OMNIPAQUE

Medicinal product

(Invented) name

OMNIPAQUE

Active substance (s)

Joheksolis

Strength

647 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	647 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
5520	10765	1010765	flakonas	stiklinis (10 ml), N10		Receptinis	LT/1/99/0871/007	Netiekiama	-	-	No	-	-
5521	10766	1010766	flakonas	stiklinis (20 ml), N25		Receptinis	LT/1/99/0871/008	Netiekiama	-	-	No	-	-
5522	10767	1010767	buteliukas	stiklinis (50 ml), N10		Receptinis	LT/1/99/0871/009	Netiekiama	-	-	No	-	-
5524	10769	1010769	buteliukas	stiklinis (100 ml), N10		Receptinis	LT/1/99/0871/010	Netiekiama	-	-	No	-	-
5525	10770	1010770	buteliukas	stiklinis (200 ml), N6		Receptinis	LT/1/99/0871/011	Netiekiama	-	-	No	-	-
24621	27267	1027267	buteliukas	stiklinis (200 ml), N10		Receptinis	LT/1/99/0871/012	Tiekiama	-	-	No	-	-
24622	27268	1027268	flakonas	polipropileno (10 ml), N10		Receptinis	LT/1/99/0871/013	Netiekiama	-	-	No	-	-
23757	26444	1026444	flakonas	polipropileno (20 ml), N10		Receptinis	LT/1/99/0871/014	Netiekiama	-	-	No	-	-
5523	10768	1010768	flakonas	polipropileno (40 ml), N10		Receptinis	LT/1/99/0871/015	Netiekiama	-	-	No	-	-
24623	27269	1027269	buteliukas	polipropileno (50 ml), N10		Receptinis	LT/1/99/0871/016	Tiekiama	-	-	No	-	-	Download
24624	27270	1027270	buteliukas	polipropileno (100 ml), N10		Receptinis	LT/1/99/0871/017	Tiekiama	-	-	No	-	-
24625	27271	1027271	buteliukas	polipropileno (200 ml), N10		Receptinis	LT/1/99/0871/018	Tiekiama	-	-	No	-	-
5526	10771	1010771	buteliukas	polipropileno (500 ml), N6		Receptinis	LT/1/99/0871/019	Netiekiama	-	-	No	-	-

Stadijos

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