Theralugand

Medicinal product

(Invented) name

Theralugand

Active substance (s)

Liutecio (177Lu) chloridas

Strength

40 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

Eckert & Ziegler Radiopharma GmbH, Vokietija

Date of authorisation

2024-11-22

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

1 ml tirpalo sudėtyje yra	1 ml
Liutecio (177Lu) chloridas	40 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
115886	101991	1101991	flakonas	3 ml N1		Receptinis	EU/1/24/1852/001	Nepradėtas tiekti	-	-	No	-	-
115887	101992	1101992	flakonas	10 ml N1		Receptinis	EU/1/24/1852/002	Nepradėtas tiekti	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-22	Registruotas