Imnovid (previously Pomalidomide Celgene) Evropská unie - maďarština - EMA (European Medicines Agency)

imnovid (previously pomalidomide celgene)

bristol-myers squibb pharma eeig - pomalidomide - myeloma multiplex - immunszuppresszánsok - imnovid kombinálva bortezomib, valamint dexametazon jelzi a felnőtt betegek kezelésére myeloma multiplex, aki kapott már legalább egy előzetes kezelést-beleértve a lenalidomid. imnovid együtt dexametazon javallt kezelésére felnőtt kiújult és tűzálló myeloma multiplexes betegeknél, akik kaptak legalább két előzetes kezelési protokollok, beleértve a lenalidomid és bortezomib, és bebizonyították betegség progresszióját az utolsó terápia.

Revlimid Evropská unie - maďarština - EMA (European Medicines Agency)

revlimid

bristol-myers squibb pharma eeig - lenalidomide - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - immunszuppresszánsok - több myelomarevlimid monoterápiában javallt a fenntartó kezelésére felnőtt betegek újonnan diagnosztizált myeloma multiplex, akik átestek autológ őssejt-transzplantáció. a revlimid-et, mint a kombinált kezelés, dexametazon, vagy a bortezomib, valamint dexametazon, vagy irányadóak a prednizont (lásd 4. 2) kezelésére javallt felnőtt betegek korábban nem kezelt, myeloma multiplex, akik nem jogosultak transzplantációs. a revlimid dexametazonnal kezelésére javallt, a myeloma-ban szenvedő felnőtt betegek aki kapott már legalább egy előzetes kezelés. mielodiszpláziás syndromesrevlimid, mint monoterápia kezelésére felnőtt betegek transzfúzió-függő miatt vérszegénység, alacsony vagy közepes-1-kockázat mielodiszpláziás szindrómában társul egy elszigetelt törlés 5q citogenetikai rendellenesség, amikor más terápiás lehetőségek elégtelen vagy nem megfelelő. köpeny sejt lymphomarevlimid, mint monoterápia kezelésére felnőtt betegek visszaesett, vagy tűzálló mantle-sejtes lymphoma. follikuláris lymphomarevlimid kombinálva rituximab (anti-cd20 antitest) kezelésére javallt felnőtt betegek korábban kezelt follicularis lymphoma (grade 1 – 3a.).

Sustiva Evropská unie - maďarština - EMA (European Medicines Agency)

sustiva

bristol-myers squibb pharma eeig - efavirenz - hiv fertőzések - vírusellenes szerek szisztémás alkalmazásra - sustiva szerepel antivirális kombináció kezelés az emberi immunhiány vírus-1-(hiv-1)-fertőzött felnőttek, serdülőkorúak és a gyermek három éves és idősebb. a sustiva-t nem vizsgálták megfelelően a betegek előrehaladott hiv-betegség, azaz a betegek cd4 számít < 50 sejt/mm3, vagy kudarca után proteáz-gátló (pi)-tartalmú kezelések. bár a keresztrezisztencia az efavirenz a pis nem dokumentált, jelenleg nem áll rendelkezésre elégséges adat, a hatékonyság, a későbbi felhasználását a pi-alapú kombinált kezelés sikertelensége után a rend, amely a sustiva.

Yervoy Evropská unie - maďarština - EMA (European Medicines Agency)

yervoy

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - daganatellenes szerek - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 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 (see sections 4. 4 és 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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 Evropská unie - maďarština - EMA (European Medicines Agency)

opdivo

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 - daganatellenes szerek - 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.