Rotarix

Medicinal product

(Invented) name

Rotarix

Active substance (s)

RIX4414 padermės žmogaus rotavirusas

Strength

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

Pharmaceutical form

geriamoji suspensija

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

Oral suspension in multi-monodose (5 single dose) squeezable tube presentation connected by a bar	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
99987	86095	1086095	tūbelė	N50 (10×5 dozės)		Receptinis	EU/1/05/330/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-02-21	Registruotas