Eiropas Savienība - latviešu - EMA (European Medicines Agency)

co.don gmbh - cilvēka autologu ar matricu saistītu hondrocītu sfēras - skrimšļu slimības - other drugs for disorders of the musculo-skeletal system - remonta femorālo condyle simptomātiska mirdza skrimšļa bojājumi un ceļa skriemelis (international skrimšļa remonta sabiedrība [icrs] pakāpes iii vai iv) ceļa ar defektu izmēri pieaugušajiem līdz 10 cm2.

Eiropas Savienība - latviešu - 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) - limfoma, mantle-cell - antineoplastiski līdzekļi - 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).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vericel denmark aps - autologās kultivētās hondrocītes - lūzumi, skrimšļi - other drugs for disorders of the musculo-skeletal system - ceļa simptomātisku skrimšļa defektu novēršana.

Eiropas Savienība - latviešu - 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 - antineoplastiski līdzekļi - 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.

Eiropas Savienība - latviešu - 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 - antineoplastiski līdzekļi - 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

takeda pharma a/s - brentuksimaba vedotīns - lymphoma, non-hodgkin; hodgkin disease - antineoplastiski līdzekļi - 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 ir norādīts ārstēšanai pieaugušiem pacientiem ar relapsed vai ugunsizturīgs cd30+ hodgkin limfomas (hl):pēc asct, orfollowing vismaz divas pirms terapiju, kad asct vai multi-agent ķīmijterapiju nav iespēja ārstēties. sistēmisko anaplastic liels šūnu lymphomaadcetris kombinācijā ar ciklofosfamīdu, doksorubicīna un prednizonu (tec) ir indicēts pieaugušiem pacientiem ar iepriekš neārstētiem sistēmisko anaplastic liels šūnu limfomas (salcl). adcetris ir norādīts ārstēšanai pieaugušiem pacientiem ar relapsed vai ugunsizturīgs salcl. Ādas t šūnu lymphomaadcetris ir norādīts ārstēšanai pieaugušiem pacientiem ar cd30+ ādas t šūnu limfomas (ctcl) pēc vismaz 1 pirms sistēmiskā terapija.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

fondazione telethon ets - autologās cd34 + bagātina cd34 + šūnu transduced ar antiretrovīrusu vektors, kas kodē cilvēka adenozīna deaminase (ada) cdna sērijai no cilvēka hematopoētisko cilmes/cilmes (cd34 +) šūnu saturošo šūnu frakciju - smags kombinētais imūndeficīts - imunitātes stimulatori, - strimvelis tiek norādīts ārstēšanai pacientiem ar nopietns kombinētās imūndeficīta sakarā ar adenozīna deaminase trūkumu (ada-scid), kuriem nav piemērota cilvēka leikocītu antigēnu (hla)-saskaņoto saistīto cilmes šūnu donors ir pieejams (skatīt 4. sadaļa. 2 un 4. sadaļa.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

dendreon uk ltd - autologās perifēro asiņu monocikliski šūnām, ieskaitot vismaz 50 miljoni autologās cd54 + šūnu aktivizē ar prostatic acid kinase granulocyte-makrofāgu koloniju stimulējot faktors - prostatas audzēji - other immunostimulants - provenge ir indicēts bez simptomiem vai minimāli simptomātiska metastātisku (bez viscerālu) kastrēt rezistentiem prostatas vēža ārstēšanai vīriešu pieaugušajiem, kuriem ķīmijterapija nav vēl klīniski norādīts.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - other nervous system drugs - 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

tigenix n.v. - raksturo dzīvotspējīgu autologās skrimšļa šūnas paplašināts ex vivo, paužot īpašu atzīmi olbaltumvielas - skrimšļu slimības - other drugs for disorders of the musculo-skeletal system - cilvēka ceļa augšstilba kondiila (starptautiskās skrimšļu labošanas biedrības [icrs] iii vai iv pakāpes biežuma simptomātisku bojājumu novēršana pieaugušajiem. paralēli norit bez simptomiem skrimšļu bojājumi (icrs pakāpes i vai ii) varētu būt klāt. demonstrējumu iedarbīguma pamatā randomizētā kontrolētā pētījumā novērtēta efektivitāte chondrocelect pacientiem ar bojājumiem, starp 1 un 5 cm2.