Onureg Europska Unija - poljski - EMA (European Medicines Agency)

onureg

bristol-myers squibb pharma eeig - azacytydyna - białaczka, szpikowe, ostre - Środki przeciwnowotworowe - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).

Abecma Europska Unija - poljski - EMA (European Medicines Agency)

abecma

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - Środki przeciwnowotworowe - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Breyanzi Europska Unija - poljski - EMA (European Medicines Agency)

breyanzi

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 - Środki przeciwnowotworowe - 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.

Reblozyl Europska Unija - poljski - EMA (European Medicines Agency)

reblozyl

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - inne leki przeciwanemiczne - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5. reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.

Inrebic Europska Unija - poljski - EMA (European Medicines Agency)

inrebic

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - Środki przeciwnowotworowe - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Imnovid (previously Pomalidomide Celgene) Europska Unija - poljski - EMA (European Medicines Agency)

imnovid (previously pomalidomide celgene)

bristol-myers squibb pharma eeig - pomalidomide - szpiczak mnogi - leki immunosupresyjne - imnovid w połączeniu z bortezomibem i deksametazonem jest wskazany do leczenia dorosłych pacjentów ze szpiczakiem mnogim, którzy otrzymali co najmniej jeden do leczenia, w tym lenalidomid. lek imnovid w skojarzeniu z deksametazonem jest wskazany w leczeniu dorosłych pacjentów z nawrotowym i opornym szpiczakiem mnogim, którzy otrzymali co najmniej dwóch schematów wcześniejszego leczenia, tym lenalidomid i bortezomib i wykazano progresji choroby ostatniego leczenia.

Revlimid Europska Unija - poljski - EMA (European Medicines Agency)

revlimid

bristol-myers squibb pharma eeig - lenalidomid - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - leki immunosupresyjne - kilka myelomarevlimid w monoterapii jest przeznaczony do leczenia dorosłych pacjentów z rozpoznaną po raz pierwszy na szpiczaka mnogiego, które odbyły się autologicznej transplantacji komórek macierzystych . revlimid jako skojarzeniu z deksametazonem lub bortezomibu i deksametazonu, lub melfalan i prednizon (patrz punkt 4. 2) jest wskazany do leczenia dorosłych pacjentów z wcześniej нелеченной ze szpiczakiem mnogim, którzy nie polega przeszczep. revlimid w skojarzeniu z deksametazonem jest wskazany do leczenia szpiczaka mnogiego u dorosłych pacjentów, którzy otrzymali co najmniej jeden kurs terapii. mielodysplastycznych syndromesrevlimid w monoterapii jest przeznaczony do leczenia dorosłych pacjentów z трансфузионно zależnej niedokrwistości z niskim lub pośrednim-1 ryzyku zespołów mielodysplastycznych, związane z izolowanym usuwanie 5v anomalie cytogenetyczne, gdy inne możliwości terapeutyczne są niewystarczające lub nieodpowiednie. z komórek płaszcza lymphomarevlimid w monoterapii jest przeznaczony do leczenia dorosłych pacjentów z nawracającą lub oporną na leczenie chłoniakiem z komórek płaszcza. lymphomarevlimid pęcherzyków w połączeniu z rytuksymab (anty-cd20 przeciwciała) jest wskazany do leczenia dorosłych pacjentów z wcześniej taktujący chłoniak grudkowy (klasa 1 – 3a).

Sustiva Europska Unija - poljski - EMA (European Medicines Agency)

sustiva

bristol-myers squibb pharma eeig - efawirenz - infekcje hiv - Środki przeciwwirusowe do użytku ogólnoustrojowego - sustiva jest wskazany w leczeniu przeciwwirusowym połączenie człowieka-niedoboru odporności wirus-1 (hiv-1)-zakażonych osób dorosłych, młodzieży i dzieci trzech lat życia i starsze. Стокрин nie zostały odpowiednio zbadane w pacjentach z zaawansowanym stadium zakażenia hiv, a mianowicie u pacjentów z poziomem cd4 < 50 komórek/mm3, lub po niepowodzeniu proteazy-inhibitor (pi)-zawierający schematów. chociaż oporności krzyżowej èfavirenza z ip nie został zarejestrowany, w chwili obecnej nie ma wystarczających danych na temat skuteczności późniejszego wykorzystania pi na podstawie połączenie terapii nieskuteczność schematów zawierających Сустива.

Yervoy Europska Unija - poljski - EMA (European Medicines Agency)

yervoy

bristol-myers squibb pharma eeig - Ипилимумаб - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - Środki przeciwnowotworowe - 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 i 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 Europska Unija - poljski - EMA (European Medicines Agency)

opdivo

bristol-myers squibb pharma eeig - niwolumab - 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 - Środki przeciwnowotworowe - 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.