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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

co.don gmbh - sferoidi humanih autolognih matriksa povezanih hondrocita - bolesti hrskavice - ostali lijekovi za poremećaje mišićno-koštanog sustava - popravak oštećenja simptomatskih zglobnih zglobova femoralnog kondila i patele koljena (međunarodna klasifikacija ictr-a iii ili iv) s veličinom kvara do 10 cm2 u odraslih osoba.

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

sandoz d.o.o., maksimirska 120, zagreb - bortezomibum - prašak za otopinu za injekciju - 3,5 mg - urbroj: svaka bočica sadrži 3,5 mg bortezomiba (u obliku estera boronatne kiseline i manitola)

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

klinimed d.o.o., zagreb - torakalni drenovi vrećica za krv za prikupljanje autologne krvi iz drenažnih prsnih katetera

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

difar d.o.o., zagreb - autologno stanično pomlađivanje, pribor za pripremu autologne trombocitima bogate plazme i njenu primjenu

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

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - бусульфан - koncentrat za otopinu za infuziju - 6 mg/ml - urbroj: jedan ml koncentrata sadrži 6 mg busulfana (60 mg u 10 ml)

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

tillomed pharma gmbh, mittelstrasse 5/5a, schonefeld, njemačka - melfalanklorid - prašak i otapalo za otopinu za injekciju / infuziju - 50 mg - urbroj: jedna bočica praška sadrži 50 mg melfalana u obliku melfalanklorida.

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

sanofi d.o.o. - lenograstim - prašak i rastvarač za rastvor za injekciju/infuziju - 263 µg/1 viala - 1 bočica sa praškom za rastvor za injekciju/infuziju sadrži: 263 mcg (33 600 000 i.j.) lenograstim, humani rekombinantni stimulator granulocitopoeze. (33 600 000 i.j.)

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

roche d.o.o.roche ltd. - epoetin beta - rastvor za injekciju - 2000 i.j./0.3 ml - 0,3 ml rastvora za injekciju sadrži: 2000 i.u. epoetin beta (humani rekombinantni eritropoetin)

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

roche d.o.o.roche ltd. - epoetin beta - prašak i rastvarač za rastvor za injekciju - 50000 i.j./1 viala - 1 bočica sa praškom za rastvor za injekciju sadrži: 50000 i.u. epoetin beta (humani rekombinantni eritropoetin)