Cyclolux

Medicinal product

(Invented) name

Cyclolux

Active substance (s)

Gadotero rūgštis

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)

V08CA02, Gadoteric acid

Marketing authorisation holder

UAB PharmaDIA, Lietuva

Date of authorisation

2018-07-05

Date of renewal

Documents

0687-001-004_Cyclolux_2021-07-07.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
Gadotero rūgštis	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
99721	85828	1085828	buteliukas	N1 - 60 ml		Receptinis	LT/L/18/0687/001	Tiekiama	-	-	No	-	-	Download
99723	85830	1085830	buteliukas	N1 - 100 ml		Receptinis	LT/L/18/0687/002	Tiekiama	-	-	No	-	-	Download
99722	85829	1085829	buteliukas	N10 - 60 ml		Receptinis	LT/L/18/0687/003	Netiekiama	-	-	No	-	-	Download
99724	85831	1085831	buteliukas	N10 - 100 ml		Receptinis	Lt/L/18/0687/004	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-07-05	Registruotas