Arsenic trioxide Tillomed

Medicinal product

(Invented) name

Arsenic trioxide Tillomed

Active substance (s)

Arseno trioksidas

Strength

2 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

Tillomed Malta Limited, Malta

Date of authorisation

2025-10-31

Date of renewal

Documents

5876_Arsenic trioxide Tillomed.docx

5876_pakuotes lapelis_2025-10-31.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/7925/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Arseno trioksidas	2 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
118992	105098	1105098	flakonas	6 ml N1		Receptinis	LT/1/25/5876/001	Netiekiama	-	-	No	-	-
118993	105099	1105099	flakonas	6 ml N10		Receptinis	LT/1/25/5876/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-10-31	Registruotas