Mifepristone Linepharma

Medicinal product

(Invented) name

Active substance (s)

Mifepristonas

Strength

200 mg

Pharmaceutical form

tabletė

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

G03XB01, Mifepristone

Marketing authorisation holder

Linepharma International Limited, Jungtinė Karalystė

Date of authorisation

2013-07-11

Date of renewal

2016-07-22

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/0986/001/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Mifepristonas	200 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
54906	68932	1068932	lizdinė plokštelė	N1		Receptinis	LT/1/13/3335/001	Netiekiama	-	-	No	-	-
56692	70796	1070796	lizdinė plokštelė	N30	ASPĮ	Receptinis	LT/1/13/3335/002	Netiekiama	-	-	No	-	-

Stadijos