Pylclari

Medicinal product

(Invented) name

Pylclari

Active substance (s)

Piflufolastatas (18F)

Strength

1500 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)

V09IX16, piflufolastat (18F)

Marketing authorisation holder

CURIUM PET France, Prancūzija

Date of authorisation

2023-07-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injectiin	1 ml
Piflufolastatas (18F)	1500 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
111301	97414	1097414	flakonas	N1 (daugiadozis, 0,5-10 ml)		Receptinis	EU/1/23/1746/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-24	Registruotas