Den Europæiske Union - dansk - EMA (European Medicines Agency)

viiv healthcare b.v. - abacavir - hiv infektioner - antivirale midler til systemisk anvendelse - ziagen er indiceret i antiretroviral kombinationsbehandling til behandling af human immundefektvirus (hiv) infektion hos voksne, unge og børn. demonstration til fordel for ziagen er primært baseret på resultaterne af undersøgelser, der udføres med en to gange dagligt, i behandling-naive voksne patienter på en kombination terapi. før du starter behandling med abacavir, screening for transport af hla-b*5701 allel bør være udført i enhver hiv-smittet patient, uanset race. abacavir bør ikke anvendes i patienter, der er kendt for at bære hla-b*5701 allel.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - hiv infektioner - antivirale midler til systemisk anvendelse - rukobia, in combination with other antiretrovirals, 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - forhøjet blodtryk - agenter, der virker på renin-angiotensinsystemet - behandling af essentiel hypertension.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - forhøjet blodtryk - agenter, der virker på renin-angiotensinsystemet - behandling af essentiel hypertension.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastiske midler - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

n.v. organon - colecalciferol, alendronic acid (as sodium trihydrate) - osteoporose, postmenopausale - narkotika til behandling af knoglesygdomme - behandling af postmenopausal osteoporose hos patienter med risiko for vitamin d-insufficiens. adrovance reducerer risikoen for vertebrale og hoftebrud.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and 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. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or 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 treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe 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 (see section 5. undtagen i nyligt diagnosticeret kronisk cml-fase, der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme. .

Den Europæiske Union - dansk - EMA (European Medicines Agency)

accord healthcare s.l.u. - lacosamid - epilepsi - antiepileptika, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, type 2 - narkotika anvendt i diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - diabetes mellitus, type 2 - narkotika anvendt i diabetes - for adult patients with type 2 diabetes mellitus:it 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. it is indicated in combination with a sulphonylurea (i. - , trepersoners-kombinationsbehandling) som supplement til diæt og motion hos patienter, der ikke er tilstrækkeligt kontrolleret på deres maksimal tolereret dosis af metformin og et sulphonylurea. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it 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.