Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radionuclide imaging - greining geislavirkja - Þetta lyf er eingöngu ætlað til greiningar. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - sýkingar af völdum sýklalyfja - bóluefni - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. notkun þetta bóluefni ætti að vera í samræmi við opinbera tillögur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

virbac s.a. - halofuginone - krabbamein - kálfar, nýfætt - in new born calves:- prevention of diarrhoea due to diagnosed cryptosporidium parvum, in farms with history of cryptosporidiosis,administration should start in the first 24 to 48 hours of age- reduction of diarrhoea due to diagnosed cryptosporidium parvum. gjöf ætti að hefjast innan 24 klukkustunda eftir að niðurgangur hefst. Í báðum tilvikum hefur verið sýnt fram á minnkun á útskilnaði oocysts.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolactone - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - umboðsmenn fyrir húðbólgu, að undanskildu barkstera - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

linde healthcare ab - nituroxíð - hypertension, pulmonary; respiratory insufficiency - Önnur öndunarfæri - Þegar, í tengslum við öndunarvél stuðning og öðrum viðeigandi virk efni, er ætlað:fyrir meðferð nýbura stærri 34 vikur meðgöngu með öndunarbilun tengslum við klínískum eða hjartaómunar vísbendingar lungum háan blóðþrýsting, til að bæta súrefni og til að draga úr þörf fyrir extracorporeal himna súrefnismettun;eins og hluti af meðferð. - og eftir aðgerð lungnaháþrýstingi í fullorðnir og nýfædd börn, börn og smábörn, börn og unglingar, aldri 0-17 ár í tengslum að hjartaaðgerð, í því skyni að vali minnka lungum slagæð þrýsting og bæta rétt op virka og súrefnismettun.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

novartis healthcare a/s - carbamazepinum inn - tafla - 200 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

novartis healthcare a/s - carbamazepinum inn - forðatafla - 200 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

novartis healthcare a/s - carbamazepinum inn - forðatafla - 400 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - sykursýki - lyf notuð við sykursýki - sykursýki þar sem meðferð með insúlíni er þörf. insúlín manna winthrop hraður er líka viðeigandi fyrir meðferð hyperglycaemic dá og ketónblóðsýringu, eins og til að ná fyrirfram, innan og aðgerð stöðugleika í sjúklinga með sykursýki.