Doxorubicin Teva

Medicinal product

(Invented) name

Doxorubicin Teva

Active substance (s)

Doksorubicinas

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

Teva Pharma B.V., Nyderlandai

Date of authorisation

2009-12-23

Date of renewal

2013-05-30

Documents

1812_1_4 Doxurubicin Teva konc inf PZ 180516.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/1403/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Doksorubicinas	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
30058	32527	1032527	flakonas	5 ml N1 (10 mg/5 ml)		Receptinis	LT/1/09/1812/001	Netiekiama	-	-	No	-	-
30059	32528	1032528	flakonas	10 ml N1 (20 mg/10 ml)		Receptinis	LT/1/09/1812/002	Netiekiama	-	-	No	-	-
30060	32529	1032529	flakonas	25 ml N1 (50 mg/25 ml)		Receptinis	LT/1/09/1812/003	Netiekiama	-	-	No	-	-
30061	32530	1032530	flakonas	100 ml N1 (200 mg/100 ml)		Receptinis	LT/1/09/1812/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-08	Išregistruotas
2013-05-30	Perregistruotas
2009-12-23	Registruotas