ZULFIJA

Medicinal product

(Invented) name

ZULFIJA

Active substance (s)

Gestodenas/Etinilestradiolis

Strength

75 µg/30 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_4_6 Zulfija 75_30 tab RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2022/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Gestodenas	75 µg
Etinilestradiolis	30 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
42876	56645	1056645	lizdinė plokštelė	N1x21		Receptinis	LT/1/12/2893/004	Netiekiama	-	-	No	-	-
52101	66018	1066018	lizdinė plokštelė	N3x21		Receptinis	LT/1/12/2893/005	Netiekiama	-	-	No	-	-
52102	66019	1066019	lizdinė plokštelė	N6x21		Receptinis	LT/1/12/2893/006	Netiekiama	-	-	No	-	-

Stadijos

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