LEVOSERT

Medicinal product

(Invented) name

LEVOSERT

Active substance (s)

Levonorgestrelis

Strength

20 µg/24 val.

Pharmaceutical form

vartojimo į gimdos ertmę sistema

Route (s) of administration

vartoti į gimdos ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G02BA03, Plastic IUD with progestogen

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2013-06-07

Date of renewal

2019-01-25

Documents

3319 LEVOSERT RPP 2024 11 07.docx

3319 Pakuotės lapelis 2024 11 07.docx

LEVOSERT mokomoji medziaga sveikatos prieziuros specialistams.pdf

LEVOSERT pacientes kortele.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

HU/H/0580/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Pradinis veikliosios medžiagos atsipalaidavimo greitis yra maždaug	1 vnt.
Levonorgestrelis	20 µg/24 val.

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
43386	57157	1057157	lizdinė plokštelė	N1		Receptinis	LT/1/13/3319/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-01-25	Perregistruotas
2013-06-07	Registruotas