Levosert Single-Handed Inserter

Medicinal product

(Invented) name

Levosert Single-Handed Inserter

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

2021-11-18

Date of renewal

Documents

4850 Pakuotės lapelis 2024 11 07.docx

4850 Levosert Single_Handed Inserter RPP 2024 11 07.docx

4850 atmintine pacientei.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

HU/H/0580/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Atpalaidavimo greitis yra:	1 vnt.
Levonorgestrelis	20 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
107540	93645	1093645	Sistema	N1		Receptinis	LT/1/21/4850/001	Tiekiama	-	-	No	-	-	Download
107541	93646	1093646	Sistema	N5		Receptinis	LT/1/21/4850/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-18	Registruotas