ARTIZIA

Medicinal product

(Invented) name

ARTIZIA

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

Zentiva k.s., Čekija

Date of authorisation

2010-01-19

Date of renewal

2015-01-27

Documents

1832 ARTIZIA PCS PL 2025 04 03.docx

1832 Pakuotės lapelis 2025 04 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0281/001/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
33646	36007	1036007	lizdinė plokštelė	N21		Receptinis	LT/1/10/1832/001	Tiekiama	-	-	No	-	-	Download
39006	52689	1052689	lizdinė plokštelė	N3x21		Receptinis	LT/1/10/1832/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-27	Perregistruotas
2010-01-19	Registruotas