isoket

Medicinal product

(Invented) name

isoket

Active substance (s)

Izosorbido dinitratas

Strength

1 mg/ml

Pharmaceutical form

koncentratas injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną, leisti į arteriją

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01DA08, Isosorbide dinitrate

Marketing authorisation holder

Merus Labs Luxco II S.à r.l, Liuksemburgas

Date of authorisation

1997-04-09

Date of renewal

2012-11-29

Documents

3142_1 Isoket_konc inj_inf PZ 181018.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Izosorbido dinitratas	1 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
5666	10892	1010892	ampulė	10 ml N10		Receptinis	LT/1/97/3142/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-11	Išregistruotas
2012-11-29	Perregistruotas
1997-04-09	Registruotas