Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

pharmathen s.a. - ibandrono rūgštis - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - narkotikai kaulų ligų gydymui - concentrate for solution for infusion prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. gydymo auglio sukeltas hypercalcaemia su arba be metastazių. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Europos Sąjunga - lietuvių - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - padalintas gripo virusas, inaktyvuotas, turintis antigeną: naudojamas a / vietnam / 1194/2004 (h5n1) padermis (nibrg-14) - influenza, human; immunization; disease outbreaks - vakcinos - imunizacijai nuo h5n1 potipio gripo virusas. Ši nuoroda yra pagrįstas immunogenicity duomenis iš sveikų žmonių nuo 18 metų amžiaus ir vėliau, po administracijos dviejų vakcinos dozių, pagamintus iš/vietnamas/1194/2004 nibrg-14 (h5n1) (žr. skyrių 5. prepandemic gripo vakcina (h5n1) (split virion, inaktyvuota, adjuvanted) glaxosmithkline biologinių 3. 75 µg turėtų būti naudojami laikantis oficialių rekomendacijų.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - padalintas gripo virusas, inaktyvuotas, turintis antigeną: naudojamas a / vietnam / 1194/2004 (h5n1) padermis (nibrg-14) - influenza, human; immunization; disease outbreaks - vakcinos - gripo profilaktika oficialiai paskelbtoje pandemijos situacijoje. pandeminio gripo vakcina turi būti vartojama laikantis oficialių nurodymų.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split gripo viruso, inaktyvuota, turintys antigenų*: a/california/7/2009 (h1n1)v, kaip padermė (x-179a)*padauginti kiaušiniai. - influenza, human; immunization; disease outbreaks - gripo vakcinos - gripo profilaktika oficialiai paskelbtoje pandemijos situacijoje. pandeminio gripo vakcina turi būti vartojama laikantis oficialių nurodymų.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - visą virion, inaktyvuota, turintys antigenų*: a/vietnam/1194/2004 (h5n1)* pagaminti kiaušiniai - influenza, human; immunization; disease outbreaks - vakcinos - gripo profilaktika oficialiai paskelbtoje pandemijos situacijoje. pandeminio gripo vakcina turi būti vartojama laikantis oficialių nurodymų.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - vakcinos - infanrix penta yra skiriamas pradinei ir revakcinacijai kūdikiams nuo difterijos, stabligės, kokliušo, hepatito b ir poliomielito.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - vakcinos - twinrix pediatric skirtas vartoti ne imuniniams kūdikiams, vaikams ir paaugliams nuo vienerių iki 15 metų imtinai, kuriems yra hepatito a ir hepatito b infekcijos pavojus..

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - pandeminio gripo vakcina (h5n1) (split virion, inaktyvuota, adjuvanted) - influenza, human; immunization; disease outbreaks - vakcinos - gripo profilaktika oficialiai paskelbtoje pandemijos situacijoje. pandemija-gripo vakcina turi būti naudojama laikantis oficialių rekomendacijų.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - difterija toxoid, stabligės toxoid, inaktyvuotų bordetella pertussis, hepatito b paviršiaus antigeno (rdna), haemophilus influenzae b tipo polisacharido - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; diphtheria - vakcinos - quintanrix yra skirtas pirminės vakcinacijos kūdikiams (per pirmaisiais gyvenimo metais) nuo difterijos, stabligės, kokliušo, hepatito b ir invazinė liga, kurią sukelia b tipo haemophilus influenzae ir stiprintuvas imunizuoti, mažiems vaikams per į antraisiais gyvenimo metais. naudoti quintanrix turėtų būti nustatoma remiantis oficialiomis rekomendacijomis.