Tecfidera

Medicinal product

(Invented) name

Tecfidera

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

Biogen Netherlands B.V., Nyderlandai

Date of authorisation

2014-01-30

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.
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
58497	72662	1072662	lizdinė plokštelė	N56		Receptinis	EU/1/13/837/002	Tiekiama	-	-	No	-	-
61821	76191	1076191	lizdinė plokštelė	N168		Receptinis	EU/1/13/837/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-01-30	Registruotas