Eileen

Medicinal product

(Invented) name

Eileen

Active substance (s)

Gestodenas/Etinilestradiolis

Strength

60 µg/13 µg//24 val

Pharmaceutical form

transderminis pleistras

Route (s) of administration

vartoti per odą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03AA10, Gestodene and ethinylestradiol

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2014-04-09

Date of renewal

Documents

3535_1_3 Eileen pleistras RPP 160819.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0547/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekvienas transderminis pleistras per 24 val. atpalaiduoja	1 vnt.
Gestodenas	60 µg/13 µg
Etinilestradiolis	/24 val

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
53701	67684	1067684	paketėlis	N3		Receptinis	LT/1/14/3535/001	Netiekiama	-	-	No	-	-	Download
58798	73013	1073013	paketėlis	N9		Receptinis	LT/1/14/3535/002	Netiekiama	-	-	No	-	-
58799	73014	1073014	paketėlis	N18		Receptinis	LT/1/14/3535/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-06-05	Išregistruotas
2014-04-09	Registruotas