Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

roche d.o.o.roche ltd. - risdiplam - prašak za oralnu otopinu - 0,75 mg/1 ml - 1 bočica sa 2 g praška za oralnu otopinu sadrži 60 mg risdiplama (1 ml rekonstituirane otopine sadrži 0,75 mg risdiplama)

Europska Unija - hrvatski - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastična sredstva - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Europska Unija - hrvatski - 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.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

b.braun adria bh d.o.o. - aminokiseline, glukoza, lipidi mjestu - emulzija za infuziju - 1.872 g/1000 ml+ 2.504 g/1000 ml+ 2.272 g/1000 ml+ 1.568 g/1000 ml+ 2.808 g/1000 ml+ 1.456 g/1000 ml+ 0.456 g/1000 ml+ 2.08 g/10 - 1000 ml emulzija za infuziju sadrži: 1,872 g izoleucin, 2,504 g leucin, 2,272 g lizin (u obliku lizinhidrohlorida), 1,568 g metionin, 2,808 g fenilalanin, 1,456 g treonin, 0,456 g triptofan, 2,080 g valin, 2,160 g arginin, 1,352 g histidinhidrohlorid, monohidrat, 3,880 g alanin, 1,320 g glicin, 1,200 g asparaginska kiselina, 2,800 g glutaminska kiselina, 2,720 g prolin, 2,400 g serin, 0,865 g natrijumhlorid, 0,435 g natrijumacetat, trihidrat, 2,354 g kalijumacetat, 0,515 g magnezijumacetat, tetrahidrat, 0,353 g kalcijumhlorid, dihidrat, 0,640 g natrijumhidroksid, 64,000 g glukoza (u obliku glukoza, monohidrata), 0,936 g natrijumdihidrogenfosfat, dihidrat, 5,280 g cinkacetat, dihidrat, 20,000 g trigliceridi, srednjelančani, 20,000 g sojino ulje, pročišćeno

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

b.braun adria bh d.o.o. - aminokiseline, glukoza, lipidi mjestu - emulzija za infuziju - 1.872 g/1000 ml+ 2.504 g/1000 ml+ 2.272 g/1000 ml+ 1.568 g/1000 ml+ 2.808 g/1000 ml+ 1.456 g/1000 ml+ 0.456 g/1000 ml+ 2.08 g/10 - 1000 ml emulzija za infuziju sadrži: 1,872 g izoleucin, 2,504 g leucin, 2,272 g lizin (u obliku lizinhidrohlorida), 1,568 g metionin, 2,808 g fenilalanin, 1,456 g treonin, 0,456 g triptofan, 2,080 g valin, 2,160 g arginin, 1,352 g histidinhidrohlorid, monohidrat, 3,880 g alanin, 1,320 g glicin, 1,200 g asparaginska kiselina, 2,800 g glutaminska kiselina, 2,720 g prolin, 2,400 g serin, 0,865 g natrijumhlorid, 0,435 g natrijumacetat, trihidrat, 2,354 g kalijumacetat, 0,515 g magnezijumacetat, tetrahidrat, 0,353 g kalcijumhlorid, dihidrat, 0,640 g natrijumhidroksid, 64,000 g glukoza (u obliku glukoza, monohidrata), 0,936 g natrijumdihidrogenfosfat, dihidrat, 5,280 g cinkacetat, dihidrat, 20,000 g trigliceridi, srednjelančani, 20,000 g sojino ulje, pročišćeno

Europska Unija - hrvatski - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastična sredstva - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astra zeneca ab - Саксаглиптин, dapagliflozin пропандиола monohidrat - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - lijekovi koji se koriste u dijabetesu - qtern, fiksnih doza kombinacija саксаглиптин i dapagliflozin, pojavljuje se kod odraslih u dobi od 18 godina i stariji sa dijabetesom tip 2:za poboljšanje glikemijski kontrole pri метформина i/ili sulfonilureje (su) i jedan od однокомпонентных od qtern ne pružaju adekvatnu glikemijski kontrole kada je već лечусь sa slobodnim kombinacijom dapagliflozin i саксаглиптин. (sl. sekcija 4. 2, 4. 4, 4. 5 i 5. 1 prema dostupnim podacima o kombinaciji studirao.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - imunosupresivi - rheumatoid arthritis  amgevita in combination with methotrexate, is indicated for: , the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. tretman teških, aktivnog i uznapredovalog reumatoidnog artritisa kod odraslih, ne ranije liječenih metotreksat. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita smanjuje brzinu progresije oštećenja zglobova kao što se mjeri x-ray i poboljšava fizičke funkcije, imenovanje u kombinaciji s metotreksatom. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). amgevita može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično (na učinkovitost u monoterapija vidi odjeljak 5. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. enthesitis-related arthritis amgevita is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritis ankylosing spondylitis (as) amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of as amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. psoriatic arthritis amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. amgevita smanjuje brzinu progresije periferne lezije zgloba, mjereno pomoću x-zraka u bolesnika s полиартикулярным mogućnost simetrične podtipovi bolesti (vidi odjeljak 5. 1) i poboljšava fizičke značajke. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs) amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 i 5. crohn’s disease amgevita is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's disease amgevita is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitis amgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitis amgevita is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Europska Unija - hrvatski - EMA (European Medicines Agency)

samsung bioepis nl b.v. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; hidradenitis suppurativa; arthritis - imunosupresivi - reumatoidni arthritisimraldi u kombinaciji s metotreksatom prikazana za:liječenje umjereni do teški, aktivan reumatoidni artritis kod odraslih pacijenata, kada odgovor na bolest-модифицирующих противоревматических lijekova, uključujući i metotreksat, bio je neadekvatno. tretman teških, aktivnog i uznapredovalog reumatoidnog artritisa kod odraslih, ne ranije liječenih metotreksat. imraldi može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično. Адалимумаб, kao što je prikazano, kako bi se smanjila brzina progresije oštećenja zglobova kao što se mjeri x-ray i poboljšati fizičku funkciju, prilikom raspoređivanja u kombinaciji s metotreksatom. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisimraldi in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. enthesitis-related arthritisimraldi is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)imraldi is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of asimraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). psorijatični arthritisimraldi indiciran za liječenje aktivnog i uznapredovalog psorijatični artritis kod odraslih, kad odgovor na prethodni заболевани-дорабатывая anti-reumatskih napitke terapija je bila neadekvatna.. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5. 1) i poboljšati tjelesne funkcije. psoriasisimraldi indiciran za liječenje umjerene do teške kronične plak psorijaze kod odraslih pacijenata koji su kandidati za sistemske terapije. vrtić plak psoriasisimraldi indiciran za liječenje teških oblika kroničnog бляшечного psorijaze u djece i adolescenata od 4-ih godina, koji su imali neadekvatan odgovor ili neprikladne kandidate za lokalne liječenje i phototherapies. hidradenitis suppurativa (hs)imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 i 5. kruna diseaseimraldi indiciran za liječenje reumatoidnog crohnove bolesti, kod odraslih pacijenata koji se nisu odazvali, unatoč potpuni i odgovarajući tečaj terapija sa kortikosteroidima i/ili imunosupresivima, ili koji ne podnose ili imaju medicinske kontraindikacije za takvu terapiju. paediatric crohn's diseaseimraldi is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or haveulcerative colitisimraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisimraldi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisimraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. paediatric uveitisimraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

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

zentiva k.s., u kabelovny 130, dolni mecholupy, prag 10, Češka - natrijev risedronat - filmom obložena tableta - 35 mg - urbroj: jedna filmom obložena tableta sadržava 35 mg natrijevog risedronata (što odgovara količini od 32,5 mg risedronatne kiseline)