velbienne

Medicinal product

(Invented) name

velbienne

Active substance (s)

Estradiolio valeratas/Dienogestas

Strength

1 mg/2 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)

G03FA15, Dienogest and estrogen

Marketing authorisation holder

UAB Exeltis Baltics, Lietuva

Date of authorisation

2014-09-04

Date of renewal

2019-11-22

Documents

3618 velbienne RPP 2024 12 15.docx

3618 Pakuotės lapelis 2024 12 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2949/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Estradiolio valeratas	1 mg
Dienogestas	2 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
55856	69910	1069910	lizdinė plokštelė	N28		Receptinis	LT/1/14/3618/001	Tiekiama	-	-	No	-	-	Download
60108	74379	1074379	lizdinė plokštelė	N3x28		Receptinis	LT/1/14/3618/002	Netiekiama	-	-	No	-	-
60109	74380	1074380	lizdinė plokštelė	N6x28		Receptinis	LT/1/14/3618/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-22	Perregistruotas
2014-09-04	Registruotas