Thiotepa Fresenius Kabi

Medicinal product

(Invented) name

Thiotepa Fresenius Kabi

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

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2023-04-18

Date of renewal

Documents

5169_5170 Pakuotės lapelis 2024 07 19.docx

5169_5170 Thiotepa Fresenius Kabi PCS PL 2024 07 19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/6942/002/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
110845	96956	1096956	flakonas	N1		Receptinis	LT/1/23/5170/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-04-18	Registruotas