FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, as long-acting muscarinic antagonists may have an effect on the heart and blood vessels, the company that markets Duaklir Genuair will provide the results of studies to further evaluate the cardiovascular safety of the medicine.
Croatian: Nadalje, budući da dugodjelujući muskarinski antagonisti mogu utjecati na srce i krvne žile, tvrtka koja stavlja u promet lijek Duaklir Genuair dostavit će rezultate ispitivanja za potrebe daljnje ocjene sigurne primjene lijeka u krvožilnom sustavu.
English: Side effects with Duaklir Genuair are similar to those with the individual components.
Croatian: Nuspojave lijeka Duaklir Genuair slične su onima individualnih komponenti.
English: What measures are being taken to ensure the safe and effective use of Duaklir Genuair?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Duaklir Genuair?
English: It is not intended to provide practical advice on how to use Duaklir Genuair.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Duaklir Genuair.
English: What are the risks associated with Duaklir Genuair?
Croatian: Koji su rizici povezani s lijekom Duaklir Genuair?
English: Duaklir Genuair is available as an inhalation powder in a portable inhaler device.
Croatian: Duaklir Genuair dostupan je kao prašak za inhalaciju u prijenosnom inhalatoru.
English: What is Duaklir Genuair and what is it used for?
Croatian: Što je Duaklir Genuair i za što se koristi?
English: Duaklir Genuair aclidinium bromide / formoterol fumarate dihydrate
Croatian: Duaklir Genuair aklidinijev bromid / formoterolfumarat dihidrat
English: Regarding safety, the number of side effects reported with Duaklir Genuair was low and did not raise any major safety concern.
Croatian: Vezano uz sigurnost, broj nuspojava prijavljen s lijekom Duaklir Genuair bio je mali i nije uzrokovao razloge veće razloge za zabrinutost za sigurnu primjenu.
English: Results showed that, after six months of treatment, the increase in FEV1 (measured one hour after an inhalation) was 293 milliliters (ml) more with Duaklir Genuair than with placebo and 118 ml more with Duaklir Genuair than with aclidinium alone.
Croatian: Rezultati su pokazali da je nakon šest mjeseci terapije povišenje u vrijednosti FEV1 (izmjereno jedan sat nakon inhalacije) iznosilo 293 mililitara (ml) više s lijekom Duaklir Genuair nego s placebom i 118 ml više s lijekom Duaklir Genuair nego u slučaju monoterapije aklidinijem.
English: A risk management plan has been developed to ensure that Duaklir Genuair is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Duaklir Genuair.
English: However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Duaklir Genuair than with formoterol alone.
Croatian: No, poboljšanje u odnosu na monoterapiju formoterolom bilo je malo i nije se moglo smatrati klinički značajnim: FEV1 izmjeren ujutro prije inhalacije iznosio je 68 ml više s lijekom Duaklir Genuair u odnosu na monoterapiju formoterolom.
English: Duaklir Genuair is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Duaklir Genuair je lijek koji ublažava simptome kronične opstruktivne pulmonalne bolesti (KOPB-a) u doraslih osoba.
English: For more information about treatment with Duaklir Genuair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Duaklir Genuair pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Duaklir Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment).
Croatian: Duaklir Genuair ispitan je u 2 glavna ispitivanja koja su obuhvatila više od 3 400 bolesnika s KOPB-om, u kojima je uspoređen s monoterapijom aklidinijem, monoterapijom formoterolom i placebom (liječenjem bez djelatne tvari).
English: Duaklir Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.
Croatian: Duaklir Genuair sadrži dvije djelatne tvari: aklidinijev bromid i formoterolfumarat dihidrat.
English: The CHMP noted that Duaklir Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Duaklir Genuair was compared with one of the components on its own, formoterol, was small.
Croatian: CHMP je zaključio kako je utvrđeno da lijek Duaklir Genuair značajno poboljšava funkciju pluća u bolesnika s KOPB-om u usporedbi s placebom, iako je uočeno poboljšanje bilo malo kada je lijek Duaklir Genuair uspoređen s monoterapijom jedne od vlastitih komponenti, formoterolom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duaklir Genuair, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Genuair nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The two active substances in Duaklir Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.
Croatian: Dvije djelatne tvari lijeka Duaklir Genuair, aklidinijev bromid i formoterolfumarat dihidrat, djeluju održavajući zračne putove otvorenima i olakšavaju bolesniku disanje.
English: What benefits of Duaklir Genuair have been shown in studies?
Croatian: Koje su koristi lijeka Duaklir Genuair dokazane u ispitivanjima?
English: Duaklir Genuair was also shown to increase the percentage of patients who had an improvement in breathlessness compared with placebo.
Croatian: Lijek Duaklir Genuair pokazao je također povećanje u postocima bolesnika koji su manje gubili dah u usporedbi s placebom.
English: Duaklir Genuair can only be obtained with a prescription.
Croatian: Duaklir Genuair se izdaje samo na liječnički recept.
English: How is Duaklir Genuair used?
Croatian: Kako se Duaklir Genuair koristi?
English: For practical information about using Duaklir Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Duaklir Genuair pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How does Duaklir Genuair work?
Croatian: Kako djeluje Duaklir Genuair?
English: For the full list of all side effects and restrictions with Duaklir Genuair, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Duaklir Genuair potražite u uputi o lijeku.
English: The PRAC reviewed the preliminary 3-year data.
Croatian: PRAC je pregledao preliminarne 3-godišnje podatke.
English: The Federal Institute for Vaccines and Biomedicines (Germany) informed the Commission on the findings on the 1st of March 2013.
Croatian: Savezni institut za cjepiva i biomedicinske lijekove (Njemačka) obavijestio je Komisiju o svojim nalazima 1. ožujka 2013.
English: Nine of these changes had a potential impact on inhibitor formation.
Croatian: Devet od ovih izmjena imalo je potencijalan utjecaj na formiranje inhibitora.
English: These products were approved in the European Union on 04 August 2000.
Croatian: Ovi su lijekovi odobreni za primjenu u Europskoj uniji 4. kolovoza 2000.
English: Both registries were part of the risk management plan (RMP) of the respective products.
Croatian: Oba su registra dijelom plana za upravljanje rizikom (RMP-a) dotičnih proizvoda.
English: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500015512.pdf
Croatian: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500015512.pdf ova i minimalno liječenih bolesnika (MTP-ova).
English: Updated results from the EUHASS registry were also provided.
Croatian: Dostavljeni su također ažurirani rezultati iz registra EUHASS.
English: EUHASS study
Croatian: Ispitivanje EUHASS
English: - the EUHASS (European Haemophilia Safety Surveillance System) registry.
Croatian: - registar EUHASS (Europski sustav za sigurnosni nadzor hemofilije).
English: The results of the RODIN/PedNet study (S. C. Gouw et al., N. Engl.
Croatian: Dostavljeni su rezultati ispitivanja RODIN/PedNet (S. C. Gouw et al., N. Engl.
English: • Quality data
Croatian: • Podaci o kvaliteti
English: - the RODIN (Research of Determinants of Inhibitor development)/PedNet registry; and
Croatian: - registar RODIN (Istraživanje determinanti razvoja inhibitora)/PedNet; i
English: RODIN/PedNet study
Croatian: Ispitivanje RODIN/PedNet
English: Overall, 9 out of 60 (15%) developed inhibitors.
Croatian: Ukupno 9 od 60 (15%) bolesnika razvilo je inhibitore.
English: • Conclusions
Croatian: • Zaključci
English: These two interventional studies were carried out as prospective, uncontrolled trials, for treatment of bleeding episodes in 37 PUPs and 23 MTPs with residual FVIII:C < 2 IU/dl.
Croatian: Ova dva intervencijska ispitivanja provedena su kao prospektivna, nekontrolirana ispitivanja za liječenje epizoda krvarenja u 37 PUP-ova i 23 MTP-ova s rezidualnim FVIII:C < 2 IU/dl.
English: The PRAC noted that all parameters were within specification and that there is no correlation between changes and inhibitor events.
Croatian: PRAC je napomenuo da su svi parametri u okviru specifikacija te da ne postoji korelacija između promjena i događaja inhibitora.
English: No update of the RMP was considered necessary by the PRAC.
Croatian: PRAC nije smatrao da je potrebno ažuriranje RMP-a.
English: These studies were either sponsored or supported by the MAH.
Croatian: Ova su ispitivanja sponzorirali ili podržali nositelji odobrenja.
English: • MAH sponsored and supported clinical trials
Croatian: • Klinička ispitivanja koja su sponzorirali i podržali nositelji odobrenja
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all FVIII products.
Croatian: U ovom ispitivanju, incidencija razvoja inhibitora kretala se unutar raspona od 28,2% do 37,7% za sve lijekove koji sadrže FVIII.
English: The PRAC noted that the Factor VIII gene mutation profile of these study population (in studies 200021EU and 100074US) reflects the typical distribution seen in patients with severe haemophilia A, indicating that there was no bias in patient recruitment.
Croatian: PRAC je uočio da profil mutacije gena faktora VIII ove populacije ispitivanja (u ispitivanjima 200021EU i 100074US) odražava tipičnu distribuciju uočenu u bolesnika s ozbiljnom hemofilijom A, indicirajući da nema pristranosti u odabiru bolesnika.
English: • Observational studies
Croatian: • Opservacijska ispitivanja
English: Therefore, the European Commission (EC) initiated a procedure under Article 20 of Regulation (EC) No 726/2004 and requested the Agency to assess available data and its impact on the benefit-risk balance of the medicinal products concerned and to give its opinion as to whether the marketing authorisations should be maintained, varied, suspended or revoked.
Croatian: Uredbe (EZ) br. 726/2004, te je zatražila od Agencije da procijeni dostupne podatke kao i utjecaj na omjer koristi i rizika predmetnih lijekova i da donese svoje mišljenje trebaju li se odobrenja za stavljanje lijeka u promet zadržati, izmijeniti, privremeno oduzeti ili opozvati.
English: One patient was lost to follow up and one patient developed a low-titre inhibitor during post study follow-up.
Croatian: Jedan je bolesnik nestao tijekom kontrolnog razdoblja, a jedan je bolesnik razvio niski titar inhibitora tijekom kontrole nakon ispitivanja.
English: In addition, upon request from the PRAC, the MAH provided analyses of the overall results on the observed inhibitor incidence in the light of the study design and patient selection.
Croatian: Nadalje, nakon zahtjeva PRAC-a, nositelj odobrenja dostavio je analize ukupnih rezultata o uočenoj incidenciji inhibitora s obzirom na dizajn ispitivanja i odabir bolesnika.
English: The EUHASS study was established in 2008 as an adverse event reporting system for patients with inherited bleeding disorders, including Haemophilia A, in Europe.
Croatian: Ispitivanje EUHASS započeto je 2008. kao sustav za prijavljivanje nuspojava za bolesnike oboljele od nasljednog poremećaja krvarenja, uključujući i hemofiliju A, diljem Europe.
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 ED (exposure days).
Croatian: Pet od 37 (14%) PUP-ova i 4 od 23 (17%) MTP-ova koji su liječeni lijekom Helixate NexGen razvilo je inhibitore unutar 20 DI (dana izlaganja).
English: Annex IV Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: As a consequence, the marketing authorisation holder (MAH) for Kogenate Bayer and Helixate NexGen supported two EU registries:
Croatian: Slijedom toga, nositelji odobrenja za stavljanje u promet lijekova Kogenate Bayer i Helixate NexGen podržali su dva registra na razini EU:
English: Grounds for the variation to the terms of the marketing authorisations
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: In 2006, an EMA expert meeting1 on FVIII products and inhibitor development concluded that there was a need to collect comparable clinical data on the immunogenicity of recombinant and plasmaderived FVIII products as a long-term objective.
Croatian: Godine 2006. na sastanku stručne skupine pri EMA-i1 o lijekovima koji sadrže FVIII i razvoju inhibitora zaključeno je da postoji potreba za prikupljanjem usporedivih kliničkih podataka o imunogenosti rekombinantnih faktora VIII i onih dobivenih iz plazme, te je to postavljeno kao dugoročan cilj.
English: Overall summary of the scientific evaluation of Kogenate Bayer and Helixate NexGen
Croatian: Cjelokupan sažetak znanstvene ocjene lijekova Kogenate Bayer i Helixate NexGen
English: Haemophilia centres in Western Europe and major haemophilia centres in North America enrolled a total of 60 PUPs/MTPs without pre-existing inhibitors in two studies (200021EU and 100074US).
Croatian: Europi kao i veći centri za liječenje hemofilije u Sjevernoj Americi upisali su ukupno 60 PUP-ova/MTP-ova bez prethodno postojećih inhibitora u dva ispitivanja (200021EU i 100074US).
English: The efficacy of Kogenate Bayer/Helixate NexGen is recognised and the PRAC reviewed the data related to inhibitor development in PUPs and MTPs.
Croatian: Prepoznata je djelotvornost lijekova Kogenate Bayer/Helixate NexGen, a PRAC je pregledao podatke povezane s razvojem inhibitora u PUP-ova i MTP-ova.
English: The PRAC was of the view that the available data are consistent with the general experience that most inhibitors develop within the first 20 EDs and that the overall data does not provide evidence that factor VIII products differ from each other in terms of inhibitor development in PUPs.
Croatian: PRAC je bio mišljenja da su dostupni podaci u skladu s općenitim iskustvom da se većina inhibitora razvija tijekom prvih 20 dana izlaganja te da cjelokupni podaci ne pružaju dovoljno dokaza da se lijekovi koji sadrže faktor VIII razlikuju jedan od drugog u smislu razvoja inhibitora u PUP-ova.
English: In patients given KOGENATE Bayer/Helixate NexGen, 64 out of 183 developed an inhibitor (37.7%), of which 40 had a high-titre inhibitor (25.2%).
Croatian: U bolesnika koji su primili lijekove KOGENATE Bayer/Helixate NexGen, 64 od 183 razvilo je inhibitor (37,7%), od kojih je 40 imalo visoki titar inhibitora (25,2%).
English: The MAH will continue to support the RODIN/PedNet registry as well as the EUHASS registry, as per current obligations defined in the RMP, to further investigate individual risk factors for inhibitor development and risk mitigation in PUPs.
Croatian: Nositelj odobrenja nastavit će podržavati registar RODIN/PedNet kao i registar EUHASS, u skladu s aktualnim obvezama definiranima u RMP-u, kako bi dalje istražio faktore individualnog rizika za razvoj inhibitora i smanjivanje rizika u PUP-ova.
English: According to the MAH, since the Marketing Authorisations, 42 changes in the manufacturing process of KOGENATE Bayer have been introduced.
Croatian: Sukladno nositelju odobrenja, od trenutka izdavanja odobrenja za stavljanje lijeka u promet, uvedene su 42 izmjene u proizvodni postupak lijeka KOGENATE Bayer.
English: Post-hoc analysis of the RODIN study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitor than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08 -2.37).
Croatian: Post-hoc analiza ispitivanja RODIN pokazala je da su PUP-ovi oboljeli od ozbiljne hemofilije A koji su primili lijek Kogenate Bayer bili podložniji razvoju inhibitora od onih koji su primili drugi rekombinantni koagulacijski faktor VIII (prilagođeni omjer opasnosti, 1,60; 95%-CI: 1,08 -2,37).
English: However, the data presented by the MAH indicate that there are no significant changes in the posttranslational modifications, aggregation profile, specific activity or excipients since MA of Kogenate Bayer that might have increased the risk for inhibitor development over time.
Croatian: No, podaci koje je dostavio nositelj odobrenja ukazivali su na to da nije bilo značajnih izmjena u posttranslacijskim modifikacijama, profilu agregacije, specifičnom djelovanju ili pomoćnim tvarima od trenutka izdavanja odobrenja za stavljanje u promet lijeka Kogenate Bayer koji bi mogli povećati rizik od razvoja inhibitora tijekom vremena.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen.
Croatian: • je PRAC razmotrio postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 za lijekove Kogenate Bayer i Helixate NexGen,
English: The MAH also submitted data from four interventional clinical trials and six observational studies, which investigated the safety and efficacy of Kogenate Bayer/Helixate NexGen in haemophilia A patients, including studies 200021EU and 100074US in PUPs and minimally treated patients (MTPs).
Croatian: Nositelj odobrenja dostavio je također podatke iz četiri intervencijska klinička ispitivanja i šest opservacijskih ispitivanja, koja su istražila sigurnost i djelotvornost lijekova Kogenate Bayer/Helixate NexGen u bolesnika koji boluju od hemofilije A, uključujući ispitivanja 200021EU i 100074US u PUP
English: In this context, the PRAC noted that Kogenate Bayer and Helixate Nexgen is potency labelled based on an one-stage clotting assay, in accordance with the approved quality documentation for the product, and not the chromogenic assay as per the European Pharmacopeia.
Croatian: U ovom kontekstu, PRAC je uočio da su lijekovi Kogenate Bayer i Helixate Nexgen potencijalno označeni na temelju eseja koagulacije jedne faze, u skladu s odobrenom dokumentacijom o kvaliteti za lijek, a ne u skladu s kromogenskim esejom prema Europskoj farmakopeji.
English: • The PRAC considered though that the frequency for inhibitor development in PUPs should be amended from “common” to “very common” in the section 4.8 of the SmPC and also recommended that the product information should be updated to reflect the most recent results from the RODIN study.
Croatian: • je PRAC zaključio da se učestalost za razvoj inhibitora u PUP-ova treba izmijeniti iz „često” u „vrlo često” u dijelu 4.8 SPC-a te je također preporučio da se informacije o lijeku trebaju ažurirati tako da prikazuju najnovije rezultate ispitivanja RODIN,
English: In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with Helixate NexGen (followed up to 75 exposure days).
Croatian: U jednom opservacijskom ispitivanju, incidencija razvoja inhibitora u prethodno neliječenih bolesnika oboljelih od ozbiljne hemofilije A iznosila je 64/183 (37,7%) s lijekom Helixate NexGen (nakon 75 dana izlaganja).
English: The CHMP considered the below PRAC recommendation dated 5 December 2013 with regards to the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen.
Croatian: CHMP je razmotrio niže navedenu preporuku PRAC-a od 5. prosinca 2013. u vezi s postupkom provedenim u skladu s člankom 20. Uredbe (EZ) br. 726/2004 za lijekove Kogenate Bayer i Helixate NexGen.
English: Kogenate Bayer and Helixate NexGen are full-length recombinant human antihaemophilic factor VIII (octocog alfa) produced in baby hamster kidney (BHK) cells.
Croatian: Kogenate Bayer i Helixate NexGen su rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa) pune dužine proizveden u bubrežnim stanicama mladunčadi hrčka (BHK).
English: Finally in support of the above mentioned clinical data, the MAH provided quality data with regards to the manufacturing process for Kogenate Bayer and Helixate Nexgen.
Croatian: Naposljetku, u prilog prethodno navedenim kliničkim podacima, nositelj odobrenja dostavio je podatke o kvaliteti u vezi s proizvodnim postupkom za lijekove Kogenate Bayer i Helixate Nexgen.
English: In addition, the PRAC noted an update from the on-going EUHASS data, and results showed an inhibitor incidence for Kogenate Bayer and Helixate Nexgen comparable to other products: whereas no adjustment for known risk factors for inhibitor development could be performed due to the study design, the PRAC noted that the 95 % CIs of the point estimates of PUP inhibitor incidence were overlapping substantially between different products.
Croatian: Nadalje, PRAC je skrenuo pozornost na ažuriranje iz kontinuiranih podataka ispitivanja EUHASS, a rezultati su dokazali incidenciju inhibitora za lijekove Kogenate Bayer i Helixate Nexgen koja je usporediva s drugim proizvodima: budući da zbog dizajna ispitivanja nisu bila moguća podešavanja poznatog faktora rizika za razvoj inhibitora, PRAC je uočio da se 95 % CI-ova točke procjene incidencije inhibitora u PUP-ova značajno preklapalo između različitih lijekova.
English: The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annexes I and III.
Croatian: Izmjene relevantnih dijelova sažetka opisa svojstava lijeka i upute o lijeku navedene su u Dodacima I i III.
English: The objective of the RODIN/Pednet study was to examine the inhibitor development in PUPs with severe haemophilia A given recombinant or plasma-derived FVIII products.
Croatian: Cilj ispitivanja RODIN/Pednet bio je ispitati razvoj inhibitora u PUP-ova koji boluju od ozbiljne hemofilije A, a koji primaju rekombinantni faktor VIII ili faktor VIII dobiven iz plazme.
English: The MAH provided data on the above-mentioned observational studies with regards to the risk of inhibitor development in PUPs receiving FVIII products, including KOGENATE Bayer/Helixate NexGen.
Croatian: Nositelj odobrenja dostavio je podatke o prethodno navedenim opservacijskim ispitivanjima u vezi s rizikom razvoja inhibitora u PUP-a koji su primali lijekove koji sadrže FVIII, uključujući KOGENATE Bayer/Helixate NexGen.
English: Kogenate Bayer/Helixate NexGen are indicated for treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency).
Croatian: Kogenate Bayer/Helixate NexGen indicirani su za liječenje i profilaksu krvarenja u bolesnika oboljelih od hemofilije A (prirođenog nedostatka faktora VIII).
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC.
Croatian: Uredbe (EZ) br. 726/2004, nakon što je razmotrio preporuku PRAC-a od 5. prosinca 2013., mišljenje je CHMP-a da se odobrenja za stavljanje u promet lijekova Kogenate Bayer i Helixate NexGen trebaju izmijeniti sukladno preporuci PRAC-a.