Unjoni Ewropea - Malti - EMA (European Medicines Agency)

infai, institut für biomedizinische analytik nmr-imaging gmbh - urea (13c) - breath tests; helicobacter infections - aġenti dijanjostiċi - helicobacter test infai jista 'jintuża għal dijanjosi in vivo ta' infezzjoni ta 'helicobacter pylori gastroduwodenali fl:adulti;l-adoloxxenti, li aktarx ikollhom mard ta' ulċeri peptiċi. helicobacter test infai għal tfal bejn l-etajiet minn tlieta sa 11-il sena jista 'jintuża għal dijanjosi in vivo ta gastrduodenal infezzjoni ta' helicobacter pylori:għall-evalwazzjoni tas-suċċess tal-qerda tal-kura, jew meta testijiet invażivi ma jistgħux jiġu mwettqa, jew;meta jkun hemm riżultati konfliġġenti li joħorġu mit-testijiet invażivi. dan il-prodott mediċinali huwa għal użu dijanjostiku biss.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. , l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the 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. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bial - portela cª, s.a. - opicapone - marda ta 'parkinson - mediċini kontra l-parkinson - ongentys huwa indikat bħala terapija adjunctive għall-preparazzjonijiet ta ' ticlopidine hydrochloride / dopa decarboxylase inibituri (ddci) fil-pazjenti adulti mal-marda ta ' parkinson's u l-tmiem tad-doża oxxillazzjonijiet vetturi bil-mutur li ma tistax tiġi stabilizzata fuq dawk l-għaqdiet. ongentys huwa indikat bħala terapija adjunctive għall-preparazzjonijiet ta ' ticlopidine hydrochloride / dopa decarboxylase inibituri (ddci) fil-pazjenti adulti mal-marda ta ' parkinson's u l-tmiem tad-doża oxxillazzjonijiet vetturi bil-mutur li ma tistax tiġi stabilizzata fuq dawk l-għaqdiet.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zentiva k.s. - pregabalin - anxiety disorders; neuralgia; epilepsy - anti-epilettiċi, - newropatiku painpregabalin zentiva k. hija indikata għat-trattament ta 'uġigħ newropatiku periferali u ċentrali fl-adulti. epilepsypregabalin zentiva k. huwa indikat bħala terapija aġġuntiva f'persuni adulti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja. ta'ansjetà ġeneralizzata disorderpregabalin zentiva k. huwa indikat għall-kura ta 'disturb ta' ansjetà ġeneralizzata (gad-generalised anxiety disorder) f'persuni adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

elanco gmbh - lotilaner - ektoparasitaċidali għall-użu sistemiku, isoxazolines - dogs; cats - għat-trattament tal-briegħed u l-qurdien infestazzjonijiet. il-briegħed u l-qurdien għandhom jingħaqdu ma 'l-ospitant u jibdew jgħumu sabiex ikunu esposti għas-sustanza attiva. il-prodott mediċinali veterinarju jista 'jintuża bħala parti minn strateġija tat-trattament għall-kontroll ta' dermatite allerġika tal-bergħud (fad). dogsthis-prodott mediċinali veterinarju jipprovdi immedjata u persistenti joqtol l-attività għal xahar 1 għall-briegħed (ctenocephalides felis u c. canis) u l-qurdien (rhipicephalus sanguineus, ixodes ricinus, i. hexagonus u dermacentor reticulatus). catsthis-prodott mediċinali veterinarju jipprovdi immedjata u persistenti joqtol l-attività għal xahar 1 kontra l-briegħed (ctenocephalides felis u c. canis) u l-qurdien (ixodes ricinus).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - pregabalin - anxiety disorders; epilepsy - anti-epilettiċi, - newropatiku painpregabalin mylan huwa indikat għat-trattament tal-uġigħ nevrotiku periferali u ċentrali f'persuni adulti. epilepsypregabalin mylan huwa indikat bħala terapija aġġuntiva f'persuni adulti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja. ta'ansjetà ġeneralizzata disorderpregabalin mylan huwa indikat għall-kura ta 'disturb ta' ansjetà Ġeneralizzata (gad-generalised anxiety disorder) f'persuni adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan s.a.s. - pregabalin - anxiety disorders; neuralgia; epilepsy - anti-epilettiċi, - epilepsypregabalin mylan pharma huwa indikat bħala terapija aġġuntiva f'persuni adulti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja. ta'ansjetà ġeneralizzata disorderpregabalin mylan pharma huwa indikat għall-kura ta 'disturb ta' ansjetà Ġeneralizzata (gad-generalised anxiety disorder) f'persuni adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zentiva, k.s. - pregabalin - anxiety disorders; epilepsy - anti-epilettiċi, - neuropathic pain , pregabalin zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. , epilepsy , pregabalin zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. , generalised anxiety disorder , pregabalin zentiva is indicated for the treatment of generalised anxiety disorder (gad) in adults.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - orlistat - obeżità - preparazzjonijiet ta 'kontra l-ossessjoni, esklużi prodotti tad-dieta - xenical hija indikata flimkien mal-mildly hypocaloric dieta għat-trattament tal-pazjenti obese mal-korp massa indiċi (bmi) ikbar jew ugwali għal 30 kg/m2, jew tas-saħħa, l-pazjenti (bmi > 28 kg/m2) mal-fatturi ta ' riskju assoċjati. kura b'orlistat għandha titwaqqaf wara 12-il ġimgħa jekk il-pazjenti ma jkunux tilfu tal-inqas 5% tal-piż tal-ġisem kif imkejjel fil-bidu tat-terapija.