Aubagio Unia Europejska - słoweński - EMA (European Medicines Agency)

aubagio

sanofi winthrop industrie - teriflunomide - multiple skleroza - selektivni imunosupresivi - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Edistride Unia Europejska - słoweński - EMA (European Medicines Agency)

edistride

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - zdravila, ki se uporabljajo pri diabetesu - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. poleg drugimi zdravili za zdravljenje diabetesa tipa 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Forxiga Unia Europejska - słoweński - EMA (European Medicines Agency)

forxiga

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - zdravila, ki se uporabljajo pri diabetesu - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. poleg drugimi zdravili za zdravljenje diabetesa tipa 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Lynparza Unia Europejska - słoweński - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - ovarijske neoplazme - antineoplastična sredstva - ciste na cancerlynparza je označen kot monotherapy za:vzdrževanje zdravljenje odraslih bolnikov z napredovalim (figo fazah iii in iv) brca1/2-mutiral (germline in/ali somatski) high-grade epitelnih jajčnikov, fallopian tube ali primarni trebušno raka, ki so v odziv (popolna ali delna) po koncu prve vrstice platinum, ki temelji kemoterapijo. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 in 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. bolniki morajo imeti predhodno že bili zdravljeni z anthracycline in taxane v (neo)adjuvant ali metastatskim nastavitev, če bolniki niso bili primerni za temi postopki (glej točko 5. bolniki z hormon receptorjev (hr)-pozitivnega raka dojk, je treba tudi napredovala na ali po predhodnem endokrine terapije, ali neprimerna za endokrine terapija. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Revolade Unia Europejska - słoweński - EMA (European Medicines Agency)

revolade

novartis europharm limited - eltrombopag - purpura, trombocitopenična, idiopatska - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 in 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 in 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Zutectra Unia Europejska - słoweński - EMA (European Medicines Agency)

zutectra

biotest pharma gmbh - humani hepatitis b imunoglobulin - immunization, passive; hepatitis b; liver transplantation - imunski sera in imunoglobulini, - preprečevanje ponovne okužbe z virusom hepatitisa b (hbv) pri hbsag in hbv-dna negativnih odraslih bolnikih, vsaj en teden po presaditvi jeter za hepatitis b, povzročeno z odpovedjo jeter. negativni status hbv-dna je treba potrditi v zadnjih 3 mesecih pred olt. bolniki morajo biti pred začetkom zdravljenja hbsag negativni. sočasno uporabo ustrezne virostatic agentov, je treba šteti kot standard hepatitisa b ponovno okužbo profilakso.

Ritonavir Accord 100 mg filmsko obložene tablete Słowenia - słoweński - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

ritonavir accord 100 mg filmsko obložene tablete

accord healthcare - ritonavir - filmsko obložena tableta - ritonavir 100 mg / 1 kapsula - ritonavir

Ritonavir Accord 100 mg filmsko obložene tablete Słowenia - słoweński - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

ritonavir accord 100 mg filmsko obložene tablete

accord healthcare - ritonavir - filmsko obložena tableta - ritonavir 100 mg / 1 kapsula - ritonavir

Trecondi Unia Europejska - słoweński - EMA (European Medicines Agency)

trecondi

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - hematopoetična presaditev izvornih celic - antineoplastična sredstva - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.