Ambirix

Medicinal product

(Invented) name

Ambirix

Active substance (s)

Hepatito A virusas (inaktyvuotas)/Hepatito B paviršinis antigenas

Strength

720 ELISA V/20 µg

Pharmaceutical form

injekcinė suspensija užpildytame švirkšte

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BC20, Combinations

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

2002-08-30

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

Suspension for injection in pre-filled syringe	1 ml
Hepatito A virusas (inaktyvuotas)	720 ELISA V
Hepatito B paviršinis antigenas	20 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
24714	27357	1027357	užpildytas švirkštas	1 ml (be adatos) N1	Receptinis	EU/1/02/224/001	Netiekiama	-	-	No	-	-
24715	27358	1027358	užpildytas švirkštas	1 ml (ir adata) N1	Receptinis	EU/1/02/224/002	Netiekiama	-	-	No	-	-
24716	27359	1027359	užpildytas švirkštas	1 ml (be adatų) N10	Receptinis	EU/1/02/224/003	Netiekiama	-	-	No	-	-
24717	27360	1027360	užpildytas švirkštas	1 ml ( ir 10 adatų) N10	Receptinis	EU/1/02/224/004	Netiekiama	-	-	No	-	-
24718	27361	1027361	užpildytas švirkštas	1 ml (be adatų) N50	Receptinis	EU/1/02/224/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-08-30	Registruotas