GalliaPharm

Medicinal product

(Invented) name

GalliaPharm

Active substance (s)

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

Strength

2,96 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

Eckert & Ziegler Radiopharma GmbH, Vokietija

Date of authorisation

2024-08-01

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

Germanio (68Ge) aktyvumas kalibravimo dieną:	1 vnt.
Germanio (68Ge) chloridas/Galio (68Ga) chloridas	2,96 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
114668	100775	1100775	Radionuklidų generatoriuje esanti kolonėlė	talpyklė su eliuentu, ventiliuojamoji adata, adapteriai, vamzdeliai, jungiamosios detalės, uždarymo vožtuvo kolektorius, kištukinė LUER jungtis N1		Receptinis	EU/1/24/1836/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-01	Registruotas