Zostavax

Medicinal product

(Invented) name

Zostavax

Active substance (s)

Oka/Merck padermės Varicella-zoster virusas

Strength

19400 PFV

Pharmaceutical form

milteliai ir tirpiklis injekcinei suspensijai

Route (s) of administration

leisti į raumenis, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J07BK02, Zoster, live attenuated

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2006-05-19

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for suspension for injection. After reconstitution, one dose (0.65 mL) contains:	0.65 ml
Oka/Merck padermės Varicella-zoster virusas	19400 PFV

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
29023	31534	1031534	flakonas	N1+N1		Receptinis	EU/1/06/341/001	Netiekiama	-	-	No	-	-
29024	31535	1031535	flakonas	N10+N10		Receptinis	EU/1/06/341/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-01	Išregistruotas
2006-05-19	Registruotas