Poltechgen

Medicinal product

(Invented) name

Poltechgen

Active substance (s)

Natrio pertechnetatas [99mTc]

Strength

8-175 GBq

Pharmaceutical form

radionuklidų generatorius

Route (s) of administration

vartoti ant akių, leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V09FX01, Technetium (99mTc) pertechnetate

Marketing authorisation holder

Narodowe Centrum Badan Jadrowych, Lenkija

Date of authorisation

2015-06-16

Date of renewal

2021-07-05

Documents

3742 Poltechgen _perr2021-07-05.docx

3742 pakuotes lapelis_2021-07-05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1365/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Technecio-99m aktyvumas kalibravimo dieną (GBq)	1 vnt.
Natrio pertechnetatas [99mTc]	8-175 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
58233	72375	1072375	nenurodyta	radionuklidų generatorius, 16 flakonų eliuatui, 16 flakonų eliuento (10 ml ) N1		Receptinis	LT/1/15/3742/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-05	Perregistruotas
2015-06-16	Registruotas