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

2022-05-13

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Gastro-resistant capsule, hard	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
108694	94800	1094800	lizdinė kortelė	N56		Receptinis	EU/1/22/1634/005	Netiekiama	-	-	No	-	-
108697	94803	1094803	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/22/1634/006	Netiekiama	-	-	No	-	-
108698	94804	1094804	lizdinė plokštelė	N168		Receptinis	EU/1/22/1634/007	Netiekiama	-	-	No	-	-
108699	94805	1094805	dalomoji lizdinė plokštelė	N168×1		Receptinis	EU/1/22/1634/008	Netiekiama	-	-	No	-	-
108702	94808	1094808	buteliukas	N56		Receptinis	EU/1/22/1634/009	Netiekiama	-	-	No	-	-
108703	94809	1094809	buteliukas	N168		Receptinis	EU/1/22/1634/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-13	Išregistruotas
2022-05-13	Registruotas