Dimethyl fumarate Zentiva

Medicinal product

(Invented) name

Dimethyl fumarate Zentiva

Active substance (s)

Dimetilfumaratas

Strength

240 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 Pakuotės lapelis 2025 02 14.docx

5120_5121 Dimethyl fumarate Zentiva RPP 2025 02 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0524/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Dimetilfumaratas	240 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
110366	96477	1096477	lizdinė plokštelė	N56		Receptinis	LT/1/23/5121/001	Netiekiama	-	-	No	-	-
110367	96478	1096478	lizdinė plokštelė	N168		Receptinis	LT/1/23/5121/002	Netiekiama	-	-	No	-	-
110368	96479	1096479	dalomoji lizdinė plokštelė	N56×1		Receptinis	LT/1/23/5121/003	Netiekiama	-	-	No	-	-
110369	96480	1096480	dalomoji lizdinė plokštelė	N168×1		Receptinis	LT/1/23/5121/004	Netiekiama	-	-	No	-	-
110370	96481	1096481	buteliukas	N100		Receptinis	LT/1/23/5121/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-13	Registruotas