Dimethyl fumarate Teva

Medicinal product

(Invented) name

Dimethyl fumarate Teva

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

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	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
110006	96116	1096116	lizdinė plokštelė	N14		Receptinis	EU/1/22/1702/001	Netiekiama	-	-	No	-	-
110008	96117	1096117	dalomoji lizdinė plokštelė	N14×1		Receptinis	EU/1/22/1702/002	Netiekiama	-	-	No	-	-
110009	96118	1096118	buteliukas	N100		Receptinis	EU/1/22/1702/003	Netiekiama	-	-	No	-	-

Stadijos

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