FrancophonIA/ELRC3.0 huggingface dataset:
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg / ml at week 2 and week 4.
Croatian: Nakon primjene adalimumaba u dozi od 160 mg u nultom tjednu i 80 mg u 2. tjednu u odraslih bolesnika s gnojnim hidradenitisom, najniže koncentracije adalimumaba u serumu u 2. i 4. tjednu iznosile su približno 7 do 8 µg/ml.
English: Patients who maintained ≥PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Croatian: A bili randomizirani za terapiju aktivnim lijekom, ponovno su randomizirani u razdoblju C tako da su tijekom dodatnih 19 tjedana primali ili adalimumab 40 mg svaki drugi tjedan ili placebo.
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg injections), followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Uobičajena doza za odrasle s nezaraznim uveitisom je početna doza od 80 mg (u obliku dvije injekcije od 40 mg), nakon čega slijedi doza od 40 mg svaka dva tjedna, počevši tjedan dana nakon početne doze.
English: Methotrexate should be continued during treatment with Hefiya.
Croatian: Za vrijeme liječenja lijekom Hefiya treba nastaviti primjenu metotreksata.
English: Subjects (n = 215, 54.7 %) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Croatian: ASAS 20 u 12., 16. ili 20. tjednu ranije su prebačeni u otvoreni dio ispitivanja i dobivali su 40 mg adalimumaba supkutano svaki drugi tjedan.
English: There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 12 godina za ovu indikaciju.
English: One 0.8 ml pre-filled syringe contains 40 mg adalimumab.
Croatian: Jedna napunjena brizgalica od 0,8 ml sadrži 40 mg adalimumaba.
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Croatian: dvostruko slijepom ispitivanju koje je uključivalo 46 pedijatrijskih bolesnika (u dobi od 6 do 17 godina) s umjerenim artritisom povezanim s entezitisom.
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Hefiya is an initial dose of 40 mg, followed by 40 mg one week later.
Croatian: Djeca i adolescenti u dobi od 6 do 17 godina, tjelesne težine 40 kg ili više Uobičajena početna doza lijeka je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg.
English: Musculoskeletal pain
Croatian: infekcije zglobova
English: Liver failure1)
Croatian: Nepoznato Zatajenje jetre1)
English: Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Croatian: Ako se unutar tog razdoblja ne postigne terapijski odgovor, potrebno je pomno razmotriti nastavak liječenja takvog bolesnika.
English: • urinary tract infection;
Croatian: • infekcije mokraćnih putova, • gljivične infekcije,
English: Headache
Croatian: Nuspojava
English: paleness.
Croatian: Hefiya.
English: ASAS 20
Croatian: Tablica 23
English: PsA study II
Croatian: ispitivanje PsA II
English: a time to treatment failure at or after week 6 in study UV I
Croatian: HRa 95% CI za HRa p-vrijednostb vrijeme do neuspjeha liječenja u 6. tjednu ili nakon njega u ispitivanju UV I
English: ACR 20 week 12 week 24 ACR 50 week 12 week 24 ACR 70 week 12 week 24
Croatian: ACR 20 12. tjedan 24. tjedan
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Croatian: Odrasli s reumatoidnim artritisom, psorijatičnim artritisom, ankilozantnim spondilitisom ili aksijalnim spondiloartritisom bez radiografskog dokaza ankilozantnog spondilitisa
English: • Crohn's disease,
Croatian: • Crohnove bolesti
English: 115 45 (39.1) NEc
Croatian: ND 9,5% 41,5%
English: Hefiya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Croatian: Aksijalni spondiloartritis bez radiografskog dokaza AS-a Hefiya je indiciran za liječenje teškog oblika aksijalnog spondiloartritisa bez radiografskog dokaza AS-a kod odraslih, ali s objektivnim znakovima upale u obliku povišenog C-reaktivnog proteina
English: 2 years.
Croatian: 10 sekundi.
English: ASAS 70 week 2 week 12 week 24
Croatian: ACR 70 12. tjedan 24. tjedan
English: Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Croatian: U bolesnika liječenih adalimumabom prijavljeni su rijetki slučajevi hepatospleničnog T-staničnog limfoma nakon stavljanja lijeka u promet.
English: The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Croatian: Djelotvornost i sigurnost adalimumaba ocjenjivale su se u randomiziranim, dvostruko slijepim, placebom kontroliranim ispitivanjima u više od 1500 bolesnika s umjerenom do teškom aktivnom
English: BASDAIb 50 week 2 week 12 week 24 ***,** statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24
Croatian: nakon 24 tjedna i nakon 52 tjedna b 40 mg adalimumaba primijenjenog svaki drugi tjedan c MTX = metotreksat ** p<0,01, adalimumab u usporedbi s placebom
English: Hefiya 40 mg solution for injection in pre-filled pen:
Croatian: Hefiya 40 mg otopina za injekciju u napunjenoj brizgalici:
English: Hefiya is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen (SensoReady) with transparent window and label.
Croatian: Hefiya se isporučuje u jednokratnoj, napunjenoj štrcaljki uloženoj u brizgalicu trokutastog oblika
English: Elderly
Croatian: Tahikardija
English: Package leaflet: Information for the patient Hefiya 40 mg solution for injection in pre-filled syringe adalimumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Hefiya 40 mg otopina za injekciju u napunjenoj štrcaljki adalimumab
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections
Croatian: infekcije kože i mekog tkiva (uključujući paronihiju, celulitis, impetigo, nekrotizirajući fasciitis i herpes zoster), infekcije uha,
English: • abnormal blood measurements for sodium;
Croatian: • razina natrija u krvi izvan normalnih vrijednosti,
English: Hefiya dose for paediatric patients with uveitis Patient weight
Croatian: Tablica 5. Doza lijeka Hefiya za pedijatrijske bolesnike s uveitisom Tjelesna težina bolesnika
English: Cardiac arrest
Croatian: Zastoj srca
English: Beyond 16 weeks, patients with inadequate response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Croatian: U bolesnika u kojih nije postignut zadovoljavajući odgovor na Hefiya u dozi od 40 mg svaki drugi tjedan nakon 16 tjedana, možda će biti korisno povećati doziranje na 40 mg lijeka svaki tjedan ili 80 mg svaki drugi tjedan.
English: Packs of 1 and 2 pre-filled syringes in a blister
Croatian: Pakiranja sadrže 1 ili 2 napunjene štrcaljke u blisteru Višestruka pakiranja sadrže 6 (3 pakiranja po 2) napunjenih štrcaljki u blisteru
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA
English: Following the administration of 24 mg / m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg / ml (102 % CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg / ml (47.7 % CV) with concomitant methotrexate.
Croatian: Nakon primjene 24 mg/m2 (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s poliartikularnim juvenilnim idiopatskim artritisom (JIA) u dobi od 4 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene od 20.
English: If this dose does not work well enough, your doctor may increase the dose frequency to 20 mg every week.
Croatian: Ako ta doza ne djeluje dovoljno dobro, Vaš liječnik Vam može povećati doziranje na 40 mg svaki ili 80 mg svaki drugi tjedan.
English: • vision disturbances;
Croatian: • poremećaj cijeljenja.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160 / 80 mg or 80 / 40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40 / 20 mg eow) or Low Dose (20 / 10 mg eow) maintenance treatment groups based on their body weight.
Croatian: U pedijatrijskih bolesnika s umjerenom do teškom Crohnovom bolešću, otvorena indukcijska doza adalimumaba bila je 160/80 mg ili 80/40 mg u nultom, odnosno drugom tjednu, ovisno o graničnoj vrijednosti za tjelesnu težinu od 40 kg.
English: The usual Hefiya dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections) two weeks later, and then 40 mg every other week.
Croatian: Uobičajena početna doza lijeka Hefiya za odrasle bolesnike s ulceroznim kolitisom je 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije na dan tijekom dva uzastopna dana), nakon čega poslije dva tjedna slijedi doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Croatian: Nema relevantne primjene adalimumaba u djece u indikacijama ankilozantnog spondilitisa i psorijatičnog artritisa.
English: Elevated liver enzymes
Croatian: povišene razine mokraćne kiseline,
English: Each 0.8 ml single-dose pre-filled syringe contains 40 mg of adalimumab.
Croatian: Jedna napunjena brizgalica s jednokratnom dozom od 0,8 ml sadrži 40 mg adalimumaba.
English: Renal impairment, haematuria
Croatian: anksioznost, nesanica
English: Dose interruption
Croatian: Prekid terapije
English: • erythema multiforme (inflammatory skin rash);
Croatian: • edem (oticanje) lica povezana s alergijskim reakcijama, • multiformni eritem (upalni kožni osip),
English: Inflammation
Croatian: anemija
English: • Once removed, throw away the cap. Do not try to re-attach the cap.
Croatian: • Nakon što ga skinete, zatvarač bacite.
English: Patients received either placebo or 20 mg adalimumab (if < 30 kg) or 40 mg adalimumab (if ≥ 30 kg) every other week in combination with their baseline dose of methotrexate.
Croatian: (ako su bili tjelesne težine < 30 kg) odnosno 40 mg adalimumaba (ako su bili tjelesne težine ≥ 30 kg)
English: Keep the pre-filled syringes in the outer carton in order to protect from light.
Croatian: Napunjene brizgalice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Adalimumab has not been studied in patients with hepatic or renal impairment.
Croatian: Oštećenje funkcije jetre ili bubrega Adalimumab nije ispitivan u bolesnika s oštećenom funkcijom jetre ili bubrega.
English: Lipids increased
Croatian: Vrlo često Povišena razina lipida Često
English: analysis
Croatian: analiza liječenje
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)1)
Croatian: demijelinizirajući poremećaji (npr. optički neuritis,
English: • injection site reactions (including pain, swelling, redness or itching);
Croatian: • reakcije na mjestu ubrizgavanja (uključujući bol, oticanje, crvenilo ili svrbež), • infekcije dišnog sustava (uključujući prehladu, curenje nosa, infekciju sinusa, upalu pluća),
English: • low blood potassium.
Croatian: • niska razina kalija u krvi.
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Hefiya.
Croatian: Nakon uzimanja lijeka Hefiya može se javiti osjećaj da se prostorija vrti (vrtoglavica) te smetnje vida.
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: The third group received 40 mg of adalimumab every other week with placebo injections on alternate weeks.
Croatian: Druga je dobivala 20 mg adalimumaba svaki tjedan tijekom 52 tjedna, dok je treća skupina svaki tjedan naizmjenično dobivala 40 mg adalimumaba ili placebo (jedan tjedan 40 mg adalimumaba, drugi tjedan placebo).
English: Marketing Authorisation Holder
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: a assessments in ankylosing spondylitis b
Croatian: Assessments in Ankylosing Spondylitis, ASAS) b Bath indeks aktivnosti ankilozantnog spondilitisa (engl.
English: • impaired healing.
Croatian: (ukidanje liječenja)
English: Paediatric Uveitis
Croatian: • nezaraznog uveitisa
English: • rash;
Croatian: • osip,
English: • fungal infections;
Croatian: • infekcije zglobova,
English: • In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
Croatian: • U bolesnika koji primjenjuju adalimumab zamijećene su i neke vrste nemelanomskog raka kože.
English: In the open-label extension for RA study III, most patients who were ACR responders maintained response when followed for up to 10 years.
Croatian: U većine je bolesnika postignuti ACR odgovor održan u otvorenom produžetku ispitivanja RA III
English: pJIA I
Croatian: RMP-a.
English: The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Croatian: Uobičajena početna doza lijeka Hefiya je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg svaki drugi tjedan.
English: The mean steady-state trough concentration at week 12 through week 36 were approximately 8 to 10 μg / ml during adalimumab 40 mg every week treatment.
Croatian: Kada se adalimumab primjenjivao u dozi od 40 mg svaki tjedan, srednja vrijednost najniže koncentracije u stanju dinamičke ravnoteže od 12. do 36. tjedna iznosila je približno 8 do 10 µg/ml.
English: Tachycardia
Croatian: EGZACERBACIJE
English: 31 July 2016
Croatian: 31.srpnja 2016
English: Within 30 days following EC decision
Croatian: Unutar 30 dana nakon odluke europske komisije
English: Date
Croatian: Datum
English: Conditions
Croatian: Uvjeti
English: Final study report by:
Croatian: Završno izvješće iz ispitivanja do:
English: 31 March 2014 and annually thereafter
Croatian: 31. ožujka 2014. te jednom godišnje nakon toga
English: • same data lock point (31st of December of each year),
Croatian: • isti datum zaključavanja podataka (31. prosinca svake godine),
English: For products without an RMP, a RMP should be submitted.
Croatian: Za proizvode bez RMP, potrebno je predati RMP.
English: • same exposure definition (expressed in 100,000 patients treated - daily dose of 100 mg equivalents),
Croatian: • istu definiciju izloženosti (izraženu na 100 000 liječenih bolesnika - dnevna doza od 100 mg ili jednako tome),
English: This will highlight the risks and warnings on hypersensitivity reactions (by e.g. a checklist, to be implemented at national level).
Croatian: To će istaknuti rizike i upozorenja o reakcijama preosjetljivosti (primjerice putem liste provjere koju treba implementirati na državnoj razini).
English: Conditions to the marketing authorisation
Croatian: Uvjeti odobrenja za stavljanje lijeka u promet
English: In order to improve the overall product comparability, the MAHs should have:
Croatian: Kako bi se poboljšala ukupna usporedivost lijeka, nositelji odobrenja trebaju:
English: • same event definition (use of the specific PT “Hypersensitivity” and the narrow and broad scope SMQs for “Anaphylactic reactions and angioedema”: the MAHs should confirm their coding convention for capturing symptoms and diagnosis as MedDRA terms)
Croatian: • istu definiciju događaja (upotrebu specifične PT „Preosjetljivosti” te široki i uski opseg standardiziranih upita u sustavu MedDRA (SMQs) za „Anafilaktičke reakcije i angioedem”: nositelji odobrenja trebaju potvrditi konvencije kodiranja za snimanje simptoma i dijagnosticiranje prema pojmovima MedDRA)
English: National competent authorities of Member State(s) coordinated by reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nadležna državna tijela države članice (država članica) koje koordiniraju referentne države članice (država članica) ukoliko je to primjenjivo pobrinut će se da nositelj(i) odobrenja ispune sljedeće uvjete:
English: The study will also have to be reflected in the updated/new RMP submission.
Croatian: Ispitivanje će se također odraziti na podnesak ažuriranog/novog RMP-a.
English: The MAHs should update the risk management plan (RMP) for products with an existing RMP to include the additional risk minimisation measures and the additional pharmacovigilance activities agreed as part of this procedure.
Croatian: Nositelji odobrenja trebaju ažurirati plan upravljanja rizicima (RMP) za lijekove s postojećim Planom upravljanja rizicima kako bi uključivali dodatne mjere minimizacije rizika i dodatne farmakovigilancijske aktivnosti koje su dogovorene kao dio ovog postupka.
English: The MAHs should circulate the agreed DHPC in coordination with the NCAs according to the action plan agreed by CHMP.
Croatian: Nositelji odobrenja trebaju prosljeđivati dogovoreni DHPC u koordinaciji s nadležnim državnim tijelima u skladu s planom koji je dogovorilo CHMP.
English: The MAHs should submit annual cumulative reviews of hypersensitivity case reports, all fatal cases and all pregnancy cases, together with usage data yearly.
Croatian: Nositelj odobrenja treba predati godišnja kumulativna izvješća o slučajevima preosjetljivosti, sve smrtne slučajeve i sve slučajeve izloženosti lijeku tijekom trudnoće skupa s podacima o upotrebljivosti istih na godišnjoj bazi.
English: The MAH(s) should provide within the risk management plan educational material for prescribers and patients.
Croatian: Nositelj(i) odobrenja treba(ju) osigurati edukativni materijal u sklopu plana upravljanja rizikom kako za propisivače tako i za bolesnike.
English: • and use the severity classification according to Ring and Messmer classification.
Croatian: • i upotrebe klasifikacije ozbiljnosti događaja u skladu s Ringovom i Messmerovom klasifikacijom.
English: The MAHs shall conduct a PASS to further characterise the safety concerns on the hypersensitivity reactions.
Croatian: Nositelji odobrenja će provesti ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet (PASS) kako bi se dalje karakterizirale sigurnosne brige o reakcijama preosjetljivosti.
English: Questions and answers
Croatian: Pitanja i odgovori
English: EMA/460814/2013 EMEA/H/C/002542
Croatian: 26. srpnja 2013. EMA/460814/2013 EMEA/H/C/002542
English: Outcome of re-examination
Croatian: Ishod ponovnog ocjenjivanja
English: 26 July 2013
Croatian: Dana 25. travnja 2013.
English: It was not clear that these risks could be managed successfully in medical practice.
Croatian: Nije bilo jasno može li se tim rizicima uspješno upravljati prilikom primjene lijeka.
English: The company will consider future requests for compassionate use on an individual basis in accordance with local regulations.
Croatian: Tvrtka će daljnje zahtjeve za milosrdnu uporabu razmotriti na individualnoj osnovi u skladu s lokalnim propisima.
English: It was to be available as tablets (5 mg).
Croatian: Trebao se koristiti u obliku tableta (5 mg).
English: What is Xeljanz?
Croatian: Što je Xeljanz?
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ukoliko ste sudionik kliničkog ispitivanja ili ste uključeni u program milosrdne uporabe, a želite dobiti više informacija o liječenju, obratite se liječniku koji vam je dao lijek.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje su posljedice odbijanja zahtjeva za bolesnike u kliničkim ispitivanjima ili za pacijente u programima milosrdne uporabe?
English: The applicant requested a re-examination of the opinion.
Croatian: Podnositelj zahtjeva podnio je molbu za preispitivanje mišljenja.
English: At re-examination in July 2013 the company proposed to remove claims of an effect on structural damage from the indication.
Croatian: Prilikom ponovnog ocjenjivanja u srpnju 2013. godine tvrtka je predložila uklanjanje tvrdnji o učinku na strukturno oštećenje iz popisa terapijskih indikacija.
English: They are produced by a method known as ‘recombinant DNA technology': they are made by cells that have received a gene (DNA) that makes them able to produce the medicine.
Croatian: Proizvode se metodom poznatom pod nazivom „rekombinantna DNK tehnologija”, tj. proizvode ih stanice u koje je ugrađen gen (DNK) koji im omogućava proizvodnju lijeka.
English: The company informed the CHMP that patients receiving tofacitinib in clinical trials will continue to receive it as planned.
Croatian: Tvrtka je obavijestila CHMP da će bolesnici koji dobivaju tofacitinib u sklopu kliničkih ispitivanja isti dobivati i dalje prema planu.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 25 July 2013.
Croatian: Nakon razmatranja osnovanosti te molbe, CHMP je preispitao prvotno mišljenje i 25. srpnja 2013. godine potvrdio uskratu odobrenja za stavljanje u promet.
English: Biological DMARDs are medicines that target specific proteins in the immune system.
Croatian: Biološki DMARD-i su lijekovi koji djeluju na specifične proteine imunološkog sustava.
English: The company that applied for authorisation is Pfizer Limited.
Croatian: Zahtjev je podnijela tvrtka Pfizer Limited.
English: The CHMP refusal was confirmed after re-examination.
Croatian: Uskrata CHMP-a potvrđena je pri ponovnom ocjenjivanju.
English: However, the lack of robust evidence on prevention of structural damage with Xeljanz in the proposed dose and population still contributed to the Committee's view that the benefits of treatment did not outweigh significant and unresolved concerns about safety.
Croatian: Međutim, nedostatak čvrstih dokaza da Xeljanz sprečava strukturno oštećenje u predloženoj dozi i populaciji ipak je pridonijelo mišljenju Povjerenstva da koristi liječenja nisu veće od značajnih i neriješenih pitanja sigurnosti.