Epirubicin EBEWE

Medicinal product

(Invented) name

Epirubicin EBEWE

Active substance (s)

Epirubicinas

Strength

2 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, vartoti į šlapimo pūslę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01DB03, Epirubicin

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2001-08-29

Date of renewal

2007-11-30

Documents

0931_1_4 Pakuotės lapelis 180928.docx

0931_1_4 Epirubicin EBEWE inj_inf RPP 180928.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo	1 ml
Epirubicinas	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
2822	8370	1008370	flakonas	5ml, N1		Receptinis	LT/1/01/0931/001	Netiekiama	-	-	No	-	-	Download
26088	28677	1028677	flakonas	25 ml, N1		Receptinis	LT/1/01/0931/002	Netiekiama	-	-	No	-	-
26089	28678	1028678	flakonas	50 ml, N1		Receptinis	LT/1/01/0931/003	Netiekiama	-	-	No	-	-
26090	28679	1028679	flakonas	100 ml, N1		Receptinis	LT/1/01/0931/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-07	Išregistruotas
2007-11-30	Perregistruotas
2001-08-29	Registruotas