Zenadea

Medicinal product

(Invented) name

Zenadea

Active substance (s)

Dienogestas/Etinilestradiolis

Strength

2 mg/0,03 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03AA16, Dienogest and ethinylestradiol

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2011-12-16

Date of renewal

2016-11-10

Documents

2717 Pakuotės lapelis 2025 04 03.docx

2717 Zenadea PCS PL 2025 04 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0282/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Dienogestas	2 mg
Etinilestradiolis	0,03 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
41565	55326	1055326	lizdinė plokštelė	N1x21		Receptinis	LT/1/11/2717/001	Tiekiama	-	-	No	-	-	Download
50593	64479	1064479	lizdinė plokštelė	N3x21		Receptinis	LT/1/11/2717/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-10	Perregistruotas
2011-12-16	Registruotas