Epirubicin Mylan

Medicinal product

(Invented) name

Epirubicin Mylan

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

Mylan S.A.S., Prancūzija

Date of authorisation

2013-02-08

Date of renewal

Documents

3198_1_2 Epirubicin Mylan inj_inf RPP 160429.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2014/001/DC

Marketing authorisation procedure

Decentralizuota 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
41820	55582	1055582	flakonas	N1 (50 mg/25 ml)		Receptinis	LT/1/13/3198/001	Netiekiama	-	-	No	-	-
41821	55583	1055583	flakonas	N1 (200 mg/100 ml)		Receptinis	LT/1/13/3198/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-07-04	Išregistruotas
2013-02-08	Registruotas