Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - drugi antihipertenzivi sredstva - liječenje plućne arterijske hipertenzije (pah) za poboljšanje sposobnosti vježbanja i simptoma u bolesnika s funkcionalnom klasom svjetske zdravstvene organizacije (who) iii. učinkovitost je prikazan u:primarna (idiopatska i nasljedna) fuj;fuj sekundarne склеродермии bez značajnog интерстициальные bolesti pluća;lag, povezana sa urođenim sistem-na-plućna шунтов i eisenmenger fiziologije. neka poboljšanja su također je prikazano u bolesnika s lag, koji funkcionalna klasa ii. stayveer također je istakao smanjenje broja novih digitalne ulkusa kod pacijenata sa sistemske склеродермией i stalnom digitalni-peptičkog ulkusa.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - Гипотензивные, - liječenje plućne arterijske hipertenzije (pah) za poboljšanje sposobnosti vježbanja i simptoma u bolesnika s who funkcionalnom klasom iii. efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. neka poboljšanja su također je prikazano u bolesnika s lag, koji funkcionalna klasa ii. tracleer također je istakao smanjenje broja novih digitalne ulkusa kod pacijenata sa sistemske склеродермией i tijeku bolesti digitalni ulkus .

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastična sredstva - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - финголимод hidroklorid - multipla skleroza - imunosupresivi - gilenya je navedeno kao jedan bolesti дорабатывая terapije kod visoke aktivnosti relapsing ublažavanje multiplom sklerozom za sljedećih skupina odraslih pacijenata i pedijatrijska bolesnika u dobi od 10 godina i stariji:pacijenti sa visokom aktivnošću bolesti, unatoč potpun i adekvatan tretman sa najmanje jednim bolest дорабатывая terapije (za iznimke i informacija o вымыванию razdoblja vidi 4. 4 i 5. orpatients s brzo razvija težak relapsing ublažavanje multiplom sklerozom određuje se 2 ili više teških recidiva u roku od jedne godine, s 1 ili više gadolinij revitalizacije lezija na mr mozga ili značajno povećanje opterećenja t2 lezija u odnosu na najnoviji mri.

Europska Unija - hrvatski - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - pioglitazone, glimepirida - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - glubravu je indiciran za liječenje bolesnika s tip 2 dijabetes mellitus koji pokazuju nepodnošenja metformina ili kojih metformin je kontraindiciran i koji se već liječe kombinacijom pioglitazon i glimepiridom.

Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - ambrisentan - hipertenzija, plućna - Гипотензивные, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - Сапроптерин дигидрохлорид - phenylketonurias - drugi gastrointestinalni trakt i metabolizam, lijekovi, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

Europska Unija - hrvatski - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinone - tyrosinemias - drugi gastrointestinalni trakt i metabolizam, lijekovi, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

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

hemofarm proizvodnja farmaceutskih proizvoda d.o.o. banja luka - aminokiseline, kombinacije - rastvor za infuziju - 15 g/1000 ml+ 15 g/1000 ml+ 14 g/1000 ml+ 12 g/1000 ml+ 9.18 g/1000 ml+ 9.28 g/1000 ml+ 7.4 g/1000 ml+ 6.6 g/1000 ml+ 6.2 g/1000 - 1000 ml rastvora za infuziju sadrži: 15,009 g analin+15,009 g prolin+14,009 g glicin+12,009 g arginin + 9,1809g natrijumglicerolfosfat + 9,2809g jabučna kiselina + 7,409 g leucin + 6,609 g lizin (u obliku llizin acetata) + 6,209 g valin + 5,109 g fenilalanin+ 5,009 g izoleucin+4,409 g treonin +4,309 g metionin + 3,009 g histidin + 2,009 g triptofan + 1,6839 g kalijumhidroksid + 1,0179 g magnezijumhlorid, heksahidrat + 0,7359 g kalcijumhlorid

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

fresenius kabi d.o.o., radnička cesta 37a, zagreb, hrvatska - ketoizoleucinkalcij ketoleucinkalcij ketofenilalaninkalcij ketovalinkalcij hidroksimetioninkalcij lizinacetat treonin triptofan histidin tirozin - filmom obložena tableta - n/a - urbroj: 1 filmom obložena tableta sadrži: d,l-alfa-keto-izoleucinkalcij 67 mg alfa-keto-leucinkalcij 101 mg alfa-keto-fenilalaninkalcij 68 mg alfa-keto-valinkalcij 86 mg d,l-alfa-hidroksimetioninkalcij 59 mg l-lizinacetat što odgovara 75 mg l-lizina 105 mg l-treonin 53 mg l-triptofan 23 mg l-histidin 38 mg l-tirozin 30 mg ukupan sadržaj dušika po tableti 36 mg sadržaj kalcija po tableti 1,25 mmol = 50 mg