Dimethyl fumarate Neuraxpharm

Medicinal product

(Invented) name

Dimethyl fumarate Neuraxpharm

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

Neuraxpharm Pharmaceuticals, S.L., 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
113449	99567	1099567	lizdinė plokštelė	N14		Receptinis	EU/1/24/1810/004	Netiekiama	-	-	No	-	-
113450	99568	1099568	lizdinė plokštelė	N56		Receptinis	EU/1/24/1810/005	Netiekiama	-	-	No	-	-
113451	99569	1099569	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/24/1810/006	Netiekiama	-	-	No	-	-
113452	99570	1099570	lizdinė plokštelė	N168		Receptinis	EU/1/24/1810/007	Netiekiama	-	-	No	-	-
113453	99571	1099571	lizdinė plokštelė	N196		Receptinis	EU/1/24/1810/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-22	Registruotas