Rumunija - rumunų - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

amgen technology (ireland) uc - irlanda - eculizumabum - conc. pt. sol. perf. - 300mg - imunosupresoare imunosupresoare selective

Rumunija - rumunų - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pantheon italia s.p.a. - italia - eculizumabum - conc. pt. sol. perf. - 300mg - imunosupresoare imunosupresoare selective

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurie, paroxismal - imunosupresoare selective - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilate - carcinomul, celula renală - agenți antineoplazici - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilate - neoplasme tiroidiene - agenți antineoplazici - lenvima este indicat în monoterapie pentru tratamentul pacienților adulți cu progresiv, avansat local sau metastatic, diferențiat (papilar/folicular/celule hürthle) carcinom tiroidian (dtc), refractare la iod radioactiv (rai). lenvima este indicat în monoterapie pentru tratamentul pacienților adulți cu avansate sau inoperabil carcinom hepatocelular (hcc), care nu au primit anterior tratament sistemic.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinurie, paroxismal - imunosupresoare - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.

Moldova - rumunų - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

astellas pharma europe b.v. - tacrolimus - capsule cu eliberare prelungită - 0,5 mg

Moldova - rumunų - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

astellas pharma europe b.v. - tacrolimus - capsule cu eliberare prelungită - 1 mg

Moldova - rumunų - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

astellas pharma europe b.v. - tacrolimus - capsule cu eliberare prelungită - 5 mg

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

gsk vaccines s.r.l. - exterior membrana veziculelor de neisseria meningitidis grup b (tulpina nz 98/254), recombinant neisseria meningitidis grup b fhbp proteină de fuziune, recombinant neisseria meningitidis grup b nada proteine, recombinant neisseria meningitidis grup b nhba proteină de fuziune - meningită, meningococică - vaccinuri meningococice - imunizarea activă împotriva bolilor invazive cauzate de tulpinile serogrup-b ale neisseria meningitidis.