SIBILLA

Medicinal product

(Invented) name

SIBILLA

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

G03HB, Antiandrogens and estrogens

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2012-06-04

Date of renewal

Documents

2967_1_3 Sibilla tab RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

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
45810	59612	1059612	lizdinė plokštelė	N21		Receptinis	LT/1/12/2967/001	Netiekiama	-	-	No	-	-
52753	66686	1066686	lizdinė plokštelė	N3x21		Receptinis	LT/1/12/2967/002	Netiekiama	-	-	No	-	-
52754	66687	1066687	lizdinė plokštelė	N6x21		Receptinis	LT/1/12/2967/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-09-10	Išregistruotas
2012-06-04	Registruotas