Union européenne - roumain - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomidă - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - imunosupresoare - mai multe myelomarevlimid ca monoterapie este indicat pentru tratamentul de întreținere al pacienților adulți diagnosticați recent cu mielom multiplu care au suferit transplantul de celule stem autologe. revlimid în asociere cu tratamentul cu dexametazona, sau bortezomib și dexametazonă, sau melfalan și prednison (a se vedea secțiunea 4. 2) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. revlimid în asociere cu dexametazona este indicat pentru tratamentul mielomului multiplu la pacienții adulți care au primit cel puțin un tratament anterior. mielodisplazice syndromesrevlimid cum este indicat în monoterapie pentru tratamentul pacienților adulți cu dependentă de transfuzie anemie din cauza scăzut sau intermediar-1-risc sindroame mielodisplazice asociat cu un izolat deleția 5q anomalii citogenetice, atunci când alte opțiuni terapeutice sunt insuficiente sau inadecvate. manta de celule lymphomarevlimid cum este indicat în monoterapie pentru tratamentul pacienților adulți cu recidivat sau refractar limfom de manta. folicular lymphomarevlimid în combinație cu rituximab (anti-cd20 anticorp) este indicat pentru tratamentul pacienților adulți tratați anterior cu limfom folicular (clasa 1 – 3a).

Union européenne - roumain - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - efavirenz - infecții cu hiv - antivirale pentru uz sistemic - sustiva este indicată în tratamentul combinat antiviral cu adulți, adolescenți și copii cu vârsta de trei ani și mai mari, infectați cu virusul-1 (hiv-1). sustiva nu a fost studiat în mod adecvat la pacienții cu boală hiv avansată, și anume în cazul pacienților cu cd4 < 50 celule/mm3, sau, după eșecul de protează-inhibitor (pi)-scheme terapeutice care conțin. deși rezistența încrucișată de efavirenz și ip nu a fost dovedită, în prezent sunt date insuficiente privind eficacitatea utilizării ulterioare a pi bazate pe o combinație de terapie, după eșecul terapeutic al regimurilor conținând sustiva.

Union européenne - roumain - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - agenți antineoplazici - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 și 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Union européenne - roumain - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - agenți antineoplazici - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Union européenne - roumain - EMA (European Medicines Agency)

bristol-myers squibb / pfizer eeig - apixaban - arthroplasty; venous thromboembolism - agenți antitrombotici - pentru eliquis 2. 5 mg comprimate filmate:prevenția evenimentelor tromboembolice venoase (etv) la pacienții adulți care au suferit electivă de înlocuire de șold sau de genunchi chirurgie. prevenirea de accident vascular cerebral și a emboliei sistemice la pacienți adulți cu fibrilație atrială non-valvulară (nvaf), cu unul sau mai mulți factori de risc, cum ar fi înainte de accident vascular cerebral sau atac ischemic tranzitor (ait); vârsta ≥ 75 ani; hipertensiune arterială; diabet zaharat; insuficiență cardiacă simptomatică (clasa nyha ≥ ii). tratamentul trombozei venoase profunde (tvp) și embolie pulmonară (ep), și prevenirea tvp și ep recurente la adulți (a se vedea secțiunea 4. 4 pentru haemodynamically instabil pe pacienți). pentru eliquis 5 mg comprimate filmate:prevenirea de accident vascular cerebral și a emboliei sistemice la pacienți adulți cu fibrilație atrială non-valvulară (nvaf), cu unul sau mai mulți factori de risc, cum ar fi înainte de accident vascular cerebral sau atac ischemic tranzitor (ait); vârsta≥ 75 ani; hipertensiune arterială; diabet zaharat; insuficiență cardiacă simptomatică (clasa nyha ≥ ii). tratamentul trombozei venoase profunde (tvp) și embolie pulmonară (ep), și prevenirea tvp și ep recurente la adulți (a se vedea secțiunea 4. 4 pentru haemodynamically instabil pe pacienți).

Roumanie - roumain - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

bristol-myers squibb srl - italia - mitotanum - compr. - 500mg - alte antineoplazice alte antineoplazice

Roumanie - roumain - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

bristol-myers squibb - franta - paracetamolum - compr. eff. - 500mg - alte analgezice si antipiretice anilide (inclusiv combinatii)

Roumanie - roumain - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

bristol-myers squibb - franta - acid ascorbicum - compr. eff. - 1g - acid ascorbic (vitamina c) (incl. combinatii) acid ascorbic (vitamina c)

Moldavie - roumain - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

bristol-myers squibb - doxylaminum - comprimate filmate - 15 mg

Roumanie - roumain - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

bristol myers squibb kft - didanosinum - caps. gastrorez. - 250mg - antivirale cu actiune directa inhib. nucleozidici si nucleotidici ai reverstranscriptazei