Pcolina

Medicinal product

(Invented) name

Pcolina

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

IASON GmbH, Austrija

Date of authorisation

2012-12-17

Date of renewal

2015-09-30

Documents

3159_1_2 Pcolina inj II PL 161117.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0471/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kalibravimo dieną ir kalibravimo laiku 1 ml injekcinio 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
47567	61387	1061387	flakonas	15 ml N1		Receptinis	LT/1/12/3159/001	Netiekiama	-	-	No	-	-
54755	68768	1068768	flakonas	25 ml N1		Receptinis	LT/1/12/3159/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-31	Išregistruotas
2015-09-30	Perregistruotas
2012-12-17	Registruotas