Gardasil

Medicinal product

(Invented) name

Gardasil

Active substance (s)

6-ojo tipo žmogaus papilomos viruso L1 baltymas/11-ojo tipo žmogaus papilomos viruso L1 baltymas/16-ojo tipo žmogaus papilomos viruso L1 baltymas/18-ojo tipo žmogaus papilomos viruso L1 baltymas

Strength

20 µg/40 µg/40 µg/20 µg

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BM01, Papillomavirus (human types 6, 11, 16, 18)

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2006-09-20

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
6-ojo tipo žmogaus papilomos viruso L1 baltymas	20 µg
11-ojo tipo žmogaus papilomos viruso L1 baltymas	40 µg
16-ojo tipo žmogaus papilomos viruso L1 baltymas	40 µg
18-ojo tipo žmogaus papilomos viruso L1 baltymas	20 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
109008	95114	1095114	flakonas	0,5 ml N1	Receptinis	EU/1/06/357/001	Netiekiama	-	-	No	-	-
109009	95115	1095115	flakonas	0,5 ml N10	Receptinis	EU/1/06/357/002	Netiekiama	-	-	No	-	-
109010	95116	1095116	flakonas	0,5 ml N20	Receptinis	EU/1/06/357/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-09-20	Registruotas