Thiotepa MSN

Medicinal product

(Invented) name

Thiotepa MSN

Active substance (s)

Tiotepa

Strength

100 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AC01, Thiotepa

Marketing authorisation holder

MSN Labs Europe Limited, Malta

Date of authorisation

2025-08-21

Date of renewal

Documents

5834-35_pakuotes lapelis_2025-08-21.docx

5834-5835_Thiotepa MSN.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/8013/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Tiotepa	100 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
118391	104497	1104497	flakonas	N1		Receptinis	LT/1/25/5835/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-21	Registruotas