IMMUNINE

Medicinal product

(Invented) name

IMMUNINE

Active substance (s)

Žmogaus IX koaguliacijos faktorius

Strength

1200 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BD04, Coagulation factor IX

Marketing authorisation holder

Baxalta Innovations GmbH, Austrija

Date of authorisation

2008-01-25

Date of renewal

2011-12-16

Documents

0992 IMMUNINE 1200TV PCS PL 2022 08 04.docx

0992 Pakuotės lapelis 1200TV 2022 08 04.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

AT/H/0177/003/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Žmogaus IX koaguliacijos faktorius	1200 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
23015	4897	1004897	flakonas	milteliai, flakonas tirpiklio (10 ml), perpylimo adata, aeracijos adata, filtravimo adata, vienkartinė adata, vienkartinis švirkštas (10 ml) ir rinkinys infuzijai N1		Receptinis	LT/1/08/0992/003	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2011-12-16	Perregistruotas
2008-01-25	Registruotas