Europäische Union - Isländisch - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - Æxlishemjandi lyf - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Europäische Union - Isländisch - EMA (European Medicines Agency)

mylan s.a.s - ambrisentan - háþrýstingur, lungnabólga - háþiýstingslækkandi - ambrisentan mylan er ætlað fyrir meðferð lungum slagæð háan blóðþrýsting (pah) í fullorðinn sjúklingum sem hagnýtur bekknum (ÍÞrÓtta) ii að iii, þar á meðal að nota í samsetning meðferð. verkun hefur verið sýnt fram í sjálfvakin pah (ipah) og í pah tengslum við tengdum vef sjúkdómur. ambrisentan mylan er ætlað fyrir meðferð lungum slagæð háan blóðþrýsting (pah) í fullorðinn sjúklingum sem hagnýtur bekknum (ÍÞrÓtta) ii að iii, þar á meðal að nota í samsetning meðferð. verkun hefur verið sýnt fram í sjálfvakin pah (ipah) og í pah tengslum við tengdum vef sjúkdómur.

Europäische Union - Isländisch - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglúmíni - samfarir í bandalaginu - sýklalyf fyrir almenn nota, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 og 5. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Europäische Union - Isländisch - EMA (European Medicines Agency)

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - leiomyoma - hinsveiflur og heilahimnubólur og hliðstæður - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Europäische Union - Isländisch - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - greining geislavirkja - Þetta lyf er eingöngu ætlað til greiningar. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. Í fullorðinn sjúklingar, til að hjálpa greina líklega með heilabilun lewy líkama frá alzheimer.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

Europäische Union - Isländisch - EMA (European Medicines Agency)

serb sas - glucarpidase - metabolic side effects of drugs and substances - Öll önnur lækningavörur - voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.

Europäische Union - Isländisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - Æxlishemjandi lyf - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Island - Isländisch - LYFJASTOFNUN (Icelandic Medicines Agency)

exeltis healthcare s.l. - drospirenonum inn; ethinylestradiolum inn - filmuhúðuð tafla - 3 mg/ 0,03 mg

Island - Isländisch - LYFJASTOFNUN (Icelandic Medicines Agency)

stada arzneimittel ag - aprepitantum inn - hart hylki - 125 mg/80 mg

Island - Isländisch - LYFJASTOFNUN (Icelandic Medicines Agency)

krka sverige ab - valsartanum inn - filmuhúðuð tafla - 160 mg