Tekcis

Medicinal product

(Invented) name

Tekcis

Active substance (s)

Natrio pertechnetatas [99mTc]

Strength

2-50 GBq

Pharmaceutical form

radionuklidų generatorius

Route (s) of administration

vartoti ženklinimui, 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

CIS bio International, Prancūzija

Date of authorisation

2012-12-17

Date of renewal

2018-07-30

Documents

3154 Tekcis PCS PL 2024 08 02.docx

3154 Pakuotės lapelis 2024 08 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

FR/H/0490/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Generatoriaus aktyvumas kalibravimo dieną	1 vnt.
Natrio pertechnetatas [99mTc]	2-50 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
45722	59524	1059524	nenurodyta	generatorius N1 (flakonai 5-6 ml, 9-11 ml, 14-16 ml išplauti, adatos apsauginis flakonas, eliucijos konteineris, švino ekranai)		Receptinis	LT/1/12/3154/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-30	Perregistruotas
2012-12-17	Registruotas