Unión Europea - lituano - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumabas - 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 - antinavikiniai vaistai - 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.

Unión Europea - lituano - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antinavikiniai vaistai - 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 ir 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%.

Lituania - lituano - SMCA (Valstybinė vaistų kontrolės tarnyba)

baxalta innovations gmbh - Žmogaus protrombino kompleksas (Žmogaus ii koaguliacijos faktorius/Žmogaus vii koaguliacijos faktorius/Žmogaus ix koaguliacijos faktorius/Žmogaus x koaguliacijos faktorius) - milteliai ir tirpiklis injekciniam tirpalui - 600 tv (450-850 tv/500 tv/600 tv/600 tv); 450-850 tv/500 tv/600 tv/600 tv; 480-900 tv/500 tv/600 tv/600 tv - coagulation factor ix, ii, vii and x in combination

Lituania - lituano - SMCA (Valstybinė vaistų kontrolės tarnyba)

pharmazeutische fabrik montavit ges.m.b.h - lidokaino hidrochloridas/chlorheksidino dihidrochloridas - šlaplės gelis - 20 mg/0,5 mg/g - lidocaine;other urologicals

Lituania - lituano - SMCA (Valstybinė vaistų kontrolės tarnyba)

walmark a.s. - melisų (melissa officinalis) lapų sausasis ekstraktas (4-6:1)/valerijonų (valerianae officinalis) šaknų sausasis alkoholinis ekstraktas (3-6:1)/pasiflorų (passiflora incarnata) žolės sausasis ekstraktas (5-7:1) - dengtos tabletės - 112,5 mg/125 mg/80 mg

Lituania - lituano - SMCA (Valstybinė vaistų kontrolės tarnyba)

b.braun melsungen ag - gliukozė, monohidratas/natrio-divandenilio fosfatas dihidratas/cinko acetatas dihidratas+trigliceridai, vidutinės grandinės/sojų aliejus, rafinuotas/omega-3 rūgščių trigliceridai+izoleucinas/leucinas/lizino hidrochloridas/metioninas/fenilalaninas/treoninas/triptofanas/valinas/argininas/histidino hidrochloridas monohidratas/alaninas/asparto rūgštis/glutamo rūgštis/glicinas/prolinas/serinas/natrio hidroksidas/natrio chloridas/natrio acetatas trihidratas/kalio acetatas/magnio acetatas tetrahidratas/kalcio chloridas dihidratas - infuzinė emulsija - 158,4 g/2,496 g/7,024 mg/1000 ml + 20 g/16 g/4 g/1000 ml + 3,284 g/4,384 g/3,98 g/2,736 g/4,916 g/2,54 g/0,8 g/3,604 g/3,78 g/2,368 g/6,792 g/2,1 g/4,908 g/2,312 g/4,76 g/4,2 g/1,171 g/0,378 g/0,25 g/3,689 g/0,91 g/0,623 g/1000 ml; 158,4 g/2,496 g/7,024 mg/1000 ml + 20 g/16 g/4 g/1000 ml + 3,284 g/4,384 g/3,98 g/2,736 g/4,916 g/2,54 g/0,8 g/3,604 g/3,78 g/2, - combinations

Lituania - lituano - SMCA (Valstybinė vaistų kontrolės tarnyba)

b.braun melsungen ag - gliukozė, monohidratas/natrio-divandenilio fosfatas dihidratas/cinko acetatas dihidratas+vidutinės grandinės trigliceridai/sojų aliejus, rafinuotas/omega-3 rūgščių trigliceridai+izoleucinas/leucinas/lizino hidrochloridas/metioninas/fenilalaninas/treoninas/triptofanas/valinas/argininas/histidino hidrochloridas monohidratas/alaninas/asparto rūgštis/glutamo rūgštis/glicinas/prolinas/serinas/natrio hidroksidas/natrio chloridas/natrio acetatas trihidratas/kalio acetatas/magnio acetatas tetrahidratas/kalcio chloridas dihidratas - infuzinė emulsija - 158,4 g/2,496 g/7,024 mg/1000 ml + 20 g/16 g/4 g/1000 ml + 3,284 g/4,384 g/3,98 g/2,736 g/4,916 g/2,54 g/0,8 g/3,604 g/3,78 g/2,368 g/6,792 g/2,1 g/4,908 g/2,312 g/4,76 g/4,2 g/1,171 g/0,378 g/0,25 g/3,689 g/0,91 g/0,623 g/1000 ml; 158,4 g/2,496 g/7,024 mg/1000 ml + 20 g/16 g/4 g/1000 ml + 3,284 g/4,384 g/3,98 g/2,736 g/4,916 g/2,54 g/0,8 g/3,604 g/3,78 g/2, - combinations

Lituania - lituano - SMCA (Valstybinė vaistų kontrolės tarnyba)

teva b.v. - diklofenako natrio druska/lidokaino hidrochloridas monohidratas - injekcinis tirpalas - 75 mg/20 mg/2 ml - diclofenac

Unión Europea - lituano - EMA (European Medicines Agency)

astrazeneca ab - andexanet alfa - su narkotikais susijusių Šalutinis poveikis, ir nepageidaujamos reakcijos - visi kiti gydomieji produktai - suaugusiems pacientams, gydytiems tiesioginis veiksnys xa (fxa) inhibitorius (apixaban ar rivaroxaban), kai atstatymas antikoaguliantais reikia dėl gyvybei ar nekontroliuojamas kraujavimas.

Lituania - lituano - SMCA (Valstybinė vaistų kontrolės tarnyba)

berlin-chemie ag (menarini group) - sulfametoksazolas/trimetoprimas - tabletės - 800 mg/160 mg - sulfamethoxazole and trimethoprim