Zostavax Unia Europejska - polski - EMA (European Medicines Agency)

zostavax

merck sharp & dohme b.v. - wirus ospy wietrznej-półpaśca (żywy, atenuowany) - herpes zoster; immunization - szczepionki wirusowe - zostavax jest wskazany w zapobieganiu półpasiec ("półpaśca" lub półpasiec) i neuralgii po opryszczce związanej z herpes-zoster. zostavax przedstawia do szczepień osób w wieku 50 lat i starsze.

Spikevax (previously COVID-19 Vaccine Moderna) Unia Europejska - polski - EMA (European Medicines Agency)

spikevax (previously covid-19 vaccine moderna)

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 - szczepionki - 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.

Qdenga Unia Europejska - polski - EMA (European Medicines Agency)

qdenga

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 - denga - szczepionki - 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.

Comirnaty Unia Europejska - polski - EMA (European Medicines Agency)

comirnaty

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna 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 - szczepionki - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. stosowanie tej szczepionki powinno odbywać się zgodnie z oficjalnymi zaleceniami.

Erysin Single Shot Inaktywowany szczep 2-64 Erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 RP *Inaktywowany szczep 2-5 Erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 RP *Inaktywowany szczep 2-II Erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 RP *Inaktywowany szczep 1-203 Erysipelothrix rhusiopathiae, serotyp 1a nie mniej niż 1 RP **) RP – miano względem standardu stosowanego w badaniach skuteczności szczepionki nadocelowych gatunkach zwierząt zgodnie z wymaganiami określonymi w monografiiFarmakopei Europejskiej Emulsja do wstrzykiwań Polska - polski - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

erysin single shot inaktywowany szczep 2-64 erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 rp *inaktywowany szczep 2-5 erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 rp *inaktywowany szczep 2-ii erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 rp *inaktywowany szczep 1-203 erysipelothrix rhusiopathiae, serotyp 1a nie mniej niż 1 rp **) rp – miano względem standardu stosowanego w badaniach skuteczności szczepionki nadocelowych gatunkach zwierząt zgodnie z wymaganiami określonymi w monografiifarmakopei europejskiej emulsja do wstrzykiwań

grabikowski-grabikowska przedsiębiorstwo produkcyjno-handlowo-usługowe „inex” spółka jawna - inaktywowany szczep 1-203erysipelothrix rhusinopathiae + inaktywowany szczep 2-ii erysipelothrix rhusinopathiae, + inaktywowany szczep 2-5 erysipelothrix rhusinopathiae, + inaktywowany szczep 2-64 erysipelothrix rhusinopathiae, serotyp 2a-nie mniej niż 1rp * - emulsja do wstrzykiwań - inaktywowany szczep 2-64 erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 rp *inaktywowany szczep 2-5 erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 rp *inaktywowany szczep 2-ii erysipelothrix rhusiopathiae, serotyp 2a nie mniej niż 1 rp *inaktywowany szczep 1-203 erysipelothrix rhusiopathiae, serotyp 1a nie mniej niż 1 rp **) rp – miano względem standardu stosowanego w badaniach skuteczności szczepionki nadocelowych gatunkach zwierząt zgodnie z wymaganiami określonymi w monografiifarmakopei europejskiej - świnia

Jyseleca Unia Europejska - polski - EMA (European Medicines Agency)

jyseleca

gilead sciences ireland uc, galapagos nv - filgotinib maleate - zapalenie stawów, reumatoidalne - leki immunosupresyjne - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

Fingolimod Mylan Unia Europejska - polski - EMA (European Medicines Agency)

fingolimod mylan

mylan ireland limited - fingolimod jest chlorowodorek - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 i 5. 1)orpatients z szybko rozwija się ciężka relapsing odpuszcza stwardnieniem rozsianym jest określona przez 2 lub więcej ciężkich nawrotów w ciągu jednego roku, i z 1 lub więcej gadolin aktywizacji ognisk w mri mózgu lub znaczny wzrost obciążenia t2 porażki w porównaniu z ostatnim mri.

Fingolimod Mylan Unia Europejska - polski - EMA (European Medicines Agency)

fingolimod mylan

mylan ireland limited - fingolimod jest chlorowodorek - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 i 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Foclivia Unia Europejska - polski - EMA (European Medicines Agency)

foclivia

seqirus s.r.l.  - antygeny powierzchniowe grypa wirus, inaktywowany: a/viet nam/1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - szczepionki przeciw grypie - profilaktyka grypy w oficjalnie ogłoszonej sytuacji pandemicznej. szczepionka przeciwko grypie pandemicznej powinna być stosowana zgodnie z oficjalnymi wskazówkami.