Mysimba Europska Unija - hrvatski - EMA (European Medicines Agency)

mysimba

orexigen therapeutics ireland limited - bupropion hidroklorid, naltrexone hydrochloride - obesity; overweight - pripravci protiv pretilosti, isključujući. prehrambeni proizvodi - mysimba drugačije, kao dodatak гипокалорийной prehrana i povećana tjelesna aktivnost, za kontrolu tjelesne težine kod odraslih bolesnika (≥18 godina) s - indeks tjelesne mase (bmi)≥ 30 kg/m2 (pretilost) ili≥ 27 kg/m2 i < 30 kg/m2 (težine) ako imate jedan ili više težine, srodne bolesti (e. tip 2 dijabetes, dislipidemija, ili kontrolirano arterijska hipertenzija)tretman s mysimba treba biti zaustavljen nakon 16 tjedana, ako je pacijent izgubio od najmanje 5% od početne tjelesne mase .

Xydalba Europska Unija - hrvatski - EMA (European Medicines Agency)

xydalba

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - antibakterijski lijekovi za sistemsku primjenu, - liječenje akutnih bakterijskih infekcija kože i strukture kože (absssi) u odraslih osoba.

Cuprior Europska Unija - hrvatski - EMA (European Medicines Agency)

cuprior

gmp-orphan sa - Триентин tetrahydrochloride - hepatolenticularna degeneracija - drugi gastrointestinalni trakt i metabolizam, lijekovi, - cuprior indiciran za liječenje bolesti wilsona kod odraslih, adolescenata i djece ≥ 5 godina s laktoza d-пеницилламин terapija.

Vyxeos liposomal (previously known as Vyxeos) Europska Unija - hrvatski - EMA (European Medicines Agency)

vyxeos liposomal (previously known as vyxeos)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - leukemija, mieloidna, akutna - antineoplastična sredstva - vyxeos liposomal indiciran za liječenje odraslih bolesnika s je prvi put dijagnosticiran, terapije povezane s oštrim миелоидными лейкозами (t-aml) ili aml s миелодисплазией promjene (aml-МРЦ).

Phelinun Europska Unija - hrvatski - EMA (European Medicines Agency)

phelinun

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - antineoplastična sredstva - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) Europska Unija - hrvatski - EMA (European Medicines Agency)

lenalidomide krka d.d. novo mesto (previously lenalidomide krka)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - imunosupresivi - multiple myelomalenalidomide krka d. novo mesto 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. novo mesto 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. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto 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. novo mesto 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. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) Europska Unija - hrvatski - EMA (European Medicines Agency)

lenalidomide krka (previously lenalidomide krka d.d. novo mesto)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - imunosupresivi - multiple myelomalenalidomide krka 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 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 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 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. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 i 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka 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 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 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 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. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 i 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Lenalidomide Krka d.d. Europska Unija - hrvatski - EMA (European Medicines Agency)

lenalidomide krka d.d.

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).

Quviviq Europska Unija - hrvatski - EMA (European Medicines Agency)

quviviq

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.

Tepmetko Europska Unija - hrvatski - EMA (European Medicines Agency)

tepmetko

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.