Evropska unija - slovenščina - EMA (European Medicines Agency)

biomarin international limited - valoctocogene roxaparvovec - antihemoragije - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva generics b.v - monohidrat zoledronske kisline - osteoporosis; osteitis deformans - bisfosfonati - zdravljenje osteoporosisin post-menopavzi womenin odraslih menat povečano tveganje za zlome, vključno s tistimi z zadnjih nizko travme, zlom kolka. zdravljenje osteoporoze, povezane z dolgoročno sistemsko glukokortikoidnih therapyin post-menopavzi womenin odraslih menat povečano tveganje za zlome. zdravljenje paget je bolezen kosti v odrasli.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - zoledronska kislina - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - zdravila za zdravljenje bolezni kosti - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. zdravljenje paget je bolezen kosti v odrasli.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - drugi zdravljene bolezni prebavil in presnove izdelki, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

Evropska unija - slovenščina - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. v kombinaciji z bortezomib, thalidomide in dexamethasone za zdravljenje odraslih bolnikov z na novo prijavljenih več plazmocitom, ki so upravičeni do autologous matičnih celic za presajanje. v kombinaciji z lenalidomide in dexamethasone, ali bortezomib in dexamethasone, za zdravljenje odraslih bolnikov z več plazmocitom, ki so prejeli vsaj en pred terapijo. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. kot monotherapy za zdravljenje odraslih bolnikov z relapsed in ognjevzdržne več plazmocitom, katerih predhodno zdravljenje vključeni proteasome serotonina in imunomodulatornimi agent in ki so pokazali napredovanja bolezni na zadnji terapija. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

clinigen healthcare b.v. - deksrazoksan hidroklorid - ekstravazacija diagnostičnih in terapevtskih materialov - vsi drugi terapevtski izdelki - zdravilo savene je indicirano za zdravljenje ekstravazacije antraciklina.

Evropska unija - slovenščina - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antineoplastična sredstva - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anemija, srčna celica - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Evropska unija - slovenščina - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofilija b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinuks natrij - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - antitrombotična sredstva - 5 mg / 0. 3 ml in 2. 5 mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. preprečevanje vte pri odraslih, ki opravljajo abdominalno kirurgijo, ki so presodilo, da je velika verjetnost, thromboembolic zapletov, kot bolnikov, ki abdominalno operacijo raka. preprečevanje vte pri odraslih bolnike, ki so presodilo, da je na visoko tveganje za vte in ki so immobilised zaradi akutne bolezni, kot so srčno insuficienco in / ali akutne dihalne motnje in / ali akutne nalezljive ali vnetnih bolezni. zdravljenje odraslih z akutno simptomatsko spontano površno-venska tromboza spodnjih okončin brez sočasnega globoko vensko trombozo. 5 mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. infarkt (stemi) pri odraslih bolnikih, ki se upravljajo z thrombolytics ali ki sprva so prejeli nobena druga oblika reperfusion terapija. 5 mg / 0. 4-ml, 7. 5 mg / 0. 6-ml in 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.