Dimetyl fumarate Sandoz

Medicinal product

(Invented) name

Dimetyl fumarate Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2024-08-05

Date of renewal

Documents

5524-25_pakuotes lapelis_2024-08-05.docx

5524-5525_Dimetyl fumarate Sandoz.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/7745/001/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
114363	100474	1100474	lizdinė plokštelė	N14		Receptinis	LT/1/24/5524/001	Netiekiama	-	2029-02-04	No	-	-
114364	100475	1100475	dalomoji lizdinė plokštelė	N14×1		Receptinis	LT/1/24/5524/002	Netiekiama	-	-	No	-	-
114365	100476	1100476	lizdinė plokštelė	N14 (kalendorinė)	kalendorinė pakuotė	Receptinis	LT/1/24/5524/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-05	Registruotas