Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemija, mijelogeni, kronični, bcr-abl pozitivan - antineoplastična sredstva - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

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)

dipharma arzneimittel gmbh - Сапроптерин дигидрохлорид - phenylketonurias - drugi gastrointestinalni trakt i metabolizam, lijekovi, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - daclatasvir dihydrochloride - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - daklinza je indiciran u kombinaciji s drugim lijekovima za liječenje infekcije kroničnog hepatitisa c (hcv) kod odraslih (vidi odjeljke 4. 2, 4. 4 i 5. za specifične aktivnosti genotip hcv, vidi 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastična sredstva - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Europska Unija - hrvatski - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, nasljedni - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karcinom, ne-malih stanica pluća - antineoplastična sredstva - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukemija, mieloid - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.

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

sintetica gmbh, albersloher weg 11, münster, njemačka - efedrinklorid - otopina za injekciju - urbroj: 1 ml otopine za injekciju sadrži 10 mg efedrinklorida

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

sintetica gmbh, albersloher weg 11, münster, njemačka - efedrinklorid - otopina za injekciju - urbroj: 1 ml otopine za injekciju sadrži 50 mg efedrinklorida