OMNISCAN

Medicinal product

(Invented) name

OMNISCAN

Active substance (s)

Gadodiamidas

Strength

0,5 mmol/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V08CA03, Gadodiamide

Marketing authorisation holder

GE Healthcare AS, Norvegija

Date of authorisation

1996-10-30

Date of renewal

2011-10-20

Documents

2661_1_5 OMNISCAN II PL 170314 taisyta.docx

Stage

Sustabdytas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Gadodiamidas	0,5 mmol

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
3265	8753	1008753	flakonas	5 ml N10		Receptinis	LT/1/96/2661/001	Netiekiama	-	-	No	-	-
3266	8754	1008754	flakonas	10 ml N10		Receptinis	LT/1/96/2661/002	Netiekiama	-	-	No	-	-	Download
3267	8755	1008755	flakonas	15 ml N10		Receptinis	LT/1/96/2661/003	Netiekiama	-	-	No	-	-
3268	8756	1008756	flakonas	20 ml N10		Receptinis	LT/1/96/2661/004	Netiekiama	-	-	No	-	-
57543	71660	1071660	buteliukas	100 ml N10		Receptinis	LT/1/96/2661/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-25	Sustabdytas
2011-10-20	Perregistruotas
1996-10-30	Registruotas