Dimethyl fumarate Teva

Medicinal product

(Invented) name

Dimethyl fumarate Teva

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

Teva GmbH, Vokietija

Date of authorisation

2022-12-12

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	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
110010	96119	1096119	lizdinė plokštelė	N56		Receptinis	EU/1/22/1702/004	Netiekiama	-	-	No	-	-
110011	96120	1096120	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/22/1702/005	Netiekiama	-	-	No	-	-
110012	96121	1096121	buteliukas	N168		Receptinis	EU/1/22/1702/006	Netiekiama	-	-	No	-	-
110013	96122	1096122	lizdinė plokštelė	N196		Receptinis	EU/1/22/1702/007	Netiekiama	-	-	No	-	-
110014	96123	1096123	buteliukas	N100		Receptinis	EU/1/22/1702/008	Netiekiama	-	-	No	-	-

Stadijos

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