Flebogamma DIF

Medicinal product

(Invented) name

Flebogamma DIF

Active substance (s)

Žmogaus normalusis imunoglobulinas, intraveninis

Strength

50 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J06BA02, Immunoglobulins, normal human, for intravascular adm.

Marketing authorisation holder

Instituto Grifols, S.A., Ispanija

Date of authorisation

2007-08-23

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

Solution for infusion	1 ml
Žmogaus normalusis imunoglobulinas, intraveninis	50 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
25815	28407	1028407	flakonas	10 ml, N1	Receptinis	EU/1/07/404/001	Netiekiama	-	-	No	-	-
25816	28408	1028408	flakonas	50 ml, N1	Receptinis	EU/1/07/404/002	Netiekiama	-	-	No	-	-
25817	28409	1028409	flakonas	100 ml, N1	Receptinis	EU/1/07/404/003	Netiekiama	-	-	No	-	-
25818	28410	1028410	flakonas	200 ml, N1	Receptinis	EU/1/07/404/004	Netiekiama	-	-	No	-	-
25819	28411	1028411	flakonas	400 ml, N1	Receptinis	EU/1/07/404/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-23	Registruotas