Onirex

Medicinal product

(Invented) name

Onirex

Active substance (s)

Zolpidemo tartratas

Strength

10 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)

N05CF02, Zolpidem

Marketing authorisation holder

UAB Uncialis, Lietuva

Date of authorisation

2017-09-15

Date of renewal

Documents

0546-01_Onirex_PZPL_PL.doc

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Zolpidemo tartratas	10 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
97834	83929	1083929	lizdinė plokštelė	N20		Receptinis	LT/L/17/0546/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-15	Registruotas