FLUOROCHOLINE (18F) SYNEKTIK

Medicinal product

(Invented) name

FLUOROCHOLINE (18F) SYNEKTIK

Active substance (s)

Fluorocholino (18F) chloridas

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)

V09IX07, fluorocholine (18F)

Marketing authorisation holder

SYNEKTIK S.A., Lenkija

Date of authorisation

2018-05-29

Date of renewal

2022-11-08

Documents

4227 Pakuotės lapelis 2025 02 10.docx

4227 FLUOROCHOLINE SYNEKTIK II PZ PL 2025 02 10.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

CZ/H/0893/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kalibravimo dieną ir kalibravimo laiku 1 ml tirpalo yra:	1 ml
Fluorocholino (18F) chloridas	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
99514	85621	1085621	flakonas	N1 (daugiadozis)		Receptinis	LT/1/18/4227/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-08	Perregistruotas
2018-05-29	Registruotas