Etoposide Kabi

Medicinal product

(Invented) name

Etoposide Kabi

Active substance (s)

Etopozidas

Strength

20 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)

L01CB01, Etoposide

Marketing authorisation holder

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

Date of authorisation

2014-05-26

Date of renewal

2019-09-12

Documents

3565 Etoposide Kabi PCS PL 2024 01 05.docx

3565 Pakuotės lapelis 2024 01 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2469/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Etopozidas	20 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
49004	62870	1062870	flakonas	5 ml N1		Receptinis	LT/1/14/3565/001	Netiekiama	-	-	No	-	-	Download
49005	62871	1062871	flakonas	10 ml N1		Receptinis	LT/1/14/3565/002	Netiekiama	-	-	No	-	-
49006	62872	1062872	flakonas	25 ml N1		Receptinis	LT/1/14/3565/003	Netiekiama	-	-	No	-	-
49007	62873	1062873	flakonas	50 ml N1		Receptinis	LT/1/14/3565/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-12	Perregistruotas
2014-05-26	Registruotas