Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

bms Češka - didanozin - gastrorezistentna kapsula, trda - didanozin 250 mg / 1 kapsula - didanozin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

bms Češka - didanozin - gastrorezistentna kapsula, trda - didanozin 400 mg / 1 kapsula - didanozin

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiki za sistemsko uporabo - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali pri bolnikih, ki so nestrpne amphotericin b;- chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - arzenov trioksid - levkemija, promyelocytic, akutna - antineoplastična sredstva - trisenox je primerna za indukcijo remisije, in konsolidacije pri odraslih bolnikih z:novo diagnosticiranih nizko-za-srednje tveganje akutna promyelocytic levkemijo (apl) (belih krvnih telesc, ≤ 10 x 103/µl) v kombinaciji z all‑trans‑retinojske kisline (atra)relapsed/ognjevzdržni akutna promyelocytic levkemijo (apl) (prejšnje zdravljenje mora imeti vključen retinoid in kemoterapijo)značilna prisotnost t(15;17) translokacija in/ali prisotnost pro-myelocytic levkemijo/retinojske kisline-receptor-alfa (pml/rar-alfa) gena. odgovor stopnja drugih akutnih myelogenous levkemijo podtipov, da arzenov trioksid, ki še niso bili pregledani.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

schulke & mayr gmbh - fenoksietanol; oktenidinijev diklorid - dermalno pršilo, raztopina - fenoksietanol 20 mg / 1 ml  oktenidinijev diklorid1 mg / 1 ml; oktenidinijev diklorid 1 mg / 1 ml - oktenidin, kombinacije

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

schulke & mayr gmbh - fenoksietanol; oktenidinijev diklorid - dermalna raztopina - fenoksietanol 20 mg / 1 ml  oktenidinijev diklorid1 mg / 1 ml; oktenidinijev diklorid 1 mg / 1 ml - oktenidin, kombinacije

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

schulke & mayr gmbh - fenoksietanol, oktenidinijev diklorid - dermalno pršilo, raztopina - fenoksietanol 20 mg / 1 ml; oktenidinijev diklorid 1 mg / 1 ml - oktenidin, kombinacije

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

schulke & mayr gmbh - fenoksietanol; oktenidinijev diklorid - dermalna raztopina - fenoksietanol 20 mg / 1 ml  oktenidinijev diklorid1 mg / 1 ml; oktenidinijev diklorid 1 mg / 1 ml - oktenidin, kombinacije

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

schulke & mayr gmbh - fenoksietanol; oktenidinijev diklorid - dermalno pršilo, raztopina - fenoksietanol 20 mg / 1 ml  oktenidinijev diklorid1 mg / 1 ml; oktenidinijev diklorid 1 mg / 1 ml - oktenidin, kombinacije

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

schulke & mayr gmbh - fenoksietanol; oktenidinijev diklorid - dermalno pršilo, raztopina - fenoksietanol 20 mg / 1 ml  oktenidinijev diklorid1 mg / 1 ml; oktenidinijev diklorid 1 mg / 1 ml - oktenidin, kombinacije