Dimethyl fumarate Gedeon Richter

Medicinal product

(Invented) name

Dimethyl fumarate Gedeon Richter

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2024-05-21

Date of renewal

Documents

5440_5441 Pakuotės lapelis 2024 12 16.docx

5440_5441 Dimethyl fumarate Gedeon Richter PCS 2025 08 20.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0851/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	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
113689	99808	1099808	lizdinė plokštelė	N56 (kalendorinė)	kalendorinė pakuotė	Receptinis	LT/1/24/5441/001	Netiekiama	-	-	No	-	-
113690	99809	1099809	lizdinė plokštelė	N168 (kalendorinė)	kalendorinė pakuotė	Receptinis	LT/1/24/5441/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-21	Registruotas