Epirubicin Actavis

Medicinal product

(Invented) name

Epirubicin Actavis

Active substance (s)

Epirubicino hidrochloridas

Strength

2 mg/ml

Pharmaceutical form

injekcinis 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

Actavis Group PTC ehf., Islandija

Date of authorisation

2008-01-25

Date of renewal

2013-07-11

Documents

0990_1_5 Epirubicin Actavis inj RPP 200813.docx

0990_1_5 Pakuotės lapelis 200813.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0279/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Epirubicino 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
20931	23858	1023858	flakonas	5 ml N1		Receptinis	LT/1/08/0990/001	Netiekiama	-	-	No	-	-
28154	30690	1030690	flakonas	10 ml N1		Receptinis	LT/1/08/0990/002	Netiekiama	-	-	No	-	-
28155	30691	1030691	flakonas	25 ml N1		Receptinis	LT/1/08/0990/003	Netiekiama	-	-	No	-	-	Download
28156	30692	1030692	flakonas	50 ml N1		Receptinis	LT/1/08/0990/004	Netiekiama	-	-	No	-	-
28157	30693	1030693	flakonas	100 ml N1		Receptinis	LT/1/08/0990/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Išregistruotas
2013-07-11	Perregistruotas
2008-01-25	Registruotas