Adixemin [Lisdexamfetamine dimesylate STADA]

Medicinal product

(Invented) name

Adixemin [Lisdexamfetamine dimesylate STADA]

Active substance (s)

Lisdeksamfetamino dimezilatas

Strength

30 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N06BA12, Lisdexamfetamine

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

2023-03-07

Date of renewal

Documents

Adixemin mokomoji medziaga sveikatos prieziuros specialistams_stebejimo lentele.pdf

5135_5140 Adixemin PCS PL 2025 05 16.docx

Adixemin mokomoji medziaga sveikatos prieziuros specialistams_kontrolinis sarasas N2.pdf

Adixemin mokomoji medziaga sveikatos prieziuros specialistams_kontrolinis sarasas N1.pdf

5135_5140 Pakuotės lapelis 2025 05 16.docx

Adixemin mokomoji medziaga pacientams_globejams.pdf

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

SI/H/0240/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Lisdeksamfetamino dimezilatas	30 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
110490	96600	1096600	buteliukas	N30		Receptinis	LT/1/23/5136/001	Tiekiama	2025-07-10	-	Yes	2024-12-31	2025-12-31	Download
110491	96601	1096601	buteliukas	N100		Receptinis	LT/1/23/5136/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-07	Registruotas