Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly nederland b.v. - pirtobrutinib - limfom, mantel-stanica - inhibitori протеинкиназы - treatment of mantle cell lymphoma (mcl).

Europska Unija - hrvatski - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastična sredstva - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - limfom, folikularni - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - Иммуностимуляторы, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Europska Unija - hrvatski - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - mcloksikam - oxicams - horses; dogs; cattle; cats; pigs; guinea pigs - mačka:ublažavanje blage do umjerene postoperativni bol i upale nakon kirurške intervencije, e. ortoza i operacije mekih tkiva . olakšanje boli i upale kod akutne i kronične bolesti mišićno-koštanog sustava. smanjenje postoperativni bol nakon овариогистерэктомии i male operacije mekih tkiva . cattle:for use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. za korištenje kod proljeva u kombinaciji s oralnu регидрационной terapija za smanjenje kliničkih znakova kod teladi u roku od jednog tjedna, u dobi i mladi, ne-mliječne krave. za olakšanje postoperativne boli nakon odstranjivanja u teladi. za pomoćnu terapiju u liječenju akutnog mastitisa, u kombinaciji s antibiotskom terapijom. dogs:alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. smanjenje postoperativni bol i upale nakon ortopediju i operacije mekih tkiva . horses:for use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. za olakšanje boli povezane s kolikom kolica. olakšanje upale i olakšavanja boli u akutni i kronični mišićno-koštanog sustava. svinje: za upotrebu u неинфекционной bolestima mišićno-koštanog sustava za smanjenje simptoma hromost i upale. za cupping postoperativni bol povezana s manjim kirurgija mekih tkiva, kao što su kastraciji. za pomoćnu terapiju u liječenju puerperalne septikemije i toksemije (mastitis-metritis-agalaktia sindrom) s odgovarajućom terapijom antibioticima. zamorci su:ublažavanje blage do umjerene postoperativni bol povezana s kirurgija mekih tkiva, kao što je kastracija muških.

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)

sandoz gmbh - epoetin alfa - anemia; kidney failure, chronic - antianemijski pripravci - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;, treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. stanje kardiovaskularnog sustava, već postojeće anemije u početku kemoterapije).

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi b.v. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation; lymphoma - Иммуностимуляторы, - mozobil je indiciran u kombinaciji sa stimulacije granulocitnih kolonija stimulirajući faktor za poboljšanje mobilizacije krvotvornih matičnih stanica periferne krvi za prikupljanje i naknadne autologne transplantacije u bolesnika s mijelomom čije stanice mobilizirati slabo.

Europska Unija - hrvatski - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Crna Gora - hrvatski - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

dio stranog druŠtva "sanofi - aventis" - podgorica - vakcina protiv difterije tetanusa i poliomijelitisa (inaktivisana, adsorbovana) - suspenzija za injekciju u napunjenom injekcionom špricu - (2i.j. + 20i.j. + 40d.j. + 8d.j. + 32d.j.)/0.5ml