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)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - trombocitopenija - antihemorrhagics - doptelet naznačeno za liječenje teških тромбоцитопении kod odraslih pacijenata s kroničnom bolešću jetre, koji planiraju proći postupak инвазивную. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosteroidi, imunoglobulini).

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - romiplostim - purpura, trombocitopenična, idiopatska - antihemorrhagics - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e. kortikosteroidi, imunoglobulini). paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e. kortikosteroidi, imunoglobulini).

Europska Unija - hrvatski - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multipli mijelom - antineoplastična sredstva - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - multipli mijelom - antineoplastična sredstva - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharma a/s - ixazomib citrat - multipli mijelom - antineoplastična sredstva - ninlaro u kombinaciji s lenalidomidom i deksametazonom je indiciran za liječenje odraslih bolesnika s multiplim mijelom koji su primili najmanje jednu prethodnu terapiju.

Europska Unija - hrvatski - EMA (European Medicines Agency)

instituto grifols s.a. - Динатриевая fostamatinib - trombocitopenija - druge sistemske кровоостанавливающие - tavlesse je indiciran za liječenje kronične imunološki тромбоцитопении (ihs) u odraslih bolesnika, vatrostalne standardnim tretmanima na druge metode liječenja.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan ireland limited - rivaroksaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotska sredstva - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Europska Unija - hrvatski - EMA (European Medicines Agency)

acino ag - klopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antitrombotska sredstva - clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , , , patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease, 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 medically treated patients eligible for thrombolytic therapy, patients suffering from acute coronary syndrome. , ,.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinux natrij - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - antitrombotska sredstva - 5 mg / 0. 3 ml i 2. 5 mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. prevencija ВТЭ kod odraslih pacijenata koji su patili operacija na organima trbušne šupljine, koje se smatraju s visokim rizikom тромбоэмболических komplikacija, kao što su pacijenti izložena abdominalnu kirurgiju raka. prevencija ВТЭ kod odraslih pacijenata zdravstvenim ustanovama, za koje se smatra da su na visokim rizikom od ВТЭ i koji обездвижены zbog akutne bolesti kao što su zatajenje srca i / ili akutnim problemima respiratornih bolesti i / ili akutne zarazne ili upalne bolesti. tretman za odrasle osobe s oštrim симптоматическим spontani površni тромбозом vena donjih ekstremiteta bez kolateralne tromboze dubokih vena. 5 mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. srčani udar (infarkt miokarda) kod odraslih pacijenata, koji se upravlja pomoću тромболитиков ili koji je u početku trebao primati nikakve druge oblike terapije реперфузионной. 5 mg / 0. 4 ml, 7. 5 mg / 0. 6-ml i 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.