Somnols

Medicinal product

(Invented) name

Somnols

Active substance (s)

Zopiklonas

Strength

7,5 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)

N05CF01, Zopiclone

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2000-12-07

Date of renewal

2010-05-12

Documents

2001 Pakuotės lapelis 2024 10 01, VRA_17041.docx

2001 Somnols PL 2024 10 01, VRA_17041.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Zopiklonas	7,5 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
656	6575	1006575	lizdinė plokštelė	N10		Receptinis	LT/1/2000/2001/001	Tiekiama	-	-	No	-	-	Download
18259	21959	1021959	lizdinė plokštelė	N20		Receptinis	LT/1/2000/2001/002	Netiekiama	-	-	No	-	-
30819	33274	1033274	lizdinė plokštelė	N30		Receptinis	LT/1/2000/2001/003	Tiekiama	2025-04-26	-	No	-	-

Stadijos

Data	Stadija
2010-05-12	Perregistruotas
2000-12-07	Registruotas