Ornique

Medicinal product

(Invented) name

Ornique

Active substance (s)

Etonogestrelis/Etinilestradiolis

Strength

120 µg/15 µg/24 val.

Pharmaceutical form

vartojimo į makštį sistema

Route (s) of administration

vartoti į makštį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G02BB01, Vaginal ring with progestogen and estrogen

Marketing authorisation holder

UAB Exeltis Baltics, Lietuva

Date of authorisation

2017-07-10

Date of renewal

2022-01-17

Documents

Paciento kortele.pdf

4101 Pakuotės lapelis 2024 12 15.docx

Mokomoji medziaga sveikatos prieziuros specialistams (kontrolinis sarasas).pdf

4101 Ornique RPP 2024 12 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3719/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Žiedas per 24 valandas atpalaiduoja vidutiniškai	1 vnt.
Etonogestrelis	120 µg
Etinilestradiolis	15 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
68717	83300	1083300	paketėlis	N1		Receptinis	LT/1/17/4101/001	Tiekiama	-	-	No	-	-	Download
68718	83301	1083301	paketėlis	N3		Receptinis	LT/1/17/4101/002	Netiekiama	-	-	No	-	-
68719	83302	1083302	paketėlis	N6		Receptinis	LT/1/17/4101/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-17	Perregistruotas
2017-07-10	Registruotas