Dimethyl fumarate Olpha

Medicinal product

(Invented) name

Dimethyl fumarate Olpha

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

Olpha AS, Latvija

Date of authorisation

2025-06-10

Date of renewal

Documents

5797-5798_pakuotes lapelis_2025-06-10.docx

5797-5798_Dimethyl_fumarate Olpha.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HR/H/0289/001/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
117712	103816	1103816	lizdinė plokštelė	N14		Receptinis	LT/1/25/5797/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-10	Registruotas