Dimethyl fumarate TevaPharm

Medicinal product

(Invented) name

Dimethyl fumarate TevaPharm

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

2023-09-19

Date of renewal

Documents

5237_5238 Pakuotės lapelis 2025 02 13.docx

5237_5238 Dimethyl fumarate TevaPharm PL 2025 02 13.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0528/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	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
111649	97762	1097762	lizdinė plokštelė	N14		Receptinis	LT/1/23/5237/001	Netiekiama	-	-	No	-	-
111650	97763	1097763	dalomoji lizdinė plokštelė	N14×1		Receptinis	LT/1/23/5237/002	Netiekiama	-	-	No	-	-
111651	97764	1097764	buteliukas	N100		Receptinis	LT/1/23/5237/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-30	Išregistruotas
2023-09-19	Registruotas