Euroopan unioni - suomi - EMA (European Medicines Agency)

fondazione telethon ets - autologinen cd34 + rikastettu cd34 + transduced antiretroviraalisten vektori, joka koodaa ihmisen adenosiini deaminase (ada) cdna järjestyksessä ihmisen hematopoeettiset varsi / (cd34 +) esisolut soluja sisältävään soluun murto-osa - vaikea yhdistetty immunodeficiency - immunostimulantit, - strimvelis on indikoitu hoitoon potilailla, joilla on vaikea yhdistää immuunipuutos johtuu adenosiini deaminase puutos (ada-scid), jolle ei ole sopivaa ihmisen valkosolujen antigeeni (hla)-hyväksytty liittyvät kantasolujen luovuttajan on saatavilla (ks osa 4. 2 ja 4.

Euroopan unioni - suomi - EMA (European Medicines Agency)

tigenix n.v. - karakterisoitiin elinkykyisiä autologisia rustosoluja, jotka laajenivat ex vivo, ilmentäen spesifisiä markkeriproteiineja - porakasvaimet - muut lääkkeet liikuntaelinten sairauksien häiriöihin - polven reisiluun condilian yksittäisten oireiden aiheuttamien rustohäiriöiden korjaaminen aikuisilla (international crust repair society [icrs] iii tai iv). samanaikainen oireeton ruston vaurioita (icrs luokan i tai ii) saattaa olla läsnä. osoitus teho perustuu satunnaistetussa kontrolloidussa tutkimuksessa arvioida tehoa chondrocelect potilailla, joilla on vaurioita välillä 1 ja 5 cm2.

Euroopan unioni - suomi - 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) - lymfooma, mantle-cell - antineoplastiset aineet - 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).

Euroopan unioni - suomi - 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 - antineoplastiset aineet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

dendreon uk ltd - autologinen perifeerinen veren valkosoluja, johon kuuluvat vähintään 50 miljoonaa autologisen cd54 + solujen käyttöön eturauhasen hapan fosfataasi granulosyytti makrofagi pesäkkeitä stimuloivaa tekijää - prostatiset kasvaimet - muut immunostimulantit - provenge on indikoitu hoitoon oireeton tai minimaalisesti oireiden metastasoitunut (ei sisäelinten) tehdä tehottomaksi kestävä eturauhassyövän mies aikuiset, joille kemoterapia ei ole vielä kliinisesti tarkoitettu.

Euroopan unioni - suomi - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - muut hermoston huumeet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - antineoplastiset aineet - 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 on tarkoitettu aikuispotilaille, joilla on uusiutunut tai vaikeahoitoinen cd30+ hodgkinin lymfooma (hl):seuraavat asct, orfollowing vähintään kaksi ennen hoitoja, kun asct tai multi-agent kemoterapia ei ole hoitovaihtoehto. systeeminen anaplastinen suuri solu lymphomaadcetris ja syklofosfamidin, doksorubisiinin ja prednisonin kanssa (chp) on tarkoitettu aikuisille potilaille, joilla on aiemmin hoitamaton systeeminen anaplastinen suuri solulymfooman (salcl). adcetris on tarkoitettu aikuispotilaille, joilla on uusiutunut tai vaikeahoitoinen salcl. ihon t-solu-lymphomaadcetris on tarkoitettu aikuisille potilaille, joilla on cd30+ ihon t-solu-lymfooma (ihon t-solulymfooma) jälkeen vähintään 1 aiempi systeeminen hoito.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - 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. yhdessä bortetsomibin kanssa, talidomidin ja deksametasonin hoitoon aikuispotilailla, joilla on äskettäin diagnosoitu multippeli myelooma, jotka ovat oikeutettuja autologisen kantasolujen siirto. yhdessä lenalidomidin ja deksametasonin tai bortetsomibi ja deksametasoni, hoitoon aikuisille potilaille, joilla on multippeli myelooma, jotka ovat saaneet vähintään yhtä aiempaa hoitoa. 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. monoterapiana aikuispotilaille, joilla oli uusiutunut ja refraktorinen multippeli myelooma, joiden aiempi hoito, mukana proteasomin estäjä ja immunomoduloivan aineen, ja jotka ovat osoittaneet taudin etenemistä viimeinen hoito. 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

holostem s.r.l - ex vivo laajennetut autologiset ihmisen sarveiskalvon epiteelisolut, jotka sisältävät kantasoluja - stem cell transplantation; corneal diseases - silmätautien - hoito aikuispotilailla, joilla on keskivaikea tai vaikea limbal kantasolujen puutos (määritelty läsnäolo pinnallinen sarveiskalvon neovascularisation vähintään kaksi sarveiskalvon neljänneksissä keski sarveiskalvon mukana ja vakavasti heikentynyt näöntarkkuus), yksipuolinen tai molemminpuolinen vuoksi fyysisiä tai kemiallisia silmän burns. biopsia vaatii vähintään 1-2 mm2 vahingoittumatonta limaa.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastiset aineet - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. potilailla, joilla egfr-tai alk positiivinen kasvain mutaatioita olisi myös saanut täsmähoitoihin ennen kuin saa keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.