GalenVita

Medicinal product

(Invented) name

GalenVita

Active substance (s)

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

Strength

3,7 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

Curium Romania SRL, Rumunija

Date of authorisation

2026-01-08

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

Germanio (68Ge) aktyvumas kalibravimo dieną	1 vnt.
Germanio (68Ge) chloridas/Galio (68Ga) chloridas	3,7 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
119596	105702	1105702	Radionuklidų generatoriuje esanti kolonėlė	N1 (talpyklė su 220 ml sterilios itin grynos 0,1 mol/l druskos rūgšties eliuavimo tirpalu ir eliuavimo priedai)		Receptinis	EU/1/25/2004/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-08	Registruotas