Epirubicin Accord

Medicinal product

(Invented) name

Epirubicin Accord

Active substance (s)

Epirubicino hidrochloridas

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2009-12-23

Date of renewal

2019-07-12

Documents

1814 Epirubicin Accord II PL 2025 07 17.docx

1814 Pakuotės lapelis 2025 07 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0751/001

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
22347	25134	1025134	flakonas	5 ml N1		Receptinis	LT/1/09/1814/001	Netiekiama	-	-	No	-	-
23874	26555	1026555	flakonas	10 ml N1		Receptinis	LT/1/09/1814/002	Netiekiama	-	-	No	-	-
23875	26556	1026556	flakonas	25 ml N1		Receptinis	LT/1/09/1814/003	Netiekiama	2025-09-04	2025-10-10	No	-	-
23876	26557	1026557	flakonas	100 ml N1		Receptinis	LT/1/09/1814/004	Netiekiama	-	-	No	-	-
55127	69160	1069160	flakonas	50 ml N1		Receptinis	LT/1/09/1814/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-07-12	Perregistruotas
2009-12-23	Registruotas