Doxorubicin Actavis

Medicinal product

(Invented) name

Doxorubicin Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2012-03-15

Date of renewal

2016-04-04

Documents

2848_1_8 Doxorubicin Actavis konc inf PCS PL 200917.docx

2848_1_8 Pakuotės lapelis 200917.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0119/001

Marketing authorisation procedure

Decentralizuota 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
44120	57910	1057910	flakonas	5 ml N1		Receptinis	LT/1/12/2848/001	Netiekiama	-	-	No	-	-
51661	65557	1065557	flakonas	5 ml N10		Receptinis	LT/1/12/2848/002	Netiekiama	-	-	No	-	-
44121	57911	1057911	flakonas	10 ml N1		Receptinis	LT/1/12/2848/003	Netiekiama	-	-	No	-	-
51662	65558	1065558	flakonas	10 ml N10		Receptinis	LT/1/12/2848/004	Netiekiama	-	-	No	-	-
44122	57912	1057912	flakonas	25 ml N1		Receptinis	LT/1/12/2848/005	Netiekiama	-	-	No	-	-	Download
44123	57913	1057913	flakonas	50 ml N1		Receptinis	LT/1/12/2848/006	Netiekiama	-	-	No	-	-
44124	57914	1057914	flakonas	75 ml N1		Receptinis	LT/1/12/2848/007	Netiekiama	-	-	No	-	-
44125	57915	1057915	flakonas	100 ml N1		Receptinis	LT/1/12/2848/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-31	Išregistruotas
2016-04-04	Perregistruotas
2012-03-15	Registruotas