Synflorix

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Medicinal product

Synflorix

1 serotipo pneumokokinis polisacharidas/4 serotipo pneumokokinis polisacharidas/5 serotipo pneumokokinis polisacharidas/6B serotipo pneumokokinis polisacharidas/7F serotipo pneumokokinis polisacharidas/9V serotipo pneumokokinis polisacharidas/14 serotipo pneumokokinis polisacharidas/18C serotipo pneumokokinis polisacharidas/19F serotipo pneumokokinis polisacharidas/23F serotipo pneumokokinis polisacharidas

1 µg/3 µg/1 µg/1 µg/1 µg/1 µg/1 µg/3 µg/3 µg/1 µg

injekcinė suspensija

leisti į raumenis

Receptinis

No

J07AL52, Pneumococcus purified polysaccharides antigen and Haemophilus influenzae, conjugated

GlaxoSmithKline Biologicals s.a., Belgija

2009-03-30

Registruotas

No

8(3)

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection 0.5 ml
1 serotipo pneumokokinis polisacharidas 1 µg
4 serotipo pneumokokinis polisacharidas 3 µg
5 serotipo pneumokokinis polisacharidas 1 µg
6B serotipo pneumokokinis polisacharidas 1 µg
7F serotipo pneumokokinis polisacharidas 1 µg
9V serotipo pneumokokinis polisacharidas 1 µg
14 serotipo pneumokokinis polisacharidas 1 µg
18C serotipo pneumokokinis polisacharidas 3 µg
19F serotipo pneumokokinis polisacharidas 3 µg
23F serotipo pneumokokinis polisacharidas 1 µg

Packages

PAKID NPAKID NPAKID-7 Pack type Pack size Type of packaging Proposed dispensing/classification Marketing authorisation no. Supply status From To Package is in foreign language From To Mock-up
98396 84499 1084499 flakonas 0,5 ml N1 Receptinis EU/1/09/508/006 Netiekiama - - No - -
98397 84500 1084500 flakonas 0,5 ml N10 Receptinis EU/1/09/508/007 Netiekiama - - No - -
98398 84501 1084501 flakonas 0,5 ml N100 Receptinis EU/1/09/508/008 Netiekiama - - No - -

Stadijos

Data Stadija
2009-03-30 Registruotas