Unió Europea - romanès - EMA (European Medicines Agency)

tigenix n.v. - caracterizată celulele cartilagiene autologe viabile extinse ex vivo care exprimă proteine ​​marker specifice - bolile cartilagiului - alte medicamente pentru tulburări ale sistemului musculo-scheletic - repararea defectelor unice ale cartilajului simptomatic ale condilului femural al genunchiului (clasa iii sau iv a icrs) la adulți. concomitent asimptomatice leziunilor cartilajului (icrs gradul i sau ii) ar putea fi prezente. demonstrarea eficacității se bazează pe un studiu randomizat controlat a evalua eficacitatea chondrocelect la pacienții cu leziuni între 1 și 5 cm2.

Unió Europea - romanès - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - mielom multiplu - 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. în asociere cu bortezomib, talidomida și dexametazona, pentru tratamentul pacienților adulți diagnosticați recent cu mielom multiplu care sunt eligibili pentru transplant autolog de celule stem. în asociere cu lenalidomidă și dexametazonă, sau bortezomib și dexametazonă, pentru tratamentul pacienților adulți cu mielom multiplu care au primit cel puțin un tratament anterior. 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. ca monoterapie pentru tratamentul pacienților adulți cu recidivat și refractar mielom multiplu, înainte de a căror terapie a inclus un inhibitor proteazomal și un agent imunomodulator și care au demonstrat progresia bolii în ultima terapie. 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.

Unió Europea - romanès - EMA (European Medicines Agency)

holostem s.r.l - celulele epiteliale coronare coronare umane expandate ex vivo conținând celule stem - stem cell transplantation; corneal diseases - oftalmologice - tratamentul pacienţilor adulţi cu moderată până la severă de celule stem limbale deficit (definit prin prezenţa neovascularisation corneene superficiale în cel puţin două quadrants corneei, cu implicarea centrul corneei, şi grav afectată acuităţii vizuale), unilaterale sau bilaterale, din cauza arsuri oculare fizice sau chimice. un minim de 1-2 mm2 de limbus nedeteriorate curselor este necesară pentru biopsie.

Unió Europea - romanès - 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 - agenți antineoplazici - 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. pacienții cu egfr sau alk pozitiv de tumoră mutații ar trebui să, de asemenea, au primit terapie vizate înainte de a primi 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.

Unió Europea - romanès - EMA (European Medicines Agency)

vericel denmark aps - autolog de culturi condrocite - fracturi, cartilaj - alte medicamente pentru tulburări ale sistemului musculo-scheletic - repararea defectelor cartilajului simptomatice ale genunchiului.

Unió Europea - romanès - EMA (European Medicines Agency)

roche registration gmbh - epoetină beta - kidney failure, chronic; anemia; cancer; blood transfusion, autologous - preparate antianemice - tratamentul anemiei simptomatice asociate cu insuficiență renală cronică (irc) la pacienți adulți și copii;tratamentul anemiei simptomatice la pacienții adulți cu neoplazii non-mieloide care primesc chimioterapie;creșterea randamentului de sânge autolog la pacienții într-o pre-donare de program. utilizarea sa în această indicație trebuie să fie echilibrată împotriva raportat un risc crescut de evenimente tromboembolice. tratamentul trebuie administrat numai pacienților cu anemie moderată (hb 10 - 13 g/dl [6. 21 - 8. 07 mmol/l], fără deficit de fier) în cazul în care sângele procedurilor de conservare nu sunt disponibile sau sunt insuficiente atunci când chirurgicale elective majore planificate necesită un volum mare de sânge (4 sau mai multe unități de sânge pentru femei sau 5 sau mai multe unități pentru bărbați).

Unió Europea - romanès - EMA (European Medicines Agency)

pfizer europe ma eeig - epoetină zeta - anemia; blood transfusion, autologous; kidney failure, chronic; cancer - alte preparate antianemice - tratamentul anemiei simptomatice asociate cu insuficiență renală cronică (irc) la pacienți adulți și copii:tratamentul anemiei asociate cu insuficiență renală cronică la adulți, copii și adolescenți la pacienții hemodializați și la pacienții adulți cu dializă peritoneală;tratamentul anemiei severe de origine renală însoțită de simptome clinice la pacienții adulți cu insuficiență renală care nu efectuează încă dializă. tratamentul anemiei și reducerea necesarului de transfuzii la pacienții adulți tratați prin chimioterapie pentru tumori solide, maligne limfom sau mielom multiplu, și la riscul de transfuzie cum a fost evaluată de starea generală a pacientului (e. statusul cardiovascular, anemie preexistentă la începerea chimioterapiei). retacrit poate fi folosit pentru a crește randamentul de sânge autolog la pacienții într-un program predonation. utilizarea sa în această indicație trebuie să fie echilibrată împotriva raportat riscul de evenimente tromboembolice. tratamentul trebuie administrat numai pacienților cu anemie moderată (fără deficit de fier), dacă tensiunea procedurile de salvare nu sunt disponibile sau sunt insuficiente atunci când chirurgicale elective majore planificate necesită un volum mare de sânge (patru sau mai multe unități de sânge pentru femei sau cinci sau mai multe unități pentru bărbați). retacrit poate fi folosit pentru a reduce expunerea la transfuzii de sânge alogen în adult non-fier-deficit de pacienți înainte de intervenție chirurgicală ortopedică electivă majoră, având un risc potențial crescut de a prezenta complicații ale transfuziei. utilizare ar trebui să fie limitată la pacienții cu anemie moderată (e. hb 10-13 g/dl) care nu au un program de pre-donare autologă disponibile și cu temperatura moderata pierdere de sânge (de la 900 la 1800 ml).

Unió Europea - romanès - 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 - agenți antineoplazici - 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.

Unió Europea - romanès - EMA (European Medicines Agency)

stada arzneimittel ag - epoetină zeta - anemia; blood transfusion, autologous; cancer; kidney failure, chronic - preparate antianemice - tratamentul anemiei simptomatice asociate cu insuficiență renală cronică (irc) la adulți, adolescenți și copii patientstreatment de anemie asociată cu insuficiență renală cronică la adulți, copii și adolescenți la pacienții hemodializați și la pacienții adulți cu dializă peritoneală. tratamentul anemiei severe de origine renală însoțită de simptome clinice la pacienții adulți cu insuficiență renală care nu efectuează încă dializă. tratamentul anemiei și reducerea necesarului de transfuzii la pacienții adulți tratați prin chimioterapie pentru tumori solide, maligne limfom sau mielom multiplu, și la riscul de transfuzie cum a fost evaluată de starea generală a pacientului (e. statusul cardiovascular, anemie preexistentă la începerea chimioterapiei). silapo poate fi folosit pentru a crește randamentul de sânge autolog la pacienții într-un program predonation. utilizarea sa în această indicație trebuie să fie echilibrată împotriva raportat riscul de evenimente tromboembolice. tratamentul trebuie administrat numai pacienților cu anemie moderată (fără deficit de fier), dacă procedurile de conservare a sângelui nu sunt disponibile sau sunt insuficiente atunci când chirurgicale elective majore planificate necesită un volum mare de sânge (4 sau mai multe unități de sânge pentru femei sau 5 sau mai multe unități pentru bărbați). silapo este indicat pentru non-deficit de fier adulți înainte de intervenție chirurgicală ortopedică electivă majoră având un risc potențial crescut de a prezenta complicații ale transfuziei pentru a reduce expunerea la transfuzii de sânge alogen. utilizare ar trebui să fie limitată la pacienții cu anemie moderată (e. concentrația hemoglobinei variază între 10 până la 13 g/dl) care nu au un program de pre-donare autologă disponibile și cu temperatura moderata pierderea de sânge (900 1 800 ml). silapo poate fi folosit pentru a crește concentrația hemoglobinei în anemie simptomatică (concentrația hemoglobinei ≤10 g/dl) la adulții cu un nivel scăzut sau intermediar-1-risc primară a sindroamelor mielodisplazice (smd) care au serică scăzută de eritropoietină (.

Unió Europea - romanès - EMA (European Medicines Agency)

co.don gmbh - sferoizi ai condrocitelor asociate cu matricea autologă umană - bolile cartilagiului - alte medicamente pentru tulburări ale sistemului musculo-scheletic - repararea cartilajului articular simptomatic defecte ale condilului femural si rotula genunchiului (international cartilaj repair societatea [icrs] gradul iii sau iv) cu defect dimensiuni până la 10 cm2 la adulţi.