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

2025-01-28

Date of renewal

Documents

5683-84_pakuotes lapelis_2025-01-28.docx

5683-5684_Dimethyl-fumarate Teva.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0571/001/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
116384	102485	1102485	lizdinė plokštelė	N14		Receptinis	LT/1/25/5683/001	Netiekiama	-	-	No	-	-
116385	102486	1102486	dalomoji lizdinė plokštelė	N14×1		Receptinis	LT/1/25/5683/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-28	Registruotas