Elistrel

Medicinal product

(Invented) name

Elistrel

Active substance (s)

Levonorgestrelis

Strength

1500 µg

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 Orivas, Lietuva

Date of authorisation

2013-12-27

Date of renewal

2019-05-27

Documents

3468 Elistrel II PL 2024 10 11.docx

3468 Pakuotės lapelis 2024 10 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/1025/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Levonorgestrelis	1500 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
52040	65957	1065957	lizdinė plokštelė	N1		Nereceptinis	LT/1/13/3468/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-27	Perregistruotas
2013-12-27	Registruotas