União Europeia - romeno - 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).

Romênia - romeno - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

patheon softgels b.v. - olanda - ibuprofenum - caps. moi masticabile - 100mg - antiinflamatoare si antireumatice nesteroidiene derivati de acid propionic

Moldávia - romeno - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

valeant llc - flumetasonum + acid salicylicum - unguent - 0,2 mg + 30 mg/g

Romênia - romeno - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pantheon softgels b.v. - olanda - ibuprofenum - caps. moi masticabile - 100mg - antiinflamatoare si antireumatice nesteroidiene derivati de acid propionic

União Europeia - romeno - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - sânii neoplasme - agenți antineoplazici - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Romênia - romeno - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

sindan-pharma s.r.l. - romania - oxaliplatinum - conc. pt. sol. perf. - 5mg/ml - alte antineoplazice compusi de platina

Romênia - romeno - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

salutas pharma gmbh - germania - alfacalcidolum - caps. moi - 0,25µg - vitamina a si d (incl. combinatii) vitamina d si analogi

Romênia - romeno - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

salutas pharma gmbh - germania - alfacalcidolum - caps. moi - 0,5µg - vitamina a si d (incl. combinatii) vitamina d si analogi

União Europeia - romeno - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - beclometasone dipropionat, fumarat de formoterol dihidrat, bromura de glicopironiu - boala pulmonară, obstructivă cronică - medicamente pentru afecțiuni obstructive ale căilor respiratorii, - maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. copdmaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5. asthmamaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Romênia - romeno - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

hwi pharma services gmbh - germania - salmeterolum+fluticasonum - pulb. de inhal. unidoza - 50micrograme/100micrograme - adrenergice inhalante adrenergice si alte med. pt. trat. bolilor obstructive c.r