Europäische Union - Italienisch - EMA (European Medicines Agency)

co.don gmbh - sferoidi di condrociti associati a matrice autologhe umane - malattie della cartilagine - altri farmaci per i disturbi del sistema muscolo-scheletrico - riparazione di difetti sintomatici della cartilagine articolare del condilo femorale e la rotula del ginocchio (international cartilage repair society [icrs] di grado iii o iv) con difetto di dimensioni fino a 10 cm2 negli adulti.

Europäische Union - Italienisch - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - agenti antineoplastici - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris è indicato per il trattamento di pazienti adulti con recidiva o refrattaria cd30+ linfoma di hodgkin (hl):dopo asct, orfollowing almeno due precedenti terapie quando asct o multi-agente di chemioterapia non è una opzione di trattamento. sistemica anaplastico a grandi cellule lymphomaadcetris in combinazione con ciclofosfamide, doxorubicina e prednisone (chp) è indicato per i pazienti adulti precedentemente non trattati sistemica linfoma anaplastico a grandi cellule (salcl). adcetris è indicato per il trattamento di pazienti adulti con recidiva o refrattaria salcl. cutaneo a cellule t lymphomaadcetris è indicato per il trattamento di pazienti adulti con cd30+ cutanea linfoma a cellule t (ctcl) dopo almeno 1 prima terapia sistemica.

Europäische Union - Italienisch - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - agenti antineoplastici - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Europäische Union - Italienisch - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustina - hodgkin disease; lymphoma, non-hodgkin - agenti antineoplastici - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

Europäische Union - Italienisch - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mucosite - tutti gli altri prodotti terapeutici - kepivance è indicato per ridurre l'incidenza, la durata e la severità della mucosite orale in pazienti adulti con tumori ematologici ricezione radiochemioterapia mieloablativa associata con un'alta incidenza di mucosite grave e che richiedono autologo--cellule staminali emopoietiche supporto.

Europäische Union - Italienisch - EMA (European Medicines Agency)

olympus biotech international limited - eptotermin alfa - fratture tibiali - farmaci per il trattamento delle malattie delle ossa, proteine morfogenetiche ossee - trattamento della mancata aderenza della tibia di almeno 9 mesi di durata, secondaria al trauma, nei pazienti scheletrici maturi, nei casi in cui il precedente trattamento con autotrapianto non è riuscito o l'uso di un innesto autologo è irrealizzabile.

Europäische Union - Italienisch - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - altri farmaci sul sistema nervoso - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Europäische Union - Italienisch - EMA (European Medicines Agency)

vericel denmark aps - condrociti autologhi in coltura - fratture, cartilagine - altri farmaci per i disturbi del sistema muscolo-scheletrico - riparazione di difetti sintomatici della cartilagine del ginocchio.

Italien - Italienisch - Ministero della Salute

cascade medical enterprises ltd - dispositivi per la preparazione automatica di gel di piastrine (escluse le sacche)

Italien - Italienisch - Ministero della Salute

cascade medical enterprises ltd - dispositivi per la preparazione automatica di gel di piastrine (escluse le sacche)