BCG Vaccine AJV

Medicinal product

(Invented) name

BCG Vaccine AJV

Active substance (s)

Mycobacterium bovis (BCG) daniškasis kamienas 1331 (gyvas, susilpnintas)

Strength

2-8x10(6) KSV

Pharmaceutical form

milteliai ir tirpiklis injekcinei suspensijai

Route (s) of administration

leisti į odą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07AN01, Tuberculosis, live attenuated

Marketing authorisation holder

AJ Vaccines A/S, Danija

Date of authorisation

1996-03-29

Date of renewal

2011-06-15

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml paruoštos vakcinos yra	1 ml
Mycobacterium bovis (BCG) daniškasis kamienas 1331 (gyvas, susilpnintas)	2-8x10(6) KSV

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
47114	60926	1060926	flakonas	milteliai ir tirpiklio flakonas (1 ml) N1		Receptinis	LT/1/96/2510/001	Netiekiama	-	-	No	-	-
9262	13929	1013929	flakonas	milteliai ir tirpiklio flakonas (1 ml) N10		Receptinis	LT/1/96/2510/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-06-15	Perregistruotas
1996-03-29	Registruotas