Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belimumab - lupus erythematosus, sistemski - imunosupresivi - benlysta je indicirano kot dodatek terapije pri bolnikih, starih 5 let in več, z aktivno, autoantibody pozitivno sistemski eritematozni lupus (sle), z visoko stopnjo aktivnosti bolezni (e. pozitivni anti dsdna in nizko dopolnitev) kljub standardne terapije. benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

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)

instituto grifols s.a. - Človekove normalno imunoglobulina - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - imunski sera in imunoglobulini, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Evropska unija - slovenščina - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide - okužbe z virusom hiv - antivirusi za sistemsko uporabo - genvoya je indicirano za zdravljenje odraslih in mladostnikov (starih 12 let in starejši z telesne teže vsaj 35 kg), okuženih z virusom človeške imunske pomanjkljivosti (hiv 1) 1 brez kakršne koli znane mutacije, povezane z odpornost proti integraze inhibitor razred, emtricitabine ali so.

Evropska unija - slovenščina - EMA (European Medicines Agency)

baxalta innovations gmbh - Človekove normalno imunoglobulina - sindromi imunološke pomanjkljivosti - imunski sera in imunoglobulini, - nadomestno zdravljenje pri odraslih, otrok in mladostnikov (0-18 let) v:primarne imunske pomanjkljivosti sindromov s slabšo proizvodnjo protiteles. hypogammaglobulinaemia in ponavljajoče se bakterijske okužbe pri bolnikih s kronično limfocitno levkemijo (cll), v katerem profilaktičnih antibiotikov ni uspelo ali pa so contra‑navedeno. hypogammaglobulinaemia in ponavljajoče se bakterijske okužbe v več plazmocitom (mm) bolnikov. hypogammaglobulinaemia pri bolnikih, pre‑ in post‑allogeneic hematopoietic matičnih celic presaditev (hsct).

Evropska unija - slovenščina - EMA (European Medicines Agency)

medtronic biopharma b.v. - dibotermin alfa - tibial fractures; fracture fixation, internal; spinal fusion - zdravila za zdravljenje bolezni kosti - inductos je indicirano za eno raven ledvene hrbtenice interbody fuzije kot nadomestek za avtogeno kostnega presadka pri odraslih z degenerativne bolezni, ki so imeli vsaj 6 mesecev brez operativnega zdravljenja za to stanje. inductos je primerna za zdravljenje akutne golenice zlomi pri odraslih, kot dodatek k standardni nego uporabljati odprt zlom zmanjšanje in intramedullary unreamed nohtov komplementa.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi b.v. - alglukozidaza alfa - bolezen tipa ii za shranjevanje glikogena - drugi zdravljene bolezni prebavil in presnove izdelki, - myozyme je indiciran za dolgoročno encimsko nadomestno zdravljenje (ert) pri bolnikih s potrjeno diagnozo pompejeve bolezni (pomanjkanje kisline-α-glukozidaze). pri bolnikih s poznim nastopom pompe bolezni dokazov o učinkovitosti, je omejeno.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningitis, meningokokni - cepiva - nimenrix je indicirano za aktivne imunizacije posameznikov v starosti od 6 tednov proti invazivni meningokokni bolezni, ki povzroča neisseria meningitidis skupine a, c, w-135, in y.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - belatacept - graft rejection; kidney transplantation - imunosupresivi - nulojix, in combination with corticosteroids and a mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.

Evropska unija - slovenščina - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.