European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - hematopoietic stem cell transplantation - antineoplastic agents - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - folinic acid - solution for injection - 50 mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - treosulfan - capsule - 250 mg milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - folinic acid - solution for injection - 50 mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - treosulfan - capsule - 250 mg milligram

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - temozolomide - glioma; glioblastoma - antineoplastic agents - temomedac hard capsules is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (rt) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - methotrexate - solution for injection - methotrexate 50 mg/ml - methotrexate - methotrexate - psoriasis in adult patients :because of the high risk attending its use, methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. rheumatoid arthritis: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose nsaids and usually a trial of at least one or more disease-modifying antirheumatic drugs.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - methotrexate - solution for injection - methotrexate 50 mg/ml - methotrexate - methotrexate - psoriasis in adult patients :because of the high risk attending its use, methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. rheumatoid arthritis: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose nsaids and usually a trial of at least one or more disease-modifying antirheumatic drugs.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - methotrexate - solution for injection - methotrexate 50 mg/ml - methotrexate - methotrexate - psoriasis in adult patients :because of the high risk attending its use, methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. rheumatoid arthritis: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose nsaids and usually a trial of at least one or more disease-modifying antirheumatic drugs.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - methotrexate - solution for injection - methotrexate 50 mg/ml - methotrexate - methotrexate - psoriasis in adult patients :because of the high risk attending its use, methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. rheumatoid arthritis: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose nsaids and usually a trial of at least one or more disease-modifying antirheumatic drugs.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.