Ryzodeg Europos Sąjunga - kroatų - EMA (European Medicines Agency)

ryzodeg

novo nordisk a/s - inzulin аспарт, inzulin degludec - Šećerna bolest - lijekovi koji se koriste u dijabetesu - liječenje dijabetes melitusa kod odraslih, adolescenata i djece od dobi od 2 godine.

Plavix Europos Sąjunga - kroatų - EMA (European Medicines Agency)

plavix

sanofi winthrop industrie - klopidogrel hidrogensulfat - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antitrombotska sredstva - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome:non-st-segment-elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st-segment-elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. sprječavanje атеротромботических i тромбоэмболических događaja kada фибрилляции fibrillationin odraslih pacijenata s фибрилляцией vrlo značajan, koje imaju najmanje jedan faktor rizika za razvoj srčanih događaja, nisu pogodni za liječenje vitamin-k-antagonisti i koji imaju nizak rizik od krvarenja, клопидогрел prikazan u kombinaciji s ask za prevenciju атеротромботических i тромбоэмболических događaja, uključujući i moždani udar.

ReFacto AF Europos Sąjunga - kroatų - EMA (European Medicines Agency)

refacto af

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 .

Clopidogrel/Acetylsalicylic acid Teva Europos Sąjunga - kroatų - EMA (European Medicines Agency)

clopidogrel/acetylsalicylic acid teva

teva pharma b.v. - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - kombinacije - klopidogrel/acetilsalicilna kiselina teva je indiciran za prevenciju aterotrombotskih događaja u odraslih bolesnika koji već uzimaju klopidogrel i acetilsalicilnu kiselinu (ask). Клопидогрел/Ацетилсалициловая kiselina tewa je fiksna kombinacija doza lijekova za nastavak terapije:ne porast segmenta st akutna koronarna sindrom (nestabilna angina, ili ne‑q‑infarkt miokarda), uključujući i bolesnike koji su patili стентирование nakon чрескожных koronarnih interventionst porast u segmentu akutnog infarkta miokarda u liječenju pacijenata koji imaju pravo na thrombolytic terapije.

Keytruda Europos Sąjunga - kroatų - EMA (European Medicines Agency)

keytruda

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.

Maci Europos Sąjunga - kroatų - EMA (European Medicines Agency)

maci

vericel denmark aps - autologni kultivirani hondrociti - prijelom, hrskavica - ostali lijekovi za poremećaje mišićno-koštanog sustava - popravak simptomatskih oštećenja hrskavice koljena.

Scenesse Europos Sąjunga - kroatų - EMA (European Medicines Agency)

scenesse

clinuvel europe limited - afamelanotide - protoporfirija, eritropoetik - oslobađanje i zaštita - prevencija fototoksičnosti kod odraslih bolesnika s eritropoetičkom protoporfirijom (epp).

Kevzara Europos Sąjunga - kroatų - EMA (European Medicines Agency)

kevzara

sanofi winthrop industrie - sarilumab - artritis, reumatoidni - imunosupresivi - kevzara u kombinaciji s metotreksatom (mtx) je indiciran za liječenje umjerenog do teškog oblika aktivnog reumatoidnog artritisa (ra) u odraslih bolesnika koji su reagirali adekvatno na, ili koji ne podnose da jedan ili više bolesti modificiranje protiv reumatskih lijekovi (dmard-ima). kevzara može se dati kao monoterapija u slučaju netolerancije na mtx ili kada liječenje sa mtx je neprimjereno.

AMINOSOL 10% 5 g/1000 mL+ 7.4 g/1000 mL+ 6.2 g/1000 mL+ 9.31 g/1000 mL+ 4.3 g/1000 mL+ 4.4 g/1000 mL+ 5.1 g/1000 mL+ 2 g/1000 mL Bosnija ir Hercegovina - kroatų - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

aminosol 10% 5 g/1000 ml+ 7.4 g/1000 ml+ 6.2 g/1000 ml+ 9.31 g/1000 ml+ 4.3 g/1000 ml+ 4.4 g/1000 ml+ 5.1 g/1000 ml+ 2 g/1000 ml

hemofarm proizvodnja farmaceutskih proizvoda d.o.o. banja luka - aminokiseline - rastvor za infuziju - 5 g/1000 ml+ 7.4 g/1000 ml+ 6.2 g/1000 ml+ 9.31 g/1000 ml+ 4.3 g/1000 ml+ 4.4 g/1000 ml+ 5.1 g/1000 ml+ 2 g/1000 ml+ 12 g/1000 m - 1000 ml rastvora za infuziju sadrži: 5,00 g lizoleucin 7,40 g lleucin 6,20 g lvalin 9,31 g llizin acetat 4,30 g lmetionin 4,40 g ltreonin 5,10 g lfenilalanin 2,00 g ltriptofan 12,00 g larginin 3,00 g lhistidin 14,00 g lalanin 11,00 g glicin 11,20 g lprolin 6,50 g lserin 0,40 g ltirozin 1,00 g taurin

AMINOSOL 15% 5.2 g/1000 mL+ 8.9 g/1000 mL+ 5.5 g/1000 mL+ 15.66 g/1000 mL+ 3.8 g/1000 mL+ 8.6 g/1000 mL+ 5.5 g/1000 mL+ 1.6 g/10 Bosnija ir Hercegovina - kroatų - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

aminosol 15% 5.2 g/1000 ml+ 8.9 g/1000 ml+ 5.5 g/1000 ml+ 15.66 g/1000 ml+ 3.8 g/1000 ml+ 8.6 g/1000 ml+ 5.5 g/1000 ml+ 1.6 g/10

hemofarm proizvodnja farmaceutskih proizvoda d.o.o. banja luka - aminokiseline - rastvor za infuziju - 5.2 g/1000 ml+ 8.9 g/1000 ml+ 5.5 g/1000 ml+ 15.66 g/1000 ml+ 3.8 g/1000 ml+ 8.6 g/1000 ml+ 5.5 g/1000 ml+ 1.6 g/1000 ml+ 20 g/1 - 1000 ml rastvora za infuziju sadrži: 5,20 g lizoleucin 8,90 g lleucin 5,50 g lvalin 15,66 g llizin acetat 3,80 g lmetionin 8,60 g ltreonin 5,50 g lfenilalanin 1,60 g ltriptofan 20,00 g larginin 7,30 g lhistidin 25,00 g lalanin 18,50 g glicin 17,00 g lprolin 9,60 g lserin 0,40 g ltirozin 2,00 g taurin