Arexvy

Medicinal product

(Invented) name

Arexvy

Active substance (s)

Respiracinio sincitinio viruso rekombinantinio glikoproteino F, stabilizuoto priešfuzinėje konformacijoje, su AS01E adjuvantu

Strength

120 µg

Pharmaceutical form

milteliai ir suspensija injekcinei suspensijai

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BX05, respiratory syncytial virus vaccines

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

2023-06-06

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

After reconstitution, 1 dose (0.5 mL) contains	0.5 ml
Respiracinio sincitinio viruso rekombinantinio glikoproteino F, stabilizuoto priešfuzinėje konformacijoje, su AS01E adjuvantu	120 µg

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
111135	97246	1097246	flakonas	N1 (milteliai (antigenas) ir suspensija (adjuvantas))		Receptinis	EU/1/23/1740/001	Netiekiama	-	-	No	-	-
111136	97247	1097247	flakonas	N10 (milteliai (antigenas) ir suspensija (adjuvantas))		Receptinis	EU/1/23/1740/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-06	Registruotas