Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - gefitinib - karcinom, ne-malih stanica pluća - antineoplastična sredstva - Иресса indiciran za liječenje odraslih bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća s aktivacijom mutacija epidermalnog faktora rasta-рецепторных тирозинкиназ.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - Пембролизумаб - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastična sredstva - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacijenata sa egfr ili ala pozitivnih tumora mutacije također treba primili таргетную terapiju prije dobivanja Кейтруда. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - epoetin beta - kidney failure, chronic; anemia; cancer; blood transfusion, autologous - antianemijski pripravci - liječenje simptomatske anemije, povezane s kroničnom bubrežnom insuficijencijom (crf) i педиатрические pacijenti odrasla osoba;liječenje simptomatske anemije kod odraslih pacijenata s миелоидными maligna новообразованиями primaju kemoterapiju;povećanje prinosa аутокрови kod bolesnika u pre-дарственной programa. njegova upotreba u ovoj brojila moraju biti уравновешены je obaviješten o povećanju rizika тромбоэмболических komplikacija . liječenje bi trebalo biti dano samo za bolesnike s umjerenom anemičan (persopn 10 - 13 g/dl [6. 21 - 8. 07 mmol/l], bez nedostatka željeza), ako je postupak spremanja krvi nema ili je nedovoljna za planirani veliki planska operacija zahtijeva velike količine krvi (4 i više jedinica krvi za žene ili 5 ili više jedinica za muškarce).

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - karcinom, ne-malih stanica pluća - Антинеопластические i иммуномодулирующие agenti, monoklonsko antitijelo - nivolumab bms je indiciran za liječenje lokalno avanziranog ili metastatskog skvamoznog ne-malih stanica raka pluća (nsclc) nakon prethodne kemoterapije kod odraslih.

Europska Unija - hrvatski - EMA (European Medicines Agency)

les laboratoires servier - irinotecan anhydrous free-base - neoplazme gušterače - antineoplastična sredstva - liječenje metastatskog adenokarcinoma gušterače, u kombinaciji s 5 fluorouracil (5 fu) i leucovorin (lv), u odraslih bolesnika napredovala nakon gemcitabinom osnovu terapije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

glenmark arzneimittel gmbh - olanzapin - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine indiciran za liječenje shizofrenije. Оланзапин učinkovit u održavanju kliničkog poboljšanja u roku od nastavka terapije kod pacijenata koji su pokazali odgovor na liječenje . Оланзапин je indiciran za liječenje umjerene do teških maničnih epizoda. kod pacijenata epizoda kojega je manično reagirao na liječenje Оланзапин, Оланзапин je indiciran za prevenciju relapsa kod pacijenata s bipolarnim poremećajem.

Europska Unija - hrvatski - EMA (European Medicines Agency)

nova laboratories ireland limited - 6-merkaptopurin monohidrat - leukemija, limfoid - antineoplastična sredstva - xaluprin je indiciran za liječenje akutne limfoblastične leukemije (all) u odraslih, adolescenata i djece.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, trombocitopenična, idiopatska - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 i 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 i 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - moroctokog alfa - hemofilija a - antihemorrhagics - liječenje i profilaksu krvarenja u bolesnika s hemofilijom a (nedostatak prirođenih faktora viii). refacto af nisu pogodne za korištenje kod odraslih i djece svih dobnih skupina, uključujući i novorođenčad. refacto af ne sadrži pozadinu-Виллебранда faktor, i, stoga, nije navedeno kada bolest pozadina Виллебранда .