Spirix

Medicinal product

(Invented) name

Spirix

Active substance (s)

Spironolaktonas

Strength

100 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C03DA01, Spironolactone

Marketing authorisation holder

Orifarm Healthcare A/S, Danija

Date of authorisation

1997-07-02

Date of renewal

2009-09-16

Documents

1694 Pakuotės lapelis 2023 12 14.docx

1694 Spirix II PL 2023 12 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Spironolaktonas	100 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
5388	10651	1010651	buteliukas	N20		Receptinis	LT/1/97/1694/005	Netiekiama	-	-	No	-	-
5389	3770	1003770	buteliukas	N30		Receptinis	LT/1/97/1694/006	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-09-16	Perregistruotas
1997-07-02	Registruotas