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)

holostem s.r.l - ex vivo paplašinātas autologas cilvēka radzenes epitēlija šūnas, kas satur cilmes šūnas - stem cell transplantation; corneal diseases - oftalmoloģiskie līdzekļi - Ārstēšana pieaugušiem pacientiem ar vidēji smagu limbal cilmes šūnu trūkums (radzenes virspusēji neovascularisation, ar vismaz diviem radzenes kvadrantos centrālā radzenes iesaistot klātbūtni nosaka un stipri samazinājusies redzes asums), vienpusējas vai divpusējas, jo fiziska vai ķīmiska acs apdegumi. biopsijai ir nepieciešams vismaz 1-2 mm2 nekaitēta limbus.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumabs - 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 - antineoplastiski līdzekļi - 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. pacientiem ar egfr vai bĀziskĀ pozitīvas mutācijas audzēja arī būtu saņēmuši mērķtiecīgu terapiju, pirms saņem 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.

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)

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)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - imūnsupresanti - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ir norādīts ārstēšanai pieaugušiem pacientiem ar iepriekš neārstētiem multiplā mieloma, kas nav tiesīgi transplantātu. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ir norādīts ārstēšanai pieaugušiem pacientiem ar iepriekš neārstētiem multiplā mieloma, kas nav tiesīgi transplantātu. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - imūnsupresanti - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ir norādīts ārstēšanai pieaugušiem pacientiem ar iepriekš neārstētiem multiplā mieloma, kas nav tiesīgi transplantātu. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 un 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ir norādīts ārstēšanai pieaugušiem pacientiem ar iepriekš neārstētiem multiplā mieloma, kas nav tiesīgi transplantātu. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 un 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

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)

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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomide - multiple mieloma - imūnsupresanti - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ir norādīts ārstēšanai pieaugušiem pacientiem ar iepriekš neārstētiem multiplā mieloma, kas nav tiesīgi transplantātu. lenalidomide vienojoties kopā ar deksametazona ir indicēts, lai ārstētu multiplā mieloma pieaugušo pacientiem, kuri ir saņēmuši vismaz vienu pirms terapijas. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).