Celsunax

Medicinal product

(Invented) name

Celsunax

Active substance (s)

Joflupanas (123I)

Strength

74 MBq/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)

V09AB03, Iodine ioflupane (123I)

Marketing authorisation holder

Pinax Pharma GmbH, Vokietija

Date of authorisation

2021-06-17

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Joflupanas (123I)	74 MBq

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
106734	92836	1092836	flakonas	2,5 ml N1		Receptinis	EU/1/21/1560/001	Netiekiama	-	-	No	-	-
106735	92837	1092837	flakonas	5 ml N1		Receptinis	EU/1/21/1560/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-30	Išregistruotas
2021-06-17	Registruotas