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)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - orkambi b'rita huma ndikati għall-kura ta 'fibrożi ċistika (cf) fl-pazjenti ta' bejn 6 snin u ikbar li omozigoti għall-f508del mutazzjoni fil-cftr ġene. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - iperplażja prostatika - uroloġiċi - trattament tas-sinjali u sintomi ta 'iperplażja beninna tal-prostata (bph).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

3m health care limited - rivastigmine - marda ta 'alzheimer - psychoanaleptics, , anticholinesterases - trattament sintomatiku ta 'dimenzja ta' alzheimer ħafifa għal moderatament gravi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - iperplażja prostatika - uroloġiċi - trattament tas-sinjali u sintomi ta 'iperplażja beninna tal-prostata (bph).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbott laboratories ltd. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; arthritis, psoriatic; crohn disease - immunosoppressanti - rewmatika arthritistrudexa flimkien ma ' methotrexate, huwa indikat għall -: - trattament ta moderata sa severa, artrite rewmatika attiva f'pazjenti adulti, meta r-rispons li jimmodifikaw il-marda anti-rewmatiċi-mediċini inkluż methotrexate, ma jkunx adegwat. il-kura ta attiva u progressiva severa, artrite rewmatika fl-adulti li ma kienux ittrattati qabel b'methotrexate. trudexa jista 'jingħata waħdu f'każ ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. intwera li trudexa jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. psorjatika arthritistrudexa huwa indikat għall-kura tas-sustanza attiva u progressiva artrite psorjatika fl-adulti meta r-rispons għall-preċedenti li jimmodifikaw il-marda anti-rewmatiċi terapija bil-mediċina kienet inadegwata. ankylosing spondylitistrudexa huwa indikat għall-kura ta ' adulti li jbatu minn ankylosing spondylitis attiva li kellhom rispons mhux adekwat għat-terapija. crohn diseasetrudexa huwa indikat għall-kura ta ' marda ta'crohn attiva, f'pazjenti li ma kellhomx rispons minkejja sħiħ u adegwat matul it-terapija b'xi corticosteroid u/jew immunosoppressanti; jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. għall-kura tal-bidu, trudexa għandu jingħata flimkien ma ' corticosteroids. trudexa jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għall-corticosteroids jew meta titkompla l-kura bil-corticosteroids m'hijiex adattata (ara sezzjoni 4.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

blue earth diagnostics ireland ltd - fluciclovine (18f) - prostatic neoplasms; radionuclide imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. axumin huwa indikat għall-positron emission tomography (pet) tal-immaġini biex jidentifikaw ir-rikorrenza tal-kanċer tal-prostata fl-irġiel adulti b'suspett rikorrenza bbażata fuq l-għoli fid-demm antiġen speċifiku għall-prostata (psa) livelli wara l-ewwel trattament kurattiv.

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)

cycle pharmaceuticals (europe) ltd - nitisinone - tyrosinemias - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - it-trattament tal-pazjenti adulti u pedjatriċi b'dijanjosi kkonfermata ta 'tirosinemia ereditarja ta' tip 1 (ht-1) flimkien ma 'restrizzjoni tad-dieta ta' tyrosine u phenylalanine.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - iperplażja prostatika - urologicals, alpha-adrenoreceptor antagonisti - trattament tas-sinjali u s-sintomi tal-iperplasija beninna tal-prostata (bph), fl-irġiel adulti.