Cervarix

Medicinal product

(Invented) name

Cervarix

Active substance (s)

16-ojo tipo žmogaus papilomos viruso L1 baltymas/18-ojo tipo žmogaus papilomos viruso L1 baltymas/Pagalbinė (adjuvantine) medžiaga AS04, adsorbuota

Strength

20 µg/20 µg/50 µg

Pharmaceutical form

injekcinė suspensija flakone

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BM02, Papillomavirus (human types 16, 18)

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

2007-09-20

Date of renewal

Documents

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 a vial	0.5 ml
16-ojo tipo žmogaus papilomos viruso L1 baltymas	20 µg
18-ojo tipo žmogaus papilomos viruso L1 baltymas	20 µg
Pagalbinė (adjuvantine) medžiaga AS04, adsorbuota	50 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
109002	95108	1095108	flakonas	0,5 ml N1	Receptinis	EU/1/07/419/001	Netiekiama	-	-	No	-	-
109003	95109	1095109	flakonas	0,5 ml N10	Receptinis	EU/1/07/419/002	Netiekiama	-	-	No	-	-
109004	95110	1095110	flakonas	0,5 ml N100	Receptinis	EU/1/07/419/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-09-20	Registruotas