Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

gilead sciences switzerland sàrl - brexucaptagenum autoleucelum (jeder patientenspezifische einzel-infusionsbeutel enthält eine dispersion von anti-cd19-car-t-zellen in ca. 68 ml für eine zieldosis von 2x10e6 anti-cd19-car-positiven, lebensfähigen t-zellen/kg körpergewicht (spanne: 1,0x10e6–2,0x10e6 zellen/kg), mit maximal 2x10e8 anti-cd19-car-positiven, lebensfähigen t-zellen) - tecartus - beutel: brexucaptagenum autoleucelum (jeder patientenspezifische einzel-infusionsbeutel enthält eine dispersion von anti-cd19-car-t-zellen in ca. 68 ml für eine zieldosis von 2x10e6 anti-cd19-car-positiven, lebensfähigen t-zellen/kg körpergewicht (spanne: 1,0x10e6–2,0x10e6 zellen/kg), mit maximal 2x10e8 anti-cd19-car-positiven, lebensfähigen t-zellen) 1,0x10e6–2,0x10e6 zellen/kg/68 ml, cryostor cs10, natrii chloridi solutio 9 g/l, albuminum humanum (25%), pro praeparatione. - mantelzell-lymphom: tecartus wird angewendet zur behandlung von erwachsenen patienten mit rezidiviertem oder refraktärem mantelzell-lymphom (mcl) nach zwei oder mehr systemischen therapien, die einen bruton-tyrosinkinase-(btk-)inhibitor einschliessen. ; akute lymphoblastische leukämie: tecartus wird angewendet zur behandlung von erwachsenen patienten mit rezidivierter oder refraktärer akuter lymphoblastischer b-vorläuferzell-leukämie (akute lymphoblastische leukämie, all) nach zwei oder mehr systemischen therapien. - trapianto: gentherapieprodukt

Unione Europea - italiano - EMA (European Medicines Agency)

biogen netherlands b.v. - dimetilfumarato - sclerosi multipla - immunosoppressori - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Unione Europea - italiano - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol acetate, mometasone furoate - asma - farmaci per le malattie respiratorie ostruttive, - atectura breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Unione Europea - italiano - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - mieloma multiplo - agenti antineoplastici - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Italia - italiano - Ministero della Salute

tecnologia ospedaliera srl -

Italia - italiano - Ministero della Salute

tecnologia ospedaliera srl -

Italia - italiano - Ministero della Salute

tecnologia ospedaliera srl -

Unione Europea - italiano - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - agenti antineoplastici - 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 come monoterapia è indicato per il trattamento di pazienti adulti con carcinoma localmente avanzato o metastatico nsclc dopo una precedente chemioterapia. 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 come monoterapia è indicato per il trattamento di pazienti adulti con carcinoma localmente avanzato o metastatico nsclc dopo una precedente chemioterapia. 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.

Unione Europea - italiano - EMA (European Medicines Agency)

biotest pharma gmbh - immunoglobulina umana da epatite b - immunization, passive; hepatitis b; liver transplantation - sieri immuni e immunoglobuline, - prevenzione della re-infezione da virus dell'epatite b (hbv) in pazienti adulti negativi con hbsag e hbv-dna almeno una settimana dopo il trapianto di fegato per insufficienza epatica indotta da epatite b. lo stato negativo di hbv-dna deve essere confermato negli ultimi 3 mesi precedenti l'olt. i pazienti devono essere hbsag negativi prima dell'inizio del trattamento. l'uso concomitante di adeguata virostatic agenti dovrebbero essere considerati come standard di epatite b re-infezione profilassi.

Unione Europea - italiano - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - linfoma, cellule del mantello - agenti antineoplastici - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).