Dimethyl fumarate Accord

Medicinal product

(Invented) name

Dimethyl fumarate Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2024-04-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

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
113483	99601	1099601	lizdinė plokštelė	N56		Receptinis	EU/1/24/1811/003	Netiekiama	-	-	No	-	-
113484	99602	1099602	lizdinė plokštelė	N168		Receptinis	EU/1/24/1811/004	Netiekiama	-	-	No	-	-
113485	99603	1099603	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/24/1811/005	Netiekiama	-	-	No	-	-
113486	99604	1099604	dalomoji lizdinė plokštelė	N168×1		Receptinis	EU/1/24/1811/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-22	Registruotas