CHOLSCAN

Medicinal product

(Invented) name

CHOLSCAN

Active substance (s)

Fluorocholino (18F) chloridas

Strength

222 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)

V09IX07, fluorocholine (18F)

Marketing authorisation holder

Advanced Accelerator Applications, Prancūzija

Date of authorisation

2017-04-27

Date of renewal

Documents

4071 Pakuotės lapelis 2021_06_25.docx

4071 CHOLSCAN inj tirp II PL 2021_06_25.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

FR/H/0612/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kalibravimo dieną ir kalibravimo laiku 1 ml yra	1 ml
Fluorocholino (18F) chloridas	222 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
68131	82697	1082697	flakonas	N1 (daugiadozis)		Receptinis	LT/1/17/4071/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-29	Išregistruotas
2017-04-27	Registruotas