SIILTIBCY

Medicinal product

(Invented) name

SIILTIBCY

Active substance (s)

Mycobacterium tuberculosis išvestinis antigenas rdESAT-6/Mycobacterium tuberculosis išvestinis antigenas rCFP-10

Strength

0,5 µg/0,5 µg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į odą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

Nesuteiktas, Netaikoma ar nesuteiktas

Marketing authorisation holder

Serum Life Science Europe GmbH, Vokietija

Date of authorisation

2025-01-13

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

1 injekcinio tirpalo yra:	1 ml
Mycobacterium tuberculosis išvestinis antigenas rdESAT-6	0,5 µg
Mycobacterium tuberculosis išvestinis antigenas rCFP-10	0,5 µg

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
116400	102501	1102501	flakonas	0,1 ml N1 (10 dozių)		Receptinis	EU/1/24/1882/001	Netiekiama	-	-	No	-	-
116401	102502	1102502	flakonas	0,1 ml N10 (10×1) (100 dozių)		Receptinis	EU/1/24/1882/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-13	Registruotas