Ondexxya

Medicinal product

(Invented) name

Ondexxya

Active substance (s)

Andeksanetas alfa

Strength

200 mg

Pharmaceutical form

milteliai infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V03AB38, Andexanet alfa

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2019-04-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for solution for infusion	1 vnt.
Andeksanetas alfa	200 mg

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
101561	87664	1087664	flakonas	N4		Receptinis	EU/1/18/1345/001	Netiekiama	-	-	No	-	-
111063	97174	1097174	flakonas	N5		Receptinis	EU/1/18/1345/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-26	Registruotas