Fludeomap

Medicinal product

(Invented) name

Fludeomap

Active substance (s)

Fludeoksigliukozė (18F)

Strength

250 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

Curium Finland Oy, Suomija

Date of authorisation

2018-03-23

Date of renewal

2022-10-17

Documents

4206 Fludeomap RPP 2024 11 28.docx

4206 Pakuotės lapelis 2024 11 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0927/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml kalibravimo dieną ir laiku yra	1 ml
Fludeoksigliukozė (18F)	250 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
99153	85259	1085259	flakonas	N1 (daugiadozis)		Receptinis	LT/1/18/4206/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-17	Perregistruotas
2018-03-23	Registruotas