CEVENFACTA

Medicinal product

(Invented) name

CEVENFACTA

Active substance (s)

Eptakogas beta (aktyvintas)

Strength

5 mg (225 KTV)

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B02BD08, Coagulation factor VIIa

Marketing authorisation holder

Laboratoire Français du Fractionnement et des Biotechnologies, Prancūzija

Date of authorisation

2022-07-15

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

Powder and solvent for solution for injection	1 vnt.
Eptakogas beta (aktyvintas)	5 mg (225 KTV)

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
109302	95408	1095408	flakonas	N1 (milteliai, sterilaus tirpiklio švirkštas, stūmoklio strypas, flakono adapteris)		Receptinis	EU/1/22/1664/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-15	Registruotas