Elucirem

Medicinal product

(Invented) name

Elucirem

Active substance (s)

Gadopiklenolas

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)

V08CA12, gadopiclenol

Marketing authorisation holder

Guerbet, Prancūzija

Date of authorisation

2023-12-07

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Gadopiklenolas	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
112321	98436	1098436	flakonas	3 ml N1		Receptinis	EU/1/23/1772/001	Netiekiama	-	-	No	-	-
112322	98437	1098437	flakonas	7,5 ml N1		Receptinis	EU/1/23/1772/002	Netiekiama	-	-	No	-	-
112323	98438	1098438	flakonas	7,5 ml N25		Receptinis	EU/1/23/1772/003	Netiekiama	-	-	No	-	-
112324	98439	1098439	flakonas	10 ml N1		Receptinis	EU/1/23/1772/004	Netiekiama	-	-	No	-	-
112325	98440	1098440	flakonas	10 ml N25		Receptinis	EU/1/23/1772/005	Netiekiama	-	-	No	-	-
112326	98441	1098441	flakonas	15 ml N1		Receptinis	EU/1/23/1772/006	Netiekiama	-	-	No	-	-
112327	98442	1098442	flakonas	15 ml N25		Receptinis	EU/1/23/1772/007	Netiekiama	-	-	No	-	-
112328	98443	1098443	flakonas	30 ml N1		Receptinis	EU/1/23/1772/008	Netiekiama	-	-	No	-	-
112329	98444	1098444	flakonas	50 ml N1		Receptinis	EU/1/23/1772/009	Netiekiama	-	-	No	-	-
112330	98445	1098445	flakonas	100 ml N1		Receptinis	EU/1/23/1772/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-07	Registruotas