FrancophonIA/ELRC3.0 huggingface dataset:
English: BE established versus non-EU RMP for Irbesartan: For the EU MA dossier for Irbesartan 75, 150 and 300 mg tablets, the following bioequivalence study has been performed: bioequivalence study for Irbesartan Film-coated Tablets using 300mg strength against EU reference product APROVEL 300 mg Film-coated Tablets.
Croatian: Utvrđeni BE u odnosu na referentni lijek koji nije odobren u EU-u za Irbesartan: Sljedeće ispitivanje bioekvivalencije provedeno je za EU MA dosje za tablete Irbesartan 75, 150 i 300 mg: ispitivanje bioekvivalencije za tablete obložene filom Irbesartan primjenom jačine od 300 mg u usporedbi s referentnim lijekom APROVEL tabletama obloženima filmom od 300 mg koji je odobren u EU-u.
English: Therefore the CHMP is of the opinion that the studies cannot be relied upon to establish bioequivalence vis-àvis the EU reference medicinal product.
Croatian: Stoga je mišljenje CHMP-a da se ispitivanja ne mogu smatrati pouzdanima za utvrđivanje bioekvivalencije u odnosu na referentni lijek odobren unutar EU-a.
English: • For medicinal products (Annex IA) for which other bioequivalence studies than the one(s) performed at GVK Biosciences Hyderabad site or claims that the medicinal products fulfil the criteria for a Biopharmaceutics Classification System (BCS)-based biowaiver as described in Appendix III of the Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98) were submitted, assessed and considered positive by the CHMP (i.e. medicinal products containing Bendroflumetiazid, Bosentan, Fexofenadine, Lansoprazole, Levetiracetam, Levocetirizine, Metoclopramide, Nebivolol and Venlafaxine), the CHMP is of the opinion that the bioequivalence has been established.
Croatian: Smjernice o istraživanju bioekvivalencije (CPMP/EWP/QWP/1401/98), te koja je CHMP ocijenio pozitivno (odnosno lijekovi koji sadrže bendroflumetijazid, bosentan, feksofenadin, lansoprazol, evetiracetam, levocetirizin, metoklopramid, nebivolol i venlafaksin), mišljenje je CHMP-a kako je bioekvivalencija utvrđena.
English: Should during this period the Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation shall apply.
Croatian: Ukoliko tijekom tog razdoblja država(e) članica(e) zaključe da lijek više nije veoma važan, primjenjuje se privremeno oduzimanje predmetnog odobrenja za stavljanje lijeka u promet.
English: Should during this period the Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation(s) shall apply.
Croatian: Ako tijekom tog razdoblja država(e) članica(e) zaključe da lijek više nije veoma važan, primijenit će se privremeno oduzimanje predmetnog(ih) odobrenja za stavljanje lijeka u promet.
English: A medicinal product listed in Annex IB may be considered critical by the Member State(s) based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective Member State(s) and, as appropriate, the nature of the disease to be treated.
Croatian: Država(e) članica(e) može(gu) zaključiti da je lijek naveden u Prilogu I.B veoma važan na temelju evaluacije potencijalno neudovoljene medicinske potrebe, uzimajući u obzir dostupnost odgovarajućih alternativnih lijekova u dotičnoj(im) državi(ama) članici(ama) i, ako je primjereno, prirodu bolesti koja će se liječiti.
English: The MAH claimed that it had not received the official notification of the inclusion of the product in the Article 31 Referral procedure.
Croatian: Nositelj odobrenja je tvrdio da nije primio službenu obavijest o uključivanje lijeka u postupak upućivanja u skladu sa člankom 31. Stoga su informacije dostavljene u fazi ponovne ocjene uzete u obzir kako bi se poštivalo pravo na obranu tvrtke.
English: This category encompasses medicinal products for which MAHs have provided biowaiver request (i.e. claims to fulfil the criteria for a Biopharmaceutics Classification System (BCS)-based biowaiver as described in Appendix III of the Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98) to establish bioequivalence to an EU Reference Medicinal Product.
Croatian: Ova kategorija obuhvaća lijekove za koje su nositelji odobrenja dostavili zahtjev za izuzeće od ispitivanja bioekvivalencije (odnosno zahtjeve za ispunjavanje kriterija za izuzeće od ispitivanja bioekvivalencijena temelju sustava kvalifikacije za biofarmaceutike (BCS-ove) kako je opisano u Dodatku III.
English: During the November 2014 meeting, after GVK Biosciences' submission of responses as well as providing information relating to the matter before the CHMP on 22 October 2014, the CHMP determined that GVK Biosciences Pvt. Ltd. did not provide evidence to demonstrate that the problem was confined to a specific time period or specific clinical trials or specific individuals and clinical activities.
Croatian: Tijekom sjednice održane u studenom 2014., nakon što je tvrtka GVK Biosciences podnijela odgovore te dostavila informacije u vezi s predmetom koji je razmatrao CHMP 22. listopada 2014., CHMP je zaključio da GVK Biosciences Pvt.
English: Finally, it is noted that bioequivalence for a generic product should be proven in line with the criteria as outlined in article 10 of Directive 2001/83/EC and the Guideline on the investigation of bioequivalence.
Croatian: Naposljetku, zaključeno je da se bioekvivalencija generičkog proizvoda treba dokazati u skladu s kriterijem navedenim u članku 10.
English: a. To suspend the marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (Annex IB), as the particulars supporting the marketing authorisations are incorrect and that the benefit-risk balance of these marketing authorisation is not positive pursuant to Article 116 of Directive 2001/83/EC.
Croatian: Privremeno oduzimanje odobrenja za stavljanje u promet lijekova za koje nisu dostavljeni podaci ili opravdanja bioekvivalencije ili ih je CHMP smatrao nedostatnima za utvrđivanje bioekvivalencije u odnosu na referentni lijek odobren unutar EU-a (Prilog I.B) budući da su podaci koji potkrepljuju odobrenja za stavljanje lijeka u promet netočni te da omjer koristi i rizika kod ovih odobrenja za stavljanje lijeka u promet nije pozitivan u skladu s člankom 116.
English: The CHMP is of the view that this argument does not substitute the need to establish bioequivalence with an EU reference medicinal product in order to conclude on the positive benefitrisk balance of the concerned medicinal products.
Croatian: CHMP je mišljenja da ovaj argument ne nadoknađuje potrebu za utvrđivanjem bioekvivalencije s referentnim lijekom odobrenim u EU-u kako bi se donijeli zaključci o pozitivnom omjeru koristi i rizika dotičnih lijekova.
English: The CHMP recommends therefore the suspension of the concerned marketing authorisations.
Croatian: CHMP preporučuje stoga privremeno oduzimanje predmetnih odobrenja za stavljanje lijeka u promet.
English: Subsequently, for AU generic dossier submission, a bioequivalence study was performed using Alembic's Irbesartan Hydrochlorothiazide Film-coated Tablets 300mg/25 mg against the AU reference product AVAPRO HCT 300mg Film-coated Tablets sourced from Australian market.
Croatian: Naknadno za potrebe dostavljanja australskog (AU) generičkog dosjea, provedeno je ispitivanje bioekvivalencije primjenom tableta obloženih filmom Irbesartan + hidroklorotiazid primjenom jačine od 300/25 mg tvrtke Alembic i AU referentnim lijekom tabletama obloženim filmom AVAPRO HCT 300 mg koje su izvorno pribavljene na australskom tržištu.
English: The MAH claims that the data obtained in the AU study are still applicable for the EU.
Croatian: Nositelj odobrenja tvrdio je da su podaci prikupljeni u australskom ispitivanju primjenjivi u EU-u.
English: Without prejudice to the above requirement, the CHMP reviewed the MAHs argumentation and considered from a scientific perspective that it is not established with the provided data that both
Croatian: Bez prejudiciranja prethodno navedenog zahtjeva, CHMP je pregledao argumentaciju nositelja odobrenja i zaključio sa znanstvenog stajališta da dostavljenim podacima nije utvrđena identičnost AU i EU referentnih lijekova (primjerice proizvodne lokacije nisu poznate, kvantitativni sastavi nisu poznati).
English: The category encompasses products for which MAHs have not provided any biowaiver request or bioequivalence study vis-à-vis the EU reference medicinal product generated elsewhere than at GVK Biosciences Pvt. Ltd. facility in Hyderabad, India, or where MAHs have not responded.
Croatian: Kategorija obuhvaća lijekove za koje nositelji odobrenja nisu dostavili nikakav zahtjev za izuzeće od ispitivanja bioekvivalencije ili ispitivanje bioekvivalencije u odnosu na referentni lijek unutar EU-a generiran na drugoj lokaciji koja nije tvornica tvrtke GVK Biosciences Pvt.
English: For generic products authorised under Article 10(1) of Directive 2001/83/EC, establishment of bioequivalence vis-à-vis a reference medicinal product is a pre-requisite.
Croatian: Utvrđivanje bioekvivalencije u odnosu na referentni lijek jest preduvjet za generičke proizvode odobrene u skladu sa člankom 10. stavkom 1. Direktive 2001/82/EZ.
English: The reference product is not authorized in the EU.
Croatian: Referentni lijek nema odobrenje za stavljanje u promet unutar EU-a.
English: The CHMP recommends therefore the maintenance of the concerned marketing authorisations.
Croatian: Slijedom navedenog, CHMP preporuča zadržavanje predmetnih odobrenja za stavljanje lijeka u promet.
English: In addition to the submitted studies, some MAHs have highlighted that some audits and inspections with a positive outcome were carried out at GVK Biosciences Pvt. Ltd. facility in Hyderabad, India, and argued that, in view of this, the bioequivalence studies conducted at the site can be relied upon as sufficient to support a Marketing Authorisation.
Croatian: Ltd. u Hyderabadu, Indiji, te su tvrdili da se, u svjetlu navedenoga, ispitivanja bioekvivalencije provedena na lokaciji mogu smatrati dostatnima kako bi podržala odobrenje za stavljanje lijeka u promet.
English: The CHMP therefore concluded that all bioequivalence studies with clinical activities carried out at GVK Biosciences Pvt. Ltd. site in Hyderabad, India, since GVK Biosciences Pvt. Ltd. started these activities in 2004 are considered unreliable to support the benefit risk balance of the medicinal products they relate to.
Croatian: Stoga je CHMP zaključio da se sva ispitivanja bioekvivalencije s kliničkim aktivnostima provedena na lokaciji tvrtke GVK Biosciences Pvt.
English: 23 May 2014 EMA/299385/2014 EMEA/H/C/002817
Croatian: EMA/299385/2014 EMEA/H/C/002817
English: What is Reasanz?
Croatian: Što je Reasanz?
English: Refusal of the marketing authorisation for Reasanz (serelaxin) EMA/299385/2014
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Reasanz (serelaksin) EMA/299385/2014
English: The main measure of effectiveness was the extent to which dyspnoea was relieved, measured short-term (after 6, 12 and 24 hours) and over 5 days.
Croatian: Glavna mjera djelotvornosti bio je omjer u kojem je dispneja ublažena, izmjereno kratkoročno (nakon 6, 12 i 24 sata) i tijekom 5 dana.
English: The effects of Reasanz were first tested in experimental models before being studied in humans.
Croatian: Djelovanje lijeka Reasanz po prvi put testirano je na eksperimentalnim modelima prije početka ispitivanja u ljudi.
English: Furthermore, the Committee had concerns about the way the effectiveness of the medicine in the study had been analysed.
Croatian: Nadalje, Povjerenstvo je bilo zabrinuto zbog načina na koji se analizirala učinkovitost lijeka u ispitivanju.
English: The medicine was to be used as an addition to other treatment.
Croatian: Predviđeno je da se lijek koristi kao dodatak drugim liječenjima.
English: The application was mainly based on the results of one main study involving 1,161 patients with an episode of acute heart failure.
Croatian: Zahtjev se uglavnom temeljio na rezultatima jednog glavnog ispitivanja koje je obuhvatilo 1 161 bolesnika s epizodama akutnog zatajenja srca.
English: Recombinant means that it is produced by bacteria into which a gene (DNA) has been introduced that makes the bacteria able to produce the hormone.
Croatian: Rekombinant znači da ga proizvode bakterije u čiji je gen (DNK) umetnut što bakterijama omogućuje proizvodnju hormona.
English: The active substance in Reasanz, serelaxin, is a recombinant form of relaxin-2, a hormone naturally found in the body.
Croatian: Djelatna tvar lijeka Reasanz, serelaksin, je rekombinantni oblik relaksina-2, hormona koji se prirodno nalazi u tijelu.
English: Refusal of the marketing authorisation for Reasanz (serelaxin)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Reasanz (serelaksin)
English: The results included assigned values for a number of patients who had died or had required additional treatment for worsening symptoms and whose actual data were not used.
Croatian: Rezultati su uključivali dodjeljivanje vrijednosti za niz bolesnika koji su umrli ili su zahtijevali dodatno liječenje u slučaju pogoršanja simptoma i čiji stvarni podaci nisu korišteni.
English: Reasanz was expected to be used to treat the symptoms of acute heart failure (an episode of severe or worsening symptoms in patients in whom the heart cannot pump sufficient blood around the body).
Croatian: Očekivano je da će se Reasanz koristiti za liječenje simptoma akutnog zatajenja srca (epizode ozbiljnih ili pogoršavajući simptoma u bolesnika u kojih srce ne može pumpati dovoljno krvi u tijelo).
English: It was to be available as a concentrate to be diluted and given by infusion (drip) into a vein.
Croatian: Trebao je biti dostupan kao koncentrat za razrjeđivanje i primjenjivati se infuzijom (dripom) u venu.
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Reasanz, intended for the treatment of acute heart failure.
Croatian: Dana 23. siječnja 2014. godine Povjerenstvo za humanu uporabu (CHMP) usvojilo je negativno mišljenje kojim se preporuča odbijanje izdavanja odobrenja za stavljanje u promet lijeka Reasanz, predviđenog za liječenje akutnog zatajenja srca.
English: At the time of the initial evaluation, the CHMP noted that the study results did not demonstrate a benefit for short-term relief of dyspnoea over up to 24 hours, and although some benefit was shown over 5 days it was not clear how this was of clinical relevance.
Croatian: U trenutku početne ocjene, CHMP je zaključio da rezultati ispitivanja ne dokazuju korist za kratkoročno ublažavanje dispneje tijekom 24 sata, a iako su određene koristi dokazane tijekom razdoblja od 5 dana, nije jasno kako je to od kliničkog značaja.
English: When serelaxin attaches to receptors for relaxin in the blood vessels, it causes these vessels to relax and widen.
Croatian: Kada se serelaksin spaja na receptore za relaksin u krvnim žilama, uzrokuje opuštanje i širenje ovih krvnih žila.
English: These symptoms include high blood pressure in the vessels leaving the lungs, leading to congestion (fluid build-up) and dyspnoea (shortness of breath).
Croatian: Ovi simptomi uključuju visoki krvni tlak u krvnim žilama koje izlaze iz pluća, što rezultira začepljenjem (nakupljanje tekućine) i dispnejom (zadihanošću).
English: Reasanz infusion was compared with placebo (a dummy treatment) as an addition to their other treatment.
Croatian: Infuzija lijeka Reasanz uspoređena je s placebo (prividnim liječenjem) kao dodatkom drugim liječenjima.
English: In addition, the CHMP questioned whether the type of the background treatment given to patients in the two study groups might have influenced the results.
Croatian: Nadalje, za CHMP je upitno nije li pozadinsko liječenje koje su bolesnici primili u dvije grupe ispitivanja moglo utjecati na rezultate.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Reasanz.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su trenutno uključeni u klinička ispitivanja ili u programe milosrdnog davanja lijeka Reasanz.
English: Reasanz is a medicine that contains the active substance serelaxin.
Croatian: Reasanz je lijek koji sadrži djelatnu tvar serelaksin.
English: Therefore, although the safety of Reasanz seemed acceptable, the CHMP concluded that the benefits of Reasanz did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Croatian: Stoga, iako je sigurnost lijeka Reasanz prihvatljiva, CHMP je zaključio da koristi od lijeka Reasanz ne nadmašuju s njim povezane rizike i zadržalo je svoju prethodnu preporuku da se izdavanje odobrenja za stavljanje lijeka u promet treba odbiti.
English: What was Reasanz expected to be used for?
Croatian: Za što se Reasanz trebao koristiti?
English: How is Reasanz expected to work?
Croatian: Kako je Reasanz trebao djelovati?
English: pressure in the blood vessels and makes it easier for the heart to pump blood around the body, which helps to relieve the symptoms of acute heart failure.
Croatian: Na taj se način snižava krvni tlak u krvnim žilama te se olakšava srcu cirkuliranje krvi diljem tijela, što pomaže pri ublažavanju simptoma akutnog zatajenja srca.
English: Since only one main study was included in the application, the CHMP concluded that further studies would be needed to confirm the effectiveness of Reasanz in the treatment of acute heart failure.
Croatian: Budući da je samo jedno glavno ispitivanje uključeno u zahtjev, CHMP je zaključio da su potrebna daljnja ispitivanja kako bi se potvrdila djelotvornost lijeka Reasanz u liječenju akutnog zatajenja srca.
English: During the re-examination, the CHMP reviewed again the data from the only main study submitted and confirmed its opinion that the effectiveness of Reasanz had not been sufficiently demonstrated.
Croatian: Tijekom ponovne procjene, CHMP je ponovno pregledao podatke iz samo jednog dostavljenog glavnog ispitivanja i potvrdio je svoje mišljenje da djelotvornost lijeka Reasanz nije dokazana u dostatnoj mjeri.
English: The company that applied for authorisation is Novartis Europharm Ltd.
Croatian: Novartis Europharm
English: Such decisions should instead be taken on a case by case basis, following an evaluation of the findings and their potential impact.
Croatian: Umjesto toga, takve odluke treba donijeti za svaki slučaj pojedinačno, nakon provedbe ocjene nalaza i njihovog mogućeg utjecaja.
English: A single bioequivalence study was conducted to support both applications.
Croatian: Provedena je jedinstvena studija bioekvivalencije kako bi se podržala oba zahtjeva.
English: Tibolone is a synthetic steroid hormone drug which acts as an agonist, mainly on oestrogen receptors.
Croatian: Tibolon je sintetski steroidni hormon koji djeluje kao agonist, uglavnom na estrogenskim receptorima.
English: Two applications under the decentralised procedure were submitted for the generic products Tibolona Aristo and Tibocina, both 2.5 mg tablets with the indication “treatment of oestrogen deficiency symptoms in women, more than one year after the menopause”.
Croatian: Predana su dva zahtjeva u okviru decentraliziranog postupka za generičke lijekove Tibolona Aristo i Tibocina, oba lijeka u obliku tableta od 2,5 mg s indikacijom „liječenje simptoma nedostatka estrogena u žena, više od godine dana nakon menopauze”.
English: These findings were classified as critical and one of the concerned member states therefore considered it impossible to conclude on the reliability of the bioequivalence study.
Croatian: Ti su nalazi klasificirani kao kritični te je jedna od dotičnih država članica stoga smatrala da nije moguće donijeti zaključak o pouzdanosti studije bioekvivalencije.
English: Overall summary of the scientific evaluation of Tibolona Aristo and associated names (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene lijeka Tibolona Aristo i srodnih naziva (vidjeti Prilog I)
English: Having reviewed the available data, the CHMP considered that there was sufficient additional evidence indicating that the study samples were not put at risks during the study and that these were maintained under adequate temperature conditions.
Croatian: Nakon pregleda dostupnih podataka, CHMP je smatrao da postoji dovoljno dodatnih podataka koji ukazuju da uzorci iz ispitivanja nisu bili ugroženi tijekom ispitivanja i da su čuvani u odgovarajućim temperaturnim uvjetima.
English: A referral under Article 29(4) of Directive 2001/83/EC was triggered and the CHMP was requested to give its opinion on whether the proposed products Tibolona Aristo and Tibocina can be considered bioequivalent to the reference product.
Croatian: Pokrenut je postupak procjene u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ te se od CHMP-a zahtijevalo da donese svoje mišljenje o tome mogu li se predloženi lijekovi Tibolona Aristo i Tibocina smatrati bioekvivalentnim referentnom lijeku.
English: During the assessment of the application dossiers, a Good Clinical Practice (GCP) inspection of the clinical site identified a lack of evidence documenting the transfer date and time and the identification of pharmacokinetic samples from the dry ice box used for flash freezing to the freezer used at this site until the samples were transferred to the bioanalytical site.
Croatian: Tijekom procjene dosjea lijeka za potrebe registracije, inspekcija dobre kliničke prakse (GCP) identificirala je nedostatak dokaza koji bi dokumentirao vrijeme i datum prijenosa te identifikaciju farmakokinetičkih uzoraka iz kutija sa suhim ledom koje su se koristile za brzo zamrzavanje u zamrzivaču koji se koristio na ovoj lokaciji sve dok uzorci nisu bili preneseni u bioanalitički laboratorij.
English: The CHMP acknowledged that the findings are considered as a critical deficiency, however it did not consider that GCP inspection findings classified as critical should automatically invalidate the results of a bioequivalence study.
Croatian: CHMP je priznao da se nalazi smatraju kritičnim nedostacima, međutim nije smatrao da nalazi inspekcije GCP klasificirani kao kritični trebaju automatski poništiti rezultate studije bioekvivalencije.
English: In addition, the bioequivalence study conducted demonstrated bioequivalence, with observed drug concentrations being comparable or superior to those reported in the literature and the CHMP considered that these results suggest that no significant degree of drug degradation occurred.
Croatian: Osim toga, provedena studija bioekvivalencije dokazala je bioekvivalenciju, pri čemu su uočene koncentracije lijeka koje bile jednake ili veće od onih zabilježenih u literaturi, a CHMP je smatrao da ti rezultati ukazuju na to da nije došlo da značajne razgradnje lijeka.
English: Whereas
Croatian: S obzirom na navedeno:
English: The CHMP therefore reviewed the additional clinical evidence available, including the assessment carried out during the CMDh procedure and the evidence submitted by the Applicant.
Croatian: CHMP je stoga pregledao dodatne dostupne kliničke dokaze uključujući i procjenu koja je provedena tijekom CMDh postupka te dokaze koje je predao podnositelj zahtjeva.
English: • the CHMP reviewed the available data, including the Rapporteurs' assessment reports and the explanations submitted by the Applicant during the CMDh procedure
Croatian: • CHMP je pregledao dostupne podatke, uključujući i izvješća iznositelja o procjeni te objašnjenja koja je predao podnositelj zahtjeva tijekom postupka CMDh.