natgillin/translations-raw huggingface dataset:
Hefiya therapy should not be continued in patients failing to respond within this time period. 
Pri bolnikih, ki se v tem času ne odzovejo, zdravljenja z zdravilom Hefiya ni priporočljivo nadaljevati.
Common (may affect up to 1 in 10 people) 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
Giving your injection: 
Injiciranje:
• Do not freeze the syringes. 
• Injekcijskih brizg ne zamrzujte.
• headache; 
• glavobol;
Hepato-biliary disorders* 
maligni melanom**
clinical remission clinical response (CR-100) patients in steroid-free remission for > = 90 daysa * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a of those receiving corticosteroids at baseline 
* p < 0,05 za parno primerjavo deležev med adalimumabom in placebom * p < 0,001 za parno primerjavo deležev med adalimumabom in placebom a od tistih, ki so izhodiščno prejemali kortikosteroide
In Psoriasis Study I, 28 % of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5 % continuing on adalimumab, p < 0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a < PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33). 
V študiji pri psoriazi I so 33. teden "izgubo ustreznega odziva" zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov,
placebo adalimumab 40 mg eow week 52 
placebo adalimumab 40 mg vsak drugi teden
• low blood measurements for red blood cells; 
• nizke krvne vrednosti za rdeče krvne celice; • povečani lipidi v krvi;
• increased sweating; 
čezmerno znojenje,
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction. 
Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
Leucopaenia (including neutropaenia and agranulocytosis), anaemia 
zelo pogosti levkopenija (vključno z nevtropenijo in agranulocitozo), anemija pogosti levkocitoza, trombocitopenija občasni idiopatska trombocitopenična purpura
a assessments in ankylosing spondylitis b 
ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis
• high blood measurements for white blood cells; 
• visoke krvne vrednosti za bele krvne celice; • nizke krvne vrednosti za trombocite;
Keep the pre-filled syringe / pre-filled pen in the outer carton in order to protect from light. 
Napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
• hearing loss, buzzing; 
• občutek siljenja na bruhanje, bruhanje;
The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same day) two weeks later. 
Običajni začetni odmerek je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
Figure I: hold the syringe 
Slika I: Držite injekcijsko brizgo
Neoplasms benign, malignant and unspecified (including cysts and polyps)* 
Benigne, maligne in neopredeljene novotvorbe
Tabulated list of adverse reactions 
Seznam neželenih učinkov v preglednici
at the investigator's discretion if the subject met the clinical response criterion 
2 Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva.
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. 
Pediatrični bolniki z zmerno do hudo Crohnovo boleznijo so odvisno od njihove telesne mase (več ali manj od 40 kg) dobivali odprt začetni odmerek adalimumaba 160/80 mg v 0. tednu in 80/40 mg v 2. tednu.
PASI 75 and PGA of clear or minimal response rates in these patients were 74.7 % and 59.0 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks). 
Po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) sta bila pri teh bolnikih delež odziva PASI 75 74,7 % in delež odziva PGA "čisto" ali "minimalno" 59,0 %.
Injection site reactions 
indukcija klinične remisije in odziva
Keep the pre-filled syringes in the outer carton in order to protect from light. 
Napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
In the pivotal controlled trials in adults and children, 12.9 % of patients treated with adalimumab developed injection site reactions (erythema and / or itching, haemorrhage, pain or swelling), compared to 7.2 % of patients receiving placebo or active control. 
imelo 12,9 % bolnikov, ki so dobivali adalimumab, in 7,2 % bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients. 
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom s kontrolnim obdobjem od 4 do 52 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 0,9 % bolnikov, zdravljenih z adalimumabom, in pri 0,9 % bolnikov v kontrolni skupini.
Continued therapy should be reconsidered in a patient not responding within this time period. 
Pri bolniku, ki se v tem času ne odzove na zdravljenje je treba ponovno razmisliti o nadaljevanju zdravljenja.
Keep the pre-filled syringe in the outer carton in order to protect from light. 
Napolnjene injekcijske brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 
V kontroliranih delih preskušanj, ki podpirajo vlogo za pridobitev dovoljenja za promet adalimumaba pri odraslih, ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS, psoriatičnim artritisom, psoriazo, hidradenitis suppurativa, Crohnovo boleznijo, ulceroznim kolitisom in uveitisom so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95 % interval zaupanja) 6,8 (4,4; 10,5) na 1000 bolnikov let med 5291 bolniki, ki so dobivali adalimumab, in 6,3 (3,4; 11,8) na 1000 bolnikov let med 3444 kontrolnimi bolniki (pri prvih je zdravljenje z adalimumabom mediano trajalo 4,0 mesece in pri drugih 3,8 meseca).
No clinical data are available on the use of an adalimumab loading dose in children < 6 years of age (see section 5.2). 
mlajših od 6 let, niso na voljo(glejte poglavje 5.2).
adalimumab 0.8 mg / kg eow N=38 
adalimumab 0,8 mg/kg vsak drugi teden N = 38
• pulmonary fibrosis (scarring of the lung); 
• srce neha črpati kri; • pljučna fibroza (brazgotinjenje pljuč);
Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53 % of subjects included) to “severe” (41 %) to “very severe” (6 %). 
"zmerne" (53 % vključenih preiskovancev) do "hude" (41 %) in "zelo hude" (6 %).
When needed (for example when you are travelling), Hefiya may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light. 
(do 25 °C) za največ 14 dni - zagotovite, da bo zaščiteno pred svetlobo.
Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 64.3 % and at week 96 was 65.1 %. 
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg v 12. tednu, in ki so prejemali neprekinjeno tedensko terapijo adalimumaba vsak teden, je bila stopnja kliničnega odziva (HiSCR)
Reproductive system and breast disorders 
Motnje reprodukcije in dojk občasni erektilna disfunkcija
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. 
Najnižja koncentracija pred naslednjim odmerkom v stanju dinamičnega ravnovesja je bila približno 8 do 10 µg/ml med 12. tednom in 36.
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists. 
Pri uporabi antagonistov TNF je bila v redkih primerih opisana pancitopenija, vključno z aplastično anemijo.
These include: 
Ti neželeni učinki so:
ALT elevations ≥ 3 x ULN occurred in 0.9 % of adalimumab-treated patients and 0.9 % of controlled-treated patients. 
≥ 3 x ULN (Upper Limits of Normal - zgornja normalna meja) pojavila pri 3,7 % bolnikov, zdravljenih z adalimumabom, in pri 1,6 % bolnikov v kontrolni skupini.
< 40 kg • 40 mg at week 0 and 20 mg at week 2 
10 mg vsak drugi teden 20 mg vsak drugi teden
Hefiya 40 mg solution for injection in pre-filled syringe: 
Hefiya 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
Autoimmune processes 
Avtoimunska dogajanja
• fungal infections; 
• okužbe sklepov;
In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 
< 40 kg • 40 mg v 0. tednu in 20 mg v 2. tednu V primeru, ko je potreben hitrejši odgovor na zdravljenje, z zavedanjem, da je tveganje za pojav neželenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek:
p-valuea p-valueb p-valuec 
vrednost Pa vrednost Pb vrednost
Mean steady-state trough levels of approximately 7 µg / ml were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week. 
Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg adalimumaba vsak drugi teden, so ugotovili najnižjo koncentracijo pred naslednjim odmerkom v stanju dinamičnega ravnovesja približno 7 µg/ml.
PROBABILITY OF NO FLARE 
VERJETNOST ZA NEUSPEH ZDRAVLJENJA
Mean steady-state trough levels of approximately 8 µg / ml were observed in ulcerative colitis patients who received a maintenance dose of 40 mg adalimumab every other week. 
Pri bolnikih z ulceroznim kolitisom, ki so dobivali vzdrževalni odmerek 40 mg adalimumaba vsak drugi teden, so ugotovili povprečno najmanjšo koncentracijo v stanju dinamičnega ravnovesja približno 8 µg/ml.
31 July 2016 
31. julij 2016
Within 30 days following EC decision 
V roku 30 dni po odločbi ES
Final study report by: 
Končno poročilo o študiji do:
31 March 2014 and annually thereafter 
31. marec 2014 in vsako leto za tem
Conditions 
Pogoji
• same exposure definition (expressed in 100,000 patients treated - daily dose of 100 mg equivalents), 
• enako opredelitev izpostavljenosti (izraženo pri 100 000 zdravljenih bolnikih - ekvivalenti dnevnega odmerka 100 mg);
The study will also have to be reflected in the updated/new RMP submission. 
Študija bo morala biti vključena tudi v posodobljeno/novo vlogo RMP.
Conditions to the marketing authorisation 
Pogoji dovoljenja za promet
• same data lock point (31st of December of each year), 
• enako zaključno obdobje zbiranja podatkov (vsako leto 31. decembra);
This will highlight the risks and warnings on hypersensitivity reactions (by e.g. a checklist, to be implemented at national level). 
V gradivu bodo izpostavljena tveganja in opozorila v zvezi s preobčutljivostnimi reakcijami (npr. kontrolni seznam, ki se ga izpolni na nacionalni ravni).
For products without an RMP, a RMP should be submitted. 
Za zdravila brez RMP je treba predložiti RMP.
Annex IV Conditions to the marketing authorisations 
Priloga IV Pogoji dovoljenj za promet z zdravili
In order to improve the overall product comparability, the MAHs should have: 
Da se izboljša celotna primerljivost zdravil, morajo imetniki dovoljenj za promet z zdravili uporabiti:
• 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) 
• enako opredelitev dogodka (uporaba specifičnega priporočenega izraza „Preobčutljivost“ ter ozek in širok obseg standardiziranih vprašanj po MedDRA za „Anafilaktične reakcije in angioedem“: imetniki dovoljenj za promet z zdravili morajo potrditi svoje kodekse kodiranja za zajetje simptomov in diagnozo z izrazi MedDRA)
• and use the severity classification according to Ring and Messmer classification. 
• razvrstitev resnosti po klasifikaciji Ring in Messmer.
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. 
Imetniki dovoljenj za promet z zdravili morajo posodobiti načrt za obvladovanje tveganja (RMP) za zdravila, za katere že obstaja RMP, tako da bo vključeval dodatne ukrepe za zmanjšanje tveganja in dodatne dejavnosti farmakovigilance, kot je bilo dogovorjeno v tem postopku.
The MAHs should submit annual cumulative reviews of hypersensitivity case reports, all fatal cases and all pregnancy cases, together with usage data yearly. 
Imetniki dovoljenj za promet z zdravili morajo skupaj z letnimi podatki o uporabi predložiti letne kumulativne preglede poročil o primerih preobčutljivosti, vse smrtne primere in vse primere nosečnosti.
The MAH(s) should provide within the risk management plan educational material for prescribers and patients. 
Imetnik(i) dovoljenj za promet za zdravili mora(jo) v okviru načrta za obvladovanje tveganja predložiti izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo, in za bolnike.
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): 
Pristojne nacionalne agencije ene ali več držav članic bodo pod organizacijo referenčnih držav članic zagotovile, kjer je to ustrezno, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
The MAHs shall conduct a PASS to further characterise the safety concerns on the hypersensitivity reactions. 
Imetniki dovoljenj za promet z zdravili morajo izvesti študijo PASS, namenjeno nadaljnji opredelitvi zadržkov glede varnosti v zvezi s preobčutljivostnimi reakcijami.
The MAHs should circulate the agreed DHPC in coordination with the NCAs according to the action plan agreed by CHMP. 
Imetniki dovoljenj za promet z zdravili morajo v sodelovanju z nacionalnimi pristojnimi organi zagotoviti neposredno obvestilo zdravstvenim delavcem (DHPC) v skladu z akcijskim načrtom, ki ga je potrdil CHMP.
26 July 2013 
26. julij 2013
It was not clear that these risks could be managed successfully in medical practice. 
Ni jasno, ali bi bilo ta tveganja mogoče uspešno obvladati v zdravniški praksi.
Outcome of re-examination 
Izid ponovnega pregleda
It was to be available as tablets (5 mg). 
Na voljo naj bi bilo v obliki tablet (5 mg).
The applicant requested a re-examination of the opinion. 
Predlagatelj je zahteval ponoven pregled mnenja.
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. 
Če ste vključeni v klinično preskušanje ali program sočutne uporabe in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
What consequences does this refusal have for patients in clinical trials or compassionate use programmes? 
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila?
What did the company present to support its application? 
Katero dokumentacijo je družba predložila v podporo svoji vlogi?
The company initially presented the results of five main studies of safety and effectiveness involving over 3,300 patients with rheumatoid arthritis. 
Družba je sprva predložila rezultate petih glavnih študij varnosti in učinkovitosti, v katere je bilo vključenih več kot 3 300 bolnikov z revmatoidnim artritisom.
The effects of Xeljanz were first tested in experimental models before being studied in humans. 
Učinki zdravila Xeljanz so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The CHMP had major concerns about the overall safety profile of Xeljanz. 
CHMP je imel velike zadržke glede splošnega varnostnega profila zdravila Xeljanz.
The company will consider future requests for compassionate use on an individual basis in accordance with local regulations. 
Prihodnje vloge za sodelovanje v programih sočutne uporabe bo družba individualno obravnavala v skladu z lokalnimi predpisi.
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. 
Proizvajajo jih z metodo, znano kot „tehnologije rekombinantne DNK“, pri kateri celice prejmejo gen (DNK), s katerim lahko tvorijo zdravilo.
At re-examination in July 2013 the company proposed to remove claims of an effect on structural damage from the indication. 
Pri ponovnem pregledu mnenja julija 2013 je družba predlagala, da bi iz indikacije umaknili trditve o učinku na strukturne okvare.
The main measures of effectiveness were changes in patient scores for signs and symptoms of disease, physical function of the patient, structural damage to joints and disease activity; these were measured after 3 or 6 months, depending on the study. 
Glavna merila učinkovitosti so bile spremembe bolnikovih ocen znakov in simptomov bolezni, fizične zmogljivosti bolnika, strukturnih okvar sklepov in dejavnosti bolezni; te parametre so ovrednotili po 3 ali 6 mesecih, odvisno od študije.
The company informed the CHMP that patients receiving tofacitinib in clinical trials will continue to receive it as planned. 
Družba je CHMP obvestila, da bodo bolniki, ki sodelujejo v kliničnih preskušanjih, še naprej prejemali tofacitinib, kot je bilo predvideno.
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. 
Po preučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in 25. julija 2013 potrdil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom.
These safety concerns also included a risk of other severe side effects including certain cancers, gastro-intestinal perforations (holes in the wall of the gut), liver damage and problems with increased lipid (fat) levels in the blood. 
Zadržki glede varnosti so se nanašali tudi na tveganje za druge hude neželene učinke, vključno z nekaterimi vrstami raka, perforacijami v črevesju (luknjami v steni črevesja), okvaro jeter in težavami z zvišanimi ravnmi lipidov (maščob) v krvi.
However, the studies were not sufficient to show a consistent reduction in disease activity and structural damage to joints, particularly at the lower 5-mg dose of Xeljanz and in the target population of patients in whom treatment with at least two other DMARDs has been unsuccessful. 
Vendar pa študije niso bile zadostne za to, da bi pokazale dosledno zmanjšanje dejavnosti bolezni in strukturnih okvar sklepov, še zlasti pri manjšem, 5-mg odmerku zdravila Xeljanz in pri ciljni populaciji bolnikov, pri katerih zdravljenje z najmanj dvema drugima DMARD ni bilo uspešno.
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. 
Kljub temu pa je pomanjkanje trdnih dokazov o tem, da zdravilo Xeljanz v predlaganem odmerku preprečuje strukturne okvare pri predlagani populaciji, še vedno prispevalo k tem, da je Odbor menil, da koristi zdravljenja ne odtehtajo pomembnih in nerešenih zadržkov glede varnosti.
It was to be used in patients in whom treatment with at least one other medicine known as a biological disease-modifying antirheumatic drug (biological DMARD1), had been unsuccessful either because patients were unable to tolerate treatment due to side effects, or because they did not respond adequately. 
Uporabljalo naj bi se pri bolnikih, pri katerih zdravljenje z najmanj enim drugim zdravilom, ki se imenuje biološko imunomodulirajoče antirevmatično zdravilo (biološko DMARD1), ni bilo uspešno, ker bolniki zaradi neželenih učinkov niso mogli prenašati zdravljenja ali ker se nanj niso ustrezno odzvali.
There were significant and unresolved concerns about the risk and type of serious infections seen with tofacitinib, which are related to the immunosuppressant action of the medicine. 
Izpostavljeni so bili pomembni in nerešeni zadržki v zvezi s tveganjem za resne okužbe in vrsto teh okužb, ki so jih opazili pri uporabi tofacitiniba in so povezane z imunosupresivnim delovanjem zdravila.
The company that applied for authorisation is Pfizer Limited. 
Vlogo za pridobitev dovoljenja za promet je predložila družba Pfizer Limited.
What were the CHMP's main concerns that led to the refusal? 
Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev dovoljenja za promet?
In April 2013, the Committee considered that, taken together, the data from the five main studies showed that treatment with Xeljanz resulted in an improvement in the signs and symptoms of rheumatoid arthritis and the physical function of patients. 
Aprila 2013 je Odbor menil, da so na splošno podatki iz petih glavnih študij pokazali, da je zdravljenje z zdravilom Xeljanz izboljšalo znake in simptome revmatoidnega artritisa ter fizično zmogljivost bolnikov.
On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xeljanz, intended for the treatment of rheumatoid arthritis. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je 25. aprila 2013 sprejel negativno mnenje, s katerim je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Xeljanz, namenjenim zdravljenju revmatoidnega artritisa.
The CHMP refusal was confirmed after re-examination. 
Zavrnitev, ki jo je predlagal Odbor, je bila po ponovnem pregledu potrjena.
Refusal of the marketing authorisation for Xeljanz (tofacitinib) 
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Xeljanz (tofacitinib)
Xeljanz is a medicine that contains the active substance tofacitinib. 
Xeljanz je zdravilo, ki vsebuje zdravilno učinkovino tofacitinib.
The active substance in Xeljanz, tofacitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases. 
Zdravilna učinkovina v zdravilu Xeljanz, tofacitinib, je imunosupresiv (zdravilo, ki zmanjša delovanje imunskega sistema), ki učinkuje tako, da preprečuje delovanje encimov, imenovanih Janus kinaze.