Shingrix

Medicinal product

(Invented) name

Shingrix

Active substance (s)

Varicella zoster viruso glikoproteino E antigenas su adjuvantu AS01B

Strength

50 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)

J07BK03, Zoster, purified antigen

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

2018-03-21

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
Varicella zoster viruso glikoproteino E antigenas su adjuvantu AS01B	50 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
99170	85276	1085276	flakonas	N1 (milteliai (antigenas)+suspensija (adjuvantas))		Receptinis	EU/1/18/1272/001	Netiekiama	-	-	No	-	-
99171	85277	1085277	flakonas	N10 (milteliai (antigenas)+suspensija (adjuvantas))		Receptinis	EU/1/18/1272/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-21	Registruotas