FrancophonIA/ELRC3.0 huggingface dataset:
English: The company informed the CHMP that, at the time of the withdrawal, there were no ongoing clinical trials or compassionate use programmes for Corluxin.
Croatian: Tvrtka je obavijestila CHMP da u vrijeme povlačenja nije bilo u tijeku nijedno kliničko ispitivanje ili program milosrdnog davanja lijekova za lijek Corluxin.
English: Corluxin is a medicine containing the active substance mifepristone.
Croatian: Corluxin je lijek koji sadrži djelatnu tvar mifepriston.
English: Corluxin was to be used to treat Cushing's syndrome in patients who cannot have surgery or for whom surgery has failed.
Croatian: Corluxin se trebao koristiti za liječenje Cushingovog sindroma u bolesnika koje se ne može podvrgnuti kirurškom zahvatu ili u kojih kirurški zahvat nije bio uspješan.
English: How is Corluxin expected to work?
Croatian: Kako Corluxin treba djelovati?
English: Withdrawal of the marketing authorisation application for Corluxin (mifepristone) EMA/261739/2015
Croatian: Povlačenje zahtjeva za odobrenje za stavljanje u promet lijeka Corluxin (mifepriston) EMA/386107/2015
English: On the whole, the evidence for effectiveness in the indication applied for was limited and there were some safety concerns with the medicine, including side effects caused by the reduced activity of circulating cortisol, fluid and mineral disturbances (particularly reduced potassium levels in blood and increased blood pressure in some patients) and thickening of the womb in some female patients.
Croatian: Načelno, dokaz djelotvornosti u indikaciji za koju je podnesen zahtjev bio je ograničen, a postojali su i određeni razlozi za zabrinutost vezani uz sigurnu primjenu lijeka, uključujući nuspojave uzrokovanje smanjenim djelovanjem kortizola u optjecaju, poremećaje tekućine i minerala (posebice smanjene koncentracije natrija u krvi i povišeni krvni tlak u pojedinih bolesnika) te zadebljanje maternice u pojedinih bolesnica.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 May 2015
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Croatian: Cushingov sindrom je bolest koja se očituje prekomjernom proizvodnjom hormona kortizola koji izlučuju nadbubrežne žlijezde, dvije žlijezde koje se nalaze iznad bubrega.
English: At the time of the withdrawal, the CHMP was of the provisional opinion that Corluxin could not be approved for use in the broad indication the company applied for, which was the “treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or for whom surgery has failed.”
Croatian: U trenutku povlačenja, privremeno mišljenje CHMP-a bilo je da se Corluxin ne može odobriti za primjenu u širokoj indikaciji za koju ju je tvrtka podnijela zahtjev, a koja je glasila „terapija odraslih bolesnika s endogenim Cushingovim sindromom kod kojih kirurški zahvat nije moguć ili nije bio uspješan.”
English: By blocking these receptors, mifepristone is expected to reduce the effects of the excess cortisol circulating in the body, thereby alleviating the symptoms of the disease.
Croatian: Inhibirajući te receptore mifepriston bi trebao smanjiti djelovanje prekomjernog kortizola koji je u optjecaju u tijelu i tako olakšati simptome bolesti.
English: What was Corluxin expected to be used for?
Croatian: Za što se Corluxin trebao koristiti?
English: The active substance in Corluxin, mifepristone, is known to block receptors for cortisol known as glucocorticoid (GR-II) receptors.
Croatian: Djelatna tvar lijeka Corluxin, mifepriston, poznat je kao inhibitor receptora kortizola poznatih pod nazivom glukokortikoidni (GR-II) receptori.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Corluxin in the proposed indication did not outweigh its risks.
Croatian: Stoga je u vrijeme povlačenja CHMP smatrao kako koristi lijeka Corluxin ne nadmašuju s njim povezane rizike.
English: Treatment continued for up to two years.
Croatian: Liječenje je trajalo najviše dvije godine.
English: The site of injection should be changed each week.
Croatian: Mjesto primjene injekcije treba mijenjati svakoga tjedna.
English: The company has not carried out any formal studies of patients under 16 years of age.
Croatian: Tvrtka nije provela nikakva službena ispitivanja na bolesnicima mlađima od 16 godina.
English: The side effects are similar in adults and in children.
Croatian: Nuspojave u odraslih osoba slične su onima u djece.
English: Further information on Avonex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/avonex.
Croatian: Više informacija o lijeku Avonex dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/avonex.
English: The main measure of effectiveness was the number of patients whose disability got worse.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika kod kojih je zabilježeno pogoršanje invalidnosti.
English: • patients with relapsing multiple sclerosis (MS).
Croatian: • bolesnika oboljelih od relapsne multiple skleroze (MS).
English: Avonex slows the progression of disability and reduces the number of relapses;
Croatian: Avonex usporava progresiju invalidnosti i smanjuje broj napadaja;
English: • patients who have had a single attack of demyelination, when this is severe enough to need treatment with injectable corticosteroids (anti-inflammatory medicines).
Croatian: • bolesnika koji su imali samo jedan napadaj demijelinizacije, koji je bio toliko jak da je bilo potrebno liječenje injekcijama kortikosteroida (protuupalnim lijekovima).
English: In adults (aged 18 years or over), the recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week.
Croatian: U odraslih osoba (u dobi od 18 godina i starijih) preporučena doza lijeka Avonex iznosi 30 mikrograma i daje se injekcijom u mišić jedanput tjedno.
English: The most common side effects with Avonex (which may affect more than 1 in 10 people) are headache, flu-like symptoms, pyrexia (fever), chills and sweating.
Croatian: Najčešće nuspojave lijeka Avonex (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja, simptomi nalik gripi, pireksija (vrućica), zimica i znojenje.
English: A painkiller that prevents fever can be given before each injection and for 24 hours after injection to reduce the flu-like symptoms that may occur during the first few months of treatment.
Croatian: Analgetik koji sprječava vrućicu može se dati prije svake injekcije i 24 sata nakon injekcije radi ublažavanja simptoma nalik gripi koji se mogu pojaviti tijekom prvih nekoliko mjeseci liječenja.
English: Other information about Avonex
Croatian: Ostale informacije o lijeku Avonex
English: What measures are being taken to ensure the safe and effective use of Avonex?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Avonex?
English: Avonex is a medicine used to treat:
Croatian: Avonex je lijek za liječenje:
English: Avonex received a marketing authorisation valid throughout the EU on 13 March 1997.
Croatian: Lijek Avonex dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 13. ožujka 1997.
English: The first study involved 301 patients aged 16 years and older with relapsing MS who had experienced at least two relapses in the previous three years or at least one relapse per year if they had had the disease for less than three years.
Croatian: Prvo je ispitivanje obuhvaćalo 301 bolesnika oboljelih od relapsnog MS-a u dobi od 16 godina i starijih koji su imali najmanje dva relapsa tijekom prethodne tri godine ili najmanje jedan relaps godišnje, ako su od te bolesti bolovali manje od tri godine.
English: Patients can inject Avonex themselves once they have been trained.
Croatian: Bolesnici si mogu sami ubrizgavati Avonex nakon što prođu odgovarajuću obuku.
English: Avonex must not be used in patients who have severe depression or have thoughts of suicide.
Croatian: Lijek Avonex ne smiju uzimati bolesnici koji pate od teške depresije ili imaju suicidalne misli.
English: In relapsing MS, the patient has attacks (relapses) between periods with no symptoms.
Croatian: U relapsnoj multiploj sklerozi bolesnik ima napadaje (relapse) između razdoblja bez simptoma.
English: Side effects reported with Avonex are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Avonex pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Avonex has been compared with placebo (a dummy treatment) in two main studies.
Croatian: Lijek Avonex uspoređen je s placebom (prividnim liječenjem) u dvama glavnim ispitivanjima.
English: What is Avonex and what is it used for?
Croatian: Što je Avonex i za što se koristi?
English: This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows the lower dose of Avonex to be injected.
Croatian: To se može učiniti isključivo uz pomoć napunjene štrcaljke ako je opremljena posebnim uređajem koji se pričvrsti na štrcaljku i dopušta samo injiciranje manje doze lijeka Avonex.
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Croatian: MS je bolest kod koje upala oštećuje zaštitnu izolacijsku ovojnicu živaca (demijelinizacija), kao i same živce.
English: However, it presented information from published studies on the use of Avonex in patients aged between 12 and 18 years, which showed that they had a decrease in the rate of relapse, possibly due to Avonex treatment.
Croatian: Međutim, predstavila je podatke iz objavljenih ispitivanja o primjeni lijeka Avonex u bolesnika u dobi između 12 i 18 godina, koja su pokazala da su bolesnici doživjeli smanjenje stope relapsa, vjerojatno zbog liječenja lijekom Avonex.
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Croatian: Kod multiple skleroze imunosni sustav (prirodna obrana tijela) ne funkcionira pravilno i napada dijelove središnjeg živčanog sustava (mozak, kralježničnu moždinu i optički živac [živac koji šalje signale iz oka u mozak]) te uzrokuje upalu koja oštećuje živce i njihovu izolacijsku ovojnicu.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avonex have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Avonex nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Each syringe and pen contains 30 micrograms of interferon beta-1a.
Croatian: Jedna štrcaljka i brizgalica sadrži 30 mikrograma interferona beta-1a.
English: After two years, 22% of the patients who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability.
Croatian: Nakon dvije godine u 22 % bolesnika liječenih lijekom Avonex i 35 % bolesnika liječenih placebom došlo je do pogoršanja invalidnosti.
English: These side effects decrease with continued treatment.
Croatian: Te se nuspojave smanjuju nastavkom liječenja.
English: To help patients adjust to treatment, the doctor may recommend that patients start with a lower dose once a week before increasing to the full dose.
Croatian: U sklopu prilagodbe bolesnika na terapiju liječnik može preporučiti da se terapija započne uzimanjem manje doze jedanput tjedno prije prelaska na punu dozu.
English: Avonex treatment should be stopped in patients who develop progressive (worsening) MS.
Croatian: Liječenje lijekom Avonex treba prekinuti u bolesnika kod kojih se razvije progresivni MS (pogoršanje bolesti).
English: The European Medicines Agency decided that Avonex's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Avonex nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The second study involved 383 adults who had experienced a single attack of demyelination and compared the ability of Avonex and placebo to reduce the risk of a second attack.
Croatian: Drugim su ispitivanjem obuhvaćene 383 odrasle osobe koje su doživjele samo jedan napadaj demijelinizacije i provedena je usporedba lijeka Avonex i placeba radi smanjenja rizika od drugog napadaja.
English: As for all medicines, data on the use of Avonex are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Avonex kontinuirano se prate.
English: Avonex can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.
Croatian: Avonex se izdaje samo na recept, a liječenje mora započeti liječnik s iskustvom u liječenju MS-a.
English: For more information about using Avonex, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Avonex pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: An overview of Avonex and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Avonex i zašto je odobren u EU-u
English: The exact way that Avonex works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Croatian: Još uvijek nije poznato točno na koji način lijek Avonex djeluje kod MS-a, ali čini se da djelatna tvar interferon beta-1a smiruje imunosni sustav i sprječava relapse MS-a.
English: Avonex is available as a solution for injection in a pre-filled syringe or pre-filled pen.
Croatian: Lijek Avonex dostupan je kao otopina za injekciju u napunjenoj štrcaljki ili brizgalici.
English: What are the risks associated with Avonex?
Croatian: Koji su rizici povezani s lijekom Avonex?
English: The estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.
Croatian: Kod lijeka Avonex rizik je iznosio 21 % u dvije godine i 35 % u tri godine, dok je rizik kod placeba iznosio 39 % u dvije godine i 50 % u tri godine.
English: Why is Avonex authorised in the EU?
Croatian: Zašto je lijek Avonex odobren u EU-u?
English: The active substance in Avonex is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Croatian: Djelatna tvar lijeka Avonex je interferon beta-1a, bjelančevina iz skupine interferona koju tijelo prirodno proizvodi i koja pomaže u borbi protiv virusa i drugih napada na tijelo.
English: How does Avonex work?
Croatian: Kako djeluje Avonex?
English: What benefits of Avonex have been shown in studies?
Croatian: Koje su koristi od lijeka Avonex utvrđene u ispitivanjima?
English: Avonex contains the active substance interferon beta-1a.
Croatian: Lijek Avonex sadrži djelatnu tvar interferon beta-1a.
English: For the full list of side effects and restrictions with Avonex, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Avonex potražite u uputi o lijeku.
English: It is used when the patient is considered to be at high risk of developing MS. Before using Avonex, doctors need to exclude other causes for the symptoms.
Croatian: Prije primjene lijeka Avonex liječnik mora isključiti druge uzročnike simptoma.
English: How is Avonex used?
Croatian: Kako se Avonex primjenjuje?
English: This period of deferral shall not exceed twenty-four months from the Commission Decision.
Croatian: Ovo razdoblje odgode ne smije biti dulje od 24 mjeseca od donošenja odluke Komisije.
English: Both the Chennai site and the Coimbatore site follow the same provisions.
Croatian: Lokacije u Chennaiju i Coimbatoreu poštuju iste zakonske odredbe.
English: Based on the submitted data during the procedure, the medicinal products Tadalafil Mylan 2.5 mg, 5 mg, 10 mg and 20 mg; Paracetamol DAWA 1000 mg film-coated tablets; Memantine Pharmascope 10 mg and 20 mg; Memantine DAWA 10 mg and 20 mg; Morysa 10 mg and 20 mg - SVUS Pharma a.s.; Bendroflumetiazid Alternova 2.5 mg and 5 mg tablets; the CHMP concluded that bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product and recommended the maintenance of these marketing authorisations.
Croatian: Na temelju podataka dostavljenih tijekom postupka, CHMP je zaključio da je za lijekove: Tadalafil Mylan 2,5 mg, 5 mg, 10 mg i 20 mg, Paracetamol DAWA 1000 mg filmom obložene tablete, Memantine Pharmascope 10 mg i 20 mg, Memantine DAWA 10 mg i 20 mg, Morysa 10 mg i 20 mg - SVUS Pharma a.s. i Bendroflumetiazid Alternova 2,5 mg i 5 mg tablete utvrđena bioekvivalencija u odnosu na referentni lijek odobren u EU-u te je preporučio zadržavanje tih odobrenja za stavljanje lijeka u promet.
English: • The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Micro Therapeutic Research Labs Limited;
Croatian: • Odbor je pregledao sve dostupne podatke i informacije koje su dostavili nositelji odobrenja za stavljanje lijeka u promet/podnositelji zahtjeva, kao i informacije koje je dostavila tvrtka Micro Therapeutic Research Labs Limited;
English: The findings of the Austrian and Dutch inspections raise serious concerns relating to the suitability of the quality management system in place at Micro Therapeutics Research LTd, India.
Croatian: Nalazi austrijskih i nizozemskih inspekcija izazivaju ozbiljnu zabrinutost u vezi s prikladnosti uspostavljenog sustava upravljanja kvalitetom tvrtke Micro Therapeutics Research LTd, Indija.
English: − Marketing authorisation applications for which no alternative data or a justification was submitted.
Croatian: − zahtjeve za odobrenje za stavljanje lijeka u promet za koje nisu dostavljeni alternativni podatci ili obrazloženja.
English: Grounds for CHMP opinion Whereas,
Croatian: Obrazloženje mišljenja CHMP-a
English: Micro Therapeutic Research Labs Ltd is a contract research organisation (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which have been used to support marketing authorisation applications of medicines in the EU.
Croatian: Tvrtka Micro Therapeutic Research Labs Ltd je ugovorna istraživačka organizacija (CRO) koja provodi analitičke i kliničke dijelove ispitivanja bioekvivalencije, od kojih se neka upotrebljavaju za potkrepljivanje zahtjeva za odobrenje za stavljanje lijekova u promet u EU-u.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Micro Therapeutic Research Labs Limited during the period between June 2012 and June 2016;
Croatian: • Odbor je razmotrio postupak proveden u skladu s člankom 31. Direktive 2001/83/EZ za odobrenja za stavljanje lijeka u promet i zahtjeve za odobrenje za stavljanje lijeka u promet za lijekove za koje su klinički i/ili bioanalitički dijelovi ispitivanja provedeni u tvrtki Micro Therapeutic Research Labs Limited u razdoblju od lipnja 2012. do lipnja 2016.;
English: In view of the critical inspection findings and the necessity to protect public health in the EU, several Member States considered that it is in the interest of the Union to refer the matter to the CHMP and request that it assesses the impact of the findings mentioned above on the benefit-risk balance of the medicinal products which have been authorised by the Member States on the basis of relevant trials performed at these sites between June 2012 and June 2016 and also that of pending marketing authorisation applications (MAA) that include such studies.
Croatian: S obzirom na kritične nalaze inspekcija i potrebu za zaštitom javnog zdravlja u EU-u, nekoliko država članica smatralo je da je u interesu Unije da se predmet uputi CHMP-u i traže da se provede procjena učinka navedenih nalaza u donosu na omjer koristi i rizika lijekova koje su države članice odobrile na temelju relevantnih ispitivanja koja su provedena na tim lokacijama u razdoblju od lipnja 2012. do lipnja 2016., kao i zahtjeva za odobrenje za stavljanje lijeka u promet koji su u tijeku i koji uključuju navedena ispitivanja.
English: Therefore, for those products bioequivalence is not established.
Croatian: Stoga bioekvivalencija tih lijekova nije utvrđena.
English: The CHMP was requested in particular to provide its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products should be maintained, varied, suspended, or revoked and whether marketing authorisations applications should be authorised.
Croatian: Od CHMP-a je posebice zatraženo da dostavi svoje mišljenje u skladu s člankom 31. Direktive 2001/83/EZ o tome treba li zadržati, izmijeniti, obustaviti ili opozvati odobrenja za stavljanje lijeka u promet za te proizvode te treba li odobriti zahtjeve za odobrenje za stavljanje lijeka u promet.
English: Data from bioequivalence studies submitted to the Competent Authorities to demonstrate bioequivalence of medicinal products with their originator is considered unreliable.
Croatian: Podatci dobiveni u ispitivanjima bioekvivalencije dostavljeni nadležnim tijelima radi dokazivanja bioekvivalencije lijekova s izvornim lijekom smatraju se nepouzdanima.
English: For marketing authorisations of a medicinal product considered critical, the suspension may be deferred in the relevant EU Member States for a period which shall not exceed twenty-four (24) months from the Commission Decision.
Croatian: U slučaju odobrenja za stavljanje u promet lijeka koji se smatra izrazito važnim obustava se u relevantnim državama članicama može odgoditi na razdoblje koje ne smije biti dulje od 24 mjeseca od dana donošenja odluke Komisije.
English: − Authorised medicinal products for which alternative data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product;
Croatian: − odobrene lijekove za koje su dostavljeni alternativni podatci o bioekvivalenciji ili obrazloženja, ali koje je CHMP smatrao nedostatnima da bi se utvrdila bioekvivalencija u odnosu na referentni lijek odobren u EU-u;
English: Where on the basis of these criteria the relevant national competent authorities of the EU Member States consider that a medicinal product is critical, the suspension of the concerned marketing authorisation(s) may be deferred by the period for which the medicinal product is considered critical.
Croatian: Ako na temelju tih kriterija relevantna nacionalna nadležna tijela država članica smatraju da je lijek izrazito važan, obustava dotičnog/dotičnih odobrenja za stavljanje lijeka u promet može se odgoditi u razdoblju tijekom kojeg se lijek smatra izrazito važnim.
English: • The Committee concluded that the particulars supporting the marketing authorisations and marketing authorisation applications are incorrect and that the benefit-risk balance is considered not favourable for:
Croatian: • Odbor je zaključio da su određeni podatci kojima se potkrepljuju odobrenja za stavljanje lijeka u promet i zahtjevi za odobrenje za stavljanje lijeka u promet netočni i da se omjer koristi i rizika ne smatra povoljnim za: