ACT-HIB

Medicinal product

(Invented) name

ACT-HIB

Active substance (s)

b tipo Haemophilus influenzae polisacharidas, konjuguotas su stabligės baltymu

Strength

10 µg/0,5 ml

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į raumenis, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07AG01, Hemophilus influenzae B, purified antigen conjugated

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2025-06-30

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Vardinis/ASPĮ

Qualitative and quantitative composition

0,5 ml yra	0.5 ml
b tipo Haemophilus influenzae polisacharidas, konjuguotas su stabligės baltymu	10 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
117879	103984	1103984	buteliukas	N1 (+užpildytas švirkštas)		Receptinis		Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-30	Registruotas