Euroopa Liit - horvaadi - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Horvaatia - horvaadi - HALMED (Agencija za lijekove i medicinske proizvode)

alk-abelló a/s, boge allé 6-8, horsholm, danska - adrenalintartarat (epinefrintartarat) - otopina za injekciju u napunjenoj brizgalici - urbroj: 1 ml otopine sadrži 1 mg adrenalina (u obliku adrenalintartarata). pojedinačna doza od 0,15 ml otopine za injekciju sadrži 150 mikrograma adrenalina (u obliku adrenalintartarata).

Horvaatia - horvaadi - HALMED (Agencija za lijekove i medicinske proizvode)

alk-abelló a/s, boge allé 6-8, horsholm, danska - adrenalintartarat (epinefrintartarat) - otopina za injekciju u napunjenoj brizgalici - urbroj: 1 ml otopine sadrži 1 mg adrenalina (u obliku adrenalintartarata). pojedinačna doza od 0,30 ml otopine za injekciju sadrži 300 mikrograma adrenalina (u obliku adrenalintartarata).

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

bayer ag - telmisartan, hydrochlorothiazide - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije. pritorplus s fiksnom kombinacijom doze (40 mg телмисартана / 12. 5 mg hidroklorotiazid телмисартан 80 mg / 12. 5 mg hidroklorotiazid) prikazan pacijentima, kod kojih je krvni pritisak nije dovoljno prati na телмисартан sami. pritorplus s fiksnom kombinacijom doza (80 mg телмисартан / hidroklorotiazid 25 mg) prikazan pacijentima, kod kojih je krvni pritisak nije dovoljno prati na pritorplus (80 mg телмисартана / 12. 5 mg hidroklorotiazid) ili bolesnika, koji su prethodno bili su uhvaćeni na телмисартана ili hidroklorotiazid odvojeno.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - karcinom, ne-malih stanica pluća - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

bayer ag - vericiguat - zastoj srca - srčana terapija - treatment of symptomatic chronic heart failure.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabine - lymphoblastic leukemija-limfom t-stanica prekursora - antineoplastična sredstva - nelarabine indiciran za liječenje bolesnika sa t-клеточным oštrim лимфобластным лейкозом (t-all) i t-stanični limfocitne limfom (t-ЛБЛ), čija bolest ne odgovara, ili je nastao recidiva nakon tretmana s najmanje dva načina kemoterapije. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

mylan s.a.s. - docetaksel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastična sredstva - liječenje raka dojke, posebni oblici raka pluća (karcinom pluća ne-malih stanica), rak prostate, rak želuca ili rak glave i vrata.