Flebogamma DIF (previously Flebogammadif) Европейски съюз - хърватски - EMA (European Medicines Agency)

flebogamma dif (previously flebogammadif)

instituto grifols s.a. - imunoglobulina osoba normalan - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - imuni serumi i homologna, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Phesgo Европейски съюз - хърватски - EMA (European Medicines Agency)

phesgo

roche registration gmbh - pertuzumab, trastuzumab - neoplazme dojki - antineoplastična sredstva - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Rivaroxaban Viatris (previously Rivaroxaban Mylan) Европейски съюз - хърватски - EMA (European Medicines Agency)

rivaroxaban viatris (previously rivaroxaban mylan)

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.

Xarelto Европейски съюз - хърватски - EMA (European Medicines Agency)

xarelto

bayer ag - rivaroksaban - arthroplasty, replacement; venous thromboembolism - antitrombotska sredstva - xarelto, uvedene zajedno sa ацетилсалициловой kiselinom (ask) sami ili sa asc plus клопидогрел ili Тиклопидин, prikazana za prevenciju атеротромботических događaja kod odraslih pacijenata nakon akutnog koronarni sindrom (acs) s povišenom razinom кардиальных biomarkera. xarelto, 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. prevencija venske tromboembolije (vte) u odraslih bolesnika koji se podvrgavaju izborni operacije zamjena kuka ili koljena. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. adultsprevention 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.

Zoledronic acid Teva Generics Европейски съюз - хърватски - EMA (European Medicines Agency)

zoledronic acid teva generics

teva generics b.v - monohidrat zoledronske kiseline - osteoporosis; osteitis deformans - bisfosfonati - liječenje osteoporosisin post-menopausal žene za odrasle Менат povećanog rizika od prijeloma, uključujući i posljednjih padove-ozljede prijeloma kuka . liječenje osteoporoze, povezan s dugoj sistemske glukokortikoidni terapiju nakon menopauze žene za odrasle Менат povećanog rizika od prijeloma. liječenje pagetova bolest kostiju kod odraslih osoba.

Zoledronic acid Teva Pharma Европейски съюз - хърватски - EMA (European Medicines Agency)

zoledronic acid teva pharma

teva b.v. - zoledronske kiseline - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - lijekovi za liječenje bolesti kostiju - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. liječenje pagetova bolest kostiju kod odraslih osoba.