Rumunsko - rumunčina - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pfizer manufacturing deutschland gmbh - germania - celecoxibum - caps. - 200mg - antiinflamatoare si antireumatice nesteroidiene coxibi

Európska únia - rumunčina - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - infecții cu citomegalovirus - antivirale pentru uz sistemic - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). trebuie luate în considerare ghidurile oficiale privind utilizarea adecvată de agenți antivirali.

Európska únia - rumunčina - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - astm - medicamente pentru afecțiuni obstructive ale căilor respiratorii, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Európska únia - rumunčina - EMA (European Medicines Agency)

zentiva k.s. - leflunomidă - arthritis, rheumatoid; arthritis, psoriatic - imunosupresoare - leflunomida este indicată pentru tratamentul pacienților adulți cu:poliartrită reumatoidă activă, ca un medicament antireumatic modificator al bolii (mamb);artrită psoriazică activă. recent sau concomitent tratament cu medicamente hepatotoxice sau haematotoxic dmard (e. metotrexatul) poate determina un risc crescut de reacții adverse grave; prin urmare, inițierea tratamentului cu leflunomidă trebuie analizată cu atenție în ceea ce privește aceste aspecte beneficiu / risc. mai mult decât atât, trecerea de la leflunomida cu alt mamb, fără a urma procedura de eliminare, de asemenea, poate crește riscul de reacții adverse grave, chiar și pentru o lungă perioadă de timp după trecerea.

Európska únia - rumunčina - EMA (European Medicines Agency)

mylan ireland limited - azacitidină - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - agenți antineoplazici - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Európska únia - rumunčina - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva este indicat pentru tratamentul ofadult și copii și adolescenți diagnosticați recent cu cromozom philadelphia (bcr‑abl) pozitiv (ph+) leucemie mieloidă cronică (lmc) pentru care transplantul de măduvă osoasă nu este considerat ca prima linie de tratament. pacienții adulți și copii cu lgc ph+ în fază cronică după eșecul tratamentului cu interferon‑alfa terapie, sau în faza accelerată sau în criză blastică. adulți și copii și adolescenți diagnosticați recent cu cromozom philadelphia pozitiv leucemie limfoblastică acută (lla ph+), integrat cu chimioterapie. pacienți adulți cu recidivat sau refractar ph+ ca monoterapie. pacienți adulți cu bolile mielodisplazice/mieloproliferative (mds/mpd) asociate cu trombocite-receptorul factorului de creștere derivat (pdgfr) gene re-aranjamente. pacienții adulți cu sindrom hipereozinofilic avansat (she) și/sau leucemie eozinofilică cronică (lec) cu fip1l1-pdgfra rearanjare. efectul de imatinib pe rezultatul de transplantul de măduvă osoasă nu a fost determinată. imatinib teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacienții care au un risc scăzut sau foarte scăzut de recidivă nu trebuie să primească tratament adjuvant. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. cu excepția nou diagnosticate în faza cronică a lgc, nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli.

Európska únia - rumunčina - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - leflunomidă - artrita, reumatoida - imunosupresoare selective - leflunomida este indicată pentru tratamentul pacienților adulți cu:poliartrită reumatoidă activă, ca un medicament antireumatic modificator al bolii (mamb). recent sau concomitent tratament cu medicamente hepatotoxice sau haematotoxic dmard (e. metotrexat) poate duce la un risc crescut de reacții adverse grave, prin urmare, inițierea tratamentului cu leflunomidă trebuie să fie luate în considerare cu atenție ceea ce privește aceste aspecte beneficiu / risc. mai mult decât atât, trecerea de la leflunomida cu alt mamb, fără a urma procedura de eliminare, de asemenea, poate crește riscul de reacții adverse grave, chiar și pentru o lungă perioadă de timp după trecerea.

Európska únia - rumunčina - 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.

Rumunsko - rumunčina - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pfizer europe ma eeig - celecoxibum - caps. - 100mg - antiinflamatoare si antireumatice nesteroidiene coxibi

Rumunsko - rumunčina - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pfizer europe ma eeig - celecoxibum - caps. - 200mg - antiinflamatoare si antireumatice nesteroidiene coxibi