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

adempas

bayer ag - riociguat - hypertension, lunge - antihypertensive midler til pulmonal arteriel hypertension - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. effekten har været vist i en pah befolkningen, herunder aetiologies af idiopatisk eller arvelige pah eller pah, der er forbundet med bindevævssygdom. paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

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

uptravi

janssen cilag international nv - selexipag - hypertension, lunge - antitrombotiske midler - uptravi er indiceret til langtidsbehandling af pulmonal arteriel hypertension (pah) hos voksne patienter med som funktionelle klasse (fc) ii – iii, enten som kombinationsbehandling hos patienter utilstrækkeligt kontrolleret med en endothelin receptor antagonist (era) og/eller en phosphodiesterase type 5 (pde-5) hæmmer, eller som monoterapi hos patienter, der ikke er kandidater til disse behandlinger. effekten har været vist i en pah befolkningen, herunder idiopatisk og arvelige pah, pah, der er forbundet med bindevæv, og pah, der er forbundet med korrigeret simple medfødt hjertesygdom.

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

imatinib koanaa

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastiske midler - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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. patienter, der har en lav eller meget lav risiko for tilbagefald, bør ikke modtage adjuverende behandling. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. 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.

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

bravecto

intervet international b.v - fluralaner - ectoparasiticides til systemisk brug, isoxazolines - dogs; cats - hunde:- til behandling af kryds og loppe angreb;produktet kan bruges som en del af en behandlingsstrategi for kontrol af loppe allergi dermatitis (fad). - til behandling af demodicosis forårsaget af demodex canis;- til behandling af sarcoptic skab (sarcoptes scabiei var. canis) angreb. - for reduction of the risk of infection with babesia canis canis via transmission by dermacentor reticulatus. [chewable tablets only]cats:- for the treatment of tick and flea infestations;the product can be used as part of a treatment strategy for the control of flea allergy dermatitis (fad). - til behandling af angreb med øremider (otodectes cynotis).

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

nexium control

glaxosmithkline dungarvan limited - esomeprazol - gastroøsofageal tilbagesvaling - proton pumpe hæmmere - nexium control er indiceret til kortvarig behandling af reflukssymptomer (f.eks. halsbrand og syreregurgitation) hos voksne.

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

xultophy

novo nordisk a/s - insulin degludec, liraglutide - diabetes mellitus, type 2 - narkotika anvendt i diabetes - xultophy er indiceret til behandling af voksne med type-2 diabetes mellitus at forbedre glykæmiske kontrol i kombination med oral glukose-sænkende lægemidler, når disse alene eller kombineret med en glp-1 receptor agonist eller basal insulin ikke giver passende glykæmiske kontrol.

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

ozempic

novo nordisk a/s - semaglutid - diabetes mellitus - narkotika anvendt i diabetes - behandling af voksne med utilstrækkeligt kontrolleret type 2-diabetes som et supplement til kost og motion:som monoterapi når metformin anses for uhensigtsmæssig på grund af intolerance eller kontraindikationer;i tillæg til andre lægemidler til behandling af diabetes. for undersøgelsens resultater med hensyn til kombinationer, effekt på glykæmisk kontrol og hjerte-kar-hændelser, og de befolkninger, der studerede, se afsnit 4. 4, 4. 5 og 5.