Epirubicin Kabi

Medicinal product

(Invented) name

Epirubicin Kabi

Active substance (s)

Epirubicinas

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

Fresenius Kabi Oncology Plc, Jungtinė Karalystė

Date of authorisation

2011-04-21

Date of renewal

Documents

2421_1_4 Pakuotės lapelis 180827.docx

2421_1_4 Epirubicin Kabi inj_inf RPP 180827.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2231/001/

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Epirubicinas	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
40250	53987	1053987	buteliukas	25 ml N1		Receptinis	LT/1/11/2421/001	Netiekiama	-	-	No	-	-
40251	53988	1053988	buteliukas	100 ml N1		Receptinis	LT/1/11/2421/002	Netiekiama	-	-	No	-	-
48817	62682	1062682	buteliukas	5 ml N1		Receptinis	LT/1/11/2421/003	Netiekiama	-	-	No	-	-
48818	62683	1062683	buteliukas	50 ml N1		Receptinis	LT/1/11/2421/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-12-05	Išregistruotas
2011-04-21	Registruotas