União Europeia - alemão - EMA (European Medicines Agency)

laboratorios syva, s.a.u. - inaktivierte virus der blauzungenkrankheit, serotyp 1, stamm alg2006/01 e1 inaktiviertes virus der blauzungenkrankheit, serotyp 4, stamm btv-4/spa-1/2004, inaktivierte virus der blauzungenkrankheit, serotyp 8, stamm bel2006/01 - inaktivierte virale impfstoffe - cattle; sheep - für die aktive immunisierung von schafen zu verhindern virämie und die verringerung der klinischen anzeichen und läsionen, verursacht durch das virus der blauzungenkrankheit der serotypen 1 und/oder 8 und/oder verringerung der virämie* und der klinischen zeichen und läsionen, verursacht durch das virus der blauzungenkrankheit serotyp 4for aktive immunisierung von rindern zu verhindern virämie verursacht durch das virus der blauzungenkrankheit der serotypen 1 und/oder 8 und/oder verringerung der virämie* verursacht durch virus der blauzungenkrankheit serotyp 4.

União Europeia - alemão - EMA (European Medicines Agency)

gilead sciences ireland uc - remdesivir - covid-19 virus infection - veklury is indicated for the treatment of coronavirus disease 2019 (covid 19) in:adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19.

União Europeia - alemão - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - antivirale mittel zur systemischen anwendung - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

União Europeia - alemão - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan 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 mylan is indicated in combination with a sulphonylurea (i. , dreifach-kombinationstherapie) als ergänzung zu diät und bewegung bei patienten, die unzureichend kontrolliert auf ihren maximalen tolerierten dosis von metformin und sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i. , 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.

União Europeia - alemão - EMA (European Medicines Agency)

mylan ireland limited - dimethylfumarat - multiple sklerose, schubförmig-remittierender - immunsuppressiva - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

União Europeia - alemão - EMA (European Medicines Agency)

gilead sciences ireland unlimited company - lenacapavir sodium - hiv-infektionen - antivirale mittel zur systemischen anwendung - sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4. 2 und 5. sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 und 5.

União Europeia - alemão - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunsuppressiva - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

União Europeia - alemão - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogen bei diabetes verwendet - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 und 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

União Europeia - alemão - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastische mittel - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

União Europeia - alemão - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hydrochloride - kolorektale neoplasmen - antineoplastische mittel - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.