Reyataz Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

reyataz

bristol-myers squibb pharma eeig - atazanavir (as sulfate) - hiv infections - antivirals for systemic use - reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of hiv-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 pi mutations).the choice of reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 pi mutations). the choice of reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).

Empliciti Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

empliciti

bristol-myers squibb pharma eeig - elotuzumab - multiple myeloma - antineoplastic agents - empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).

Sprycel Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

sprycel

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - sprycel is indicated for the treatment of paediatric patients with:newly diagnosed philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (ph+ cml cp) or ph+ cml cp resistant or intolerant to prior therapy including imatinib.newly diagnosed ph+ acute lymphoblastic leukaemia (all) in combination with chemotherapy.sprycel is indicated for the treatment of adult patients with:newly diagnosed philadelphia-chromosome-positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase;chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib mesilate;ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy.sprycel is indicated for the treatment of paediatric patients with:newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.

Nulojix Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

nulojix

bristol-myers squibb pharma eeig - belatacept - graft rejection; kidney transplantation - immunosuppressants - nulojix, in combination with corticosteroids and a mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant. 

Orencia Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

orencia

bristol-myers squibb pharma eeig - abatacept - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid - immunosuppressants - rheumatoid arthritisorencia, in combination with methotrexate, is indicated for:the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) including methotrexate (mtx) or a tumour necrosis factor (tnf)-alpha inhibitor.the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.a reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.psoriatic arthritisorencia, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis (psa) in adult patients when the response to previous dmard therapy including mtx has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. polyarticular juvenile idiopathic arthritisorencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pjia) in paediatric patients 2 years of age and older who have had an inadequate response to previous dmard therapy.orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.

Abraxane Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

abraxane

bristol-myers squibb pharma eeig - paclitaxel - breast neoplasms; pancreatic neoplasms; carcinoma, non-small-cell lung - antineoplastic agents - abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

Thalidomide BMS (previously Thalidomide Celgene) Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

thalidomide bms (previously thalidomide celgene)

bristol-myers squibb pharma eeig - thalidomide - multiple myeloma - immunosuppressants - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy.thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.4).

Onureg Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

onureg

bristol-myers squibb pharma eeig - azacitidine - leukemia, myeloid, acute - antineoplastic agents - 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).

Inrebic Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

inrebic

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastic agents - 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.

Vidaza Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

vidaza

bristol-myers squibb pharma eeig - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification.vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.