Fludeoxyglucose (18F) Karolinska

Medicinal product

(Invented) name

Fludeoxyglucose (18F) Karolinska

Active substance (s)

Fludeoksigliukozė (18F)

Strength

450-11250 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)

V09IX04, Fludeoxyglucose (18F)

Marketing authorisation holder

Karolinska University Hospital, Švedija

Date of authorisation

2020-06-11

Date of renewal

Documents

4579 Fludeoxyglucose (18F) Karolinska.docx

4579 pakuotes lapelis_2020-06-11.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

SE/H/1841/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kalibravimo dieną ir laiku 1 ml tirpalo yra:	1 ml
Fludeoksigliukozė (18F)	450-11250 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
104302	90404	1090404	flakonas	N1 (daugiadozis)		Receptinis	LT/1/20/4579/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-30	Išregistruotas
2020-06-11	Registruotas