Dimethyl fumarate Olpha

Medicinal product

(Invented) name

Dimethyl fumarate Olpha

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

Olpha AS, Latvija

Date of authorisation

2025-06-10

Date of renewal

Documents

5797-5798_Dimethyl_fumarate Olpha.docx

5797-5798_pakuotes lapelis_2025-06-10.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HR/H/0289/002/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
117713	103817	1103817	lizdinė plokštelė	N56		Receptinis	LT/1/25/5798/001	Netiekiama	-	-	No	-	-
117714	103818	1103818	lizdinė plokštelė	N168		Receptinis	LT/1/25/5798/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-10	Registruotas