Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - dabigatran etexilate mesilate - arthroplasty, replacement; venous thromboembolism - aġenti antitrombotiċi - pradaxa 75 mgprimary il-prevenzjoni ta 'każi trombo-emboliċi venużi f'pazjenti adulti li kellhom operazzjoni mhux urġenti operazzjoni tas-sostituzzjoni totali tal-ġenbejn jew totali ta' l-irkobba. pradaxa 110 mgprimary il-prevenzjoni ta 'każi trombo-emboliċi venużi f'pazjenti adulti li kellhom operazzjoni mhux urġenti operazzjoni tas-sostituzzjoni totali tal-ġenbejn jew totali ta' l-irkobba. il-prevenzjoni ta 'puplesija u emboliżmu sistematiku f'pazjenti adulti b'nuqqas valvulari fibrillazzjoni atrijali (nvaf), ma'wieħed jew aktar fatturi ta' riskju, bħal qabel puplesija jew attakk iskemiku temporanju (tia); età ≥ 75-il sena; insuffiċjenza tal-qalb (nyha klassi ≥ ii); id-dijabete mellitus; pressjoni għolja. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. pradaxa 150 mgprevention ta 'puplesija u emboliżmu sistematiku f'pazjenti adulti b'nuqqas valvulari fibrillazzjoni atrijali (nvaf), ma'wieħed jew aktar fatturi ta' riskju, bħal qabel puplesija jew attakk iskemiku temporanju (tia); età ≥ 75-il sena; insuffiċjenza tal-qalb (nyha klassi ≥ ii); id-dijabete mellitus; pressjoni għolja. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - emoglobinurja, paroxysmal - immunosuppressanti selettivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - dabigatran etexilate mesilate - venous thromboembolism; arthroplasty, replacement - aġenti antitrombotiċi - prevention of venous thromboembolic events.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - zoledronic acid monohydrate - fractures, bone; cancer - drogi għat-trattament ta 'mard tal-għadam - prevenzjoni ta 'avvenimenti relatati mal-iskeletru (fratturi patoloġiċi, kompressjoni spinali, radjazzjoni jew kirurġija għal għadam, jew iperkalċemija kkawżata minn tumur) f'pazjenti adulti b'tumuri avvanzati malinni li jinvolvu l-għadam. it-trattament ta ' pazjenti adulti b'iperkalċemja kkawżata minn tumur (tih).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - aġenti antineoplastiċi - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti b'lokalment avvanzat jew metastatiku nsclc wara l-kimoterapija qabel. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti b'lokalment avvanzat jew metastatiku nsclc wara l-kimoterapija qabel. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - ibandronic acid - hypercalcemia; breast neoplasms; neoplasm metastasis; fractures, bone - drogi għat-trattament ta 'mard tal-għadam - bondronat huwa indikat għal:prevenzjoni ta 'episodji skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl-għadam li jeħtieġu r-radjuterapija jew il-kirurġija) f'pazjenti b'kanċer tas-sider u metastasi fl-għadam;trattament ta' l-iperkalċemja kkawżata minn tumuri bi jew mingħajr metastażi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - ocrelizumab - sklerosi multipla - immunosoppressanti - trattament ta 'pazjenti adulti b'forom ta' sklerożi multipla (rms) li jirkadu b'mard attiv iddefinit minn karatteristiċi kliniċi jew ta 'immaġini. it-trattament ta 'pazjenti adulti b'kmieni sklerosi multipla progressiva primarja (ppms) fit-termini tal-mard tal-tul u l-livell tad-diżabilità, u bl-immaġni karatteristiċi ta' l-attività infjammatorja.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ultragenyx germany gmbh - vestronidase alfa - mucopolysaccharidosis vii - l-enżimi - mepsevii huwa indikat għall-kura ta 'manifestazzjonijiet mhux newroloġiċi ta' mucopolysaccharidosis vii (mps vii; hekk syndrome).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pharmathen s.a. - ibandronic acid - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - drogi għat-trattament ta 'mard tal-għadam - concentrate for solution for infusion prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. trattament ta ' l-iperkalċemja kkawżata minn tumuri bi jew mingħajr metastażi. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - temsirolimus - carcinoma, renal cell; lymphoma, mantle-cell - aġenti antineoplastiċi - renali taċ-ċelluli carcinomatorisel huwa indikat għall-kura tal-ewwel linja ta ' pazjenti adulti b'indeboliment avanzat tal-karċinoma taċ-ċellola (rcc) li jkollhom mill-inqas tlieta minn sitt fatturi tar-riskju pronjostiċi. f'forma ta'tubu taċ-ċelluli lymphomatorisel huwa indikat għall-kura ta ' pazjenti adulti b'all rikadut u / jew refrattorji f'forma ta'tubu taċ-ċellula tal-limfoma (mcl).