LABELLA

Medicinal product

(Invented) name

LABELLA

Active substance (s)

Levonorgestrelis

Strength

1,5 mg

Pharmaceutical form

tabletė

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03AD01, Levonorgestrel

Marketing authorisation holder

UAB Exeltis Baltics, Lietuva

Date of authorisation

2014-04-09

Date of renewal

2019-02-08

Documents

3538 Pakuotės lapelis 2024 12 15.docx

3538 LABELLA RPP 2024 12 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2653/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Levonorgestrelis	1,5 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
52037	65954	1065954	lizdinė plokštelė	N1		Nereceptinis	LT/1/14/3538/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-02-08	Perregistruotas
2014-04-09	Registruotas