Dimethyl fumarate Mylan

Medicinal product

(Invented) name

Dimethyl fumarate Mylan

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

Mylan Ireland Limited, Airija

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
113458	99576	1099576	lizdinė plokštelė	N56		Receptinis	EU/1/24/1814/005	Netiekiama	-	-	No	-	-
113459	99577	1099577	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/24/1814/006	Netiekiama	-	-	No	-	-
113460	99578	1099578	lizdinė plokštelė	N168		Receptinis	EU/1/24/1814/007	Netiekiama	-	-	No	-	-
113461	99579	1099579	dalomoji lizdinė plokštelė	N168×1		Receptinis	EU/1/24/1814/008	Netiekiama	-	-	No	-	-
113462	99580	1099580	buteliukas	N56		Receptinis	EU/1/24/1814/009	Netiekiama	-	-	No	-	-
113463	99581	1099581	buteliukas	N168		Receptinis	EU/1/24/1814/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-22	Registruotas