Dimforda

Medicinal product

(Invented) name

Dimforda

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

Bausch Health Ireland Limited, Airija

Date of authorisation

2024-09-09

Date of renewal

Documents

5554-55_pakuotes lapelis_2024-09-09.docx

5554-5555_Dimforda.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3420/002/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
114894	100999	1100999	lizdinė plokštelė	N56		Receptinis	LT/1/24/5555/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-09	Registruotas