Rumanía - rumano - ICBMV (Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar)

bioveta romania srl, romania - l. canicola, l. grippotyphosa, parvovirus suis inactivat, l. pomona, l. hardjo, l. icterohaemorrhagiae inact., l. bratislava - emulsie injectabilă - produse biologice - porcine - porcine (scroafe, scrofiţe şi vieri) pentru vaccinarea preventivă împotriva parvovirozei şi leptospirozei.

Rumanía - rumano - ICBMV (Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar)

boehringer ingelheim animal health france scs, franța - l. canicola, l.icterohaemorrhagiae, l. grippotyphosa - suspensie injectabilă - produse biologice - câini - câini imunoprofilaxia leptospirozei.

Rumanía - rumano - ICBMV (Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar)

boehringer ingelheim animal health france scs, franța - virusul bolii carre, tulpina ba5, adenovirus canin tip 2, tulpina dk13, parvovirus canin tip 2, tulpina cag2, leptospira interrogans inactivat serogrup și serotip canicola, tulpina 16070, leptospira interrogans inactivat serogrup și serotip icterohaemorrhagiae, tulpina 16069, leptospira interrogans inactivat serogrup și serotip grippotyphosa, tulpina grippo mal 1540 - liofilizat şi solvent pentru suspensie injectabilă - produse biologice - câini - câini imunoprofilaxia bolii carre, hepatitei infecţioase, bolii respiratorii cauzate de adenovirusul canin tip 2, adenovirozei, parvovirozei și leptospirozei.

Rumanía - rumano - ICBMV (Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar)

boehringer ingelheim animal health france scs, franța - cav 2, cdv, cpv, l. canicola, l.icterohaemorrhagiae, cpi, l. grippotyphosa - liofilizat şi solvent pentru suspensie injectabilă - produse biologice - câini - câini imunoprofilaxia bolii carre, hepatitei infecţioase, parvovirozei, parainfluenţei și leptospirozei.

Unión Europea - rumano - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - agenți antineoplazici - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. sunt disponibile doar date limitate privind eficacitatea și siguranța pentru pacienții tratați anterior cu anticorpi monoclonali inclusiv rituximab sau pacienții refractari la anterior cu rituximab plus chimioterapie. a se vedea secțiunea 5. 1 pentru informații suplimentare. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituximab a fost demonstrat de a reduce rata progresiei distrucției articulare prin x-ray și de a îmbunătăți funcția fizică, atunci când este administrat în asociere cu metotrexat. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Unión Europea - rumano - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - agenți antineoplazici - rixathon is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rixathon is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. rixathon monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. rixathon is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. rixathon in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). leucemia limfocitară cronică (llc)rixathon în asociere cu chimioterapie este indicat pentru tratamentul pacienților cu netratați anterior și refractar/recidivat, leucemie limfocitară cronică. sunt disponibile doar date limitate privind eficacitatea și siguranța pentru pacienții tratați anterior cu anticorpi monoclonali inclusiv rituximab sau pacienții refractari la anterior cu rituximab plus chimioterapie. a se vedea secțiunea 5. 1 pentru informații suplimentare. poliartrita arthritisrixathon în asociere cu metotrexat este indicat pentru tratamentul pacienților adulți cu poliartrită reumatoidă activă, severă, care au avut un răspuns inadecvat sau intoleranță la alte boli medicamente antireumatice modificatoare (mamb), inclusiv una sau mai multe factorul de necroză tumorală (tnf) inhibitor de terapii. rituximab a fost demonstrat de a reduce rata progresiei distrucției articulare prin x-ray și de a îmbunătăți funcția fizică, atunci când este administrat în asociere cu metotrexat. granulomatosis with polyangiitis and microscopic polyangiitisrixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). rixathon, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisrixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Unión Europea - rumano - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - agenți antineoplazici - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris is indicated for the treatment of adult patients with relapsed or refractory cd30+ hodgkin lymphoma (hl):following asct, orfollowing at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option. systemic anaplastic large cell lymphomaadcetris in combination with cyclophosphamide, doxorubicin and prednisone (chp) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (salcl). adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl. cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Unión Europea - rumano - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - agenți antineoplazici - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Unión Europea - rumano - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - agenți antineoplazici - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Unión Europea - rumano - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.