Uni Eropa - Inggris - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - temozolomide - glioma; glioblastoma - antineoplastic agents - temozolomide sun 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.

Uni Eropa - Inggris - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastic agents - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients

Uni Eropa - Inggris - EMA (European Medicines Agency)

csl behring gmbh - alpha1-proteinase inhibitor (human) - genetic diseases, inborn, lung diseases - antihemorrhagics, - respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes pizz, piz(null), pi(null,null), pisz). patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (fev1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.,

Uni Eropa - Inggris - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sonidegib diphosphate - carcinoma, basal cell - antineoplastic agents - odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (bcc) who are not amenable to curative surgery or radiation therapy.

Uni Eropa - Inggris - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.sitagliptin/metformin hydrochloride sun is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist.sitagliptin/metformin hydrochloride sun is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Uni Eropa - Inggris - EMA (European Medicines Agency)

sandoz gmbh - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Uni Eropa - Inggris - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by rocuronium or vecuronium.for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Uni Eropa - Inggris - EMA (European Medicines Agency)

sandoz gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - 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 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 filgrastim are similar in adults and children receiving cytotoxic chemotherapy.mobilisation of peripheral blood progenitor cells (pbpc).in children and 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 filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.treatment of persistent neutropenia (anc ≤ 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

Uni Eropa - Inggris - EMA (European Medicines Agency)

orphelia pharma sas - clofarabine - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - treatment of acute lymphoblastic leukaemia (all) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.

Uni Eropa - Inggris - EMA (European Medicines Agency)

bayer ag - telmisartan - hypertension - agents acting on the renin-angiotensin system - hypertensiontreatment of essential hypertension in adults.cardiovascular preventionreduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type-2 diabetes mellitus with documented target-organ damage.