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

raxone

chiesi farmaceutici s.p.a - ibedenon - optika atrofija, nasljedna, leber - drugi психостимуляторы i nootropics, psychoanaleptics, - raxone je indiciran za liječenje oštećenja vida kod adolescentnih i odraslih bolesnika s leber's hereditary optic neuropathy (lhon).

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

renagel

sanofi b.v. - sevelamer - renal dialysis; hyperphosphatemia - svi ostali terapeutski proizvodi - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

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

trumenba

pfizer europe ma eeig - neisseria meningitidis serotip b fhbp (rekombinantni lipidirani fhbp (protein koji veže faktor h)) podfamilija a; neisseria meningitidis serotip b fhbp (rekombinantni lipidirani fhbp (faktor vezanja h proteina)) podskupina b - meningitis, meningokokal - bacterial vaccines, meningococcal vaccines - trumenba je indicirana za aktivnu imunizaciju osoba starijih od 10 godina kako bi se spriječila invazivna meningokokna bolest uzrokovana neisseria meningitidis serotipom b. korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

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

brineura

biomarin international limited - cerliponaza alfa - neuronske ceroidne lipofuscinoze - drugi gastrointestinalni trakt i metabolizam, lijekovi, - brineura indiciran za liječenje нейрональных цероид-липофусциноз tipa 2 (cln2) bolest, također poznat kao tripeptidyl peptidaza 1 (tpp1) deficit,.

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

maviret

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.

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

ontruzant

samsung bioepis nl b.v. - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastična sredstva - grudi cancermetastatic grudi cancerontruzant indiciran za liječenje odraslih bolesnika s her2 pozitivnim metastatskih tumora dojke (mbk):u monoterapiji za liječenje onih pacijenata koji su primili najmanje dva načina kemoterapije za метастатической bolesti. prije kemoterapije moraju biti uključena barem антрациклина i таксана, ako pacijenti nisu prikladni za tih postupaka. hormon-receptor-pozitivnih bolesnika također mora biti hormonske terapije, ako pacijenti nisu prikladni za tih postupaka. u kombinaciji s паклитакселом za liječenje onih pacijenata koji nisu primili kemoterapiju za метастатической bolesti i za koga антрациклиновый ne odgovara. u kombinaciju sa docetaxel za liječenje bolesnika koji nisu primali kemoterapiju za метастатической bolesti. u kombinaciji s inhibitor aromataze za liječenje pacijenata u postmenopauzi s hormon-receptor pozitivnim ГБЦ, ne ranije liječenih трастузумаб. rano cancerontruzant grudi indiciran za liječenje odraslih bolesnika s her2 pozitivnim karcinomom dojke (ЕДК)nakon operacije, kemoterapije (неоадъювантной ili adjuvantne) i radioterapije (ako je primjenjivo). nakon adjuvantne kemoterapije doksorubicin i ciklofosfamid, u kombinaciji s паклитакселом ili docetaxel. u kombinaciji s adjuvantne kemoterapije, koji se sastoji od доцетаксела i карбоплатина. u kombinaciji s неоадъювантной kemoterapije, nakon čega slijedi ontruzant adjuvantne terapije, lokalno (uključujući i upalne bolesti ili tumora >2 cm u promjeru. ontruzant treba koristiti samo u bolesnika s metastaze ili ranog raka dojke, tumora kojih je bilo her2 i гиперэкспрессии ili амплификации gena her2, kako se određuje točan i dokazani анализами. Метастатические cancerontruzant želuca u kombinaciji s Капецитабин ili 5‑фторурацилом i цисплатином indiciran za liječenje odraslih bolesnika s her2 pozitivnim metastaze аденокарциномой želučane ili probavne пищеводный veze, koji nisu primili do противоопухолевое liječenje bolesti метастатической. ontruzant treba koristiti samo u bolesnika s диссеминированным raka želuca (lecs), čiji je tumor гиперэкспрессии her2 i kako se određuje ihc2+ i prateću СИШ ili ribe rezultat, ili igh 3+ rezultat. treba koristiti točne i dokazane metode analize .

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

tecentriq

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastična sredstva - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq u monoterapiji namijenjen za liječenje odraslih bolesnika s lokalno-uobičajena ili metastatskih НМРЛ nakon što je ranije kemoterapije. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq u monoterapiji namijenjen za liječenje odraslih bolesnika s lokalno-uobičajena ili metastatskih НМРЛ nakon što je ranije kemoterapije. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

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

crysvita

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - lijekovi za liječenje bolesti kostiju - crysvita is indicated for the treatment of x-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. crysvita is indicated for the treatment of fgf23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

REAGENSI ZA IN VITRO ODREĐIVANJE NA APARATU EVOLIS MICROPLATE SYSTEMS Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

reagensi za in vitro odreĐivanje na aparatu evolis microplate systems

biomax d.o.o., zagreb - in vitro dijagnostika za potvrdu anti hiv-2 antitijela, anti hiv-1 antitijela, određivanje antitijela za hcv, određivanje antiti