Levothyroxine sodium Zentiva

Medicinal product

(Invented) name

Levothyroxine sodium Zentiva

Active substance (s)

Levotiroksino natrio druska

Strength

50 µg/5 ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H03AA01, Levothyroxine sodium

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2020-11-25

Date of renewal

Documents

4639_4641 Pakuotės lapelis 2021 08 18.docx

4639_4641 Levothyroxine sodium Zentiva PCS PL 2021 08 18.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

DE/H/6461/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

5 ml tirpalo yra:	5 ml
Levotiroksino natrio druska	50 µg

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
105355	91457	1091457	buteliukas	75 ml, dozavimo švirkštas (5 ml) ir švirkšto adapteris, N1		Receptinis	LT/1/20/4640/001	Netiekiama	-	-	No	-	-
105356	91458	1091458	buteliukas	100 ml, dozavimo švirkštas (5 ml) ir švirkšto adapteris, N1		Receptinis	LT/1/20/4640/002	Netiekiama	-	-	No	-	-
105357	91459	1091459	buteliukas	75 ml, dozavimo švirkštas (5 ml) ir švirkšto adapteris, N2		Receptinis	LT/1/20/4640/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Išregistruotas
2020-11-25	Registruotas