Leflunomide medac

Medicinal product

(Invented) name

Leflunomide medac

Active substance (s)

Leflunomidas

Strength

15 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L04AK01, Leflunomide

Marketing authorisation holder

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2010-07-27

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Leflunomidas	15 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
61081	75393	1075393	buteliukas	N30	Receptinis	EU/1/10/637/010	Netiekiama	-	-	No	-	-
61082	75394	1075394	buteliukas	N60	Receptinis	EU/1/10/637/011	Netiekiama	-	-	No	-	-
61083	75395	1075395	buteliukas	N90	Receptinis	EU/1/10/637/012	Netiekiama	-	-	No	-	-
61084	75396	1075396	buteliukas	N100	Receptinis	EU/1/10/637/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-07-27	Registruotas