Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate mbh - bendamustine hydrochloride - pdr/conc/soln for infus - 100 milligram - alkylating agents

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft für klinische spezialpräparate mbh - mitomycin - powder and solvent for intravesical solution - 40 milligram(s) - other cytotoxic antibiotics; mitomycin

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate mbh - urokinase - powder for solution for infusion - 10,000 international unit(s) - enzymes; urokinase

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate mbh - urokinase - powder for solution for infusion - 50,000 international unit(s) - enzymes; urokinase

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate mbh - urokinase - powder for solution for infusion - 100,000 international unit(s) - enzymes; urokinase

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate mbh - urokinase - powder for solution for infusion - 250,000 international unit(s) - enzymes; urokinase

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate mbh - urokinase - powder for solution for infusion - 500,000 international unit(s) - enzymes; urokinase

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 - 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.

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.