Clefirem

Medicinal product

(Invented) name

Clefirem

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

Bausch Health Ireland Limited, Airija

Date of authorisation

2023-09-19

Date of renewal

Documents

5236 Pakuotės lapelis 2024 07 29.docx

5236 Clefirem PCS PL 2024 07 29.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1153/001/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
111638	97751	1097751	lizdinė plokštelė	N28		Receptinis	LT/1/23/5236/001	Netiekiama	-	-	No	-	-
111639	97752	1097752	lizdinė plokštelė	N84		Receptinis	LT/1/23/5236/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-19	Registruotas