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

cipla europe nv, uitbreidingstraat 80, antwerpen, belgija - imatinibum - kapsula, tvrda - 400 mg - urbroj: 1 tvrda kapsula sadrži 400 mg imatiniba (u obliku mesilata)

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti. .

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - atazanavir Майлана, uvedeni zajedno s malom dozom ritonavir, indiciran za liječenje hiv-1 zaraženih odraslih i pedijatrijska bolesnika 6 godina i stariji u kombinaciji s drugim antiretrovirusne lijekove. na osnovu вирусологических i kliničkih podataka kod odraslih pacijenata, nikakvu korist ne očekuje se da će u bolesnika s sojeva rezistentnih na više inhibitori proteaze (≥ 4 mutacije pi). dostupne su vrlo ograničene podatke od djece u dobi od 6 do manje od 18 godina. izbor atazanavir Майлана u liječenju iskusni, odrasli i педиатрические pacijenti moraju se temeljiti na individualnoj virusne rezistencije i povijesti liječenja pacijenta .

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

alvogen malta operations (row) ltd., malta life sciences park, building 1, level 4, sir temi zammit buildings, san gwann, malta - temozolomidum - kapsula, tvrda - 100 mg - urbroj: jedna tvrda kapsula sadrži 100 mg temozolomida

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

alvogen malta operations (row) ltd., malta life sciences park, building 1, level 4, sir temi zammit buildings, san gwann, malta - temozolomidum - kapsula, tvrda - 140 mg - urbroj: jedna tvrda kapsula sadrži 140 mg temozolomida

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

alvogen malta operations (row) ltd., malta life sciences park, building 1, level 4, sir temi zammit buildings, san gwann, malta - temozolomidum - kapsula, tvrda - 180 mg - urbroj: jedna tvrda kapsula sadrži 180 mg temozolomida

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

alvogen malta operations (row) ltd., malta life sciences park, building 1, level 4, sir temi zammit buildings, san gwann, malta - temozolomidum - kapsula, tvrda - 20 mg - urbroj: jedna tvrda kapsula sadrži 20 mg temozolomida

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

alvogen malta operations (row) ltd., malta life sciences park, building 1, level 4, sir temi zammit buildings, san gwann, malta - temozolomidum - kapsula, tvrda - 250 mg - urbroj: jedna tvrda kapsula sadrži 250 mg temozolomida

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

alvogen malta operations (row) ltd., malta life sciences park, building 1, level 4, sir temi zammit buildings, san gwann, malta - temozolomidum - kapsula, tvrda - 5 mg - urbroj: jedna tvrda kapsula sadrži 5 mg temozolomida

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.