Eiropas Savienība - horvātu - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolakton - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 i 5.

Horvātija - horvātu - HALMED (Agencija za lijekove i medicinske proizvode)

nordic pharma s.r.o., k rybniku 475, jesenice, Češka - ekstrakt lista zelenog čaja - mast - 100 mg/g - urbroj: 1 g masti sadrži 100 mg ekstrakta (u obliku suhog ekstrakta, rafiniranog) camellia sinensis (l.) o. kuntze, folium (list zelenog čaja) (24-56:1), što odgovara: 55-72 mg (-)-epigalokatehingalata: otapalo kod prve ekstracije: voda

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (kao fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastična sredstva - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Полицитемия vjera (mf)jakavi indiciran za liječenje odraslih bolesnika s полицитемия vjera, koje su otporne na ili netoleranciju hidroksiurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Bosnija un Hercegovina - horvātu - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

mylan d.o.o. - валсартан - film tableta - 160 mg/1 tableta - 1 film tableta sadrži: 160 mg valsartana

Bosnija un Hercegovina - horvātu - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

mylan d.o.o. - валсартан - film tableta - 80 mg/1 tableta - 1 film tableta sadrži: 80 mg valsartana

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - 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 - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy 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. abevmy 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 abevmy in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. abevmy, 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 other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, 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. abevmy, 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 vegf inhibitors or vegf receptor–targeted agents. abevmy 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. abevmy, 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.

Bosnija un Hercegovina - horvātu - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

mylan d.o.o. - hidrohlorotiazid, валсартан - film tableta - 160 mg/1 tableta+ 12,5 mg/1 tableta - 1 tableta sadrži: 160 mg valsartana i 12,5 mg hidrohlorotiazida

Bosnija un Hercegovina - horvātu - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

mylan d.o.o. - hidrohlorotiazid, валсартан - film tableta - 80 mg/1 tableta+ 12,5 mg/1 tableta - 1 tableta sadrži: 80 mg valsartana i 12,5 mg hidrohlorotiazida

Bosnija un Hercegovina - horvātu - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

takeda pharmaceuticals bh d.o.o. sarajevo - alogliptin, metformin - film tableta - 1000 mg/1 tableta+ 12.5 mg/1 tableta - 1 film tableta sadrži: 1000 mg metformina (u obliku metformin hidrohlorida) 12,5 mg alogliptina (u obliku alogliptin benzoata)

Bosnija un Hercegovina - horvātu - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

takeda pharmaceuticals bh d.o.o. sarajevo - alogliptin, metformin - film tableta - 850 mg/1 tableta+ 12.5 mg/1 tableta - 1 film tableta sadrži: 850 mg metformina (u obliku metformin hidrohlorida) 12,5 mg alogliptina (u obliku alogliptin benzoata)