Európai Unió - horvát - EMA (European Medicines Agency)

roche registration gmbh - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - imunosupresivi - esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.

Európai Unió - horvát - EMA (European Medicines Agency)

theravia - hidroksikarbamid - anemija, sickle cell - antineoplastična sredstva - Шиклоше je indiciran za prevenciju рецидивирующих boli сосудисто-jamice кризов, uključujući akutni sindrom grudnog koša kod djece i odraslih pacijenata koji boluju od simptomatske anemija srpastih stanica sindrom.

Európai Unió - horvát - 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.

Európai Unió - horvát - EMA (European Medicines Agency)

chiesi farmaceutici spa - citrat kofeina - apneja za vrijeme - psychoanaleptics, - liječenje primarnog apneja za vrijeme rođene novorođenčadi.

Európai Unió - horvát - EMA (European Medicines Agency)

gennisium pharma - citrat kofeina - apneja za vrijeme - psychoanaleptics, - liječenje primarnog apneja za vrijeme rođene novorođenčadi.

Európai Unió - horvát - EMA (European Medicines Agency)

axunio pharma gmbh - pirfenidone - idiopatska plućna fibroza - imunosupresivi - pirfenidone aet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Európai Unió - horvát - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - imunosupresivi - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Európai Unió - horvát - EMA (European Medicines Agency)

virbac s.a. - hidrokortizon aceponat - kortikosteroidi, dermatološki pripravci - psi - za simptomatsko liječenje upalnih i prurijskih dermatoza kod pasa. for alleviation of clinical signs associated with atopic dermatitis in dogs.

Európai Unió - horvát - EMA (European Medicines Agency)

elanco gmbh - pegbovigrastim - Колониестимулирующие faktori, иммуностимуляторы, imaju antikancerogena posrednika - cattle (cows and heifers); cattle - kao pomoć u programu upravljanja stada, kako bi se smanjio rizik od kliničkog mastitisa kod periparturient mliječnih krava i junica tijekom 30 dana nakon teljenja.

Európai Unió - horvát - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - svinjski circovirus tip 2 orf2 proteina - imunološke za suidae - svinje - za aktivne imunizacije svinja u dobi od dva tjedna od svinjske цирковирус tipa 2 (pcv2) smanjiti smrtnost, kliničke znakove, uključujući gubitak težine i poraza u лимфоидных tkivima, u svezi s ЦВС2-bolest povezana s (pcvd). osim toga, cijepljenje je pokazalo da smanjuje pcv2 nazalno prolijevanja, virusni opterećenje u krvi i limfna tkiva, te trajanje viremije. početak zaštite dolazi već dva tjedna nakon cijepljenja i traje najmanje 17 tjedana.