Evrópusambandið - íslenska - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatíð - osteoporosis; osteoporosis, postmenopausal - kalsíumsterastasis - teriparatide sun is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - Æxlishemjandi lyf - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):fyrir meðferð hiv-1 sýkingu í andretróveirumeðferð (list)-reynda hjá fullorðnum, þar á meðal þeirra sem hafa verið mjög fyrir fengu. fyrir meðferð hiv-1 sýkingu í börn sjúklingar frá 3 ára og að minnsta kosti 15 kg. Í ákveðið að hefja meðferð með darunavir co-gefið með lítinn skammt rítónavír, vandlega íhugun ætti að meðferð sögu sjúklingur og mynstur stökkbreytingar tengslum með mismunandi lyf. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 og 5. darunavir co-gefið með lítinn skammt rítónavír er ætlað ásamt öðrum antiretroviral lyf til meðferð við sjúklinga með hiv veira (hiv-1) sýkingu.  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. Í ákveðið að hefja meðferð með darunavir í svona list-upplifað sjúklingar, arfgerðar prófa ætti að fylgja því að nota darunavir (sjá kafla 4. 2, 4. 3, 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

csl behring gmbh - manna eðlilegt immúnóglóbúlín (scig) - Ónæmisfræðilegir skortsyndar - Ónæmiskerfið sera og mótefni, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - brjóstakrabbamein - Æxlishemjandi lyf - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - felodipinum inn - forðatafla - 2,5 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - enalaprilum maleat; hydrochlorothiazidum inn - tafla - 20 mg/12,5 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - felodipinum inn - forðatafla - 10 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - felodipinum inn - forðatafla - 5 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amryt pharmaceuticals dac - octreotide acetate - acromegaly - hinsveiflur og heilahimnubólur og hliðstæður - mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.