KOPAQ

Medicinal product

(Invented) name

KOPAQ

Active substance (s)

Joheksolis

Strength

647 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į arteriją, leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V08AB02, Iohexol

Marketing authorisation holder

UAB Rx pharma, Lietuva

Date of authorisation

2026-01-29

Date of renewal

Documents

3166_KOPAQ 647 mgml injekcinis tirpalas_PZ.docx

3166_KOPAQ 647 mgml injekcinis tirpalas_PL.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
119985	106091	1106091	flakonas	50 ml N1	ASPĮ	Receptinis	LT/L/26/3166/001	Netiekiama	-	-	No	-	-	Download
119986	106092	1106092	flakonas	100 ml N1	ASPĮ	Receptinis	LT/L/26/3166/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2026-01-29	Registruotas