European Union - English - EMA (European Medicines Agency)

meda ab - zaleplon - sleep initiation and maintenance disorders - psycholeptics - sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. it is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.

European Union - English - EMA (European Medicines Agency)

meda ab - zaleplon - sleep initiation and maintenance disorders - psycholeptics - zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. it is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.

Australia - English - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 60512 - shoulder humeral body prosthesis - an eccentric tapered connector that is connected to the anatomic metaphysis by means of a press-fit cylinder. the humeral head is then coupled to the double eccenter by means of an eccentric morse taper connection. the anatomic medacta shoulder system is intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

Australia - English - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 60512 - shoulder humeral body prosthesis - the anatomic metaphysis is a wedged component that has to be mounted on the humeral diaphysis in order to obtain an anatomic stem. the possibility to adjust the inclination of the proximal plane of the anatomic stem is important to correctly reconstruct the inclination of the humeral head of the patient. the device is available in 3 inclination options, providing 128?, 135? and 142? ccd angles the anatomic medacta shoulder system is intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

Australia - English - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 48088 - humeral head prosthesis - the humeral head is coupled to the double eccenter by means of an eccentric morse taper connection. the double eccenter provides a 2.5mm offset with respect to the stem, while the humeral head provides a 2.5mm offset with respect to the double eccenter. by adjusting the angular positions of the double eccenter and the humeral head, it is possible to obtain infinite offset values ranging from 0mm to 5mm in infinite possible directions. the anatomic medacta shoulder system is intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

Australia - English - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the anatomic glenoid implant is a polyethylene (pe) component characterized by a spherical surface articulating on the humeral head, and a pattern of fixation pegs to be press-fit and cemented into the bone. the pegs have barbed structures that deform while the pegs are inserted into the bone, providing an immediate fixation even when the cement is still hardening. the anatomic medacta shoulder system is intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

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 - 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.