AZALIA

Medicinal product

(Invented) name

AZALIA

Active substance (s)

Dezogestrelis

Strength

75 µg

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)

G03AC09, Desogestrel

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2007-11-30

Date of renewal

2012-06-29

Documents

0911 Pakuotės lapelis 2021 10 22.docx

0911 AZALIA tab RPP 2021 10 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/1080/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Dezogestrelis	75 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
21212	24122	1024122	lizdinė plokštelė	N28		Receptinis	LT/1/07/0911/001	Tiekiama	-	-	No	-	-	Download
21213	24123	1024123	lizdinė plokštelė	N84		Receptinis	LT/1/07/0911/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-06-29	Perregistruotas
2007-11-30	Registruotas