Galio (68Ga) chloridas IRE ELiT

Medicinal product

(Invented) name

Galio (68Ga) chloridas IRE ELiT

Active substance (s)

Germanio (68Ge) chloridas/Galio (68Ga) chloridas

Strength

0,74-1,85 GBq

Pharmaceutical form

radionuklidų generatorius

Route (s) of administration

vartoti radioaktyviai pažymėjus in vitro

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V09X, OTHER DIAGNOSTIC RADIOPHARMACEUTICALS

Marketing authorisation holder

IRE ELiT, Belgija

Date of authorisation

2025-06-17

Date of renewal

Documents

5807_pakuotes lapelis_2025-06-17.docx

5807_Galio_Cl_IRE.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/2690/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Germanio (68Ge) aktyvumas kalibravimo dieną	1 vnt.
Germanio (68Ge) chloridas/Galio (68Ga) chloridas	0,74-1,85 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
117777	103881	1103881	Radionuklidų generatoriuje esanti kolonėlė	N1 (0,74 GBq, 1,11 GBq, 1,48 GBq, 1,85 GBq)		Receptinis	LT/1/25/5807/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-17	Registruotas