natgillin/translations-raw huggingface dataset:
In these patients, clinical remission was achieved in 46% of patients by 28 weeks and 41% of patients by 52 weeks. 
Kod tih bolesnika klinička remisija postignuta je kod 46% bolesnika u 28 tjedana te kod 41% bolesnika u
Patients who failed to demonstrate response at week 6 in GEMINI II were retained in the study and received vedolizumab every four weeks. 
Bolesnici koji nisu postigli odgovor u 6. tjednu u ispitivanju GEMINI II zadržani su u ispitivanju te su primali vedolizumab svaka četiri tjedna.
GEMINI II contained two cohorts of patients that received vedolizumab at weeks 0 and 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 461 patients from cohorts 1 and 2, who were treated with vedolizumab and had achieved clinical response (defined as a ≥ 70-point decrease in CDAI score from baseline) at week 6, were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks. 
52. tjednu, 461 bolesnik iz kohorte 1 i 2 koji su liječeni vedolizumabom i koji su postigli klinički odgovor (definiran kao smanjenje od ≥ 70 bodova u rezultatu CDAI u odnosu na vrijednosti prije početka ispitivanja) u 6. tjednu, dvostruko slijepo su randomizirani (1:1:1) u jedan od sljedećih režima počevši od 6. tjedna: vedolizumab 300 mg svakih osam tjedana, vedolizumab 300 mg svaka četiri tjedna ili placebo svaka četiri tjedna.
Vedolizumab Every 8 weeks n = 154 
Vedolizumab svakih 8 tjedana n = 154
Therapy should be continued every eight weeks from week 14 in responding patients. 
Kod bolesnika koji postignu odgovor, liječenje je od 14. tjedna potrebno nastaviti svakih osam tjedana.
Patients who lost response to vedolizumab when treated every eight weeks were allowed to enter an open-label extension study and receive vedolizumab every four weeks. 
Bolesnici koji su izgubili odgovor na vedolizumab pri liječenju svakih osam tjedana mogli su ući u otvoreni nastavak ispitivanja i primati vedolizumab svaka četiri tjedna.
There is insufficient information on what effect this may have on your baby. 
Nema dovoljno podataka o učinku vedolizumaba na dojenčad.
Infusion related reactions after vedolizumab infusion are reported in subjects with anti-vedolizumab antibodies. 
U ispitanika s anti-vedolizumab protutijelima su nakon primjene infuzije vedolizumaba prijavljene reakcije povezane s infuzijom.
Vedolizumab Every 4 weeks n = 125 
Vedolizumab svakih 4 tjedna n = 125
If you get any side effects, talk to your doctor or nurse. 
Prije nego što dobijete Entyvio razgovarajte sa svojim liječnikom ili medicinskom sestrom.
§Clinical remission: Complete Mayo score of ≤ 2 points and no individual subscore > 1 point 
*p < 0,0001 †p ≤ 0,001 ‡p < 0,05 §Klinička remisija: Ukupna Mayo ocjena ≤ 2 boda i bez individualnog podrezultata > 1 boda ¶Cijeljenje sluznice: Mayo endoskopski podrezultat ≤ 1 boda
• redness of skin 
• crvenilo kože
Vedolizumab reduces gastrointestinal inflammation in UC and CD patients. 
Vedolizumab smanjuje gastrointestinalnu upalu kod bolesnika s ulceroznim kolitisom i Crohnovom bolešću.
The following information is intended for healthcare professionals only: 
Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Upute za rekonstituciju i infuziju 1.
• chills or shivering 
• peckanje ili trnci
Week 52 Efficacy Results of GEMINI I 
Tablica 5. Rezultati djelotvornosti u ispitivanju GEMINI II u 52. tjednu
• blocked nose 
• začepljen nos
: +358 20 746 5000 infoposti@takeda.com 
Puh./Tel.: +358 20 746 5000 infoposti@takeda.com
Vedolizumab has been detected in human milk. 
Zabilježena je prisutnost vedolizumaba u majčinom mlijeku.
Exploratory analysis showed clinically meaningful improvements were observed for the vedolizumab every four weeks and every eight weeks groups in GEMINI II and the improvements were significantly greater as compared with the placebo group from baseline to week 52 on EQ-5D and EQ-5D VAS scores, total IBDQ score, and IBDQ subscales of bowel symptoms and systemic function. 
Eksplorativne analize pokazale su da su u ispitivanju GEMINI II uočena klinički značajna poboljšanja uz vedolizumab primijenjen svaka četiri tjedna i svakih osam tjedana i ta su poboljšanja bila znatno veća u usporedbi sa skupinom koja je primala placebo od početka do 52. tjedna prema ljestvicama
Unopened vial: Store in a refrigerator (2 °C-8 °C). 
Neotvorena bočica: Čuvati u hladnjaku (2 ˚C-8 ˚C).
In these patients, clinical remission was achieved in 45% of patients by 28 weeks and 36% of patients by 52 weeks. 
Kod tih bolesnika klinička remisija postignuta je kod 45% bolesnika u 28. tjednu i kod 36% u 52. tjednu.
Improvements in durable clinical response (47%, 43%, 16%), mucosal healing (42%, 48%, 8%), durable clinical remission (21%, 13%, 3%) and corticosteroid-free clinical remission (23%, 32%, 4%) were seen in the prior TNFα antagonist failure population treated with vedolizumab every eight weeks, vedolizumab every four weeks and placebo, respectively. 
48%, 8%), trajnoj kliničkoj remisiji (21%, 13%, 3%) i kliničkoj remisiji bez kortikosteroida (23%,
In these patients, clinical remission was achieved in 23% of patients at week 28 and 32% of patients at week 52. 
Kod tih bolesnika klinička remisija postignuta je kod 23% bolesnika u 28. tjednu, te kod 32%
Use aseptic technique when preparing Entyvio solution for intravenous infusion. 
Pri pripremi otopine lijeka Entyvio za intravensku infuziju pridržavajte se aseptične tehnike.
NAME OF THE MEDICINAL PRODUCT Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab 
Uputa o lijeku: Informacija za bolesnika Entyvio 300 mg prašak za koncentrat za otopinu za infuziju vedolizumab
Corticosteroid-free clinical remission♠ 
Trajna klinička remisija# Klinička remisija bez kortikosteroida♠
No vedolizumab clinical trial data are available for patients previously treated with natalizumab or rituximab. 
Prethodna i istovremena uporaba bioloških lijekova Nema podataka iz kliničkih ispitivanja o primjeni vedolizumaba u bolesnika koji su prethodno liječeni natalizumabom ili rituksimabom.
approximately half of patients had previously failed TNFα antagonist therapy. 
U ispitivanju GEMINI II približno polovica bolesnika prethodno nije odgovorila na terapiju antagonistom TNFα.
• pain in the limb 
• bol u udovima
Inspect the reconstituted solution visually for particulate matter and discolouration prior to dilution. 
Prije razrjeđivanja provjerite rekonstituiranu otopinu kako biste isključili prisutnost čestica i promjenu boje.
• feeling sick 
Maligne bolesti
Pyrexia 
Često pireksija
: +30 210 6387800 gr.info@takeda.com 
TAKEDA ΕΛΛΑΣ Α.Ε. Τηλ.: +30 210 6387800 gr.info@takeda.com
Takeda Pharma A/S Tlf./Tel. 
Takeda Italia S.p.A Tel.:
• haemorrhoids 
• koprivnjaču
One serious adverse reaction of IRR was reported in a Crohn's disease patient during the second infusion (symptoms reported were dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was successfully managed with discontinuation of infusion and treatment with antihistamine and intravenous hydrocortisone. 
Jedna ozbiljna nuspojava obilježena kao RPI prijavljena je kod bolesnika s Crohnovom bolešću tijekom druge infuzije (prijavljeni simptomi bili su dispneja, bronhospazam, urtikarija, naleti crvenila,
TNFα Antagonist(s) Failure¶,‡ 
Neuspjeh liječenja antagonistom (antagonistima) TNFα¶,‡
Takeda Pharma Ges.m.b.H. 
Takeda Pharma Kft.
Very rare 
Manje često folikulitis
Oropharyngeal pain, Nasal congestion, Cough 
Često bol u ždrijelu i grkljanu, nazalna kongestija, kašalj
• pneumonia 
• upala pluća
In GEMINI I, two cohorts of patients received vedolizumab at week 0 and week 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 373 patients from cohort 1 and 2 who were treated with vedolizumab and had achieved clinical response at week 6 were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks. 
U ispitivanju GEMINI II dvije kohorte bolesnika primile su vedolizumab u 0. i 2. tjednu: u kohorti 1 bolesnici su dvostruko slijepo randomizirani za primanje bilo vedolizumaba 300 mg ili placeba, a bolesnici iz kohorte 2 su otvoreno liječeni vedolizumabom 300 mg.
Patients should be monitored closely for infections before, during and after treatment. 
Prije, tijekom i nakon liječenja bolesnike se mora pomno nadzirati kako bi se uočile infekcije.
• anal infection 
• analna infekcija
• rash and redness 
• osip i crvenilo
GEMINI III Study Clinical remission, week 6 Overall‡ 
Stopa kliničke remisije u ispitivanju GEMINI II u 6. tjednu iznosila je
TNFα Antagonist(s) Failure¶ 
Neuspjeh liječenja antagonistom (antagonistima) TNFα
Tell your doctor as soon as possible if you notice any of the following: 
Razgovarajte sa svojim liječnikom što je prije moguće ako primijetite bilo što od sljedećeg: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
Tel.: +43 (0) 800 20 80 50 
Takeda Pharma Ges.m.b.H. Tel.: +43 (0) 800 20 80 50
The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection, bronchitis, influenza and sinusitis), headache, nausea, pyrexia, fatigue, cough, arthralgia. 
bronhitis, influenca i sinusitis), glavobolja, mučnina, pireksija, umor, kašalj, artralgija.
You must not be given Entyvio: 
Što morate znati prije nego primite Entyvio Ne smijete primiti Entyvio:
*p < 0.05 †not statistically significant ‡secondary endpoint to be viewed as exploratory by pre-specified statistical testing procedure §not statistically significant, the other endpoints were therefore not tested statistically ¶n = 157 for placebo and n = 158 for vedolizumab #Sustained clinical remission: clinical remission at weeks 6 and 10 ^Exploratory Endpoint 
‡sekundarni ishod treba gledati kao eksplorativni putem prethodno navedenog postupka statističkog testiranja §nije statistički značajno, drugi ishodi stoga nisu statistički testirani
(see Annex I: Summary of Product Characteristics, section 4.2). 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
B e lgië/Belgique/Belgien Takeda Belgium Tel./Tél. 
België/Belgique/Belgien
• muscle cramps 
• nadut trbuh-plinovi
Tel: +420 731 620 870 
Takeda Pharmaceuticals Czech Republic s.r.o. Tel: + 420 731 620 870
Clinical response Clinical remission§ Mucosal healing¶ 
Klinički odgovor Klinička remisija§
Tlf. 
SN:
Clinical remission 
Prijavljivanje nuspojava
By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect specific to the gut. 
Vezanjem na integrin α4β7 izražen na limfocitima u crijevima,
Week 6 Efficacy Results of GEMINI I 
Tablica 2. Rezultati djelotvornosti u ispitivanju GEMINI I u 6. tjednu
Takeda Products Ireland Ltd. Tel.: +353 (0) 1 6420021 
Takeda Pharmaceuticals Slovakia s.r.o. Tel.: +421 (2) 20 602 600
TNFα Antagonist(s) Naïve^ 
Bez prethodnog liječenja TNFα antagonistom (antagonistima) ^
Malignancies 
• mučninu
Common side effects (may affect up to 1 in 10 people): 
Česte nuspojave (mogu se javiti u do 1 na 10 osoba): • vrućica
The combined in-use stability of Entyvio in the vial and infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection is a total of 12 hours at 20°C-25°C or 24 hours at 2°C-8°C. 
otopinom natrijeva klorida za injekciju iznosi ukupno 12 sati pri 20 °C-25 °C ili 24 sata pri 2 °C-8 °C.
Sve rige 
Ukupno^
The procedure started on 25 September 2014. 
Postupak je započeo 25. rujna 2014.
These statements were carefully assessed. 
Ove su izjave pažljivo ocijenjene.
The data manipulations took place between at least July 2008 and 2013. 
Manipulacije podacima događale su se u najmanju ruku tijekom razdoblja od srpnja 2008. i 2013.
Discussions 
Rasprave
These data manipulations cast doubts on the authenticity of all other clinical records of these nine clinical trials. 
Te manipulacije podacima bacaju sumnju na autentičnost svih drugih kliničkih evidencija ovih devet kliničkih ispitivanja.
Grounds for CHMP Opinion 
Razlozi za mišljenje CHMP-a
This period of deferral shall not exceed twenty-four months from the Commission Decision. 
Ovo razdoblje odgode ne smije premašivati dvadeset četiri mjeseca od donošenja odluke Komisije.
Neo Balkanika (for Nebivolol); 
Neo Balkanika (za Nebivolol);
That being the case, volunteers would be unnecessarily exposed to a medicinal product without a clear need, which is not acceptable from an ethical point of view. 
Budući da je to slučaj, dobrovoljci bi nepotrebno bili izloženi lijeku bez jasne potrebe, što nije prihvatljivo s etičkog stajališta.
Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP recommends: 
Stoga, u skladu s člankom 31. i 32. Direktive 2001/83/EZ, CHMP preporuča:
The full bioanalytical report is missing. 
Nedostaje potpuni bioanalitički izvještaj.
Nor does it allow for the findings of a previous inspection to be ignored. 
Niti se mogu zanemariti nalazi prethodnih inspekcija.
The European Commission initiated a referral under article 31 of Directive 2001/83/EC on 4 August 2014. 
Europska komisija pokrenula je postupak upućivanja u skladu sa člankom 31. Direktive 2001/83/EZ dana 4. kolovoza 2014.
The CHMP therefore decided to extend the scope of the review by also including studies performed between 2004 and 2008. 
Stoga je CHMP odlučio proširiti predmet pregleda uključujući i ispitivanja provedena između 2004. i 2008.
Category 2 medicinal products 
Lijekovi kategorije 2
It is recognised that alendronate occupies an important place in the treatment of post-menopausal osteoporosis. 
Priznato je da alendronat zauzima važno mjesto u terapiji osteoporoze u postmenopauzi.
However, prescription of the suspended MAs can be reported to another generic or the innovator brand. 
No, propisivanje suspendiranih MA-ova može se prijaviti drugoj generičkoj ili inovatorskoj marki.
Category 1 medicinal products 
Lijekovi kategorije 1
This reference medicinal product has to be authorised in the EU under the EU procedures described in Article 6 and in accordance with the EU requirements defined in Article 8 of the said Directive. 
Ovaj referentni lijek mora biti odobren u EUu u skladu s EU postupcima opisanima u članku 6. i u skladu s EU zahtjevima definiranima u članku 8. navedene Direktive.
As stated in Article 62(1) paragraph 4 of Regulation (EC) No 726/2004 and Article 32(4) paragraph 3 of Directive 2001/83/EC, “the re-examination procedure may deal only with the points of the opinion initially identified by the applicant/MAH and may be based only on the scientific data available when the Committee adopted the initial opinion.” Therefore these scientific data can not be considered during the re-examination procedure. 
Kako je navedeno u članku 62. stavki 1., točki 4 Uredbe (EZ) br. 726/2004 i članku 32. stavki 4., točki 3 Direktive 2001/83/EZ "postupak ponovne ocjene može se provoditi samo u točkama mišljenja koje su prvotno identificirane od strane podnositelja zahtjeva/nositelja odobrenja, i mogu se temeljiti samo na znanstvenim podacima dostupnima u trenutku kada je Povjerenstvo usvajalo prvotno mišljenje."
The medicinal products concerned are listed in Annex I. 
Lijekovi obuhvaćeni ovim postupkom navedeni su u Prilogu I.
In addition, inspections by regulatory authorities follow a sampling process in which specific parts of a particular activity are looked at in detail to establish whether its conduct complied with all relevant guidelines and regulations. 
Nadalje, inspekcije provedena od strane regulatornih tijela nakon postupka uzrokovanja, tijekom koje su pobliže pregledani specifični dijelovi određenog djelovanja kako bi se utvrdilo je li postupak proveden u skladu sa svim relevantnim smjernicama i propisima.
• Re-examination request for Nebivolol Genericon Pharma Austria 
• Zahtjev za ponovnu ocjenu lijeka Nebivolol Genericon Pharma Austria
• Composition differences - the test product contains critical excipients that may affect the pharmacokinetics profile of the medicinal product (absorption). 
• Razlike u sastavu - testni lijekovi sadrže kritične pomoćne tvari koje mogu utjecati na farmakokinetički profil lijeka (apsorpcija).
This means that a successful outcome in a particular inspection cannot be taken as a guarantee that all processes are properly run and GCP compliant. 
To znači da se uspješan ishod dotične inspekcije ne može uzeti kao garancija da su svi postupci ispravno provedeni i skladu s DKP-om.
The MAHs argue that this generalisation can only be justified if evidence is provided that individual audits were not conducted to the appropriate standard, and that no such evidence has been provided. 
Nositelji odobrenja tvrdili su da se ova generalizacija može opravdati samo ako su dostavljeni dokazi da pojedinačne revizije nisu provedene u skladu s odgovarajućim standardom, te da takav dokaz nije dostavljen.
• The Committee reviewed all available data and information provided by the MAHs, as well as information provided by GVK Bio; 
• Odbor je pregledao sve dostupne podatke i informacije koje su dostavili nositelji odobrenja, kao i informacije koje je dostavila tvrtka GVK Bio;
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products concerned by the GVK Bio procedure; 
• Odbor je razmotrio postupak proveden sukladno članku 31. Direktive 2001/83/EZ za predmetne lijekove obuhvaćene postupkom tvrtke GVK Bio;
Considerations to all products reviewed within the framework of this procedure 
Razmatranja o svim lijekovima pregledanima u okviru ovog postupka
The information was noted, but as no data of this bioequivalence study have been submitted within the article 31 procedure, it was not considered in the review. 
Informacije su uzete u obzir, no budući da nisu dostavljeni podaci ovog ispitivanja bioekvivalencije u okviru postupka članka 31., iste nisu uzete u obzir prilikom pregleda.
Importance of alendronate therapy for patients: The MAHs argue on the importance of the alendronate therapy for patients and continuous availability of the medicine to safeguard public health. 
Važnost terapije alendronatom za bolesnike: Nositelji odobrenja argumentirali su važnost terapije alendronatom u bolesnika i kontinuiranu dostupnost lijeka za očuvanje javnoga zdravstva.
• Absorption through the oral cavity for an orodispersible formulation cannot be excluded 
• ne može se isključiti apsorpcija kroz usnu šupljinu za orodisperzibilne formulacije
Ranbaxy, Basics GmbH, Takeda Belgium, Pensa Pharma and Labesfal Genéricos (for Alendronate); 
1. Ranbaxy, Basics GmbH, Takeda Belgium, Pensa Pharma i Labesfal Genéricos (za Alendronate);
Genericon Pharma Austria (for Nebivolol). 
5. Genericon Pharma Austria (za Nebivolol).
The French Agency on medicinal products (ANSM) conducted an inspection on 19-23 May 2014 (inspection reference GCP-141001-FR) at GVK Biosciences Private Limited, Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, India. 
Francuska agencija za lijekove (ANSM) provela je pregled u razdoblju od 19. do 23. svibnja 2014. (referenca pregleda GCP-141001-FR) u tvrtci GVK Biosciences Private Limited, poslovni kompleks Swarna Jayanthi, Ameerpet, Hyderabad 500 038, Indija.
• The Committee considered the grounds for re-examination provided by the MAHs in writing; 
• Odbor je razmatrao temelje za ponovnu procjenu koje je osigurao nositelj odobrenja napismeno;
Post-marketing experience: The MAH argues on the long term post marketing experience of almost seven years for Alendronic acid containing formulations. 
Iskustvo nakon stavljanja u promet: Nositelj odobrenja argumentirao je dugoročno iskustvo nakon stavljanja lijeka u promet od gotovo sedam godina za formulacije koje sadrže alendronijsku kiselinu.
Only a synopsis of a pilot study has been submitted. 
Dostavljena je samo sažetak pilot ispitivanja.
However, in light of the nature, the severity and the extent of the GCP findings identified in the ANSM's inspection in May 2014, these arguments do not demonstrate that the said studies can be relied upon. 
No, uzimajući u obzir prirodu, ozbiljnost i razmjere nalaza o DKP-u utvrđenih tijekom inspekcije ANSM-a u svibnju 2014., ovi argumenti ne potvrđuju da su navedena ispitivanja pouzdana.
In addition, the MAH claims that in art 10 of Directive 2001/83/EC there is ‘room for interpretation', and it is not specifically mentioned that an EU reference product must be used. 
Nadalje, nositelj odobrenja tvrdio je da u čl. 10. Direktive 2001/83/EZ postoji "prostora za tumačaenje", te da nije nigdje izričito navedeno da se mora koristiti referentni proizvod odobren u EUu.
According to the MAH, this is only mentioned in the Guideline on the Investigation of Bioequivalence. 
Prema nositelju odobrenja, to je samo navedeno u smjernicama o istraživanju bioekvivalencije.
• Re-examination request for Nebivolol Neo-Balkanika: 
• Zahtjev za ponovnu ocjenu lijeka Nebivolol Neo-Balkanika:
The following findings were reported in the French inspection report dated 02 July 2014, to which GVK Bio have responded on 18 July 2014 and in the final inspection report, which was issued on 21 July 2014: data manipulations of electrocardiograms (ECGs) were detected in each and every one of the 9 trials inspected by the ANSM. 
Sljedeći nalazi izneseni su u izvještaju francuske inspekcije od 2. srpnja 2014., na koji je tvrtka GVK Bio odgovorila 18. srpnja 2014. kao i u završnom izvještaju inspekcije, koji je objavljen 21. srpnja 2014.: otkrivene su manipulacije podacima elektrokardiograma (EKG) u svakom od 9 ispitivanja koje je pregledao ANSM.
However, the CHMP is of the opinion that the absence of the identification of any pharmacovigilance signals does not provide sufficient reassurance because it is not established that the pharmacovigilance activities may be designed to detect such a signal. 
No, CHMP je mišljenja da izostanak identifikacije bilo kakvog signala farmakovigilancije ne pruža dovoljno sigurnosti budući da se ne može utvrditi da farmakovigilancijske aktivnosti mogu biti dizajnirane kako bi otkrile takav signal.
For the above reasons, the lack of proof of bioequivalence can not be substituted by post marketing experience data. 
Uslijed prethodno navedenih razloga, nedostatak dokaza bioekvivalencije se ne može zamijeniti podacima prikupljenima nakon stavljanja lijeka u promet.
However the CHMP is of the view that the findings by ANSM in 2014 were serious in terms of the impact on the integrity of the studies. 
No, CHMO je mišljenja da nalazi su prikupljeni od strane ANSM-a u 2014. godini bili ozbiljni u smislu utjecaja na integritet ovih ispitivanja.
Based on the same argumentation as described above for Irbesartan, the MAH claims that the data obtained in the AU study are still applicable for the EU. 
Na temelju iste argumentacije kako je prethodno opisano za Irbesartan, nositelj odobrenja tvrdi da su prikupljeni podaci u AU ispitivanju primjenjivi na EU.
They also show a lack of GCP training, awareness and understanding of members of GVK Bio staff, a lack of understanding by them of the importance of data integrity and of the possible consequences of their acts, as well as a lack of overview of clinical trial activities by the investigators. 
To također ukazuje na nedostatak obuke za DKP, svjesnosti i razumijevanja među članovima osoblja tvrtke GVK Bio, nedostatak njihovog razumijevanja važnosti cjelovitosti podataka i mogućih posljedica njihovih postupaka, kao i manjak pregleda istražitelja nad aktivnostima kliničkog ispitivanja
Annex II Scientific conclusions and grounds for the recommendations for maintenance and suspension of the marketing authorisations 
Znanstveni zaključci i razlozi za preporuke za zadržavanje i privremeno oduzimanje odobrenja za stavljanje lijeka u promet