Skilarence

Medicinal product

(Invented) name

Skilarence

Active substance (s)

Dimetilfumaratas

Strength

30 mg

Pharmaceutical form

skrandyje neirios tabletės

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

Almirall, S.A., Ispanija

Date of authorisation

2017-06-23

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 tablets	1 vnt.
Dimetilfumaratas	30 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
68671	83253	1083253	lizdinė plokštelė	N42		Receptinis	EU/1/17/1201/001	Netiekiama	-	-	No	-	-
102319	88419	1088419	lizdinė plokštelė	N70		Receptinis	EU/1/17/1201/013	Netiekiama	-	-	No	-	-
102320	88420	1088420	lizdinė plokštelė	N210		Receptinis	EU/1/17/1201/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-23	Registruotas