Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viatris healthcare limited - tobramycin - cystic fibrosis; respiratory tract infections - antibatteriċi għal użu sistemiku, - tobi podhaler huwa indikat għat-terapija suppressiva ta 'infezzjoni pulmonari kronika minħabba pseudomonas aeruginosa fl-adulti u tfal ta' 6 snin 'il fuq b'fibrożi ċistika. ara t-taqsimiet 4. 4 u 5. 1 rigward data fi gruppi ta 'etajiet differenti. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - gefapixant - cough - sogħla u preparazzjonijiet kesħin - lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.

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)

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)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomide - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - immunosoppressanti - multipli myelomarevlimid bħala monoterapija huwa indikat għall-manteniment tat-trattament ta ' pazjenti adulti li jkunu għadhom kif ġew dijanjostikati mjeloma multipla li jkunu għaddew minn awtologi t-trapjant taċ-ċelluli staminali. revlimid bħala terapija kombinata ma ' dexamethasone, jew bortezomib u dexamethasone, jew melphalan u prednisone (ara sezzjoni 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. revlimid flimkien ma 'dexamethasone hu indikat għall-kura ta' majeloma multipla f'pazjenti adulti li jkunu rċevew mill-anqas terapija waħda qabel. majelodisplastiċi syndromesrevlimid bħala monoterapija hija indikata għat-trattament ta 'pazjenti adulti b'trasfużjoni dipendenti fuq l-anemija minħabba baxx intermedju jew 1-riskju sindromi majelodisplastiċi assoċjata ma' iżolati tal-tħassir 5q ċitoġenetiku anormalità meta għażliet terapewtiċi oħrajn ma jkunux biżżejjed jew inadegwata. f'forma ta'tubu taċ-ċelluli lymphomarevlimid bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti b'all rikadut jew refrattarju f'forma ta'tubu taċ-ċelluli tal-limfoma. follikulari lymphomarevlimid flimkien ma 'rituximab (kontra l-antiġen cd20 ta' antikorpi) huwa indikat għat-trattament ta ' pazjenti adulti li kienu kkurati qabel limfoma follikulari (grad 1 – 3a).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomide - majloma multipla - immunosoppressanti - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide qbil flimkien ma 'dexamethasone hu indikat għall-kura ta' majeloma multipla f'pazjenti adulti li jkunu rċevew mill-anqas terapija waħda qabel. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - immunosoppressanti - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 u 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 u 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).