OMNIPAQUE

Medicinal product

(Invented) name

OMNIPAQUE

Active substance (s)

Joheksolis

Strength

518 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į arteriją

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V08AB02, Iohexol

Marketing authorisation holder

GE Healthcare AS, Norvegija

Date of authorisation

1994-03-31

Date of renewal

2007-10-22

Documents

0871 OMNIPAQUE PL 2024 04 25, VRA_rastas 16090.docx

0871 Pakuotės lapelis 2024 04 25, VRA_rastas 16090.docx

Stage

Perregistruotas

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
Joheksolis	518 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
5517	10762	1010762	flakonas	stiklinis (10 ml), N10		Receptinis	LT/1/99/0871/001	Netiekiama	-	-	No	-	-
23756	26443	1026443	flakonas	stiklinis (20 ml), N25		Receptinis	LT/1/99/0871/002	Netiekiama	-	-	No	-	-
5519	10764	1010764	buteliukas	stiklinis (50 ml), N10		Receptinis	LT/1/99/0871/003	Netiekiama	-	-	No	-	-
24619	27265	1027265	flakonas	polipropileno (10 ml), N10		Receptinis	LT/1/99/0871/004	Netiekiama	-	-	No	-	-
5518	10763	1010763	flakonas	polipropileno (20 ml), N10		Receptinis	LT/1/99/0871/005	Netiekiama	-	-	No	-	-
24620	27266	1027266	buteliukas	polipropileno (50 ml), N10		Receptinis	LT/1/99/0871/006	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2007-10-22	Perregistruotas
1994-03-31	Registruotas