Evarrest Evropská unie - islandština - EMA (European Medicines Agency)

evarrest

omrix biopharmaceuticals n. v. - mannafíbrógen manna, trombín manna - hemostasis - heimamaður hemostatics - stuðningsmeðferð við fullorðinsskurðaðgerð þar sem venjulegar skurðaðgerðir eru ófullnægjandi (sjá kafla 5. 1):- til að bæta blóðstorknun.

Ledaga Evropská unie - islandština - EMA (European Medicines Agency)

ledaga

helsinn birex pharmaceuticals ltd. - chlormethine - mycosis fungoides - Æxlishemjandi lyf - ledaga er ætlað til staðbundinnar meðhöndlunar á t-frumu eitilæxli (mycosis fungoides-type t-cell lymphoma) hjá fullorðnum sjúklingum.

Mysildecard Evropská unie - islandština - EMA (European Medicines Agency)

mysildecard

viatris limited - síldenafílsítrat - háþrýstingur, lungnabólga - Þvaglát - adultstreatment fullorðinna sjúklinga með lungum háþrýsting flokkast sem hagnýtur ii og iii, til að bæta æfing getu. verkun hefur verið sýnd í frumum lungnaháþrýstingi og lungnaháþrýstingi sem tengist bandvefssjúkdómum. börn populationtreatment af börnum sjúklinga á aldrinum 1 ár til 17 ára gamall með lungum háþrýsting. verkun með tilliti til endurbóta á æfingargetu eða lungnablóðþrýstingi hefur sést við frumháþrýstingi og lungnaháþrýstingi sem tengist meðfæddan hjartasjúkdóm (sjá kafla 5.

Xromi Evropská unie - islandština - EMA (European Medicines Agency)

xromi

nova laboratories ireland limited - hýdroxýkarbamíð - blóðleysi, blóðkorn - Æxlishemjandi lyf - fyrirbyggja vaso-tum fylgikvillar sker klefi sjúkdóminn í sjúklingar yfir 2 ára aldri.

Sugammadex Mylan Evropská unie - islandština - EMA (European Medicines Agency)

sugammadex mylan

mylan ireland limited - sugammadex sodium - taugakerfi - Öll önnur lækningavörur - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Scemblix Evropská unie - islandština - EMA (European Medicines Agency)

scemblix

novartis europharm limited - asciminib hydrochloride - kyrningahvítblæði, mergbreytilegt, langvinnt, bcr-abl jákvætt - Æxlishemjandi lyf - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Locametz Evropská unie - islandština - EMA (European Medicines Agency)

locametz

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.

Eladynos Evropská unie - islandština - EMA (European Medicines Agency)

eladynos

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - kalsíumsterastasis - meðferð beinþynningar hjá konum eftir tíðahvörf við aukna hættu á beinbrotum.

Qaialdo Evropská unie - islandština - EMA (European Medicines Agency)

qaialdo

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.

Axura Evropská unie - islandština - EMA (European Medicines Agency)

axura

merz pharmaceuticals gmbh - memantínhýdróklóríð - alzheimer sjúkdómur - Önnur lyf gegn vitglöpum - meðferð sjúklinga með miðlungsmikla til alvarlega alzheimerssjúkdóma.