Unione Europea - sloveno - EMA (European Medicines Agency)

les laboratoires servier - stroncijev ranelat - osteoporoza, postmenopavz - zdravila za zdravljenje bolezni kosti - zdravljenje hude osteoporoze pri ženskah po menopavzi z velikim tveganjem za zlom, da se zmanjša tveganje za zlome vretenc in kolkov. zdravljenje hude osteoporoze pri odraslih moških na povečano tveganje za zlom. odločitev za predpisovanje stroncij ranelate mora temeljiti na oceni posameznih bolnikov je splošna tveganja.

Unione Europea - sloveno - EMA (European Medicines Agency)

accord healthcare s.l.u. - monohidrat zoledronske kisline - hypercalcemia; fractures, bone; cancer - bisfosfonati - preprečevanje skeletnih povezane dogodke (patološki zlomi, hrbtenice stiskanje, sevanja ali operacijo kosti ali tumor povzroča hypercalcaemia) pri odraslih bolnikih z napredno malignih bolezni, ki vključujejo kosti. zdravljenje odraslih bolnikov z tumor povzroča hypercalcaemia (tih).

Unione Europea - sloveno - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zoledronska kislina - zlomi, kosti - zdravila za zdravljenje bolezni kosti - preprečevanje skeletne dogodki, povezani (patološki zlomi, hrbtenjača, stiskanje, sevanja ali operacijo na kosti, ali tumor povzroča hypercalcaemia) pri odraslih bolnikih z napredovalim malignancies, ki vključujejo kosti;zdravljenje odraslih bolnikov z tumor povzroča hypercalcaemia (tih).

Unione Europea - sloveno - EMA (European Medicines Agency)

teva b.v. - zoledronska kislina - fractures, bone; cancer - zdravila za zdravljenje bolezni kosti - preprečevanje z okostjem povezanih dogodkov in zdravljenje tumorsko povzročene hiperkalciemije.

Unione Europea - sloveno - EMA (European Medicines Agency)

almirall s.a - dimetil fumarat - psoriaza - imunosupresivi - skilarence je indicirano za zdravljenje zmerne do hude psoriaze v odrasli potrebujejo sistemska zdravila zdravljenje.

Unione Europea - sloveno - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - ropeginterferon alfa-2b - polycythemia vera - immunostimulants, - besremi je označen kot monotherapy pri odraslih za zdravljenje polycythaemia vera brez simptomatsko splenomegaly.

Unione Europea - sloveno - EMA (European Medicines Agency)

orphelia pharma sas - klofarabin - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - zdravljenje akutno limfoblastno levkemijo, (vse), pri pediatričnih bolnikih, ki so ponovila ali so ognjevarni po prejemu vsaj dve predhodni režimi in če ni druge možnosti zdravljenja, predvidene za posledico trajno odgovor. varnost in učinkovitost sta bili ocenjeni pri študijah pri bolnikih ≤ 21 let pri začetni diagnozi.

Unione Europea - sloveno - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - zavrnitev presadka - imunosupresivi - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Unione Europea - sloveno - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multiple myeloma - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Unione Europea - sloveno - EMA (European Medicines Agency)

lipomed gmbh - thalidomide - multiple myeloma - imunosupresivi - thalidomide lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. thalidomide lipomed is prescribed and dispensed in accordance with the thalidomide lipomed pregnancy prevention programme (see section 4.