Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artrite, rewmatika - immunosoppressanti - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 u 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pharma mar s.a. - trabectedin - ovarian neoplasms; sarcoma - aġenti antineoplastiċi - yondelis huwa indikat għat-trattament tal-pazjenti bl-avvanzata soft-tissue sarcoma, wara nuqqas ta ' anthracyclines u ifosfamide, jew li mhumiex xierqa ma jirċievi dawn l-aġenti. id-dejta dwar l-effikaċja hija bbażata prinċipalment fuq il-pazjenti b'liposarkoma u leiomyosarcoma. yondelis flimkien ma 'liposomal doxorubicin (pld) huwa indikat għall-kura ta' pazjenti b'reġgħet tfaċċat il-marda sensittiva għall-platinum kanċer fl-ovarji.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

grünenthal gmbh - lesinurad - iperurċemija - preparazzjonijiet antigout - zurampic, f ' għaqda mal-inibitur oxidase xanthine, huwa indikat fl-adulti għall-trattament adjunctive ta ' hyperuricaemia fil-pazjenti gout (bi jew mingħajr tophi) li ma kisbux mira tas-serum uric acid livelli b ' doża xierqa ta ' l-oxidase ta ' xanthine inibitur waħdu.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto - clopidogrel (as hydrogen sulfate) - peripheral vascular diseases; stroke; acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - - prevenzjoni sekondarja prevenzjoni ta ' avvenimenti aterotrombotiċi clopidogrel huwa indikat fl:pazjenti adulti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. pazjenti adulti li jsofru mis-sindromu koronarju akut:- nuqqas ta elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma ' acetylsalicylic acid (asa). l - elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. il-prevenzjoni ta aterotrombotiċi u avvenimenti tromboemboliċi fil-fibrillazzjoni atrijali:- fil-pazjenti adulti li jbatu minn fibrillazzjoni atrijali li jkollhom mill-inqas fattur ta 'riskju wieħed għall-episodji vaskulari, mhumiex adattati għall-kura bl-antagonisti tal-vitamina k (vka) u li għandhom baxx-riskju ta'fsada, clopidogrel huwa indikat, flimkien ma' asa għall-prevenzjoni tal-aterotrombotiċi u avvenimenti tromboemboliċi, inkluż puplesija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - lacosamide - epilessija - anti-epilettiċi, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gedeon richter - idroklorur tal-karprażina - skizofrenija - psikolettiċi - reagila huwa indikat għall-kura ta 'l-iskiżofrenja f'pazjenti adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pierre fabre medicament - encorafenib - melanoma; colorectal neoplasms - aġenti antineoplastiċi - encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, who have received prior systemic therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pierre fabre medicament - neratinib - neoplażmi tas-sider - aġenti antineoplastiċi - nerlynx huwa indikat għall-estiż kura awżiljarja ta 'pazjenti adulti bil-istadju bikri pożittiv għar-riċetturi tal-ormon tat-her2-overexpressed/amplifikati-kanċer tas-sider u li huma anqas minn sena mill-tlestija ta'qabel l-adjuvant' trastuzumab terapija bbażata fuq.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

grunenthal gmbh - allopurinol, lesinurad - gotta - preparazzjonijiet antigout - duzallo huwa indikat fl-adulti għat-trattament ta'l-iperuriċemija fil-gotta pazjenti li ma kisbux-mira tal-uric acid fis-serum livelli b'doża adegwata ta ' allopurinol waħdu.