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

2017-06-30

Date of renewal

Documents

0519-001-006_Cyclolux.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
68655	83237	1083237	buteliukas	10 ml N1		Receptinis	LT/L/17/0519/001	Tiekiama	-	-	No	-	-
68656	83238	1083238	buteliukas	10 ml N10		Receptinis	LT/L/17/0519/002	Netiekiama	-	-	No	-	-
68657	83239	1083239	buteliukas	15 ml N1		Receptinis	LT/L/17/0519/003	Tiekiama	-	-	No	-	-
68658	83240	1083240	buteliukas	15 ml N10		Receptinis	LT/L/17/0519/004	Netiekiama	-	-	No	-	-
68659	83241	1083241	buteliukas	20 ml N1		Receptinis	LT/L/17/0519/005	Tiekiama	-	-	No	-	-
68660	83242	1083242	buteliukas	20 ml N10		Receptinis	LT/L/17/0519/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Registruotas
2017-06-30	Registruotas