Zopiclone Olpha

Medicinal product

(Invented) name

Zopiclone Olpha

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

Olpha AS, Latvija

Date of authorisation

2025-04-07

Date of renewal

Documents

5756 Zopiclone Olpha 7,5 RPP 2025 09 29.docx

5756 Pakuotės lapelis 2025 09 29.docx

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(1)

Procedure number

IT/H/0951/002/DC

Marketing authorisation procedure

Decentralizuota 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
117147	103247	1103247	lizdinė plokštelė	N10		Receptinis	LT/1/25/5756/001	Netiekiama	-	-	No	-	-
117148	103248	1103248	lizdinė plokštelė	N20		Receptinis	LT/1/25/5756/002	Netiekiama	-	-	No	-	-
117149	103249	1103249	lizdinė plokštelė	N30		Receptinis	LT/1/25/5756/003	Netiekiama	-	-	No	-	-
118900	105006	1105006	lizdinė plokštelė	N100		Receptinis	LT/1/25/5756/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-07	Registruotas