Teriflunomide Olpha [Bozilos]

Medicinal product

(Invented) name

Teriflunomide Olpha [Bozilos]

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

Olpha AS, Latvija

Date of authorisation

2022-11-18

Date of renewal

Documents

5072 Pakuotės lapelis 2026 03 20.docx

5072 Teriflunomide Olpha RPP 2026 03 20.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0479/001/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
109853	95960	1095960	lizdinė plokštelė	N28		Receptinis	LT/1/22/5072/001	Netiekiama	-	-	No	-	-
109854	95961	1095961	lizdinė plokštelė	N98		Receptinis	LT/1/22/5072/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-18	Registruotas