Европска Унија - Дански - EMA (European Medicines Agency)

bayer ag  - octocog alfa - hemophilia a - antihemorrhagics - behandling og profylakse af blødning hos patienter med hæmofili a (medfødt faktor viii-mangel). dette præparat indeholder ikke von willebrand-faktor og er derfor ikke indiceret ved von willebrand ' s sygdom.

Европска Унија - Дански - EMA (European Medicines Agency)

astrazeneca ab - roflumilast - pulmonal sygdom, kronisk obstruktiv - medicin for obstruktiv sygdomme, - libertek er indiceret til vedligeholdelsesbehandling af svær kronisk og obstruktiv lungesygdom (kol) (fev1 efter bronkodilatator mindre end 50% forventet) forbundet med kronisk bronkitis hos voksne patienter med en anamnese med hyppige eksacerbationer som tilføjelse bronkodilatator behandling.

Европска Унија - Дански - EMA (European Medicines Agency)

provepharm sas - methylthioniniumchlorid - methæmoglobinæmi - alle andre terapeutiske produkter - akut symptomatisk behandling af medicinske og kemiske produkter - induceret methaemoglobinaemia. methylthioninium chlorid proveblue er indiceret hos voksne, børn og unge (i alderen 0 til 17 år).

Европска Унија - Дански - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykotika til systemisk brug - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 og 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 og 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 og 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 og 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 og 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 og 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 og 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasiv aspergillose hos patienter med sygdom, der er refraktære over for amphotericin b eller itraconazol eller patienter, der ikke tåler disse lægemidler;- fusariosis hos patienter med sygdom, der er refraktære over for amphotericin b eller patienter, der er intolerante over for amphotericin b;- chromoblastomycosis og mycetoma hos patienter med sygdom, der er refraktære over for itraconazol eller patienter, der er intolerante over for itraconazol;- coccidioidomycosis hos patienter med sygdom, der er refraktære over for amphotericin b, itraconazol eller fluconazol eller patienter, der ikke tåler disse lægemidler.- oropharyngeale candidiasis: som første linje behandling til patienter, som har svær sygdom eller er immunsvækkede, i, som reaktion på aktuelle behandling forventes at være fattig. uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Европска Унија - Дански - EMA (European Medicines Agency)

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrémidler, tarm antiinflammatorisk / antiinfective agenter - truberzi er indiceret hos voksne til behandling af irritabel tarmsyndrom med diarré (ibs d).

Европска Унија - Дански - 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.

Европска Унија - Дански - EMA (European Medicines Agency)

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

Европска Унија - Дански - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren, hydrochlorthiazid - forhøjet blodtryk - agenter, der virker på renin-angiotensinsystemet - behandling af essentiel hypertension hos voksne. riprazo hct er indiceret hos patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret på aliskiren eller hydrochlorthiazid anvendt alene. rirpozo hct er angivet som substitutionsbehandling i patienter, der er tilstrækkeligt kontrolleret med aliskiren og hydrochlorthiazid, givet samtidigt, på samme dosisniveau som i kombinationen.

Европска Унија - Дански - EMA (European Medicines Agency)

meda ab - zaleplons - søvninitierings- og vedligeholdelsesforstyrrelser - psykoleptika - sonata er indiceret til behandling af patienter med søvnløshed, som har svært ved at falde i søvn. det indikeres kun, når lidelsen er alvorlig, invaliderende eller udsættes for ekstrem lidelse.

Европска Унија - Дански - EMA (European Medicines Agency)

ceft biopharma s.r.o. - ibritumomab tiuxetan - lymfom, follikulært - terapeutiske radioaktive lægemidler - zevalin er indiceret hos voksne. [90y]-mærket zevalin er angivet som konsolidering behandling efter induktion af remission hos tidligere ubehandlede patienter med follikulært lymfom. fordelen ved zevalin følgende rituximab i kombination med kemoterapi er ikke blevet oprettet. [90y]-mærket zevalin er indiceret til behandling af voksne patienter med rituximab relapsedorrefractory cd20+ follikulært b-celle non-hodgkin ' s lymfom (nhl).