Prevenar (flakone)

Medicinal product

(Invented) name

Prevenar (flakone)

Active substance (s)

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

Strength

2 µg/4 µg/2 µg/2 µg/2 µg/2 µg/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 Limited, Jungtinė Karalystė

Date of authorisation

2001-02-02

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

suspension for injection	0.5 ml
4 serotipo pneumokokinis polisacharidas	2 µg
6B serotipo pneumokokinis polisacharidas	4 µg
9V serotipo pneumokokinis polisacharidas	2 µg
14 serotipo pneumokokinis polisacharidas	2 µg
18C serotipo pneumokokinis polisacharidas	2 µg
19F serotipo pneumokokinis polisacharidas	2 µg
23F serotipo pneumokokinis polisacharidas	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
2270	7899	1007899	flakonas	N1 x 0.5 ml	Receptinis	EU/1/00/167/001	Netiekiama	-	-	No	-	-
3028	8542	1008542	flakonas	N10 x 0.5 ml	Receptinis	EU/1/00/167/002	Netiekiama	-	-	No	-	-
27857	30399	1030399	flakonas	N1 +1 švirkštas ir 2 adatos x 0.5 ml	Receptinis	EU/1/00/167/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-14	Išregistruotas
2001-02-02	Registruotas