Synflorix

Medicinal product

(Invented) name

Synflorix

Active substance (s)

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

Strength

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

Pharmaceutical form

injekcinė suspensija užpildytame švirkšte

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07AL52, Pneumococcus purified polysaccharides antigen and Haemophilus influenzae, conjugated

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

2009-03-30

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 in pre-filled syringe	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	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
34774	37115	1037115	užpildytas švirkštas	0.5 ml N1	Receptinis	EU/1/09/508/001	Netiekiama	-	-	No	-	-
34775	37116	1037116	užpildytas švirkštas	0.5 ml N10	Receptinis	EU/1/09/508/002	Netiekiama	-	-	No	-	-
34776	37117	1037117	užpildytas švirkštas	0.5 ml N1 ( + 1 adata)	Receptinis	EU/1/09/508/003	Tiekiama	-	-	No	-	-
34777	37118	1037118	užpildytas švirkštas	0.5 ml N10 (+10 adatų)	Receptinis	EU/1/09/508/004	Netiekiama	-	-	No	-	-
34778	37119	1037119	užpildytas švirkštas	0.5 ml N1 (+ 2 adatos)	Receptinis	EU/1/09/508/005	Netiekiama	-	-	No	-	-
47378	61194	1061194	užpildytas švirkštas	0,5 ml N50	Receptinis	EU/1/09/508/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-03-30	Registruotas