Ongavia

Medicinal product

(Invented) name

Ongavia

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2019-03-25

Date of renewal

Documents

4353_1_2 Pakuotės lapelis 190813.docx

4353_1_2 Ongavia PCS PL 190813.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0986/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

3 savaičių laikotarpiu per 24 valandas iš žiedo išsiskiria 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
101279	87386	1087386	paketėlis	N1		Receptinis	LT/1/19/4353/001	Netiekiama	-	-	No	-	-
101280	87387	1087387	paketėlis	N3		Receptinis	LT/1/19/4353/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-29	Išregistruotas
2019-03-25	Registruotas