Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidin - leukemija, myeloid, akutna - antineoplastična sredstva - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).

Evropska unija - slovenščina - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - difelikefalin - pruritus - vsi drugi terapevtski izdelki - kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

axunio pharma gmbh - pirfenidone - idiopatska pljučna fibroza - imunosupresivi - pirfenidone aet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Evropska unija - slovenščina - EMA (European Medicines Agency)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - drugi zdravljene bolezni prebavil in presnove izdelki, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

Evropska unija - slovenščina - EMA (European Medicines Agency)

billev pharma aps - lutetium (177lu) chloride - radionuklidno slikanje - terapevtski radiofarmacevtiki - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multiplo sklerozo, recidivno-nakazila - imunosupresivi - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Evropska unija - slovenščina - EMA (European Medicines Agency)

strides pharma (cyprus) limited - teriparatid - osteoporosis; osteoporosis, postmenopausal - kalcij homeostaza - kauliv 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - vsi drugi terapevtski izdelki - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Evropska unija - slovenščina - EMA (European Medicines Agency)

amgen europe bv - apremilast - arthritis, psoriatic; psoriasis - imunosupresivi - psoriatični arthritisotezla, samostojno ali v kombinaciji z boleznijo spreminjanje antirheumatic drugs (dmards), je primerna za zdravljenje aktivnega psoriatičnega artritisa (psa) pri odraslih bolnikih, ki so imeli ustreznega odgovora, ali ki so bili nestrpni, da pred terapijo dmard. psoriasisotezla je primerna za zdravljenje zmerno do hudo kronično psoriazo v plakih pri odraslih bolnikih, ki odzvali na ali ki so kontraindikacija za, ali so nestrpni do drugih sistemsko terapijo, vključno z ciklosporin, metotreksat ali psoralen in uv-svetlobe (puva).

Evropska unija - slovenščina - EMA (European Medicines Agency)

ucb pharma ltd - natrijev oksibat - cataplexy; narcolepsy - druga zdravila na živčnem sistemu - zdravljenje narkolepsije s katapleksijo pri odraslih bolnikih.