Isosorbide mononitrate Vitabalans

Medicinal product

(Invented) name

Isosorbide mononitrate Vitabalans

Active substance (s)

Izosorbido mononitratas

Strength

20 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01DA14, Isosorbide mononitrate

Marketing authorisation holder

Vitabalans Oy, Suomija

Date of authorisation

2007-10-30

Date of renewal

2011-03-16

Documents

0875_1_2 Isosorbide mononitrate Vitabalans PZ PL 181207.docx

0875_1_2 PAKUOTĖS LAPELIS 181207.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0105/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Izosorbido mononitratas	20 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
22374	4939	1004939	buteliukas	N30		Receptinis	LT/1/07/0875/001	Netiekiama	-	-	No	-	-	Download
24444	5066	1005066	buteliukas	N100		Receptinis	LT/1/07/0875/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-03-16	Perregistruotas
2007-10-30	Registruotas