Dimethyl fumarate Zentiva

Medicinal product

(Invented) name

Dimethyl fumarate Zentiva

Active substance (s)

Dimetilfumaratas

Strength

120 mg

Pharmaceutical form

skrandyje neirios kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AX07, Dimethyl fumarate

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2023-02-13

Date of renewal

Documents

5120_5121 Dimethyl fumarate Zentiva RPP 2025 02 14.docx

5120_5121 Pakuotės lapelis 2025 02 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0524/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Dimetilfumaratas	120 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
110363	96474	1096474	lizdinė plokštelė	N14		Receptinis	LT/1/23/5120/001	Netiekiama	-	-	No	-	-
110364	96475	1096475	dalomoji lizdinė plokštelė	N14×1		Receptinis	LT/1/23/5120/002	Netiekiama	-	-	No	-	-
110365	96476	1096476	buteliukas	N100		Receptinis	LT/1/23/5120/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-13	Registruotas