Zomiren

Medicinal product

(Invented) name

Zomiren

Active substance (s)

Alprazolamas

Strength

0,5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05BA12, Alprazolam

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

1995-04-05

Date of renewal

2009-10-14

Documents

1740 Pakuotės lapelis tab 2022 09 30.docx

1740 Zomiren tab RPP 2022 09 30.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Vienoje tabletėje yra	1 vnt.
Alprazolamas	0,5 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
1345	7103	1007103	lizdinė plokštelė	N30		Receptinis	LT/1/95/1740/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-10-14	Perregistruotas
1995-04-05	Registruotas