Activelle

Medicinal product

(Invented) name

Activelle

Active substance (s)

Estradiolis/Noretisteronas

Strength

1 mg/0,5 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)

G03FA01, Norethisterone and estrogen

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2005-09-29

Date of renewal

2014-06-13

Documents

0298 Pakuotės lapelis 2024 09 25.docx

0298 Activelle PCS PL 2024 09 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/0150/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Estradiolis	1 mg
Noretisteronas	0,5 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
16156	3449	1003449	tablečių talpyklė	N1x28		Receptinis	LT/1/05/0298/001	Tiekiama	-	-	No	-	-
16157	20221	1020221	tablečių talpyklė	N3x28		Receptinis	LT/1/05/0298/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-06-13	Perregistruotas
2005-09-29	Registruotas