FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of CYP3A4 enzyme-inhibiting agents (e.g. cimetidine, itraconazole and grapefruit juice) may cause an increase in the plasma concentrations of nicardipine.
Slovenian: Sočasno dajanje učinkovin, ki zavirajo encim CYP3A4 (npr. cimetidin, itrakonazol in sok grenivke) lahko povzroči zmanjšanje plazemske koncentracije nikardipina.
English: Nicardipine has a greater selectivity for L-type calcium channels in vascular smooth muscle than cardiac myocytes.
Slovenian: Selektivnost nikardipina je za kalcijeve kanalčke tipa L v gladkih mišicah krvnih žil boljša kot za srčne miocite.
English: It is advised to change the infusion site in case of any suspicion of infusion site irritation.
Slovenian: V primeru kakršnega koli suma na draženje na mestu infundiranja je priporočena sprememba mesta infundiranja.
English: Other medicines and Nicardipine solution for injection
Slovenian: Druga zdravila in zdravilo Nikardipin raztopina za injiciranje
English: When an oral antihypertensive agent is being instituted, consider the lag time of onset of the oral agent's affect.
Slovenian: Pri uvedbi peroralnega antihipertenziva upoštevajte čas zamika začetka delovanja peroralnega zdravila.
English: Reduction in blood platelets, which may increase the risk of bleeding or bruising Slow heart rhythm
Slovenian: Zmanjšanje števila trombocitov, kar lahko poveča možnost krvavenja ali nastanka podplutb.
English: Nicardipine solution for injection contains nicardipine hydrochloride, which belongs to a group of medicines called calcium channel blockers.
Slovenian: Kaj je zdravilo Nikardipin raztopina za injiciranje in za kaj ga uporabljamo Nikardipin raztopina za injiciranje vsebuje nikardipinijev klorid, ki sodi v skupino zdravil, imenovanih zaviralci kalcijevih kanalčkov.
English: Due to the possible risk of pulmonary oedema or excessive decrease in blood pressure, caution should be taken if magnesium sulphate is used concomitantly (see section 4.4) CYP3A4 inducers and inhibitors
Slovenian: Zaradi možnega tveganja za nastanek pljučnega edema ali pretiranega znižanja krvnega tlaka je ob sočasni uporabi magnezijevega sulfata potrebna previdnost (glejte poglavje 4.4).
English: Each pack contains [to be completed nationally].
Slovenian: Eno pakiranje vsebuje [izpolni se individualno].
English: Occasionally, patients have developed an increased frequency, duration, or severity of angina upon starting or increasing nicardipine dosage, or during the course of treatment.
Slovenian: Po začetku prejemanja nikardipina, zvečanju odmerka ali med zdravljenjem se je pri bolnikih občasno razvila pogostejša, daljša ali resnejša oblika angine pektoris.
English: Transition to an oral antihypertensive agent: discontinue nicardipine or titrate downward while appropriate oral therapy is established.
Slovenian: Prehod na peroralno antihipertenzivno zdravilo: ko se odločite za primerno peroralno zdravilo, prekinite dajanje nikardipina ali postopoma zmanjšujte odmerek.
English: Each [to be completed nationally] contains [to be completed nationally]
Slovenian: Ena [izpolni se individualno] vsebuje [izpolni se individualno].
English: Digoxin levels should be monitored when concomitant therapy with nicardipine is initiated.
Slovenian: Ob uvedbi sočasnega zdravljenja z nikardipinom je treba ravni digoksina spremljati.
English: Reversal of neuromuscular block by neostigmine appears not to be affected by nicardipine infusion.
Slovenian: Kaže, da infuzija nikardipina ne vpliva na reverzibilnost živčno-mišičnega bloka z neostigminom.
English: Nicardipine has been reported to increase the plasma levels of digoxin in pharmacokinetic studies.
Slovenian: Farmakokinetične študije so pokazale, da nikardipin zvišuje koncentracije digoksina v plazmi.
English: If your liver is not working properly, or you have had liver disease in the past If you have high pressure in the brain
Slovenian: če imate srčno popuščanje, če imate angino pektoris, če vaša jetra ne delujejo pravilno ali ste imeli bolezen jeter v preteklosti, če imate visok tlak znotraj lobanje, če ste pred kratkim utrpeli možgansko kap, če jemljete zaviralce blokatorjev beta, če ste noseči, če ste mlajši od 18 let.
English: This is because Nicardipine solution for injection can affect the way some other medicines work.
Slovenian: Zdravilo Nikardipin raztopina za injiciranje namreč lahko vpliva na delovanje drugih zdravil, ta pa lahko vplivajo na delovanje zdravila Nikardipin raztopina za injiciranje.
English: If you have any further questions, ask your doctor, pharmacist, or nurse.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Vecuronium infusion dose requirements could be reduced by the concurrent use of nicardipine.
Slovenian: Odmerek infuzije vekuronija bi bil ob sočasni uporabi nikardipina morda lahko zmanjšan.
English: If you get any side effects, talk to your doctor, pharmacist, or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Nicardipine is also indicated for the treatment of post-operative hypertension 4.2 Posology and method of administration
Slovenian: Nikardipin je indiciran tudi za zdravljenje pooperativne hipertenzije.
English: In such case, the posology of the beta blocker should be individualized to the clinical situation.
Slovenian: V takem primeru je treba odmerjanje zaviralcev adrenergičnih receptorjev beta prilagoditi kliničnemu stanju (glejte poglavje 4.5).
English: Redness of the skin
Slovenian: Rdečica na koži.
English: Heart rate is temporarily increased; as a result of a decrease in after-load, cardiac output is markedly and durably increased.
Slovenian: Minutni volumen srca se občutno in trajno zviša kot posledica manjšega sistoličnega bremena.
English: What Nicardipine solution for injection looks like and contents of the pack
Slovenian: Izgled zdravila Nikardipin raztopina za injiciranje in vsebina pakiranja
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema neznano - trombocitopenija
English: Common - flushing Not known - erythema
Slovenian: Pogosti - vročinski oblivi Neznano - eritem
English: Annex III Summary of Product Characteristics and Package Leaflet
Slovenian: Povzetek glavnih značilnosti zdravila in Navodilo za uporabo
English: Caution should be exercised when using nicardipine in combination with a beta-blocker in patients with decreased cardiac function.
Slovenian: Pri bolnikih z zmanjšano srčno funkcijo je treba nikardipin v kombinaciji z zaviralci adrenergičnih receptorjev beta uporabljati previdno.
English: Nicardipine should be used with particular caution in children with renal impairment.
Slovenian: Pri otrocih z okvaro ledvic je treba nikardipin uporabljati posebej previdno.
English: Nicardipine should be used with caution in patients with acute cerebral infarction.
Slovenian: Pri bolnikih z akutno možgansko kapjo je treba nikardipin uporabljati previdno.
English: How to store Nicardipine solution for injection
Slovenian: Shranjevanje zdravila Nikardipin raztopina za injiciranje
English: How to take Nicardipine solution for injection
Slovenian: Kaj vsebuje zdravilo Nikardipin raztopina za injiciranje
English: Inflammation of the vein where the medicine has been given Changes in blood tests of how your liver is working
Slovenian: Spremembe krvnih parametrov v povezavi z delovanjem jeter.
English: Hepatobiliary disorders
Slovenian: Inhalacijski anestetiki
English: If you have chest pain
Slovenian: Bolečina v prsih.
English: Hepatic Impairment
Slovenian: Bolezni prebavil
English: Limited pharmacokinetic data have shown that nicardipine i.v.
Slovenian: Omejeni farmakokinetični podatki kažejo, da se intravenski nikardipin ne akumulira in v majhni meri prehaja skozi placento.
English: Chest pain
Slovenian: Okvara jeter
English: MARKETING AUTHORISATION HOLDER To be completed nationally 8.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Izpolni država članica
English: Significant difference has been identified with regard to clinical safety.
Slovenian: Pomembne razlike so bile ugotovljene v zvezi z klinično varnostjo.
English: The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Slovenia, Slovak Republic and United Kingdom.
Slovenian: Referenčna država članica je bila Švedska, zadevne države članice pa so bile Avstrija, Belgija, Bolgarija, Češka, Nemčija, Danska, Estonija, Španija, Finska, Francija, Madžarska, Irska, Islandija, Italija, Litva, Luksemburg, Latvija, Nizozemska, Norveška, Portugalska, Romunija, Slovenija, Slovaška republika in Združeno kraljestvo.
English: The Mutual Recognition Procedure started on 20 September 2007.
Slovenian: Postopek medsebojnega priznavanja se je začel 20. septembra 2007.
English: The final opinion was converted into a Decision by the European Commission on 11 September 2008.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 11. septembra 2008.
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Te države članice se niso mogle sporazumeti glede medsebojnega priznavanja dovoljenja za promet z zdravilom, ki ga je odobrila referenčna država članica.
English: The arbitration procedure started on 19 March 2008 with the adoption of a list of questions.
Slovenian: Arbitražni postopek se je začel 19. marca 2008 s sprejetjem seznama vprašanj.
English: A positive opinion was adopted by majority on 26 June
Slovenian: Odbor je dne 26. junija 2008 z večino glasov sprejel pozitivno mnenje.
English: Sweden referred the reasons for disagreement to the EMEA on 3 March 2008.
Slovenian: Švedska je agenciji EMEA posredovala razloge za nestrinjanje dne 3. marca 2008.
English: The Rapporteur was Dr Pierre Demolis (FR) as Rapporteur and Co-Rapporteur(s) was Dr Ingemar Persson (SE).
Slovenian: Poročevalec je bil dr. Pierre Demolis (FR), soporočevalec pa dr. Ingemar Persson (SE).
English: The Marketing Authorisation Holder provided written explanations on 5 May 2008.
Slovenian: Imetnik dovoljenja za promet z zdravilom je priskrbel pisna pojasnila dne 5. maja 2008.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, povzetek glavnih značilnosti zdravila pa v Dodatku III.
English: During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Activelle and associated names, that the objections raised by France and Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med srečanjem junija 2008 je CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru Odbora predstavil svoje mnenje, da je razmerje med koristmi in tveganji za zdravilo Activelle in povezana imena ugodno ter da ugovori, ki sta jih podali Francija in Nemčija, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom, pa tudi da je treba povzetek glavnih značilnosti zdravila, označevanja in navodila za uporabo referenčne države članice spremeniti.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Activelle and associated names International Non-Proprietary Name (INN): Estradiol and norethisterone acetate
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4)1 ZA ZDRAVILO Activelle in povezana imena Mednarodno nelastniško ime (INN): Estradiol in noretisteron acetat
English: This refers to endometrial safety of Activelle 0.5 mg/0.1 mg, which had been insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/CHMP/021/97 rev 1) and this was considered to be of serious public health concern.
Slovenian: To se nanaša na endometrijsko varnost zdravila Activelle, 0,5 mg/0,1 mg, ki v skladu s smernicami CHMP za zdravila za hormonsko nadomestno terapijo (EMEA/CHMP/021/97 rev. 1) ni bila zadostno dokazana, kar predstavlja resen zadržek v zvezi z javnim zdravjem.
English: Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets is a continuous combined hormone replacement therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.
Slovenian: Zdravilo Activelle in povezana imena, estradiol 0,5 mg in noretisteron acetat, 0,1 mg, filmsko obložene tablete, se uporablja za kontinuirano kombinirano hormonsko nadomestno zdravljenje (HNZ) simptomov pomanjkanja estrogena pri ženskah več kot eno leto po menopavzi.
English: Novo Nordisk A/S submitted applications for mutual recognition of Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets on the basis of the marketing authorisation granted by Sweden on 3 August 2007.
Slovenian: Družba Novo Nordisk A/S je predložila vloge za medsebojno priznavanje zdravila Activelle in povezana imena, estradiol, 0,5 mg, ter noretisteron acetat, 0,1 mg, filmsko obložene tablete, na podlagi dovoljenja za promet z zdravilom, ki ga je odobrila Švedska dne 3. avgusta 2007.
English: ‘Idiopathic' means that the cause of the disease is unknown.
Slovenian: „Idiopatska“ pomeni, da je vzrok bolezni neznan.
English: Esbriet pirfenidone
Slovenian: Esbriet pirfenidon
English: The CHMP also noted the lack of effective alternative treatments.
Slovenian: Prav tako je izpostavil pomanjkanje učinkovitih nadomestnih zdravljenj.
English: What measures are being taken to ensure the safe and effective use of Esbriet?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Esbriet?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Esbriet on 28 February 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Esbriet, veljavno po vsej Evropski uniji, izdala 28. februarja 2011.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Esbriet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Esbriet je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Other information about Esbriet
Slovenian: Druge informacije o zdravilu Esbriet
English: In both studies, the main measure of effectiveness was the change in the functioning of the patients' lungs after 72 weeks of treatment, measured by their ‘forced vital capacity' (FVC).
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti sprememba delovanja bolnikovih pljuč po 72 tednih zdravljenja, ki so jo merili s „forsirano vitalno kapaciteto“ (FVK).
English: The first study also found Esbriet to be most effective at the higher dose.
Slovenian: V prvi študiji se je tudi pokazalo, da je zdravilo Esbriet najučinkovitejše pri večjem odmerku.
English: It therefore decided that Esbriet's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Esbriet večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Patients who have side effects such as stomach problems, skin reactions to light or significant changes in the levels of liver enzymes may need to take a lower dose at least temporarily.
Slovenian: Pri bolnikih, pri katerih se pojavijo neželeni učinki, kot so težave z želodcem, reakcije kože na svetlobo ali večje spremembe ravni jetrnih encimov, bo morda treba odmerek vsaj začasno zmanjšati.
English: This is a summary of the European public assessment report (EPAR) for Esbriet.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Esbriet.
English: The first study also compared two doses of Esbriet (399 mg and 801 mg three times a day).
Slovenian: V prvi študiji so primerjali tudi dva različna odmerka zdravila Esbriet (399 mg in 801 mg trikrat na dan).
English: Esbriet must not be used by patients already taking fluvoxamine (a medicine used to treat depression and obsessive compulsive disorder) or patients with severe liver or kidney problems.
Slovenian: Zdravila Esbriet ne smejo jemati bolniki, ki že jemljejo fluvoksamin (zdravilo, ki se uporablja za zdravljenje depresije in obsesivno-kompulzivne motnje) ali bolniki s hudimi težavami z jetri ali ledvicami.
English: For more information about treatment with Esbriet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Esbriet preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Esbriet have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Esbriet izkazalo v študijah?
English: Esbriet is available as capsules (267 mg) and tablets (267, 534 and 801 mg) that are taken at mealtimes.
Slovenian: Zdravilo Esbriet je na voljo v obliki kapsul (267 mg) in tablet (267 mg, 534 mg in 801 mg), ki se jemljejo ob obroku.
English: What are the risks associated with Esbriet?
Slovenian: Kakšna tveganja so povezana z zdravilom Esbriet?
English: The dose of Esbriet is increased steadily, starting with 267 mg three times a day in the first week, 534 mg three times a day in the second week and 801 mg three times a day from the third week onwards.
Slovenian: Odmerek zdravila Esbriet se postopno povečuje, pri čemer se zdravljenje začne z odmerkom v višini 267 mg trikrat na dan v prvem tednu, nadaljuje z odmerkom v višini 534 mg trikrat na dan v drugem tednu, od tretjega tedna naprej pa v višini 801 mg trikrat na dan.
English: The higher dose results from the first study, combined with the results of the second study (which involved the same higher dose), showed that the average reduction in FVC was 8.5% for patients taking Esbriet compared with 11% for patients taking placebo.
Slovenian: Rezultati pri večjem odmerku v prvi študiji so skupaj z rezultati druge študije (pri kateri so uporabili enak večji odmerek) pokazali, da je bilo povprečno zmanjšanje forsirane vitalne kapacitete pri bolnikih, ki so jemali zdravilo Esbriet, 8,5-odstotno, pri bolnikih, ki so jemali placebo, pa 11-odstotno.
English: Why is Esbriet approved?
Slovenian: Zakaj je bilo zdravilo Esbriet odobreno?
English: Because the number of patients with IPF is low, the disease is considered ‘rare', and Esbriet was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 November 2004.
Slovenian: Ker je bolnikov z idiopatsko pljučno fibrozo malo, velja ta bolezen za redko, zato je bilo zdravilo Esbriet 16. novembra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esbriet have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Esbriet upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
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 Esbriet.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The company must also ensure that all doctors who are expected to prescribe Esbriet are provided with information material containing safety information on liver function and light-sensitive reactions.
Slovenian: Prav tako mora zagotoviti, da bodo vsi zdravniki, ki naj bi predpisovali zdravilo Esbriet, prejeli informativno gradivo za zdravnike, ki vsebuje podatke o varnosti v zvezi z delovanjem jeter in reakcijami preobčutljivosti na svetlobo.
English: The mechanism of action of pirfenidone, the active substance in Esbriet, is not fully understood but it has been shown to reduce the production of fibroblasts and other substances involved in the formation of fibrous tissue during the body's tissue repair process, thereby slowing down the progression of the disease in IPF patients.
Slovenian: Mehanizem delovanja zdravilne učinkovine zdravila Esbriet, pirfenidona, še ni popolnoma znan, vendar je bilo ugotovljeno, da zmanjšuje tvorbo fibroblastov in drugih snovi, ki vplivajo na oblikovanje fibroznega tkiva med procesom obnavljanja tkiv, ter tako upočasnjuje napredovanje bolezni pri bolnikih z idiopatsko pljučno fibrozo.
English: IPF is a long-term disease in which fibrous scar tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath.
Slovenian: Idiopatska pljučna fibroza je dolgotrajna bolezen, pri kateri se v pljučih nenehno tvori fibrozno brazgotinasto tkivo, ki povzroča stalen kašelj, pogoste okužbe pljuč in zelo oteženo dihanje.
English: What is Esbriet and what is it used for?
Slovenian: Kaj je zdravilo Esbriet in za kaj se uporablja?
English: The most common side effects with Esbriet during clinical studies were nausea (feeling sick), rash, tiredness, diarrhoea, dyspepsia (heartburn), loss of appetite, headache and photosensitivity reactions (sunburn-like reactions following exposure to light).
Slovenian: V kliničnih študijah zdravila Esbriet so glede neželenih učinkov najpogosteje poročali o navzeji (slabosti), izpuščajih, utrujenosti, driski, dispepsiji (zgagi), izgubi teka, glavobolu in reakciji preobčutljivosti na svetlobo (kožnih reakcijah, podobnih sončnim opeklinam, zaradi izpostavljenosti svetlobi).
English: Esbriet can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of IPF.
Slovenian: Predpisovanje in izdaja zdravila Esbriet je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem idiopatske pljučne fibroze.
English: Esbriet contains the active substance pirfenidone.
Slovenian: Zdravilo Esbriet vsebuje zdravilno učinkovino pirfenidon.
English: Esbriet was more effective than placebo (a dummy treatment) at slowing down the worsening of lung function in two main studies involving a total of 779 IPF patients.
Slovenian: Zdravilo Esbriet je bilo pri upočasnjevanju poslabšanja delovanja pljuč učinkovitejše od placeba (zdravila brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo skupno 779 bolnikov z idiopatsko pljučno fibrozo.
English: FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath, which decreases as the condition gets worse.
Slovenian: Forsirana vitalna kapaciteta je največja količina zraka, ki jo lahko bolnik naglo izdihne po globokem vdihu, kar pa se pri poslabšanju bolezni zmanjšuje.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Esbriet has been shown to slow down the progression of IPF, as measured by FVC, without serious risks for patients.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da zdravilo Esbriet upočasni napredovanje idiopatske pljučne fibroze, kakor je bilo izmerjeno s forsirano vitalno kapaciteto, brez resnega tveganja za bolnike.