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

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	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
113454	99572	1099572	lizdinė plokštelė	N14		Receptinis	EU/1/24/1814/001	Netiekiama	-	-	No	-	-
113455	99573	1099573	dalomoji lizdinė plokštelė	N14×1		Receptinis	EU/1/24/1814/002	Netiekiama	-	-	No	-	-
113456	99574	1099574	buteliukas	N14		Receptinis	EU/1/24/1814/003	Netiekiama	-	-	No	-	-
113457	99575	1099575	buteliukas	N60		Receptinis	EU/1/24/1814/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-22	Registruotas