BCG vaccin SSI

Medicinal product

(Invented) name

BCG vaccin SSI

Active substance (s)

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

Strength

2-8x10(6) KSV/ml

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

UAB Adeofarma, Lietuva

Date of authorisation

2020-01-22

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

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

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
103105	89206	1089206	flakonas	milteliai ir tirpiklio flakonas (1 ml) N1	ASPĮ	Receptinis	LT/L/20/1178/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2020-01-22	Registruotas