobne stopnje prekinitve zdravljenja v skupini z zdravilom Seasonique (51,6 %) in primerjalni skupini (49,5 %).
English: As mentioned, the applicant presented during the DCP additional analysis with the bootstrap method reaching adequate precision for contraceptive methods as shown by the 95 % CI: 0.0 - 1.76, however concerns were raised regarding the coverage probability properties of this posthoc analysis.
Slovenian: Kot je bilo že omenjeno, je predlagatelj med decentraliziranim postopkom predložil dodatno analizo z metodo zankanja, ki je zagotovila zadostno natančnost za kontracepcijske metode, kot so pokazali s 95─odstotnim IZ: 0,0─1,76, vendar pa so se pojavili pomisleki glede lastnosti verjetnosti pokritosti v tej analizi post hoc.
English: In conclusion, as shown in study PSE-302 the total number of bleeding/spotting days was higher for Seasonique than for the comparator, Nordette.
Slovenian: Kot je torej pokazala študija PSE─302, je bilo skupno število dni krvavitve/krvavkastega izcedka višje pri uporabi zdravila Seasonique kot primerjalnega zdravila Nordette.
English: This more pronounced suppression was also demonstrated with 24/4 drospirenone 3 mg/EE 2 µg regimen compared to a standard 21/7 regimen (Klipping, 2008), for the 24/4 oral regimen with a nomegestrol acetate/17b-estradiol compared to the 21/7 regimen (ChristinMaitre, 2011), and for a 23-day regimen of 0.075 mg gestodene/20 µg EE compared with a 21-day regimen (Spona, 1996).
Slovenian: Okrepljeno zaviranje so pokazali tudi pri režimu 24/4 drospirenona 3 mg/EE 2 µg v primerjavi s standardnim režimom 21/7 (Klipping 2008), peroralnem režimu 24/4 z nomegestrol acetatom/17b-estradiolom v primerjavi z režimom 21/7 (Christin-Maitre 2011) in 23─dnevnem režimu 0,075 mg gestodena/20 µg EE v primerjavi z 21─dnevnim režimom (Spona 1996).
English: Moreover the pregnancy rate observed in the phase III clinical trial was relatively low (PI<1), and no signal of a reduced efficacy was detected in the large experience obtained post-marketing.
Slovenian: 3. faze, relativno majhen (PI < 1), v obsežnih izkušnjah, pridobljenih v obdobju trženja zdravila, pa niso ugotovili nobenega pomisleka o zmanjšani učinkovitosti.
English: Similar number of patients reported unscheduled bleeding of each severity: 64 (80.0%) and 69 (78.4%) for light bleeding, 42 (52.5%) and 42 (47.7%) for moderate bleeding and 14 (17.5%) and 13 (14.8%) for heavy bleeding, for Seasonique and for the comparator groups, respectively.
Slovenian: O nepredvideni krvavitvi določene stopnje je poročalo podobno število bolnic: 64 (80,0 %) in 69 (78,4 %) o rahli krvavitvi, 42 (52,5 %) in 42 (47,7 %) o srednje močni krvavitvi ter 14 (17,5 %) in 13 (14,8 %) o močni krvavitvi, pri čemer prvi podatki veljajo za zdravilo Seasonique, drugi pa za primerjalne skupine.
English: A published study with 3 different combined oral contraceptives (COCs) arms, reported that women treated with a continuous 28-day regimen had more pronounced follicular suppression than women who were either supplemented with 5 days of 10 µg EE or had a 7-day HFI (Schlaff, 2004).
Slovenian: V objavljeni študiji s 3 skupinami z različnimi kombiniranimi peroralnimi kontracepcijskimi sredstvi (KPK) so poročali, da je bilo folikularno zaviranje pri neprekinjenem 28─dnevnem režimu bolj izrazito kot pri ženskah, ki so 5 dni prejemale nadomestek 10 µg EE ali imele 7─dnevni presledek brez hormonov (Schlaff 2004).
English: This study included 52,664 women (mean age, 27.3 years) in the 84/7 vs. 21/7 analysis (n=26,332 in both groups) and 50,694 (mean age, 27.8 years) in the 84/7 vs. 24/4 analysis (n=25,347 in both groups).
Slovenian: V tej študiji so 52 664 žensk (povprečne starosti 27,3 leta) vključili v analizo režima 84/7 v primerjavi z 21/7 (n = 26 332 v obeh skupinah) in 50 694 žensk (povprečne starosti 27,8 leta) v analizo režima 84/7 v primerjavi s 24/4 (n = 25 347 v obeh skupinah).
English: Ovulation occurred in two subjects (5.71% of the women) during the second 28-day period, one whom also ovulated in the third period, resulting in an overall ovarian activity rate of 2.86 (95% CI: 0.78 -7.22) over a period of 91 days.
Slovenian: Pri dveh preizkušankah (5,71 % žensk) je v drugem 28─dnevnem obdobju prišlo do ovulacije, ena od njiju pa je imela ovulacijo tudi med tretjim obdobjem, kar je pomenilo skupno dejavnost jajčnikov 2,86 (95 % IZ: 0,78─7,22) v obdobju 91 dni.
English: Therefore the CHMP considered that the bleeding pattern with Seasonique neither constitutes a safety issue for women nor impairs the contraceptive efficacy and adequate information in this respect is already included in the proposed product information.
Slovenian: Odbor CHMP je zato menil, da vzorec krvavitev pri uporabi zdravila Seasonique ne predstavlja varnostnega tveganja za ženske niti ne zmanjšuje kontracepcijske učinkovitosti in da so v predlagane informacije o zdravilu že vključene ustrezne informacije v zvezi s tem.
English: One-year pregnancy rates were statistically significantly lower with the 84/7 regimen compared with the 21/7 (4.4% vs. 7.3%; p<0.0001) and with the 24/4 (4.4% vs. 6.9%, p<0.0001) regimens.
Slovenian: Stopnje zanositve v obdobju enega leta so bile statistično značilno nižje pri režimu 84/7 kot pri režimih 21/7 (4,4 % v primerjavi s 7,3 %; p < 0,0001) in 24/4 (4,4 % v primerjavi s 6,9 %, p < 0,0001).
English: In addition, the OMS considered that the bleeding pattern is not favourable and could not rule out a potential impact on treatment compliance and contraceptive efficacy.
Slovenian: Poleg tega je država članica, ki je izrazila pomisleke, menila, da vzorec krvavitev ni ugoden in da ni mogoče izključiti, da bi lahko vplival na upoštevanje navodil za zdravljenje in kontracepcijsko učinkovitost.
English: • The Committee is of the opinion that the available data is supportive of the efficacy of Seasonique and associated names as an extended regimen of an existing combined oral contraceptive.
Slovenian: • odbor meni, da razpoložljivi podatki podpirajo učinkovitost zdravila Seasonique in povezanih imen kot obstoječih kombiniranih peroralnih kontraceptivov s podaljšanim režimom;
English: A referral was thus triggered at the CMDh.
Slovenian: Skupina CMDh je zato sprožila napotitveni postopek.
English: Additionally several published pharmacodynamic studies demonstrated that the degree of ovulation inhibition is increased with a shorter HFI.
Slovenian: Poleg tega so objavljene farmakodinamične študije pokazale, da je stopnja zaviranja ovulacije pri krajšem presledku brez hormonov povečana.
English: Statistically significantly higher rates of pregnancy with 21/7 and 24/4 regimens compared to the 84/7 regimen (p<0.0001) were also seen in the 2- and 3-year cohorts (Howard, 2014).
Slovenian: Statistično značilno višje stopnje zanositve pri režimih 21/7 in 24/4 v primerjavi z režimom 84/7 (p < 0,0001) so opazili tudi v 2─ in 3─letni kohortni študiji (Howard 2014).
English: Indeed, as in the pivotal study PSE-301 the classic Poisson method failed to reach adequate precision for the 95% CI of the overall Pearl Index (PI) point estimate for Seasonique in women aged 18-35 years (point estimate 0.76, 95% CI of 0.16 - 2.22), the Applicant presented additional analyses using a bootstrap method for calculation of the 95% CI.
Slovenian: Dejansko je predlagatelj zaradi dejstva, da v ključni študiji PSE─301 klasična Poissonova metoda ni zagotovila zadostne natančnosti pri 95─odstotnem intervalu zaupanja (IZ) ocenjene vrednosti skupnega Pearlovega indeksa za zdravilo Seasonique pri ženskah, starih od 18 do 35 let (ocenjena vrednost 0,76, 95─odstotni IZ 0,16─2,22), predložil dodatne analize, pri katerih je za izračun 95─odstotnega intervala zaupanja uporabil metodo zankanja („bootstrap“).
English: Further analyses including both arms (DP384/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique)) of the pivotal study PSE-301 and the supportive study PSE-302 did not provide a more reliable estimation of contraceptive efficacy of Seasonique despite the increase in sample size and resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80).
Slovenian: Dodatne analize, ki so zajele obe skupini (DP3─84/30 (večji odmerek EE kot zdravila Seasonique v zadnjih 7 dneh cikla) in DP3─84/10 (zdravilo Seasonique)) iz ključne študije PSE─301 ter podporne študije PSE─302, kljub večji velikosti vzorca niso zagotovile zanesljivejše ocene kontracepcijske učinkovitosti zdravila Seasonique in so pokazale višji Pearlov indeks, ki je znašal 1,67 (95─odstotni IZ 0,91─2,80).
English: On the contrary, the total number of unscheduled bleeding/spotting days was twice higher for Seasonique than for the comparator (mean 53 vs. 24).
Slovenian: Nasprotno pa je bilo skupno število nepredvidenih krvavitev/krvavkastega izcedka dvakrat večje pri zdravilu Seasonique kot pri primerjalnem zdravilu (povprečno 53 v primerjavi s 24).
English: It has also been shown in the literature that the elimination of the HFI is associated with a better inhibition of the ovarian activity.
Slovenian: V literaturi so pokazali, da je odsotnost presledka brez hormonov povezana z boljšim zaviranjem delovanja jajčnikov.
English: The increased number of unscheduled bleeding/spotting days with Seasonique appeared not to have an effect on compliance compared to other 21/7-day OC.
Slovenian: Kot kaže, pa višje število dni nepričakovane krvavitve/krvavkastega izcedka pri uporabi zdravila Seasonique ni vplivalo na upoštevanje navodil za zdravljenje v primerjavi z drugimi 21/7─dnevnimi peroralnimi kontraceptivi.
English: The bleeding pattern of Seasonique was compared to the standard 21/7-day cycle regimen (Nordette, LGN 150 µg/ EE 30 µg and 7-day HFI) in the study PSE 302.
Slovenian: Vzorec krvavitev pri zdravilu Seasonique so v študiji PSE-302 primerjali s standardnim 21/7─dnevnim režimom (Nordette, LGN 150 µg/EE 30 µg in 7─dnevni presledek brez hormonov).
English: As expected, due to the extended regimen, the total number of scheduled bleeding/spotting within the planned study duration was 3 times lower for Seasonique than for the comparator (mean 11 vs. 33).
Slovenian: Skupno število rednih krvavitev/krvavkastega izcedka v načrtovanem obdobju trajanja študije je bilo zaradi podaljšanega režima po pričakovanju 3─krat nižje pri zdravilu Seasonique kot pri primerjalnem zdravilu (povprečno 11 v primerjavi s 33).
English: Of note, combined analyses including both arms (DP3-84/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique regimen)) of the pivotal study PSE-301 and the supportive study PSE-302 resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80).
Slovenian: Treba je omeniti, da so v analizah, ki so vključevale obe skupini DP3─84/30 (večji odmerek EE kot v zdravilu Seasonique v zadnjih 7 dneh cikla) in DP3─84/10 (režim zdravila Seasonique) ključne študije PSE─301 in podporne študije PSE─302, dobili večji Pearlov indeks 1,67 (95 % IZ 0,91─2,80).
English: Another published pharmacodynamic study reported a continuous COC regimen with Levonorgestrel/EE and norgestimate/EE to result in a more effective follicular suppression than the same COC dosing regimen with a monthly 7-day HFI (Birtch, 2006).
Slovenian: V drugi objavljeni farmakodinamični študiji so poročali, da je neprekinjen režim s KPK, levonogesrelom/EE in norgestimatom/EE povzročil učinkovitejše folikularno zaviranje kot enak režim odmerjanja KPK s
English: The absence of a comparator arm was considered justified given that the mechanism of action of this hormonal combination in this dose is well known, that the only differences between Seasonique and existing LNG/EE combination products are the treatment duration (84 days versus 21 days, respectively) and the administration of 10µg EE during the last 7 days of the cycle instead of an hormone free interval (HFI), respectively.
Slovenian: Edini razliki med zdravilom Seasonique in obstoječimi kombiniranimi zdravili LNG/EE sta trajanje zdravljenja (84 dni v primerjavi z 21 dnevi) in uporaba 10 µg EE v zadnjih 7 dneh cikla namesto presledka brez hormonov.
English: Comparable withdrawal rates, including discontinuation due to adverse events, were also observed in an open label, randomised phase II study comparing Seasonique (34.5%) to two 28-day OC (35.2% and 39.1%) in 265 women for 8 months.
Slovenian: faze, v kateri so primerjali zdravilo Seasonique (34,5 %) z dvema 28─dnevnima peroralnima kontraceptivoma (35,2 % in 39,1 %) pri 265 ženskah v obdobju 8 mesecev.
English: In the pivotal study PSE-301, 3 pregnancies were observed for Seasonique in 1,578 91-day cycles in 621 women aged 18-35 years, resulting in an overall PI of 0.76 with a 95% CI of 0.16 - 2.22 using the Poisson model.
Slovenian: 91─dnevnih ciklov pri 621 ženskah, starih od 18 do 35 let, tako da so s Poissonovim modelom dobili skupni Pearlov indeks 0,76 s 95─odstotnim IZ 0,16─2,22.
English: For these reasons the CHMP did not consider this higher PI as relevant in the assessment of the efficacy of Seasonique.
Slovenian: Zato je odbor CHMP menil, da pri oceni učinkovitosti zdravila Seasonique ta večji Pearlov indeks ni enako pomemben.
English: It must not be used in women who are more than three months pregnant.
Slovenian: Ne smejo ga uporabljati ženske, ki so noseče več kot tri mesece.
English: Its use during the first three months of pregnancy is not recommended.
Slovenian: Uporaba zdravila v prvih treh mesecih nosečnosti ni priporočljiva.
English: ‘Essential' means that the hypertension has no obvious cause.
Slovenian: Esencialna pomeni, da za hipertenzijo ni jasnega vzroka.
English: The European Commission granted a marketing authorisation valid throughout the EU for Dafiro on 16 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Dafiro, veljavno po vsej Evropski uniji, izdala 16. januarja 2007.
English: The full EPAR for Dafiro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dafiro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Slovenian: Obe učinkovini sta zdravili proti zvišanemu krvnemu tlaku, ki sta bili v Evropski uniji (EU) od sredine 90. let prejšnjega stoletja na voljo kot ločeni zdravili.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Slovenian: Povzroča zaporo posebnih kanalčkov na površini celic, imenovanih kalcijevi kanalčki, skozi katere v celico običajno vstopajo kalcijevi ioni.
English: The medicine can only be obtained with a prescription
Slovenian: Izdaja zdravila je le na recept.
English: Dafiro amlodipine / valsartan
Slovenian: Dafiro amlodipin/valsartan
English: This is a summary of the European public assessment report (EPAR) for Dafiro.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dafiro.
English: In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti znižanje diastoličnega krvnega tlaka (krvnega tlaka, izmerjenega med dvema srčnima utripoma).
English: Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.
Slovenian: Ker se zdravili amlodipin in valsartan uporabljata že vrsto let, je družba predložila podatke, ki so o obeh učinkovinah na razpolago že iz prejšnjih študij in znanstvene literature, kot tudi iz novih študij, v katerih so raziskovali kombinacijo obeh zdravilnih učinkovin.
English: Other information about Dafiro
Slovenian: Druge informacije o zdravilu Dafiro
English: The CHMP decided that Dafiro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Dafiro večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: For more information about treatment with Dafiro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Dafiro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).
Slovenian: Na voljo je v obliki tablet (5 mg amlodipina in 80 mg valsartana; 5 mg amlodipina in 160 mg valsartana; 10 mg amlodipina in 160 mg valsartana).
English: What benefit has Dafiro shown during the studies?
Slovenian: Kakšne koristi je zdravilo Dafiro izkazalo med študijami?
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Dafiro and people taking the separate medicines.
Slovenian: Družba je prav tako predložila dokaze o tem, da sta bili ravni amlodipina in valsartana v krvi enaki pri ljudeh, ki so jemali zdravilo Dafiro, in ljudeh, ki so obe zdravilni učinkovini jemali ločeno.
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Valsartan je antagonist receptorja za angiotenzin II, kar pomeni, da zavira delovanje telesnega hormona, imenovanega angiotenzin II.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dafiro.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo , na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.