Lysodren

Medicinal product

(Invented) name

Lysodren

Active substance (s)

Mitotanas

Strength

500 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XX23, Mitotane

Marketing authorisation holder

Esteve Pharmaceuticals S.A., Ispanija

Date of authorisation

2004-04-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Mitotanas	500 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
27076	29634	1029634	buteliukas	N100		Receptinis	EU/1/04/273/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-04-28	Registruotas