Lutetium (177Lu) chloride Billev [ilLuzyce]

Medicinal product

(Invented) name

Lutetium (177Lu) chloride Billev [ilLuzyce]

Active substance (s)

Liutecio (177Lu) chloridas

Strength

51,8 GBq/ml

Pharmaceutical form

radiofarmacinis pirmtakas (tirpalas)

Route (s) of administration

vartoti radioaktyviai pažymėjus in vitro

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V10X, OTHER THERAPEUTIC RADIOPHARMACEUTICALS

Marketing authorisation holder

Billev Pharma ApS, Danija

Date of authorisation

2022-09-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Radiopharmaceutical precursor, solution	1 ml
Liutecio (177Lu) chloridas	51,8 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
109441	95547	1095547	flakonas	5 ml N1		Receptinis	EU/1/22/1680/001	Netiekiama	-	-	No	-	-
109442	95548	1095548	flakonas	5 ml N2		Receptinis	EU/1/22/1680/002	Netiekiama	-	-	No	-	-
109443	95549	1095549	flakonas	5 ml N3		Receptinis	EU/1/22/1680/003	Netiekiama	-	-	No	-	-
109444	95550	1095550	flakonas	10 ml N1		Receptinis	EU/1/22/1680/004	Netiekiama	-	-	No	-	-
109445	95551	1095551	flakonas	10 ml N2		Receptinis	EU/1/22/1680/005	Netiekiama	-	-	No	-	-
109446	95552	1095552	flakonas	10 ml N3		Receptinis	EU/1/22/1680/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-15	Registruotas