Havrix

Medicinal product

(Invented) name

Havrix

Active substance (s)

Hepatito A viruso antigenas (inaktyvuotas)

Strength

1440 ELISA V/ml

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J07BC02, Hepatitis A, inactivated, whole virus

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

1996-03-29

Date of renewal

2012-06-15

Documents

2979 Havrix RPP 2025 03 06.docx

2979 Pakuotės lapelis 1440 ELISA 2025 03 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

BE/H/0388/001/II/002

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Vienoje 1 ml dozėje (flakone arba užpildytame švirkšte) yra	1 ml
Hepatito A viruso antigenas (inaktyvuotas)	1440 ELISA V

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
52827	66762	1066762	užpildytas švirkštas	1 ml ir injekcinė adata N1		Receptinis	LT/1/96/2979/002	Tiekiama	-	-	No	-	-	Download
3403	8866	1008866	flakonas	1 ml N1		Receptinis	LT/1/96/2979/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-06-15	Perregistruotas
1996-03-29	Registruotas