European Union - English - EMA (European Medicines Agency)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - protein kinase inhibitors - imatinib medac is indicated for the treatment of:paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;paediatric patients with ph+cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase;adult and paediatric patients with ph+cml in blast crisis;adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy;adult patients with relapsed or refractory ph+all as monotherapy;adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement;adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp.the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - pemetrexed - carcinoma, non-small-cell lung; mesothelioma - folic acid analogues, antineoplastic agents - malignant pleural mesothelioma pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer pemetrexed medac 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 medac 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 medac 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.,

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Malta - English - Medicines Authority

medac gesellschaft fur klinische spezialpräparate mbh theaterstr. 6 22880 wedel, germany - soft capsule - vinorelbine 20 mg - antineoplastic agents

Malta - English - Medicines Authority

medac gesellschaft fur klinische spezialpräparate mbh theaterstr. 6 22880 wedel, germany - soft capsule - vinorelbine 30 mg - antineoplastic agents

Malta - English - Medicines Authority

medac gesellschaft fur klinische spezialpräparate mbh theaterstr. 6 22880 wedel, germany - soft capsule - vinorelbine 80 mg - antineoplastic agents

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - leflunomide - arthritis, rheumatoid - selective immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard).recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - capecitabine - colorectal neoplasms - antineoplastic agents - capecitabine medac is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine medac is indicated for the treatment of metastatic colorectal cancer.capecitabine medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.capecitabine medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - gemcitabine as hydrochloride - powder for solution for infusion - gemcitabine as hydrochloride 1500 mg - gemcitabine - gemcitabine - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locallyadvanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreaticcancer.gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage.breast cancer:gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locallyrecurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.prior chemotherapy should have included an anthracycline unless clinically contraindicated.ovarian cancer:gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelialovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - oxaliplatin - powder for solution for infusion - oxaliplatin 50 mg/vial - oxaliplatin - oxaliplatin - oxaliplatin in combination with 5-fluorouracil (5-fu) and folinic acid (fa) is indicated for: • adjuvant treatment of stage iii (duke‘s c) colon cancer after complete resection of primary tumor. • treatment of metastatic colorectal cancer. oxaliplatin in combination with leucovorin, irinotecan and 5-fluorouracil is indicated for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (based on nccn guidelines, version 2.2014).