Rotarix

Medicinal product

(Invented) name

Rotarix

Active substance (s)

RIX4414 padermės žmogaus rotavirusas

Strength

>=10(x6,0) CCID(50)

Pharmaceutical form

geriamoji suspensija užpildytame geriamajame aplikatoriuje

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J07BH01, Rota virus, live attenuated

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

2006-02-21

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 dozėje (1,5 ml) yra:	1.5 ml
RIX4414 padermės žmogaus rotavirusas	>=10(x6,0) CCID(50)

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
42797	56565	1056565	aplikatorius	N1		Receptinis	EU/1/05/330/005	Netiekiama	-	-	No	-	-
42798	56566	1056566	aplikatorius	N5		Receptinis	EU/1/05/330/006	Netiekiama	-	-	No	-	-
42799	56567	1056567	aplikatorius	N10		Receptinis	EU/1/05/330/007	Netiekiama	-	-	No	-	-
42800	56568	1056568	aplikatorius	N25		Receptinis	EU/1/05/330/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-02-21	Registruotas