האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - homeostaza kalcija - liječenje osteoporoze kod žena u postmenopauzi s povećanim rizikom od prijeloma.

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ruxolitinib phosphate - vitiligo - ostali dermatološki pripravci - opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - drugi antiepileptici sredstva - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - antineoplastična sredstva - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropenija - Иммуностимуляторы, - accofil indiciran za smanjenje trajanja нейтропении i frekvencije фебрильной нейтропении kod pacijenata s utvrđenim цитотоксической kemoterapije na maligni tumori (osim kroničnog миелоидного leukemije i миелодиспластических sindromi), kao i za smanjenje trajanja нейтропении pacijenti koji primaju миелоаблативную terapiju s naknadnim transplantacije koštane srži se smatra rizičnim duge teške нейтропении. sigurnost i učinkovitost accofil-a slične su kod odraslih i djece s citotoksičnom kemoterapijom. accofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs). kod bolesnika, djece i odraslih s teške urođene, ciklički ili idiopatskom нейтропении apsolutni broj neutrofila (anc) ≤ 0. 5 x 109/l, a u prošlosti teških ili рецидивирующих infekcije, dugoročno uprave accofil ukazuje na povećanje neutrofila i smanjenje učestalosti i trajanja zaraznih događaja. accofil is indicated for the treatment of persistent neutropenia (anc less than or equal to 1. 0 x 109/l) u bolesnika s poodmakloj fazi hiv-infekcije za smanjenje rizika od bakterijske infekcije, kada su druge opcije za upravljanje нейтропения zagubljen.

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - bromid umeclidinium, vilanterol trifenatate - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - anoro ellipta navodi kao terapiju održavanja бронходилататор za ublažavanje simptoma kod odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (kopb).

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

pfizer europe ma eeig - nonacog alfa - hemofilija b - antihemorrhagics - liječenje i profilaksu krvarenja kod bolesnika s hemofilijom b (nedostatak prirođenih faktora ix).

האיחוד האירופי - קרואטית - 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.

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

teva b.v. - reslizumab - astma - drugi sistemski lijekovi za opstruktivne plućne bolesti dišnih putova, - cinqaero je indiciran kao dodatna terapija u odraslih bolesnika s teškom astmom eozinofilni glikemija unatoč visokom dozom udahnuti kortikosteroidi plus još jedan lijek za terapiju održavanja.

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

takeda manufacturing austria ag - c1 inhibitor (humani) - angioedemas, nasljedni - c1-inhibitor; u plazmi derivata, lijekova koji se koriste u потомственное angioedema - liječenje i pre-postupak prevencije angioedemskih napada u odraslih, adolescenata i djece (2 godine i više) s nasljednim angioedemom (hae). rutinski profilaksa angioedema, udara kod odraslih, djece i adolescenata (sa 6 godina); kod teških i рецидивирующих udara nasljedni ангионевротического edema (he), koji ne podnose ili nedovoljno zaštićeni usmeno upozorenje liječenje, ili u pacijenata koji su neadekvatno upravlja, kada se ponavljaju akutno liječenje.