Nonafact

Medicinal product

(Invented) name

Nonafact

Active substance (s)

Žmogaus IX koaguliacijos faktorius

Strength

100 TV/ml

Pharmaceutical form

milteliai ir tirpiklis injekciniam 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

Sanquin Plasma Products B.V., Nyderlandai

Date of authorisation

2001-07-03

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	1 ml
Žmogaus IX koaguliacijos faktorius	100 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
27137	29694	1029694	flakonas	milteliai ir tirpiklis (5 ml) N1		Receptinis	EU/1/01/186/001	Netiekiama	-	-	No	-	-
27138	29695	1029695	flakonas	milteliai ir tirpiklis (10 ml) N1		Receptinis	EU/1/01/186/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-15	Išregistruotas
2001-07-03	Registruotas