REGULON

Medicinal product

(Invented) name

REGULON

Active substance (s)

Dezogestrelis/Etinilestradiolis

Strength

150 µg/30 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)

G03AA09, Desogestrel and ethinylestradiol

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

1998-08-26

Date of renewal

2011-07-28

Documents

0187 REGULON PCS PL 2022 11 28.docx

0187 Pakuotės lapelis 2022 11 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Dezogestrelis	150 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
7715	12637	1012637	lizdinė plokštelė	N1x21		Receptinis	LT/1/98/0187/001	Netiekiama	-	-	No	-	-
7716	12638	1012638	lizdinė plokštelė	N3x21		Receptinis	LT/1/98/0187/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2011-07-28	Perregistruotas
1998-08-26	Registruotas