Vizamyl

Medicinal product

(Invented) name

Vizamyl

Active substance (s)

Flutemetamolis (18F)

Strength

400 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)

V09AX04, Flutemetamol (18F)

Marketing authorisation holder

GE Healthcare AS, Norvegija

Date of authorisation

2014-08-22

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
Flutemetamolis (18F)	400 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
59603	73834	1073834	flakonas	10 ml N1		Receptinis	EU/1/14/941/001	Netiekiama	-	-	No	-	-
59604	73835	1073835	flakonas	15 ml N1		Receptinis	EU/1/14/941/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-08-22	Registruotas