Etoposide Accord

Medicinal product

(Invented) name

Etoposide Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2014-08-01

Date of renewal

2019-11-11

Documents

3602 Pakuotės lapelis 2024 10 16.docx

3602 Etoposide Accord II PL 2024 10 16.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1330/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo 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
55273	69320	1069320	flakonas	5 ml N1		Receptinis	LT/1/14/3602/001	Tiekiama	-	-	No	-	-
59720	73954	1073954	flakonas	12,5 ml N1		Receptinis	LT/1/14/3602/002	Netiekiama	-	-	No	-	-
62018	76391	1076391	flakonas	10 ml N1		Receptinis	LT/1/14/3602/003	Netiekiama	-	-	No	-	-
62019	76392	1076392	flakonas	20 ml N1		Receptinis	LT/1/14/3602/004	Netiekiama	-	-	No	-	-
62020	76393	1076393	flakonas	25 ml N1		Receptinis	LT/1/14/3602/005	Netiekiama	-	-	No	-	-
62021	76394	1076394	flakonas	50 ml N1		Receptinis	LT/1/14/3602/006	Netiekiama	2024-12-16	-	No	-	-

Stadijos

Data	Stadija
2019-11-11	Perregistruotas
2014-08-01	Registruotas