Prevenar 13 (vienadoziame flakone)

Medicinal product

(Invented) name

Active substance (s)

1 serotipo pneumokokinis polisacharidas/3 serotipo pneumokokinis polisacharidas/4 serotipo pneumokokinis polisacharidas/5 serotipo pneumokokinis polisacharidas/6A serotipo pneumokokinis polisacharidas/6B serotipo pneumokokinis polisacharidas/7F serotipo pneumokokinis polisacharidas/9V serotipo pneumokokinis polisacharidas/14 serotipo pneumokokinis polisacharidas/18C serotipo pneumokokinis polisacharidas/19A serotipo pneumokokinis polisacharidas/19F serotipo pneumokokinis polisacharidas/23F serotipo pneumokokinis polisacharidas

Strength

2,2 µg/2,2 µg/2,2 µg/2,2 µg/2,2 µg/4,4 µg/2,2 µg/2,2 µg/2,2 µg/2,2 µg/2,2 µg/2,2 µg/2,2 µg/0,5 ml

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07AL02, Pneumococcus, purified polysaccharides antigen conjugated

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2009-12-09

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection	0.5 ml
1 serotipo pneumokokinis polisacharidas	2,2 µg
3 serotipo pneumokokinis polisacharidas	2,2 µg
4 serotipo pneumokokinis polisacharidas	2,2 µg
5 serotipo pneumokokinis polisacharidas	2,2 µg
6A serotipo pneumokokinis polisacharidas	2,2 µg
6B serotipo pneumokokinis polisacharidas	4,4 µg
7F serotipo pneumokokinis polisacharidas	2,2 µg
9V serotipo pneumokokinis polisacharidas	2,2 µg
14 serotipo pneumokokinis polisacharidas	2,2 µg
18C serotipo pneumokokinis polisacharidas	2,2 µg
19A serotipo pneumokokinis polisacharidas	2,2 µg
19F serotipo pneumokokinis polisacharidas	2,2 µg
23F serotipo pneumokokinis polisacharidas	2,2 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
58043	72166	1072166	flakonas	0,5 ml N1	Receptinis	EU/1/09/590/007	Netiekiama	-	-	No	-	-
58044	72167	1072167	flakonas	0,5 ml N5	Receptinis	EU/1/09/590/008	Netiekiama	-	-	No	-	-
58045	72168	1072168	flakonas	0,5 ml N10	Receptinis	EU/1/09/590/009	Netiekiama	-	-	No	-	-
58046	72169	1072169	flakonas	0,5 ml N25	Receptinis	EU/1/09/590/010	Netiekiama	-	-	No	-	-
58047	72170	1072170	flakonas	0,5 ml N50	Receptinis	EU/1/09/590/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-09	Registruotas