Vagifem

Medicinal product

(Invented) name

Vagifem

Active substance (s)

Estradiolis

Strength

10 µg

Pharmaceutical form

makšties tabletės

Route (s) of administration

vartoti į makštį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03CA03, Estradiol

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2010-05-04

Date of renewal

2015-02-25

Documents

0157 Vagifem PL 2024 12 09.docx

0157 Pakuotės lapelis 2024 12 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/2992/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Estradiolis	10 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
32007	34403	1034403	lizdinė plokštelė	N18 su aplikatoriais		Receptinis	LT/1/94/0157/002	Tiekiama	-	-	No	-	-
40884	54621	1054621	lizdinė plokštelė	N24 su aplikatoriais		Receptinis	LT/1/94/0157/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-02-25	Perregistruotas
2010-05-04	Registruotas