Sodium iodide (131I) POLATOM

Medicinal product

(Invented) name

Sodium iodide (131I) POLATOM

Active substance (s)

Natrio jodidas [¹³¹ I]

Strength

37-7400 MBq

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V10XA01, Sodium iodide (131I)

Marketing authorisation holder

Narodowe Centrum Badan Jadrowych, Lenkija

Date of authorisation

2019-01-25

Date of renewal

2024-08-14

Documents

4327 Sodium iodide POLATOM PCS PL 2024 12 06.docx

4327 Pakuotės lapelis 2024 12 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

PL/H/0492/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kalibravimo laiku kiekvienoje kapsulėje yra:	1 vnt.
Natrio jodidas [¹³¹ I]	37-7400 MBq

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
100901	87012	1087012	flakonas	N1 (pridėtas atskiras polipropileno aplikatorius)		Receptinis	LT/1/19/4327/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-08-14	Perregistruotas
2019-01-25	Registruotas