Axumin

Medicinal product

(Invented) name

Axumin

Active substance (s)

Fluciklovinas (18F)

Strength

1600 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)

V09IX12, Fluciclovine (18F)

Marketing authorisation holder

Blue Earth Diagnostics Ireland Ltd., Airija

Date of authorisation

2017-05-22

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
Fluciklovinas (18F)	1600 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
68404	82981	1082981	flakonas	N1 (10 ml)		Receptinis	EU/1/17/1186/001	Netiekiama	-	-	No	-	-
100646	86756	1086756	flakonas	N1 (15 ml)		Receptinis	EU/1/17/1186/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-05-22	Registruotas