Европейски съюз - български - 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 - Антинеопластични средства - 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.

Европейски съюз - български - EMA (European Medicines Agency)

takeda gmbh - dengue virus, serotype 2, expressing dengue virus, serotype 1, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 3, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 4, surface proteins, live, attenuated, dengue virus, serotype 2, live, attenuated - Денга - Ваксини - qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. the use of qdenga should be in accordance with official recommendations.

Европейски съюз - български - EMA (European Medicines Agency)

sanofi pasteur - influenza a virus subtype h1n1 haemagglutinin, recombinant, influenza a virus subtype h3n2 haemagglutinin, recombinant, influenza b virus victoria lineage haemagglutinin, recombinant, influenza b virus yamagata lineage haemagglutinin, recombinant - Грип, Човек - Ваксини - supemtek is indicated for active immunization for the prevention of influenza disease in adults. supemtek should be used in accordance with official recommendations.

Европейски съюз - български - EMA (European Medicines Agency)

merck sharp & dohme b.v. - човешка папиломавирусна ваксина [видове 6, 11, 16, 18, 31, 33, 45, 52, 58] (рекомбинантна, адсорбирана) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - Ваксина срещу папилломавируса - Гардасил 9 е показан за активна имунизация на хора на възраст от 9 години срещу hpv следните заболявания:на преканцерозни лезии и рак, които засягат шийката на матката, вульву, влагалището и ануса, причинени от ваксината срещу hpv typesgenital кондиломи (брадавици брадавици), причинени от определени типове hpv. Вижте раздели 4. 4 и 5. 1, за получаване на важна информация относно данните, които подкрепят тези показания. Използването на Гардасила 9 трябва да бъдат в съответствие с официалните препоръки.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f - pneumococcal infections; immunization - Ваксини - Активна имунизация за предотвратяване на инвазивни заболявания, пневмония и остър отит на средното ухо, причинени от streptococcus pneumoniae при бебета, деца и юноши от 6 седмици до 17 годишна възраст. Активна имунизация за профилактика на инвазивни заболявания, причинени от streptococcus pneumoniae при възрастни ≥18 години и по-възрастни хора. Вижте раздели 4. 4 и 5. 1 за информация относно защитата срещу специфични пневмококови серотипове. Използването на Превенар 13 трябва да се определи въз основа на официални препоръки, като се вземе предвид рискът от инвазивни заболявания в различните възрастови групи, в основата на съпътстващи заболявания, както и вариабельность серотипа на епидемиологията в различни географски райони.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 8, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 10a, pneumococcal polysaccharide serotype 11a, pneumococcal polysaccharide serotype 12f, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 15b, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 22f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 33f - Пневмококови инфекции - Ваксини - active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. Вижте раздели 4. 4 и 5. 1 за информация относно защитата срещу специфични пневмококови серотипове. apexxnar should be used in accordance with official recommendations. .

Европейски съюз - български - EMA (European Medicines Agency)

sanofi pasteur - chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated) - Денга - Ваксини - dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4. 2, 4. 4 и 4. Използването на dengvaxia трябва да бъде в съответствие с официалните препоръки.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer europe ma eeig - respiratory syncytial virus, subgroup a, stabilized prefusion f protein / respiratory syncytial virus, subgroup b, stabilized prefusion f protein - Инфекции на респираторния синцитиален вирус - Ваксини - abrysvo is indicated for:passive protection against lower respiratory tract disease caused by respiratory syncytial virus (rsv) in infants from birth through 6 months of age following maternal immunisation during pregnancy. Вижте раздели 4. 2 и 5. active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by rsv. Използването на тази ваксина трябва да бъде приложена в съответствие с официалните препоръки.

Европейски съюз - български - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - Ваксини - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Европейски съюз - български - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - Пневмококови инфекции - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. Вижте раздели 4. 4 и 5. 1 за информация относно защитата срещу специфични пневмококови серотипове. the use of vaxneuvance should be in accordance with official recommendations.