ZULFIJA

Medicinal product

(Invented) name

ZULFIJA

Active substance (s)

Gestodenas/Etinilestradiolis

Strength

75 µg/20 µg

Pharmaceutical form

dengtos tabletės

Route (s) of administration

vartoti per burną

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

2012-04-06

Date of renewal

Documents

2893_1_3 Zulfija 75_20 tab RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2022/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Gestodenas	75 µg
Etinilestradiolis	20 µg

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
42875	56644	1056644	lizdinė plokštelė	N1x21		Receptinis	LT/1/12/2893/001	Netiekiama	-	-	No	-	-
52099	66016	1066016	lizdinė plokštelė	N3x21		Receptinis	LT/1/12/2893/002	Netiekiama	-	-	No	-	-
52100	66017	1066017	lizdinė plokštelė	N6x21		Receptinis	LT/1/12/2893/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-05-14	Išregistruotas
2012-04-06	Registruotas