Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastična sredstva - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

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

amicus pharma d.o.o. - nivolumab - koncentrat za otopinu za infuziju - 10 mg/1 ml - jedna bočica sa 4 ml koncentrata za otopinu za infuziju sadrži 40 mg nivolumaba (10mg/ml)

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

amicus pharma d.o.o. - nivolumab - koncentrat za otopinu za infuziju - 10 mg/1 ml - jedna bočica sa 10 ml koncentrata za otopinu za infuziju sadrži 100 mg nivolumaba (10mg/ml)

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

amicus pharma d.o.o. - nivolumab - koncentrat za otopinu za infuziju - 10 mg/1 ml - jedna bočica sa 24 ml koncentrata za otopinu za infuziju sadrži 240 mg nivolumaba (10mg/ml)

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

amicus pharma d.o.o. - nivolumab - koncentrat za otopinu za infuziju - 10 mg/1 ml - jedna bočica sa 12 ml koncentrata za otopinu za infuziju sadrži 120 mg nivolumaba (10mg/ml)

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

servier pharma d.o.o., ulica grge tuškana 37, zagreb, hrvatska - gliklazid - tableta s prilagođenim oslobađanjem - 60 mg - urbroj: jedna tableta s prilagođenim oslobađanjem sadrži 60 mg gliklazida

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

servier pharma d.o.o., tuškanova 37, zagreb, hrvatska - trimetazidindiklorid - tableta s prilagođenim oslobađanjem - 35 mg - urbroj: jedna tableta s prilagođenim oslobađanjem sadržava 35 mg trimetazidindiklorida

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

servier pharma d.o.o., tuškanova 37, zagreb, hrvatska - tianeptinnatrij - obložena tableta - 12,5 mg - urbroj: jedna tableta sadrži 12,5 mg tianeptinnatrija što odgovara 11,90 mg tianeptina

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

servier pharma d.o.o., ulica grge tuškana 37, zagreb, hrvatska - mikronizirana, pročišćena smjesa flavonoida koja se sastoji od 90% diosmina i 10% flavonoida izraženih kao hesperidin - filmom obložena tableta - 450 mg + 50 mg - urbroj: jedna filmom obložena tableta sadrži 500 mg pročišćene mikronizirane smjese flavonoida koja se sastoji od 450 mg diosmina (90 %) i 50 mg flavonoida izraženih kao hesperidin (10 %)

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

servier pharma d.o.o., tuškanova 37, zagreb, hrvatska - metoprololum, ivabradinum - filmom obložena tableta - 50 mg + 5 mg - urbroj: jedna filmom obložena tableta sadrži 50 mg metoprololtartarata i 5 mg ivabradina (što odgovara 5,390 mg ivabradinklorida)