Opdualag Europska Unija - hrvatski - EMA (European Medicines Agency)

opdualag

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Sotyktu Europska Unija - hrvatski - EMA (European Medicines Agency)

sotyktu

bristol-myers squibb pharma eeig - deucravacitinib - psorijaza - imunosupresivi - treatment of moderate-to-severe plaque psoriasis in adults.

Camzyos Europska Unija - hrvatski - EMA (European Medicines Agency)

camzyos

bristol-myers squibb pharma eeig - mavacamten - cardiomyopathy, hypertrophic - ostali srčani pripravci - treatment of symptomatic obstructive hypertrophic cardiomyopathy.

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

imnovid (previously pomalidomide celgene)

bristol-myers squibb pharma eeig - pomalidomide - multipli mijelom - imunosupresivi - imnovid u kombinaciji s бортезомибом i дексаметазоном indiciran za liječenje odraslih bolesnika s multiplog mijeloma, koji je dobio barem jedan do tretman, uključujući леналидомид. imnovid u kombinaciji s deksametazonom indiciran je u liječenju odraslih bolesnika s relapsnim i refraktornim oblikom multiplog mijeloma koji su primili barem dvije linije liječenja režima, uključujući i lenalidomid i bortezomib, i pokazali bolest napredovala tijekom zadnje terapije.

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

revlimid

bristol-myers squibb pharma eeig - lenalidomid - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - imunosupresivi - nekoliko myelomarevlimid u monoterapiji namijenjen za liječenje odraslih bolesnika s prvi put utvrđenom multiplog mijeloma, koji su prošli autologna transplantacija matičnih stanica . Ревлимид kao kombinirane terapije s дексаметазоном, ili бортезомиб i Дексаметазон, ili мелфалан i prednizon (vidi odjeljak 4. 2) indiciran za liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma koji se ne oslanja transplantacije. Ревлимид u kombinaciji s дексаметазоном indiciran za liječenje multiple myeloma kod odraslih pacijenata koji su primili barem jedan kolegij terapija. Миелодиспластические syndromesrevlimid u monoterapiji namijenjen za liječenje odraslih bolesnika s трансфузионно ovisi o anemija zbog niske ili srednje-1 rizik миелодиспластические sindromi povezani s izoliranim uklanjanje 5v цитогенетические anomalije, kada su druge terapijske mogućnosti su nedovoljna ili neadekvatna. iz stanica plašt lymphomarevlimid u monoterapiji namijenjen za liječenje odraslih pacijenata s relaps ili vatrostalne limfoma iz stanica plašt. lymphomarevlimid folikula u kombinaciji s rituksimab (anti-cd20 protutijela) indiciran za liječenje odraslih bolesnika s prethodno obrađena фолликулярная limfom (klasa 1 – 3a).

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

sustiva

bristol-myers squibb pharma eeig - efavirenz - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - sustiva je indicirana u antivirusnom kombiniranom tretmanu odraslih osoba, adolescenata i djece starijih od tri godine starijih od ljudske imunodeficijencije-1 (hiv-1). Стокрин nisu bili pravilno istražena u bolesnika s uznapredovalom faze infekcije hiv-om, a upravo je u bolesnika s razinom cd4 < 50 ćelija/mm3, ili nakon neuspjeha протеаза-inhibitora (pi)-sadrže sheme. iako je cross-otpornost эфавиренза sa ip nije bio registriran, trenutno nema dovoljno podataka o efikasnosti kasniju upotrebu pi na temelju kombinirane terapije neučinkovitosti sheme sadrže Сустива.

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

yervoy

bristol-myers squibb pharma eeig - Ипилимумаб - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastična sredstva - 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 - hrvatski - 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 - antineoplastična sredstva - 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.