Sverige - svenska - Läkemedelsverket (Medical Products Agency)

zoetis animal health aps - clostridium tetanitoxoid; hästinfluensavirus a/equi 1/newmarket 77, inaktiverat antigen; hästinfluensavirus a/equi 2/borlänge 91, inaktiverat antigen; hästinfluensavirus a/equi 2/kentucky 98, inaktiverat antigen - injektionsvätska, suspension - hästinfluensavirus a/equi 1/newmarket 77, inaktiverat antigen 1,2 log10 hi aktiv substans; hästinfluensavirus a/equi 2/kentucky 98, inaktiverat antigen 2,4 log10 hi aktiv substans; hästinfluensavirus a/equi 2/borlänge 91, inaktiverat antigen 2,1 log10 hi aktiv substans; aluminiumfosfat 4,5 - 5,5 mg adjuvans; clostridium tetanitoxoid 140 ie aktiv substans - ekvint influensavirus + clostridium - häst

Europeiska unionen - svenska - EMA (European Medicines Agency)

gsk vaccines s.r.l. - yttre membranet blåsor från neisseria meningitidis grupp b (stam nz 98/254), rekombinant neisseria meningitidis grupp b fhbp fusion protein, rekombinant neisseria meningitidis grupp b nada protein, rekombinant neisseria meningitidis grupp b nhba fusion protein - meningit, meningokock - meningokockvacciner - aktiv immunisering mot invasiv sjukdom orsakad av neisseria meningitidis serogrupp-b-stammar.

Europeiska unionen - svenska - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multipel skleros - selektiva immunsuppressiva medel - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 och 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.

Europeiska unionen - svenska - 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) - denguefeber - vacciner - 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 och 4. användning av dengvaxia bör ske i enlighet med officiella rekommendationer.

Europeiska unionen - svenska - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunsuppressiva - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 och 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

gsk vaccines s.r.l. - neisseria meningitidis, serogrupp c, stam c11, oligosackarid - pulver och vätska till injektionsvätska, suspension i förfylld spruta - neisseria meningitidis, serogrupp c, stam c11, oligosackarid 10 mikrog aktiv substans; corynebacterium diphtheriae crm197 bärarprotein 12,5 - 25 mikrog konjugand; aluminiumoxid, hydratiserad adjuvans; mannitol hjälpämne - konjugerat renat polysackaridantigen

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

gsk vaccines s.r.l. - neisseria meningitidis, serogrupp c, stam c11, oligosackarid - injektionsvätska, suspension - 10 mikrogram - corynebacterium diphtheriae crm197 bärarprotein 12,5 - 25 mikrog konjugand; aluminiumoxid, hydratiserad adjuvans; neisseria meningitidis, serogrupp c, stam c11, oligosackarid 10 mikrog aktiv substans - vaccin mot meningokockinfektioner

Europeiska unionen - svenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - rotavirus serotyp g1, serotyp g2, serotyp g3, serotyp g4, serotyp p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq är indicerat för aktiv immunisering av spädbarn från sex veckors ålder till 32 veckor för förebyggande av gastroenterit på grund av rotavirusinfektion. rotateq är att användas på grundval av officiella rekommendationer.

Europeiska unionen - svenska - 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 - vacciner - aktiv immunisering för förebyggande av invasiv sjukdom, pneumoni och akut otitis media orsakad av streptococcus pneumoniae hos spädbarn, barn och ungdomar från 6 veckor till 17 år. aktiv immunisering för förebyggande av invasiv sjukdom orsakad av streptococcus pneumoniae hos vuxna ≥18 år och äldre. se avsnitt 4. 4 och 5. 1 för information om skydd mot specifika pneumokockserotyper. användningen av prevenar 13 skall bestämmas på grundval av officiella rekommendationer som tar hänsyn till risken för invasiv sjukdom i olika åldersgrupper, underliggande sjukdomstillstånd liksom variationen av serotyp epidemiologi i olika geografiska områden.

Europeiska unionen - svenska - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunsuppressiva - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.