Vumerity

Medicinal product

(Invented) name

Vumerity

Active substance (s)

Diroksimelio fumaratas

Strength

231 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)

L04AX09, Diroximel fumarate

Marketing authorisation holder

Biogen Netherlands B.V., Nyderlandai

Date of authorisation

2021-11-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Gastro-resistant hard capsules	1 vnt.
Diroksimelio fumaratas	231 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
107585	93690	1093690	buteliukas	N120		Receptinis	EU/1/21/1585/001	Netiekiama	-	-	No	-	-
107586	93691	1093691	buteliukas	N360 (3×120)		Receptinis	EU/1/21/1585/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-15	Registruotas