Dimethyl fumarate Mylan

Medicinal product

(Invented) name

Dimethyl fumarate Mylan

Active substance (s)

Dimetilfumaratas

Strength

120 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	120 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
108692	94798	1094798	lizdinė plokštelė	N14		Receptinis	EU/1/22/1634/001	Netiekiama	-	-	No	-	-
108693	94799	1094799	dalomoji lizdinė plokštelė	N14×1		Receptinis	EU/1/22/1634/002	Netiekiama	-	-	No	-	-
108700	94806	1094806	buteliukas	N14		Receptinis	EU/1/22/1634/003	Netiekiama	-	-	No	-	-
108701	94807	1094807	buteliukas	N60		Receptinis	EU/1/22/1634/004	Netiekiama	-	-	No	-	-

Stadijos

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