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)

teva b.v. - topotekan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - antineoplastična sredstva - topotecan monotherapy is indicated for the treatment of: , patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;, patients with relapsed small cell lung cancer [sclc] for whom re-treatment with the first-line regimen is not considered appropriate. , Топотекана u kombinaciji s цисплатином je indiciran u bolesnika s карциномой relaps grlića maternice nakon radioterapije i za pacijente sa fazi bolesti instituta svjetske banke . pacijenti s preliminarnim utjecajem cisplatinu, zahtijevaju stalnu besplatno liječenje interval, da se opravda liječenje kombinacije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - besponsa je indicirana kao monoterapija za liječenje odraslih osoba s recidiviranom ili refraktornom cd22 pozitivnom akutnom limfoblastičnom leukemijom b stanica (all). odrasli bolesnici s philadelphia kromosomom pozitivnim (ph +) relapsiranim ili vatrostalnim b stanicama prekursora all trebali bi imati neuspješan tretman s najmanje 1 inhibitorom tirozin kinaze (tki).

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

novo nordisk a/s, novo alle, bagsvaerd, danska - estradiol hemihidrat noretisteronacetat - filmom obložena tableta - 1 mg + 0,5 mg - urbroj: jedna filmom obložena tableta sadrži 1 mg estradiola u obliku estradiol hemihidrata i 0,5 mg noretisteronacetata

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

sandoz d.o.o., maksimirska 120, zagreb - duloxetinum - želučanootporna kapsula, tvrda - 30 mg - urbroj: svaka kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida)

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

sandoz d.o.o., maksimirska 120, zagreb - duloxetinum - želučanootporna kapsula, tvrda - 60 mg - urbroj: svaka kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida)

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

novo nordisk a/s, novo alle, bagsvaerd, danska - estradiol hemihidrat noretisteronacetat - filmom obložena tableta - 1 mg + 1 mg - urbroj: jedna crvena filmom obložena tableta sadrži 1 mg estradiola (u obliku estradiol hemihidrata) jedna bijela filmom obložena tableta sadrži 1 mg estradiola (u obliku estradiol hemihidrata) i 1 mg noretisteronacetata

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

octapharma (ip) sprl, allee de la recherche 65, anderlecht, belgija - адррес proteini ljudske plazme koji djeluju protiv inhibitora koagulacijskog faktora viii u - otopina za infuziju - 45-70 mg/ml - urbroj: 1 ml otopine za infuziju sadrži 45-70 mg proteina ljudske plazme

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

octapharma (ip) sprl, allee de la recherche 65, anderlecht, belgija - imunoglobulin normalni, ljudski, intravenski - otopina za infuziju - 100 mg/ml - urbroj: 1 ml otopine za infuziju sadrži 100 mg imunoglobulina normalnog, ljudskog (čistoća od najmanje 95 % igg)

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

bavarian nordic a/s, philip heymans allé 3, hellerup, danska - virus bjesnoće, soj flury lep (inaktiviran) - prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki - 1 doza = 1 ml - urbroj: 1 bočica (1,0 ml) nakon rekonstitucije sadrži: virus bjesnoće (inaktivirani, soj flury lep) ≥ 2,5 internacionalne jedinice (iu), proizveden na pročišćenim stanicama pilećih embrija (pcec)