Kyprolis Europese Unie - Kroatisch - EMA (European Medicines Agency)

kyprolis

amgen europe b.v. - carfilzomib - multipli mijelom - antineoplastična sredstva - kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Lemtrada Europese Unie - Kroatisch - EMA (European Medicines Agency)

lemtrada

sanofi belgium - alemtuzumab - multipla skleroza - selektivni imunosupresivi - lemtrada je indicirana za odrasle bolesnike s relapsno-remitantnom multipla sklerozom (rrms) s aktivnom bolešću definiranom kliničkim ili imaging značajkama.

Lenvima Europese Unie - Kroatisch - EMA (European Medicines Agency)

lenvima

eisai gmbh - lenvatinib mesilat - neoplazme štitnjače - antineoplastična sredstva - lenvima prikazan kao monoterapija za liječenje odraslih bolesnika s прогрессирующим, lokalno-uobičajena ili metastaze, diferencira (папиллярный/фолликулярный/hürthle staničnog) rak štitnjače (dtc), рефрактерным na konstanta Йоду (rai). lenvima prikazan kao monoterapija za liječenje odraslih bolesnika s preliminarnim ili operirati гепатоцеллюлярной karcinom (hcc), koji su primili ne prije sistemske terapije.

Lifmior Europese Unie - Kroatisch - EMA (European Medicines Agency)

lifmior

pfizer europe ma eeig - etanercept - arthritis, psoriatic; spondylitis, ankylosing; psoriasis - imunosupresivi - reumatoidni artritis;juvenilni idiopatski artritis arthritispsoriatic;аксиальный спондилоартрит;Бляшковидный psorijaza;dječju бляшковидный psorijaza.

M-M-RVaxPro Europese Unie - Kroatisch - EMA (European Medicines Agency)

m-m-rvaxpro

merck sharp & dohme b.v.  - virus ospica soj edmonston enders' (živa, progib), virusa паротита jeryl lynn u (razina b) soja (živa, progib), virus rubeole Вистар ra 27/3 soj (živa, progib) - rubella; mumps; immunization; measles - cjepiva - m-m-rvaxpro dizajniran za simultano cijepljenje protiv ospica, паротита i rubeole kod osoba od 12 mjeseci i stariji. za uporabu bljeskalice ospica, ili za постконтактной cijepljenja, ili za uporabu u prethodno непривитым djeca starija od 12 mjeseci koji dolaze u kontakt s osjetljiv trudnice, kao i osobe koje mogu biti izloženi паротита i rubeole.

Mekinist Europese Unie - Kroatisch - EMA (European Medicines Agency)

mekinist

novartis europharm limited - trametinib - melanoma - antineoplastična sredstva - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 i 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. Немелкоклеточный rak pluća (НМРЛ)trametinib u kombinaciji s dabrafenib indiciran za liječenje odraslih bolesnika s preliminarnim non-mali raka pluća stanice s Браф mutacija v600 daleko .

Mepact Europese Unie - Kroatisch - EMA (European Medicines Agency)

mepact

takeda france sas - mifamurtide - osteosarkom - Иммуностимуляторы, - mepact je indiciran u djece, adolescenata i mladih osoba za liječenje visokokvalitetnog resektabilnog ne-metastatskog osteosarkoma nakon makroskopski kompletne kirurške resekcije. koristi se u kombinaciji s postoperativnom multi-agentom kemoterapijom. sigurnost i učinkovitost procijenjeni su u ispitivanjima bolesnika od dvije do 30 godina kod početne dijagnoze.

Nimenrix Europese Unie - Kroatisch - EMA (European Medicines Agency)

nimenrix

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningitis, meningokokal - cjepiva - nimenrix je indiciran za aktivnu imunizaciju osoba od dobi od 6 tjedana protiv invazivnih meningokoknih bolesti uzrokovanih neisseria meningitidis grupom a, c, w-135 i y.

Ninlaro Europese Unie - Kroatisch - EMA (European Medicines Agency)

ninlaro

takeda pharma a/s - ixazomib citrat - multipli mijelom - antineoplastična sredstva - ninlaro u kombinaciji s lenalidomidom i deksametazonom je indiciran za liječenje odraslih bolesnika s multiplim mijelom koji su primili najmanje jednu prethodnu terapiju.

Noxafil Europese Unie - Kroatisch - EMA (European Medicines Agency)

noxafil

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotika za sustavnu uporabu - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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):- 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;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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.