Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

baxalta innovations gmbh - koagulationsfaktor viii inhibitor passerende aktivitet - pulver og solvens til infusionsvæske, opløsning - 50 enheder/ml

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

paranova danmark a/s - koagulationsfaktor viii inhibitor passerende aktivitet - pulver og solvens til injektions- /infusionsvæske, opløsning

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

baxalta innovations gmbh - koagulationsfaktor viii inhibitor passerende aktivitet - pulver og solvens til infusionsvæske, opløsning - 25 enheder/ml

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

orifarm a/s - koagulationsfaktor viii inhibitor passerende aktivitet - pulver og solvens til infusionsvæske, opløsning - 50 enheder/ml

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

laboratoire francais du fractionnement et des biotechnologies - eptacog beta (activated) - hemophilia a; hemophilia b - antihemorrhagics - cevenfacta is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors viii or ix (i. ≥5 bethesda units (bu)); in patients with congenital haemophilia with low titre inhibitors (bu.

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

roche registration limited - emicizumab - hemophilia a - antihemorrhagics - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra kan bruges i alle aldersgrupper.

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

janssen-cilag international nv - becaplermin - wound healing; skin ulcer - præparater til behandling af sår og sår - regranex angives i forening med andre gode sår pleje foranstaltninger, at fremme granulering og dermed heling af fuld-tykkelse, neuropatiske, kronisk, diabetisk sår mindre end eller lig til 5 cm2.

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

bpl bioproducts laboratory gmbh - human koagulationsfaktor x - faktor x-mangel - vitamin k and other hemostatics, antihemorrhagics, coagulation factor x - coagadex er indiceret til behandling og profylakse af blødninger episoder og for perioperative management hos patienter med arvelig faktor x mangel. coagadex er angivet i alle aldersgrupper.

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

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastiske midler - glivec 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-pdgfra rearrangement. virkningen af glivec om resultatet af knogle-marrow transplantation er ikke fastlagt. glivec is indicated for: , 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. patienter, der har en lav eller meget lav risiko for tilbagefald, bør ikke modtage adjuverende behandling, behandling af voksne patienter med inoperabel dermatofibrosarcoma protuberans (dfsp) og voksne patienter med tilbagevendende og / eller metastatisk dfsp, som ikke er berettiget til kirurgi. i voksne og pædiatriske patienter, virkningen af glivec er baseret på det samlede hæmatologiske og cytogenetisk respons priser og progression-fri overlevelse i cml, på hæmatologiske og cytogenetisk respons priser i ph+ all, mds / mpd, på hæmatologiske svarprocenten i hes / cel og på objektive responsrater i voksne patienter med inoperabel og / eller metastatisk gist og dfsp og på recidiv-fri overlevelse i adjuvans kernen. erfaringerne med glivec hos patienter med mds / mpd, der er forbundet med pdgfr gen re-arrangementer er meget begrænset (se afsnit 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)

zoetis belgium sa - synthetic peptide analogue of gnrf conjugated to diptheria toxoid - immunologiske stoffer til suidae - male pigs (from 8 weeks of age); female pigs (from 14 weeks of age) - male pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of testicular function. for use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. en anden vigtig bidragyder til vildsvin, skatole, kan også reduceres som en indirekte virkning. aggressive og seksuelle (montering) adfærd reduceres også. female pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).