Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - aġenti antineoplastiċi - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radjonuklidi imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinone - tyrosinemias - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

norton healthcare ltd. - paclitaxel - sarcoma, kaposi; carcinoma, non-small-cell lung; ovarian neoplasms; breast neoplasms - aġenti antineoplastiċi - paxene huwa indikat għall-kura ta 'pazjenti b':• avvanzati relatat mal-aids sarkoma ta'kaposi (aids-ks) li ma rnexxewx qabel anthracycline liposomali-terapija;• karċinoma metastatika ta'l-sider (mbc) li ma jkunux ħadmu jew ma jkunux-kandidati għall-istandard anthracycline-terapija li jkun fiha;• karċinoma avvanzata ta 'l-ovarji (aoc) jew bi residwu tal-marda (> 1 ċm) wara l-ewwel laparotomija, flimkien ma' cisplatin bħala l-ewwel linja ta 'trattament;• karċinoma metastatika ta' l-ovarju (moc) wara l-falliment ta jkun fihom il-platinu terapija kombinata mingħajr taxanes bħala t-tieni linja ta 'trattament;• non-small cell lung avvanzata (nsclc) li mhumiex kandidati għall-potenzjalment kurattiva-kirurġija u/jew terapija ta' radjazzjoni, flimkien ma ' cisplatin. dejta ta 'effikaċja limitata tappoġġja din l-indikazzjoni (ara sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastoma - aġenti antineoplastiċi - unituxin huwa indikat għat-trattament ta ' riskju għoli neuroblastoma fil-pazjenti l-età ta ' 12-il xahar li 17years, li kienu riċevuti induzzjoni chemotherapy qabel u miksub mill-inqas tweġiba parzjali, segwita minn terapija myeloablative u ċelluli staminali awtologi trapjant (asct). jingħata flimkien ma 'fattur li jistimula l-kolonja tal-granuloċit-makrofagi (gm-csf), interleukin-2 (il-2), u isotretinoin.

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)

glaxo group ltd - retapamulin - impetigo; staphylococcal skin infections - antibijotiċi u kimoterapewtiċi għal użu dermatoloġiku - short term treatment of the following superficial skin infections: , impetigo;, infected small lacerations, abrasions or sutured wounds. , ara sezzjonijiet 4. 4 u 5. 1 għal tagħrif importanti dwar l-attivita'klinika ta 'retapamulin kontra tipi differenti ta' staphylococcus aureus. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - lewkimja, linfokitika, kronika, b-Ċellula - antikorpi monoklonali - ma kienux trattati qabel lewkimja limfoċitika kronika (cll): arzerra flimkien ma 'chlorambucil jew bendamustine huwa indikat għall-kura ta' pazjenti b'cll li ma rċevew terapija minn qabel u li mhumiex eliġibbli għall-fludarabine-terapija bbażata fuq. rkadew cll: arzerra huwa indikat flimkien ma 'fludarabine u cyclophosphamide għat-trattament ta' pazjenti adulti b'all rikadut cll. refrattarji cll: arzerra huwa indikat għall-kura ta cll f'pazjenti li huma refrattarji għal pazjenti b'b-ll u alemtuzumab.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm ltd - valsartan, amlodipine (as amlodipine besilate) - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. imprida huwa indikat f'pazjenti li l-pressjoni tad-demm mhijiex ikkontrollata adegwatament bl-amlodipina jew valsartan monoterapija.