Meliterix

Medicinal product

(Invented) name

Meliterix

Active substance (s)

Teriflunomidas

Strength

14 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AK02, Teriflunomide

Marketing authorisation holder

UAB Norameda, Lietuva

Date of authorisation

2023-05-08

Date of renewal

Documents

5180_Meliterix.docx

5180_pakuotes lapelis_2023-05-08.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2225/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Teriflunomidas	14 mg

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
110971	97082	1097082	lizdinė plokštelė	N28		Receptinis	LT/1/23/5180/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-29	Išregistruotas
2023-05-08	Registruotas