Europska Unija - hrvatski - EMA (European Medicines Agency)

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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - karcinom, ne-malih stanica pluća - antineoplastična sredstva - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Europska Unija - hrvatski - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - eptacog beta (activated) - hemophilia a; hemophilia b - antihemorrhagics - cevenfacta is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors viii or ix (i. ≥5 bethesda units (bu)); in patients with congenital haemophilia with low titre inhibitors (bu.

Europska Unija - hrvatski - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - imunosupresivi - molimo pogledajte dokument s informacijama o proizvodu.

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

sanofi-aventis croatia d.o.o., heinzelova 70, zagreb - enoxaparinum natricum - otopina za injekciju - 30 000 iu (300 mg)/3 ml - urbroj: jedna bočica sadrži 30 000 iu anti xa aktivnosti enoksaparinnatrija (što odgovara 300 mg) + 45 mg benzilnog alkohola u 3,0 ml vode za injekcije

Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxo group limited  - retigabinje - epilepsija - antiepileptici sredstva, - trobalt je indiciran kao adjuvantna terapija otporna djelomično pojavu napadaja sa ili bez sekundarne generalizacije u bolesnika u dobi od 18 godina ili stariji od epilepsije, gdje druge odgovarajuće droge kombinacije pokazale neprikladnima ili nisu podnosi.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningitis, meningokokal - cjepiva - nimenrix je indiciran za aktivnu imunizaciju osoba od dobi od 6 tjedana protiv invazivnih meningokoknih bolesti uzrokovanih neisseria meningitidis grupom a, c, w-135 i y.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astellas pharma europe b.v. - micafungin - kandidijaza - antimikotika za sustavnu uporabu - Микамин indiciran za:odrasli, adolescenti ≥ 16 godina i elderlytreatment od invazivnog kandidijaza;liječenje kandidijaza jednjaka u bolesnika za koje внутривенная terapija;prevencija candida infekcije kod pacijenata koji su patili аллогенную transplantaciju гемопоэтических matičnih stanica ili transplantacije pacijenti, koji, kako se očekuje, нейтропении (apsolutni broj neutrofila < 500 stanica/μl) u roku od 10 dana ili više. djecu (uključujući i novorođenčad) i teen < 16 godina agetreatment od invazivnog kandidijaza. prevencija candida infekcije kod pacijenata koji su patili аллогенную transplantaciju гемопоэтических matičnih stanica ili transplantacije pacijenti, koji, kako se očekuje, нейтропении (apsolutni broj neutrofila < 500 stanica/μl) u roku od 10 dana ili više. rješenje koristiti lijek Микамин treba uzeti u obzir potencijalni rizik od razvoja tumora jetre . tako Микамин treba primijeniti samo ako su drugi antifungalni lijekovi nisu prikladni.

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

bayer d.o.o., radnička cesta 80, zagreb, hrvatska - gadobutrol - otopina za injekciju - 1 mmol/ml - urbroj: 1 ml otopine za injekciju sadržava 604,72 mg gadobutrola (što odgovara 1,0 mmol gadobutrola koji sadržava 157,25 mg gadolinija)

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

bayer d.o.o., radnička cesta 80, zagreb, hrvatska - gadobutrol - otopina za injekciju u napunjenoj štrcaljki - 1 mmol/ml - urbroj: 1 ml otopine za injekciju sadržava 604,72 mg gadobutrola (što odgovara 1,0 mmol gadobutrola koji sadržava 157,25 mg gadolinija)