Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropenia - immunostimulants, - accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of accofil are similar in adults and children receiving cytotoxic chemotherapy.accofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.accofil is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - antineoplastic agents - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd).adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct).adcetris is indicated for the treatment of adult patients with relapsed or refractory cd30+ hodgkin lymphoma (hl):following asct, orfollowing at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option.systemic anaplastic large cell lymphomaadcetris in combination with cyclophosphamide, doxorubicin and prednisone (chp) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (salcl).adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl.cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. (miol) - febuxostat - gout - antigout preparations - 80 mg strength:treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).adenuric is indicated in adults.120 mg strength:adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (tls).adenuric is indicated in adults.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hydrochloride - vomiting; neoplasms; nausea; cancer - antiemetics and antinauseants, - akynzeo is indicated in adults for the:prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

eli lilly nederland b.v. - pemetrexed - mesothelioma; carcinoma, non-small-cell lung - antineoplastic agents - malignant pleural mesotheliomaalimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.non-small-cell lung canceralimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd. - palonosetron hydrochloride - vomiting; cancer - antiemetics and antinauseants, , serotonin (5ht3) antagonists - aloxi is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.aloxi is indicated in paediatric patients 1 month of age and older for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

amgen europe b.v. - darbepoetin alfa - anemia; cancer; kidney failure, chronic - other antianemic preparations - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adults and paediatric patients.treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

actavis group ptc ehf - pemetrexed diacid monohydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabine - precursor t-cell lymphoblastic leukemia-lymphoma - antineoplastic agents - nelarabine is indicated for the treatment of patients with t-cell acute lymphoblastic leukaemia (t-all) and t-cell lymphoblastic lymphoma (t-lbl) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.,

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; carcinoma, renal cell - antineoplastic agents - bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. for further information as to human epidermal growth factor receptor 2 (her2) status.bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with avastin in combination with capecitabine. for further information as to her2 status.bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations.bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer.bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents.bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents.bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.