Octanate

Medicinal product

(Invented) name

Octanate

Active substance (s)

Žmogaus VIII 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)

B02BD02, Coagulation factor VIII

Marketing authorisation holder

Octapharma (IP) SPRL, Belgija

Date of authorisation

2014-11-10

Date of renewal

2022-10-24

Documents

0261 Octanate 100TV, 200TV RPP 2025 04 01.docx

0261 Pakuotės lapelis 100TV, 200TV 2025 04 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1070/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Vaistiniame preparate, ištirpintame 5 ml tirpiklio, yra maždaug	1 ml
Žmogaus VIII 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
58234	72376	1072376	flakonas	milteliai (500 TV), tirpiklio flakonas (5 ml), vienkartinis švirkštas, sujungimo rinkinys, infuzinis rinkinys ir 2 alkoholiu suvilgyti tamponai N1		Receptinis	LT/1/05/0261/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-24	Perregistruotas
2014-11-10	Registruotas