Europska Unija - hrvatski - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multipli mijelom - antineoplastična sredstva - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - zoledronske kiseline - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - lijekovi za liječenje bolesti kostiju - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. liječenje osteoporoze, povezan s dugoj sistemske glukokortikoidni terapije kod žena u postmenopauzi i muškaraca sa povećanim rizikom od prijeloma. liječenje pagetova bolest kostiju.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafil - hipertenzija, plućna - urologicals - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. učinkovitost je pokazana u idiopatskom pah (ipah) i pah povezanoj na vaskularnu bolest kolagena. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Europska Unija - hrvatski - EMA (European Medicines Agency)

n.v. organon - dcsloratadin - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistaminici za sistemsku primjenu, - Эриус je propisan za ublažavanje simptoma povezanih s:alergijski rinitis;osip.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi b.v. - laronidase - mukopolisaharidoza i - drugi gastrointestinalni trakt i metabolizam, lijekovi, - aldurazyme prikazana je dugoročna ферментозаместительная terapija u bolesnika s potvrdila dijagnoza мукополисахаридоз i tip (ipu i; alfa-l-iduronidase deficit) za liječenje nonneurological manifestacije bolesti.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabine - lymphoblastic leukemija-limfom t-stanica prekursora - antineoplastična sredstva - nelarabine indiciran za liječenje bolesnika sa t-клеточным oštrim лимфобластным лейкозом (t-all) i t-stanični limfocitne limfom (t-ЛБЛ), čija bolest ne odgovara, ili je nastao recidiva nakon tretmana s najmanje dva načina kemoterapije. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Europska Unija - hrvatski - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - Антитромбин alfa - nedostatak antitrombina iii - antitrombotska sredstva - atryn je indiciran za profilaksu venske tromboembolije u kirurgiji bolesnika s kongenitalnim nedostatkom antitrombina. atryn se normalno daje u kombinaciji s heparinom ili heparinom male molekulske mase.

Europska Unija - hrvatski - EMA (European Medicines Agency)

n.v. organon - dcsloratadin - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistaminici za sistemsku primjenu, - azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5. 1)urticaria (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gsk vaccines s.r.l. - vanjska membrana везикулы od менингококк grupe b (soj 98/254 nc), рекомбинантный менингококк grupe u fhbp sintezu proteina, rekombinantnog менингококк grupe b nada protein, рекомбинантный менингококк grupe u nhba sintezu proteina - meningitis, meningokokal - meningokokna cjepiva - aktivna imunizacija protiv invazivnih bolesti uzrokovanih sojima neisseria meningitidis serogroup-b.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.