Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entecavir monohydrate - epatite b - antivirali għal użu sistemiku - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. mard tal-fwied dekompensat. kemm għall-kkumpensati u mard tal-fwied dikumpensat, din l-indikazzjoni hija bbażata fuq tagħrif minn provi kliniċi f'pazjenti li huma nucleoside naïve b'hbeag pożittiv u hbeag negattiv li jaqbadhom infezzjoni hbv. fir-rigward ta 'pazjenti b'epatite b refrattarja għal lamivudine. entecavir mylan huwa indikat ukoll għat-trattament ta ' infezzjoni hbv kronika nucleoside naïve pazjenti pedjatriċi minn 2 sa.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - aġenti antineoplastiċi - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - sklerosi multipla - immunosuppressanti selettivi - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

smithkline beecham ltd - rosiglitazone, glimepiride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - avaglim hu indikat biss fit-trattament tad-dijabete tat-tip 2 mellitus il-pazjenti li ma jistgħux jiksbu kontroll gliċemiku biżżejjed bl-aħjar dożaġġ ta ' monoterapija b'sulphonylurea, u li għalihom metformin mhux adattat minħabba kontra-indikazzjoni jew intolleranza.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - aġenti antineoplastiċi - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudine, raltegravir potassju - infezzjonijiet ta 'hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis huwa indikat f ' għaqda ma ' oħrajn anti‑retroviral prodotti mediċinali għat-trattament ta ' l-infezzjoni tal-virus ta ' immunodefiċjenza umani (hiv‑1) fl-adulti, adolixxenti u tfal mill-età ta ' 6 snin u mill-anqas 30 kg mingħajr preżent użin jew imgħoddi evidenza ta ' reżistenza virali għal aġenti antivirali tal-insti (integrase il-faxxa trasferiment inhibitor) u nrti (inibitur ta ' rivers transcriptase nukleosidi) klassijiet (ara sezzjonijiet 4. 2, 4. 4 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirine hydrochloride - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - edurant, f ' għaqda mal-oħrajn prodotti mediċinali antiretroviral, huwa indikat għall-trattament tal-virus ta ' immunodefiċjenza umani tat-tip 1 (hiv‑1) infezzjoni fil-pazjenti treatment‑naïve antiretroviral 12-il sena ta ' l-età u l-aktar antiki mal-≤ tagħbija virali 100,000 hiv‑1 rna kopji/ml. bħala ma ' prodotti mediċinali antiretrovirali oħra, l-ittestjar tar-reżistenza ġenotipika għandhom jiggwidaw l-użu tal-edurant.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin, linagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - glyxambi, taħlita fissa tad-doża ta empagliflozin u linagliptin, huwa indikat f'adulti ta ' 18-il sena u akbar b'dijabete mellitus tip 2:biex ittejjeb il-kontroll gliċemiku meta metformin u/jew mediċina tat-tip sulphonylurea (su) u waħda mill-monokomponenti tal-glyxambi ma jipprovdux kontroll gliċemiku adegwat;meta diġà qegħdin jiġu ttrattati bil-kombinazzjoni ħielsa ta empagliflozin u linagliptin.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (bħala fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - aġenti antineoplastiċi - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. poliċitemija vera (pv)jakavi huwa indikat għall-kura ta ' pazjenti adulti b'poliċitemija vera li huma reżistenti jew intolleranti għal hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.