DaTSCAN

Medicinal product

(Invented) name

DaTSCAN

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

GE Healthcare B.V., Nyderlandai

Date of authorisation

2000-07-27

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

injekcinis tirpalas	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
6619	11685	1011685	flakonas	2,5 ml N1		Receptinis	EU/1/00/135/001	Tiekiama	-	-	No	-	-
25259	27869	1027869	flakonas	5 ml N1		Receptinis	EU/1/00/135/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2000-07-27	Registruotas