Arsenic trioxide Accord

Medicinal product

(Invented) name

Arsenic trioxide Accord

Active substance (s)

Arseno trioksidas

Strength

1 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XX27, Arsenic trioxide

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2019-11-14

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Arseno trioksidas	1 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
102867	88968	1088968	flakonas	10 ml N1		Receptinis	EU/1/19/1398/001	Netiekiama	-	-	No	-	-
102868	88969	1088969	flakonas	10 ml N5		Receptinis	EU/1/19/1398/002	Netiekiama	-	-	No	-	-
102869	88970	1088970	flakonas	10 ml N10		Receptinis	EU/1/19/1398/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-14	Registruotas