FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Neofordex and Dectancyl, dexamethasone, belongs to a group of medicines known as corticosteroids, which reduce the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cells.
Croatian: Djelatna tvar lijekova Neofordex i Dectancyl, deksametazon, ubrajaju se u grupu lijekova poznatih kao kortikosteroidi, koji smanjuju djelovanje imunosnog sustava (prirodnih obrana tijela) vezivanjem na receptore u različitim tipovima imunosnih stanica.
English: Neofordex was to be used in combination with other medicines to treat adult patients with multiple myeloma who have developed symptoms.
Croatian: Neofordex se trebao koristiti u kombinaciji s drugim lijekovima za liječenje odraslih bolesnika oboljelih od multipla mijeloma u kojih su se razvili simptomi.
English: Because Neofordex was assessed as a hybrid medicine, and the effects of high-dose dexamethasone in multiple myeloma are well established, the company presented the results of a study carried out to investigate whether it is bioequivalent to the reference medicine, Dectancyl.
Croatian: Budući da je Neofordex ocijenjen kao hibridni lijek, a djelovanje velikih doza deksametazona u slučaju multipla mijeloma je dobro utvrđeno, tvrtka je predstavila rezultate ispitivanja provedenog kako bi se istražilo je li ovaj lijek bioekvivalentan referetnom lijeku, Dectancyl.
English: The company also presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.
Croatian: Tvrtka je također dostavila ispitivanja iz literature o primjeni deksametazona za liječenje multipla mijeloma.
English: Multiple myeloma is a cancer of the plasma cells in the bone marrow.
Croatian: Multipli mijelom je rak stanica plazme u koštanoj srži.
English: Withdrawal of the marketing authorisation application for Neofordex (dexamethasone) EMA/443387/2014
Croatian: (deksametazon) EMA/443387/2014
English: Withdrawal of the marketing authorisation application for Neofordex (dexamethasone)
Croatian: Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Neofordex (deksametazon)
English: The company had not yet responded to the last round of questions at the time of the withdrawal.
Croatian: U trenutku povlačenja tvrtka još nije bila dostavila svoje odgovore.
English: Neofordex is a corticosteroid medicine that contains the active substance dexamethasone.
Croatian: Neofordex je kortikosteroid koji sadrži djelatnu tvar deksametazon.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Neofordex could not have been approved for the treatment of multiple myeloma.
Croatian: Na temelju pregleda podataka te odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja, CHMP je izrazio svoju zabrinutost oko određenih pitanja te je njegovo privremeno mišljenje bilo da je moguće dati odobrenje za Neofordex za liječenje multipla mijeloma.
English: What was Neofordex expected to be used for?
Croatian: Za što se Neofordex trebao koristiti?
English: Neofordex was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 6 June 2010 for the treatment of multiple myeloma.
Croatian: Neofordex je označen kao lijek za liječenje rijetkih i teških bolesti dana 6. lipnja 2010. za liječenje multipla mijeloma.
English: How is Neofordex expected to work?
Croatian: Kako je Neofordex trebao djelovati?
English: dexamethasone is used together with chemotherapy to make chemotherapy more effective and to reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom smanjile određene nuspojave liječena raka, poput mučnine (osjećaja slabosti) i povraćanja.
English: For the suspension to be lifted, National competent authorities of Member States or reference Member States, if applicable, shall ensure that the following condition is fulfilled by the MAHs:
Croatian: Za ukidanje suspenzije, nadležna nacionalna tijela država članica ili referentnih država članica trebaju, ako je primjenjivo, potvrditi da su nositelji odobrenja ispunili sljedeće uvjete:
English: The MAHs should appropriately reformulate the product taking into account its misuse potential.
Croatian: Nositelji odobrenja trebaju preformulirati lijek na odgovarajući način uzimajući u obzir njegov potencijal za zloporabu.
English: Annex IV Condition for lifting the suspension of the marketing authorisations
Croatian: Dodatak IV Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: Conditions for lifting the suspension of the marketing authorisations for methadone oral solutions containing povidone
Croatian: Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet za oralne otopine metadona koje sadrže povidon
English: Language regime
Croatian: Jezični režim
English: The Agency aims to allocate 10 minutes per person.
Croatian: Agencija nastoji odrediti 10 minuta po osobi.
English: In such case no prior registration is required.
Croatian: U tom slučaju nije potrebna prethodna prijava.
English: Draft agenda and list of speakers
Croatian: Nacrt dnevnog reda i popis govornika
English: Legal basis
Croatian: Pravna osnova
English: These requests will only be accommodated if space permits.
Croatian: Ti se zahtjevi odobravaju samo ako to prostor dopušta.
English: The Agency processes personal data in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data.
Croatian: Agencija obrađuje osobne podatke u skladu s Uredbom (EZ) br. 45/2001 Europskog parlamenta i Vijeća od 18. prosinca 2000. o zaštiti pojedinaca u vezi s obradom osobnih podataka u institucijama i tijelima Zajednice i o slobodnom kretanju takvih podataka.
English: Key principles
Croatian: Glavna načela
English: The time the Agency allocates to each speaker is dependent upon the number of requests received.
Croatian: Vrijeme koje Agencija odredi za svakog govornika ovisi o broju primljenih zahtjeva.
English: If the PRAC cannot reach an agreement by consensus, the decision is taken by vote as provided for in the PRAC rules of procedure.
Croatian: Ako PRAC ne može konsenzusom postići dogovor, odluka se donosi glasanjem kako je predviđeno poslovnikom PRAC-a.
English: The PRAC Chair gives the floor to the speakers.
Croatian: Predsjednik PRAC-a daje riječ govornicima.
English: 13 April 2016 EMA/363479/2015
Croatian: EMA/389921/2016
English: The Agency cannot be held liable for any expenses occurred in case of cancellation.
Croatian: Agencija nije odgovorna za troškove nastale u slučaju otkazivanja.
English: Impact on PRAC opinion
Croatian: Utjecaj na mišljenje PRAC-a
English: • Potential impact of possible regulatory actions on therapeutic practice and availability of treatments.
Croatian: • potencijalni učinak mogućih regulatornih mjera na terapijsku praksu i dostupnost liječenja
English: The legal basis for holding public hearings in the defined procedures is Article 107j of Directive 2001/83/EC:
Croatian: Pravna osnova za održavanje javne rasprave prema definiranim postupcima je članak 107.j Direktive 2001/83/EZ:
English: The Agency will facilitate these efforts.
Croatian: Agencija će pomoći u takvom nastojanju.
English: • Contact information (postal address, e-mail address, telephone number).
Croatian: • podatke za kontakt (poštanska adresa, e-adresa, telefonski broj)
English: Cancellation
Croatian: Otkazivanje
English: The announcement shall specify the modalities of participation.
Croatian: U najavi se određuje način sudjelovanja.
English: Speakers should be aware that they have a fixed maximum time to make their intervention.
Croatian: Govornici moraju biti svjesni da imaju određeno maksimalno vrijeme za svoju intervenciju.
English: If they are unable to present in English, the European Medicines Agency (hereafter referred to as “Agency”) will provide translation from the official EU languages into English.
Croatian: Ako nisu u mogućnosti izlagati na engleskom jeziku, Europska agencija za lijekove (u daljnjem tekstu „Agencija”) osigurava prevođenje sa službenih jezika EU-a na engleski.
English: • Speakers can make an intervention in person or via teleconferencing facilities (Adobe Connect) where possible and feasible (See section 3.3 for more information on how to submit a request to participate as a speaker).
Croatian: • Govornici mogu intervenirati osobno ili putem sustava za telekonferencije (Adobe Connect) kada je to moguće i izvedivo (više informacija o podnošenju zahtjeva za sudjelovanje u ulozi govornika potražite u odjeljku 3.3.).
English: • Level of public interest.
Croatian: • razinu interesa javnosti
English: • Name of the individual.
Croatian: • ime osobe
English: • Therapeutic effect of the medicine/class of medicines and availability of therapeutic alternatives.
Croatian: • terapijski učinak lijeka / klase lijekova i dostupnost terapijskih alternativa
English: • Information about live-broadcast/web stream.
Croatian: • informacije o prijenosu uživo / putem interneta (web stream)
English: The requester should also clearly indicate whether he or she intends to participate in person or whether the intervention will be made via teleconference.
Croatian: Podnositelj zahtjeva također treba navesti namjerava li sudjelovati osobno ili će se intervencija održati putem telekonferencije.
English: However, the PRAC continues to have the sole responsibility for giving its scientific recommendation on the safety of the medicine(s) concerned.
Croatian: Međutim, PRAC i dalje snosi isključivu odgovornost za znanstvene preporuke koje daje o sigurnosti lijeka(ova) u razmatranju.
English: The announcement is published on the Agency's website1, together with:
Croatian: Najava se objavljuje na internetskim stranicama Agencije1, zajedno sa sljedećim podatcima:
English: • Nature and extent of the safety concern.
Croatian: • vrstu i opseg sigurnosnog problema
English: All public hearings will be conducted in English.
Croatian: Sve se javne rasprave održavaju na engleskom jeziku.
English: The PRAC Chair can also stop a speaker if his or her intervention does not address the questions asked by the PRAC or if the speaker does not adhere to the general ground rules.
Croatian: Predsjednik PRAC-a također može zaustaviti govornike ako se njihova intervencija ne tiče pitanja koje je postavio PRAC ili ako se govornici ne pridržavaju općih temeljnih pravila.
English: The interests declared will be minuted in the meeting record.
Croatian: Navedeni interesi navode se u zapisniku sastanka.
English: Members of the public can participate actively, as speakers, or they can opt to participate as observers.
Croatian: Članovi javnosti mogu sudjelovati aktivno, kao govornici, ili mogu sudjelovati kao promatrači.
English: In case of cancellation, the Agency will publically announce as early as possible, and will provide a justification for such cancellation.
Croatian: U slučaju otkazivanja, Agencija to javno najavljuje što je prije moguće te navodi razlog otkazivanja.
English: The assessment report will be made public once the decision-making process has been finalised.
Croatian: Izvješće o ocjeni objavljuje se nakon završetka postupka odlučivanja.
English: The PRAC Chair concludes the public hearing and explains the next steps of the procedure.
Croatian: Predsjednik PRAC-a zatvara javnu raspravu i objašnjava sljedeće korake postupka.
English: • Affiliation (i.e. name of the organisation/pharmaceutical company the individual represents), if applicable.
Croatian: • povezanost (tj. naziv organizacije / farmaceutske tvrtke koju osoba predstavlja), ako je primjenjivo
English: Arrangements to be put in place for such non-public hearings fall outside the scope of these rules of procedure.
Croatian: Pripreme koje se trebaju provesti za takve rasprave koje nisu javne izvan su područja primjene ovog poslovnika.
English: Public hearings will take place as part of meetings of the PRAC, with attendance of the Committee members.
Croatian: Javne rasprave održavaju se u sklopu sastanaka PRAC-a uz sudjelovanje članova Odbora.
English: Public hearings are open to all members of the public.
Croatian: Javne rasprave otvorene su čitavoj javnost.
English: In the public hearing, due regard shall be given to the therapeutic effect of the medicinal product.
Croatian: Na javnoj raspravi posebna se pažnja posvećuje terapijskom učinku lijeka.
English: Public hearings at the PRAC - a definition
Croatian: 1.2. Javne rasprave u PRAC-u - definicija
English: However, if they do wish to be present in the room, they must register in advance.
Croatian: Međutim, ako mediji žele prisustvovati, moraju se prijaviti unaprijed.
English: • A list of specific questions on which information from the public is sought during the public hearing.
Croatian: • popis određenih pitanja o tome koje se informacije žele dobiti od javnosti tijekom javne rasprave
English: Media organisations who wish to cover the public hearing may attend as observers.
Croatian: Medijske organizacije (mediji) koje žele izvještavati o javnoj raspravi mogu prisustvovati kao promatrači.
English: The Committee shall endeavour to reach agreement on holding a public hearing by consensus.
Croatian: Odbor nastoji konsenzusom postići dogovor o organizaciji javne rasprave.
English: Where a marketing authorisation holder or another person intending to submit information has confidential data relevant to the subject matter of the procedure, he may request permission to present that data to the Pharmacovigilance Risk Assessment Committee in a non-public hearing.”
Croatian: Kad nositelj odobrenja za stavljanje lijeka u promet ili druga osoba koja namjerava dostaviti informacije ima povjerljive podatke relevantne za predmet postupka, može zatražiti da te podatke predstavi Odboru za ocjenu rizika na području farmakovigilancije na raspravi koja nije javna.”
English: The Agency will endeavour to accommodate all speaking requests.
Croatian: Agencija će pokušati ispuniti sve zahtjeve za izlaganje.
English: • Information on how to ask for the provision of translation from an official EU language into English in case of attendance as a speaker.
Croatian: • informacije o tome kako zatražiti prijevod sa službenog jezika EU-a na engleski u slučaju da sudjelujete kao govornik
English: When discussing the merits of holding a public hearing, the PRAC should consider the following elements:
Croatian: Prilikom rasprave o meritumu organiziranja javne rasprave PRAC treba uzeti u obzir sljedeće elemente:
English: However, each individual who has not been admitted as a speaker has the right to submit, prior to the public hearing, a written statement for consideration by the PRAC.
Croatian: Međutim, svaka osoba koja nije odabrana kao govornik ima pravo prije rasprave podnijeti pisanu izjavu PRAC-u na razmatranje.
English: • Registration information, including the deadline by which participants can register to attend the hearing as speakers or observers.
Croatian: • podatci za prijavu, uključujući krajnji rok do kojeg se sudionici mogu prijaviti za sudjelovanje na raspravi kao govornici ili promatrači.
English: Participation requests should be sent in writing to the Agency using a dedicated form and should include the following information:
Croatian: Zahtjevi sudionika šalju se Agenciji u pisanom obliku na određenom obrascu i trebaju sadržavati sljedeće podatke:
English: Public hearings can add various elements to the considerations of the PRAC.
Croatian: Javne rasprave mogu raznim elementima doprinijeti razmatranjima PRAC-a.
English: • Agency's contact email address and phone number.
Croatian: • e-adresa i telefonski broj Agencije za kontakt
English: The PRAC Chair, in collaboration with Agency staff, is responsible for the preparation of the public hearing and the conduct of the public hearing and shall take appropriate measures to ensure that the public hearing is run effectively and efficiently.
Croatian: Predsjednik PRAC-a, u suradnji s osobljem Agencije, odgovoran je za pripremu i provedbu javne rasprave te poduzima potrebne mjere kako bi osigurao učinkovito i djelotvorno provođenje javne rasprave.
English: In situations where it is not feasible for the Agency to reschedule the public hearing, the Agency will announce on its website the modalities for receiving written contributions.
Croatian: U slučaju kada nije moguće da Agencija zakaže novi termin održavanja javne rasprave, Agencija na svojim internetskim stranicama objavljuje način primanja pisanih doprinosa.
English: Organisation of a public hearing - before the hearing
Croatian: Organizacija javne rasprave - prije rasprave
English: The primary purpose of a public hearing is to hear the public's view on the acceptability of the risks associated with the medicinal product/medicinal substance/class of medicinal products concerned, particularly in relation to its therapeutic effects and therapeutic alternatives available, as well as to seek suggestions and recommendations on the feasibility and acceptability of risk management and minimisation activities.
Croatian: Glavna svrha javne rasprave je saslušati mišljenje javnosti o prihvatljivosti rizika povezanih s lijekom / aktivnom tvari / klasom lijekova u pitanju, posebice u vezi s njihovim terapijskim učinkom i dostupnim terapijskim alternativama, kao i zatražiti prijedloge i preporuke o provedivosti i prihvatljivosti mjera za upravljanje rizicima i aktivnostima smanjenja rizika.
English: The PRAC has the possibility to hold public hearings in the context of safety referral procedures under Article 20 of Regulation (EC) 726/2004, Article 31 or Article 107i of Directive 2001/83/EC.
Croatian: PRAC ima odgovornost organizirati javne rasprave u okviru postupaka procjene sigurnosti lijekova u skladu s člankom 20. Uredbe (EZ) br. 726/2004., člankom 31. ili člankom 107.i Direktive 2001/83/EZ.
English: If the number of requests still exceeds the allocated time, the Agency will review the requests and decide on the list of speakers, taking into account elements such as the most relevant speakers with regard to the questions to be addressed at the public hearing and/or the geographical spread of the speakers.
Croatian: Ako broj zahtjeva i dalje premašuje predviđeno vrijeme, Agencija razmatra zahtjeve i odabire određene govornike, uzimajući u obzir elemente poput važnosti govornika u pogledu pitanja o kojima će se raspravljati na javnoj raspravi i/ili geografskom podrijetlu govornika.
English: • Capacity (i.e. whether the person is speaking as a patient or carer, a healthcare professional, an academic or a representative of the pharmaceutical industry, irrespective of whether the person speaks as an individual or a representative of an organisation/pharmaceutical company).
Croatian: • svojstvo (tj. izlaže li osoba kao bolesnik ili njegovatelj, zdravstveni radnik, akademik ili predstavnik farmaceutske industrije, bez obzira na to izlaže li osoba u svoje ime ili kao predstavnik organizacije / farmaceutske tvrtke)
English: However, it may decline a request to speak at the public hearing if the outline of the planned intervention addresses a matter that is not prima facie related to the subject matter of the public hearing.
Croatian: Međutim, može odbiti zahtjev za izlaganje na javnoj raspravi ako se utvrdi pregledom planirane intervencije da se ona prima facie ne tiče pitanja povezanog s predmetom javne rasprave.
English: 1 The Agency's website will serve as the European medicines webportal until further notice.
Croatian: 1 Internetske stranice Agencije do daljnjeg služe kao europski portal za lijekove.
English: • A brief outline of the planned intervention, specifically how it addresses the questions on which the PRAC is seeking public opinion and the estimated amount of time requested for the presentation.
Croatian: • kratki pregled planirane intervencije, posebice njena povezanost s pitanjem za koje PRAC traži mišljenje javnosti i predviđeno vrijeme potrebno za izlaganje.
English: He or she will be assisted by Agency staff on any administrative and organisational issues.
Croatian: U administrativnim i organizacijskim pitanjima pomaže mu osoblje Agencije.
English: • A summary of the safety concern.
Croatian: • sažetak sigurnosnog problema
English: The Agency reserves the right to cancel a public hearing in case circumstances emerge that impact on the feasibility of holding it.
Croatian: Agencija zadržava pravo otkazati javnu raspravu u slučaju da se pojave okolnosti koje utječu na mogućnost organiziranja javne rasprave.
English: If the speaker does not conclude his or her intervention after being asked to do so, the microphone may be turned off.
Croatian: Ako govornici ne završe svoje intervencije nakon upozorenja, mikrofon se isključuje.
English: Following the opening of the public hearing, the PRAC Rapporteur and/ or PRAC Co-Rapporteur give(s) an overview of the procedure, including the main issues and present(s) the questions on which public input is sought.
Croatian: Nakon otvorenja javne rasprave, izvjestitelj PRAC-a i/ili suizvjestitelj PRAC-a daje pregled postupka, uključujući glavna pitanja i predstavlja pitanja za koja se traži doprinos javnosti.
English: Specific arrangements will be put in place to allow wide media coverage of the public hearing.
Croatian: Moguće je uspostaviti poseban dogovor kako bi se omogućila veća medijska pokrivenost javne rasprave.
English: Interventions
Croatian: 4.3. Intervencije
English: • Where relevant, request for the provision of translation in case of attendance as a speaker, including information on which official EU language should be translated into English.
Croatian: • Ako je to potrebno, uključuje i zahtjev za prevođenje u slučaju sudjelovanja u svojstvu govornika, s podatkom o tome s kojeg je službenog jezika EU-a potreban prijevod na engleski jezik.
English: The outcome of the discussion on the need to hold a public hearing, including a justification of the decision taken will be recorded in the minutes of the PRAC which are published on the Agency's website.
Croatian: Ishod rasprave o potrebi organiziranja javne rasprave, uključujući obrazloženje donesene odluke, navodi se u zapisniku PRAC-a koji se objavljuje na internetskim stranicama Agencije.
English: Where the number of requests within a group cannot be accommodated during the time allocated, people interested in speaking at the public hearing are encouraged to team-up among themselves.
Croatian: Kada je broj zahtjeva unutar skupine veći od predviđenog vremena za njih, osobe zainteresirane za izlaganje na javnoj raspravi potiču se da se međusobno udruže.
English: However, if a large number of requests have been received to attend the public hearing as a speaker, the Agency may reduce the time allocated for each speaker and/or extend the duration of the public hearing.
Croatian: Međutim, ako Agencija primi veliki broj zahtjeva za izlaganje na javnoj raspravi, ona može smanjiti vrijeme određeno za svakog govornika i/ili produžiti trajanje javne rasprave.
English: • Information on date and time of the public hearing.
Croatian: • informacije o datumu i vremenu održavanja javne rasprave
English: He or she states the purpose of the public hearing and presents the order of the day and operational aspects for the meeting.
Croatian: Navodi svrhu javne rasprave te predstavlja dnevni red i operativne aspekte sastanka.
English: For organisational reasons, participants must register in advance.
Croatian: Iz organizacijskih razloga sudionici se moraju unaprijed prijaviti.
English: Interventions given by participants at the public hearing should focus on providing responses to the questions asked by the PRAC.
Croatian: Intervencije sudionika javne rasprave trebale bi biti usredotočene na odgovaranje na pitanja koja postavi PRAC.