Pheburane Union européenne - roumain - EMA (European Medicines Agency)

pheburane

eurocept international b. v. - fenilbutirat de sodiu - carbamoil-fosfat sintetazei am boala deficit - diverse pentru tractul digestiv și metabolism - tratamentul cronic de management de uree-tulburări ale ciclului.

Vumerity Union européenne - roumain - EMA (European Medicines Agency)

vumerity

biogen netherlands b.v. - diroximel fumarate (biib098) - scleroză multiplă, scleroză multiplă recurent-remisivă - imunosupresoare - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Angilex-Zdorovie spray bucofaringian 100 mg + 500 mg + 250 mg Moldavie - roumain - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

angilex-zdorovie spray bucofaringian 100 mg + 500 mg + 250 mg

zdorovie srl, companie farmaceutica - hexetidinum + cholini salicilatum + chlorbutanoli hemihydratum - spray bucofaringian - 100 mg + 500 mg + 250 mg

Apoquel Union européenne - roumain - EMA (European Medicines Agency)

apoquel

zoetis belgium sa - oclacitinib maleat - agenți pentru dermatită, cu excepția corticosteroizilor - câini - - treatment of pruritus associated with allergic dermatitis in dogs. - treatment of clinical manifestations of atopic dermatitis in dogs.

Imatinib Koanaa Union européenne - roumain - EMA (European Medicines Agency)

imatinib koanaa

koanaa healthcare gmbh - imatinib mesilat - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - agenți antineoplazici - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa 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.

Alkindi Union européenne - roumain - EMA (European Medicines Agency)

alkindi

diurnal europe b.v. - hidrocortizon - supravegherea insuficienței suprarenale - corticosteroizi pentru uz sistemic - terapia de substituție de insuficiență suprarenală la sugari, copii și adolescenți (de la naștere până la < 18 ani).

Evrenzo Union européenne - roumain - EMA (European Medicines Agency)

evrenzo

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - preparate antianemice - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Trodelvy Union européenne - roumain - EMA (European Medicines Agency)

trodelvy

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - agenți antineoplazici - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Chlorophyllin-OZ spray bucofaringian/cutanat/vaginal, solutie 2 mg/ml Moldavie - roumain - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

chlorophyllin-oz spray bucofaringian/cutanat/vaginal, solutie 2 mg/ml

gntls srl, uzina experimentala - extract de folii eucalipții gros - spray bucofaringian/cutanat/vaginal, solutie - 2 mg/ml