Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan ireland limited - финголимод hidroklorid - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 i 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - эмтрицитабин, Тенофовир дизопроксил maleat - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5. emtricitabine/tenofovir disoproxil mylan is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, (see sections 4. 2, 4. 4 i 5. pre-exposure prophylaxis (prep):emtricitabine/tenofovir disoproxil mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk (see sections 4. 2, 4. 4 i 5.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastična sredstva - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Europska Unija - hrvatski - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multipla skleroza - selektivni imunosupresivi - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 i 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - antineoplastična sredstva - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudin, ралтегравир kalija - hiv infekcije - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis je indiciran u kombinaciji s drugim anti‑retroviral lijekovima za liječenje humane imunodeficijencije (hiv‑1) infekcija u odraslih, adolescenata i djece u dobi od 6 godina i tjelesne težine najmanje 30 kg bez sadašnjosti ili prošlosti dokaz virusne otpornosti na antivirusne lijekove institucije (rezistencije strand prijenos inhibitor) i eng. (inhibitor reverzne transkriptaze nukleozida) klase (vidjeti dio 4. 2, 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viiv healthcare bv - lamivudin, зидовудин - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - combivir is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabina - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - emtriva je indicirana za liječenje hiv-1 inficiranih odraslih i djece u kombinaciji s drugim antiretrovirusnim sredstvima. ovaj prikaz se temelji na istraživanjima u liječenju naivnih bolesnika i liječenje bolesnika sa stalnim вирусологическим kontrolom. nema iskustvo korištenja Эмтрива kod pacijenata koji nisu u mogućnosti da ih trenutnog načina rada ili пропустившие nekoliko krugova. pri odabiru novog profila za pacijente koji nisu антиретровирусные lijekovi, pažljivo razmatranje treba dati model mutacije povezane s različitim lijekovima i povijest liječenja pojedinog pacijenta. gdje je to moguće, ispitivanje otpora može biti prikladno.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - artritis, reumatoidni - imunosupresivi - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.