Arsenic trioxide Mylan

Medicinal product

(Invented) name

Arsenic trioxide Mylan

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

Mylan Ireland Limited, Airija

Date of authorisation

2020-04-01

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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
103742	89844	1089844	flakonas	10 ml N1		Receptinis	EU/1/20/1427/001	Netiekiama	-	-	No	-	-
103743	89845	1089845	flakonas	10 ml N10		Receptinis	EU/1/20/1427/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-14	Išregistruotas
2020-04-01	Registruotas