Fludeoxyglucose (18F) Synektik

Medicinal product

(Invented) name

Fludeoxyglucose (18F) Synektik

Active substance (s)

Fludeoksigliukozė (18F)

Strength

1 GBq/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

SYNEKTIK S.A., Lenkija

Date of authorisation

2016-11-22

Date of renewal

2021-10-01

Documents

4003 Pakuotės lapelis 2025 07 07.docx

4003 Fludeoxyglucose Synektik RPP 2025 07 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

CZ/H/0901/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kalibravimo dieną ir kalibravimo laiku 1 ml tirpalo yra	1 ml
Fludeoksigliukozė (18F)	1 GBq

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
67153	81696	1081696	flakonas	25 ml N1		Receptinis	LT/1/16/4003/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-01	Perregistruotas
2016-11-22	Registruotas