Dimethyl fumarate MSN

Medicinal product

(Invented) name

Dimethyl fumarate MSN

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

MSN Labs Europe Limited, Malta

Date of authorisation

2024-07-05

Date of renewal

Documents

5479_5480 Pakuotės lapelis 2025 03 12.docx

5479_5480 Dimethyl fumarate MSN RPP 2025 03 12.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5715/001/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
114121	100233	1100233	lizdinė plokštelė	N14		Receptinis	LT/1/24/5479/001	Netiekiama	-	-	No	-	-
114122	100234	1100234	lizdinė plokštelė	N56		Receptinis	LT/1/24/5479/002	Netiekiama	-	-	No	-	-
114123	100235	1100235	dalomoji lizdinė plokštelė	N14×1		Receptinis	LT/1/24/5479/003	Netiekiama	-	-	No	-	-
114124	100236	1100236	dalomoji lizdinė plokštelė	N56×1		Receptinis	LT/1/24/5479/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-05	Registruotas