Natrii fluoridum (18F) Synektik

Medicinal product

(Invented) name

Natrii fluoridum (18F) Synektik

Active substance (s)

Natrio fluoridas (18F)

Strength

2 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)

V09IX06, Sodium fluoride (18F)

Marketing authorisation holder

SYNEKTIK S.A., Lenkija

Date of authorisation

2019-07-12

Date of renewal

2022-08-01

Documents

4428 Natrii fluoridum Synektik PCS PL 2024 09 18.docx

4428 Pakuotės lapelis 2024 09 18.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

PL/H/0971/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kalibravimo dieną ir kalibravimo laiku 1 ml tirpalo yra:	1 ml
Natrio fluoridas (18F)	2 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
102171	88272	1088272	flakonas	15 ml (daugiadozis) N1		Receptinis	LT/1/19/4428/001	Netiekiama	-	-	No	-	-
102172	88273	1088273	flakonas	25 ml (daugiadozis) N1		Receptinis	LT/1/19/4428/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-01	Perregistruotas
2019-07-12	Registruotas