Doxorubicin EBEWE

Medicinal product

(Invented) name

Doxorubicin EBEWE

Active substance (s)

Doksorubicino hidrochloridas

Strength

2 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną, vartoti į šlapimo pūslę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01DB01, Doxorubicin

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

1995-10-04

Date of renewal

2007-01-12

Documents

0631 Doxorubicin EBEWE konc inf PCS PL 2023 08 08.docx

0631 Pakuotės lapelis 2023 08 08.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Doksorubicino hidrochloridas	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
18621	661	1000661	flakonas	5 ml N1		Receptinis	LT/1/95/0631/001	Tiekiama	2025-01-09	-	No	-	-	Download
18622	660	1000660	flakonas	25 ml N1		Receptinis	LT/1/95/0631/002	Tiekiama	2025-01-09	-	No	-	-

Stadijos

Data	Stadija
2007-01-12	Perregistruotas
1995-10-04	Registruotas