Europska Unija - hrvatski - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - imunosupresivi - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) indiciran za liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma koji se ne oslanja transplantacije. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

hameln pharma gmbh, inselstrasse 1, hameln, njemačka - amiodaronklorid - otopina za infuziju - 20 mg/ml - urbroj: jedan ml otopine sadrži 20 mg amiodaronklorida što odgovara 18,9 mg amiodarona.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Europska Unija - hrvatski - EMA (European Medicines Agency)

idorsia pharmaceuticals deutschland gmbh - daridorexant hydrochloride - poremećaji uvođenja i održavanja spavanja - psycholeptics - quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - karcinom, ne-malih stanica pluća - antineoplastična sredstva - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemija, mijelogeni, kronični, bcr-abl pozitivan - antineoplastična sredstva - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

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)

sun pharmaceutical industries europe b.v. - kapecitabin - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - kapecitabin - kapecitabin je indiciran za adjuvantno liječenje bolesnika nakon operacije raka debelog crijeva fazi-iii (dukes fazi-c). Капецитабином namijenjen za liječenje метастатического raka debelog crijeva . Капецитабин propisan za prva linija terapije popularnog raka želuca u kombinaciji s platinum temelju stanja. Капецитабин u kombinaciju sa docetaxel indiciran za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti цитотоксической kemoterapije. prethodna terapija mora sadržavati антрациклиновый. Капецитабин je također indiciran u monoterapiji za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti Таксанов i антрациклин sadrže načina kemoterapije ili za koje antikancerogena terapija nije naveden.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eco animal health europe limited - tylvalosin - Противоинфекционные za sistemsku upotrebu antibakterijski lijekovi za sistemsku upotrebu makrolidi - pheasants; chicken; turkeys; pigs - pigstreatment i methaphylaxis svinja энзоотической upale pluća;liječenje svinjske пролиферативной энтеропатии (ileitis);liječenje i methaphylaxis dizenterija svinja. chickenstreatment i methaphylaxis respiratorne bolesti povezanih s галисептикум микоплазмоза kod pilića. pheasantstreatment respiratorne bolesti povezanih s галисептикум микоплазмы . turkeystreatment respiratorne bolesti povezanih s tylvalosin osjetljivih sojeva ornithobacterium rhinotracheale u purana.