Uniunea Europeană - malteză - EMA (European Medicines Agency)

merck europe b.v. - cladribine - sklerosi multipla - immunosoppressanti - trattament ta 'pazjenti adulti li għandhom sklerosi multipla li tirkadi attiva ħafna (ms) kif iddefinita minn karatteristiċi kliniċi jew ta' immaġini.

Uniunea Europeană - malteză - 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.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

janssen-cilag international nv - guselkumab - psorajiżi - immunosoppressanti - plaque psoriasis tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritis tremfya, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (dmard) therapy (see section 5.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid - diabetes mellitus, tip 2 - drugs used in diabetes, sodium-glucose co-transporter 2 (sglt2) inhibitors - steglatro huwa indikat f'adulti ta '18-il sena u akbar b'dijabete mellitus tip 2 bħala żieda mad-dieta u l-eżerċizzju biex itejjeb il-kontroll gliċemiku:bħala monoterapija f'pazjenti li għalihom l-użu ta' metformin huwa kkunsidrat xieraq minħabba 'intolleranza jew ta' kontra-indikazzjonijiet. barra minn hekk oħra prodotti mediċinali għall-kura tad-dijabete.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

alnylam netherlands b.v. - patisiran sodium - amilojdożi, familjali - drogi oħra tas-sistema nervuża - onpattro huwa indikat għall-kura ta ' transthyretin medjat amilojdożi (hattr amilojdożi) f'pazjenti adulti bil-istadju ta'l-1 jew l-istadju 2 polinewropatija.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

pierre fabre medicament - binimetinib - melanoma - aġenti antineoplastiċi - binimetinib flimkien ma encorafenib huwa indikat għat-trattament ta ' pazjenti adulti li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza melanoma bil-braf v600.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

pfizer europe ma eeig - talazoparib - neoplażmi tas-sider - aġenti antineoplastiċi - talzenna huwa indikat bħala monoterapija għall-kura ta ' pazjenti adulti bil-linja ġerminali brca1/2 mutazzjonijiet, li għandhom her2-negattivi avvanzat lokalment jew metastatiku tas-sider kanċer. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. pazjenti bl-ormon tat-riċettur (hr)-kanċer tas-sider posittiv għandhom kienu ttrattati minn qabel endokrinali bbażata fuq it-terapija, jew jiġu kkunsidrati bħala mhux tajbin għall-endokrinali-terapija bbażata fuq.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karċinoma, Ċellula squamous - aġenti antineoplastiċi - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

plethora pharma solutions limited - lidocaine, prilocaine - prematuri eġakulazzjoni - anestetiċi - senstend huwa indikat għall-kura primarja tal-eġakulazzjoni prematura fl-irġiel adulti.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - cannabidiol - lennox gastaut syndrome; epilepsies, myoclonic - anti-epilettiċi, - epidyolex huwa indikat għall-użu bħala terapija aġġuntiva ta 'aċċessjonijiet assoċjati mas-sindrome lennox gastaut (lgs) jew sindromu ta'dravet (ds), flimkien ma' clobazam, għall-pazjenti 2 snin ta ' età u anzjani.