Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - alectinib hydrochloride - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - alecensa bħala monoterapija hija indikata għat-trattament tal-ewwel linja ta 'pazjenti adulti b'kanċer tal-pulmun taċ-ċelluli mhux żgħar żgħar (nsclc) b'posfoma kinase anaplastika (alk). alecensa bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti bil-alk‑pożittivi nsclc avvanzat li qabel kienu kkurati bil-krizotinib.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - temozolomide - glioma; glioblastoma - aġenti antineoplastiċi - temodal kapsuli iebsin huma indikati għal-kura ta': pazjenti adulti li jkunu għadhom kif ġew dijanjostikati b'i glijoblastoma multiforme flimkien mar-radjuterapija u wara bħala kura b'monoterapija;it-tfal mill-età ta ' tliet snin fuq, adolexxenti, u pazjenti adulti bi glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika, li jerġgħu jirkadu jew progressjoni wara terapija standard.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

teva b.v.  - temozolomide - glioma; glioblastoma - aġenti antineoplastiċi - għat-trattament ta 'pazjenti adulti b'glioblastoma multiforme dijanjostikata fl-istess ħin ma' radjuterapija (rt) u sussegwentement bħala trattament b'monoterapija. għall-kura tat-tfal mill-età ta ' tliet snin fuq, adolexxenti, u pazjenti adulti bi glijoma malinna, bħal glioblastoma multiforme jew astroċitoma anaplastika, li jerġgħu jirkadu jew progressjoni wara terapija standard.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - aġenti antitrombotiċi - xarelto, mogħti flimkien ma 'acetylsalicylic acid (asa) waħdu jew ma' asa flimkien ma ' clopidogrel jew ticlopidine, huwa indikat għall-prevenzjoni ta'avvenimenti aterotrombotiċi f'pazjenti adulti wara l-sindromu koronarju akut (acs) mal-bijomarkaturi kardijaċi għoljin. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. prevenzjoni ta ' l-thromboembolism venous (vte) fil-pazjenti adulti li għaddejjin minn elettiva għadma jew irkoppa sostituzzjoni kirurġija. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 u 5. 1 għad-data disponibbli dwar kombinazzjonijiet differenti).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

advanced accelerator applications - lutetium (177lu) oxodotreotide - tumuri newroentokrini - radjufarmaċewtiċi terapewtiċi oħra - lutathera huwa indikat għat-trattament ta ' unresectable jew metastatic, b'mod progressiv, ukoll differenzjati (g1 u g2), somatostatin r-riċevitur gastroenteropancreatic pożittiv neuroendocrine tumuri (gep‑nets) fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - aġenti antineoplastiċi - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - aġenti antitrombotiċi - prevenzjoni ta ' l-thromboembolism venous (vte) fil-pazjenti adulti li għaddejjin minn elettiva għadma jew irkoppa sostituzzjoni kirurġija. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 għall-emodinamikament instabbli pe pazjenti). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 u 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

albireo - odevixibat - cholestasis, intrahepatic - terapija biljari u tal-fwied - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4. 4 u 5.