Levothyroxine sodium Accord

Medicinal product

(Invented) name

Levothyroxine sodium Accord

Active substance (s)

Levotiroksino natrio druska

Strength

12,5 µg

Pharmaceutical form

tabletės

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2020-03-27

Date of renewal

2024-11-21

Documents

4528_4539 Levothyroxine sodium Accord RPP 2024 11 21, KR_2112.docx

4528_4539 Pakuotės lapelis 2024 11 21, KR_2112.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/4465/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Levotiroksino natrio druska	12,5 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
103623	89725	1089725	lizdinė plokštelė	N10		Receptinis	LT/1/20/4528/001	Netiekiama	-	-	No	-	-
103624	89726	1089726	lizdinė plokštelė	N50		Receptinis	LT/1/20/4528/002	Netiekiama	-	-	No	-	-
103625	89727	1089727	lizdinė plokštelė	N100		Receptinis	LT/1/20/4528/003	Netiekiama	-	-	No	-	-
103626	89728	1089728	lizdinė plokštelė	N200		Receptinis	LT/1/20/4528/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-21	Perregistruotas
2020-03-27	Registruotas