IMOGAM RABIES

Medicinal product

(Invented) name

IMOGAM RABIES

Active substance (s)

Žmogaus pasiutligės imunoglobulinas

Strength

>=150 TV/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BB05, Rabies immunoglobulin

Marketing authorisation holder

Sanofi Pasteur, Prancūzija

Date of authorisation

1997-10-01

Date of renewal

2013-05-07

Documents

3291 Pakuotės lapelis 2022 01 01.docx

3291 IMOGAM RABIES inj PL 2022 01 01_VRA 22021.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Žmogaus pasiutligės imunoglobulinas	>=150 TV

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
11504	15958	1015958	flakonas	2 ml N1		Receptinis	LT/1/97/3291/001	Netiekiama	-	-	No	-	-	Download
56150	70233	1070233	flakonas	10 ml N1		Receptinis	LT/1/97/3291/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-31	Išregistruotas
2013-05-07	Perregistruotas
1997-10-01	Registruotas