Uniunea Europeană - română - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimicotice pentru uz sistemic - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 și 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 și 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. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. 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 și 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 și 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 și 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. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. 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 și 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 și 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. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. 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):- aspergiloză invazivă la pacienții cu boală rezistentă la amfotericina b sau itraconazol sau la pacienți care nu tolerează aceste medicamente;- fuzarioză la pacienții cu boală rezistentă la amfotericina b sau itraconazol sau la pacienți care nu tolerează amfotericina b;- cromoblastomicoză și micetom la pacienții cu boală rezistentă la itraconazol sau la pacienți care prezintă intoleranță la itraconazol;- coccidioidomicoză la pacienții cu boală rezistentă la amfotericina b, itraconazol sau fluconazol sau la pacienții care au intoleranță la aceste medicamente;- candidoza oro-faringiană: ca terapie de prima linie la pacienții care au boli grave sau sunt imunocompromiși, în care, ca răspuns la terapia topică este de așteptat să fie săraci. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. 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.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

astellas pharma europe b.v. - olanda - podophyllotoxinum - sol. cut. - 5mg/ml - chimioterapice de uz local antivirale

Republica Moldova - română - ANSA (Agenţia Naţională pentru Siguranţa Alimentelor)

Îp barieră-profi, ucraina - imidacloprid, - soluţie pentru aplicarea cutanată - câini

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

delpharm bladel b.v. - olanda - podophyllotoxinum - sol. cut. - 5mg/ml - chimioterapice de uz local antivirale

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

chanelle medical - irlanda - amorolfinum - lac de unghii medicinal - 50mg/ml - antifungice de uz dermatologic alte antifungice de uz dermatologic

Uniunea Europeană - română - EMA (European Medicines Agency)

intervet international bv - indoxacarb, permethrin - permetrin, combinații, ectoparasiticides pentru uz topic, incl. insecticide - câini - tratamentul infestărilor cu purici (ctenocephalides felis); produsul are eficacitate insecticidă persistentă timp de până la 4 săptămâni împotriva ctenocephalides felis. produsul are o eficacitate acaricidă persistentă de până la 5 săptămâni împotriva ixodes ricinus și până la 3 săptămâni împotriva rhipicephalus sanguineus. un tratament oferă o activitate respingătoare (anti-hrănire) împotriva muștelor de nisip (phlebotomus perniciosus) timp de până la 3 săptămâni.

Uniunea Europeană - română - EMA (European Medicines Agency)

teva b.v.  - oxibutinină - incontinența urinară, urge - urologicals - tratamentul simptomatic al incontinenței urgente și / sau frecvenței și urgenței urinare crescute, care pot apărea la pacienții adulți cu vezică instabilă.

Uniunea Europeană - română - EMA (European Medicines Agency)

mallinckrodt pharmaceuticals ireland limited - fibrinogenul uman, trombina umană - hemostază, chirurgicală - hemostatice - tratament suportiv în cazul în care tehnicile chirurgicale standard nu sunt suficiente pentru ameliorarea hemostazei. raplixa trebuie să fie utilizate în combinație cu aprobarea unui burete de gelatină. raplixa este indicat la adulți cu vârsta peste 18 ani.

Uniunea Europeană - română - EMA (European Medicines Agency)

3m health care limited - rivastigmină - boala alzheimer - psychoanaleptics, , anticolinesterazice - tratamentul simptomatic al demenței alzheimer ușoară până la moderată.

Uniunea Europeană - română - EMA (European Medicines Agency)

janssen-cilag international nv - becaplermin - wound healing; skin ulcer - preparate pentru tratarea rănilor și ulcerelor - regranex este indicată, în asociere cu alte măsuri de îngrijire bine rana, pentru a promova granulare şi astfel vindecarea completa-grosime, neuropatice, cronice, diabetici ulcere mai mică sau egală cu a 5 cm2.