Dimtelzo

Medicinal product

(Invented) name

Dimtelzo

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

2023-11-06

Date of renewal

Documents

5256_5257 Pakuotės lapelis 2024 06 18.docx

5256_5257 Dimtelzo PCS PL 2024 06 18.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/7425/001/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
111887	98002	1098002	lizdinė plokštelė	N14		Receptinis	LT/1/23/5256/001	Netiekiama	-	-	No	-	-
111888	98003	1098003	dalomoji lizdinė plokštelė	N14×1		Receptinis	LT/1/23/5256/002	Netiekiama	-	-	No	-	-
111889	98004	1098004	buteliukas	N100		Receptinis	LT/1/23/5256/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-06	Registruotas