Natrio fluoridas (18F) Alliance Medical

Medicinal product

(Invented) name

Natrio fluoridas (18F) Alliance Medical

Active substance (s)

Natrio fluoridas (18F)

Strength

0,1-4 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

Alliance Medical RP Berlin GmbH, Vokietija

Date of authorisation

2014-10-27

Date of renewal

2021-06-14

Documents

3649 Natrio fluoridas Alliance Medical RPP 2024 05 15.docx

3649 Pakuotės lapelis 2024 05 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

DE/H/3517/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kalibravimo metu (sintezės pabaigoje) viename ml yra	1 ml
Natrio fluoridas (18F)	0,1-4 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
53711	67694	1067694	flakonas	1,0-13 ml N1		Receptinis	LT/1/14/3649/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-14	Perregistruotas
2014-10-27	Registruotas