Unione Europea - italiano - 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.

Unione Europea - italiano - EMA (European Medicines Agency)

fondazione telethon ets - autologhe cd34 + arricchita frazione di cellule che contiene le cellule cd34 + trasformate con un vettore retrovirale che codifica per la sequenza del cdna umano adenosina deaminasi (ada) da umano cellule staminali/progenitrici (cd34 +) - immunodeficienza grave associata - immunostimolanti, - strimvelis è indicato per il trattamento di pazienti con immunodeficienza combinata grave deficit di adenosina deaminasi (ada-scid), per i quali nessun antigene umano adatto del leucocita (hla)-donatore di cellule staminali correlate abbinato è disponibile (vedere paragrafo 4. 2 e sezione 4.

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

co.don schweiz gmbh - autologous cultured il chondrocytes ogni siringa preriempita o ogni applicatore contiene un certo numero di sferici in base alla defektgröße (da 10 a 70 visualizzazione sferoidale/cm2), che deve essere trattato. - sospensione zur impianto - sospensione: autologous cultured il chondrocytes ogni siringa preriempita o ogni applicatore contiene un certo numero di sferici in base alla defektgröße (da 10 a 70 visualizzazione sferoidale/cm2), che deve essere trattato. 10 a 70 visualizzazione sferoidale/cm2, natrii chloridum, per praeparatione. - riparazione sintomatica gelenkknorpeldefekte il femurkondyle e della rotula del ginocchio (international cartilage rigenerazione & joint preservation society [icrs]-grado iii o iv) con defektgrößen di 2 qcm fino a 10 qcm negli adulti, solo inadeguate conservativa (non operativa) trattamenti hanno risposto. - trapianto: gewebeprodukt

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).

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

b. braun medical ag - autologous cultured chondrocytes (entspricht 0.75 mio zellen/qcm) - transplantatprodukt - autologous cultured chondrocytes (entspricht 0.75 mio zellen/qcm) 8.25 - 44 mio/11 cm², collagenum ex pericardio bovis (matrize), dulbecco's modified eagle medium /f12 (kommerziell hergestelltes medium mit vertraglich vereinbarter rezeptur), folgende komponenten sind enthalten in den 14.8 ml acidum ascorbicum, chondroitini sulfas natricus, insulinum humanum (emp), diboterminum alfa, albuminum seri humani, glucosum, calcii pantothenas, acidum folicum, inositolum, nicotinamidum, pyridoxini hydrochloridum, riboflavinum, thiamini hydrochloridum, acidum (+)-alpha-liponicum, biotinum, ethylis linolenas, cyanocobalaminum hypoxanthin, thymidin, putrescin, alaninum, arginini hydrochloridum, asparaginum monohydricum, acidum glutamicum, cysteini hydrochloridum monohydricum, acidum glutamicum, histidini hydrochloridum monohydricum, isoleucinum , leucin, lysini hydrochloridum, methioninum, phenylalaninum, prolinum, serinum, threoninum, tryptophanum , thyrosin, valinum, cystinum, glycinum, glutaminum, acidum hydroxyethylpi - chirurgische therapie zur biologischen rekonstruktion artikulärer knorpeldefekte, des kniegelenks mittels matrixgekoppelter autologer knorpelzelltransplantation (mact). - trapianto: gewebeprodukt

Unione Europea - italiano - EMA (European Medicines Agency)

dendreon uk ltd - cellule mononucleate autologhe del sangue periferico comprendenti almeno 50 milioni di cellule cd54 + autologhe attivate con fattore stimolante la colonia dei fosfatasi granulociti-macrofagi - neoplasie prostatiche - altri immunostimolanti - provenge è indicato per il trattamento del carcinoma prostatico metastatico (non viscerale) asintomatico o minimamente sintomatico nei pazienti adulti in cui la chemioterapia non è ancora clinicamente indicata.

Italia - italiano - Ministero della Salute

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

Unione Europea - italiano - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimolanti, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Unione Europea - italiano - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - agenti antineoplastici - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Unione Europea - italiano - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - mieloma multiplo - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combinazione con bortezomib, talidomide e desametasone per il trattamento di pazienti adulti con nuova diagnosi di mieloma multiplo che sono eleggibili per il trapianto di cellule staminali autologhe. in combinazione con lenalidomide e desametasone, o bortezomib e desametasone per il trattamento di pazienti adulti con mieloma multiplo che hanno ricevuto almeno una precedente terapia. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. come monoterapia per il trattamento di pazienti adulti con recidivo e refrattario mieloma multiplo, la cui prima terapia incluso un inibitore del proteasoma e un agente immunomodulante e che hanno dimostrato la progressione della malattia, l'ultima terapia. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.