octanine

Medicinal product

(Invented) name

octanine

Active substance (s)

Žmogaus IX koaguliacijos faktorius

Strength

500 TV

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

Octapharma (IP) SPRL, Belgija

Date of authorisation

2010-07-15

Date of renewal

2015-01-27

Documents

2098 Pakuotės lapelis 2025 05 02.docx

2098 octanine RPP 2025 05 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0213/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Viename flakone yra	1 vnt.
Žmogaus IX koaguliacijos faktorius	500 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
38292	5619	1005619	flakonas	milteliai, tirpiklio flakonas (5 ml), injekcinis švirkštas, sujungimo rinkinys, infuzinis rinkinys, 2 alkoholiu suvilgyti tamponai N1		Receptinis	LT/1/10/2098/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-27	Perregistruotas
2010-07-15	Registruotas