Zopiclone Olpha

Medicinal product

(Invented) name

Zopiclone Olpha

Active substance (s)

Zopiklonas

Strength

3,75 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

Olpha AS, Latvija

Date of authorisation

2025-04-07

Date of renewal

Documents

5755 Pakuotės lapelis 2025 09 29.docx

5755 Zopiclone Olpha 3,75 RPP 2025 09 29.docx

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(1)

Procedure number

IT/H/0951/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Zopiklonas	3,75 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
117146	103246	1103246	lizdinė plokštelė	N20		Receptinis	LT/1/25/5755/001	Netiekiama	-	-	No	-	-
118899	105005	1105005	lizdinė plokštelė	N30		Receptinis	LT/1/25/5755/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-07	Registruotas